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H.C. Wainwright Thinks BioNTech SE’s Stock is Going to Recover
Source: TipRanks
H.C. Wainwright analyst Robert Burns reiterated a Buy rating on BioNTech SE (BNTX – Research Report) today and set a price target of $298.00. The company's shares closed last Tuesday at $159.80, close to its 52-week low of $121.32. According to TipRanks.com, Burns has 0 stars on 0-5 stars ranking scale with an average return of -29.6% and a 17.8% success rate. Burns covers the Healthcare sector, focusing on stocks such as Turning Point Therapeutics, Black Diamond Therapeutics, and Springworks Therapeutics. Currently, the analyst consensus on BioNTech SE is a Moderate Buy with an average price target of $243.30, a 57.4% upside from current levels.
https://www.tipranks.com/news/blurbs/h-c-wainwright-thinks-biontech-ses-stock-is-going-to-recover-2?utm_source=advfn.com&utm_medium=referral
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Pfizer and BioNTech Granted U.S. Emergency Use Authorization for Booster Dose of Their COVID-19 Vaccine in Children 5 Through 11 Years of Age
Source: Business Wire
EUA is based on data that show children 5 through 11 years of age had a robust immune response with a favorable safety profile following a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine at a time when Omicron was the prevalent variant
Children 5 through 11 years of age now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
To date, 4,500 children 5 through 11 years of age have participated in the companies’ COVID-19 vaccine clinical trial
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age. The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. To date, more than 8 million 5- to 11-year-olds in the U.S. have completed a primary series.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220516005789/en/
The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralizing antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed. The third dose was well tolerated, with a safety profile similar to the two-dose primary series.
This Phase 2/3 data builds on efficacy data for the primary two-dose series which showed 90.7% efficacy in children 5 through 11 without prior SARS-CoV-2 infection, measured from 7 days after the second dose, at a period when Delta was the prevalent strain.
The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 Vaccine is the only COVID-19 vaccine authorized for use in the U.S. for children 5 through 11 years of age.
The Phase 1/2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of a 3-µg formulation of the Pfizer-BioNTech COVID-19 Vaccine on a three-dose schedule in children ages 6 months through 4 years (also known as under 5) is ongoing. Initial data is expected in the coming weeks.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3-µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3-µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10-µg formulation in children 5 to under 12 years of age.
U.S. Indication & Authorized Use
Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:
Primary Series
a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise
Booster Series
a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
COMIRNATY® INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
COMIRNATY® is administered as a 2-dose primary series
COMIRNATY® AUTHORIZED USES
COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:
Primary Series
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
Booster Dose
a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine
Emergency Use Authorization
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
INTERCHANGEABILITY
FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.
The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY® (COVID-19 Vaccine, mRNA).
IMPORTANT SAFETY INFORMATION
Tell your vaccination provider about all of your medical conditions, including if you:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
You should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital
Seek medical attention right away if you have any of the following symptoms:
difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low
Seek medical attention right away if you have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine
Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
Additional side effects include injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; rash; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; and fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.
You should always ask your healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov/reportevent.html. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985
Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (16 years of age and older), DILUTE BEFORE USE, Purple Cap
COMIRNATY® Full Prescribing Information (16 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of May XX, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including emergency use authorization in the U.S. of a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age, potential data readout of a Phase 1/2/3 clinical trial evaluating a vaccine for children 6 months through 4 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data) for BNT162b2 or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2 or any potential future vaccines (including potential future annual boosters or re-vaccinations) and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including emergency use authorization in the U.S. of a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age, potential data readout of a Phase 1/2/3 clinical trial evaluating a vaccine for children 6 months through 4 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for BNT162, or any future vaccine, in additional populations, or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; the availability of raw material to manufacture BNT162 or other vaccine formulation; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; and uncertainties regarding the impact of COVID-19 on BioNTech’s trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
1 Centers for Disease Control and Prevention. COVID-19 Vaccination Demographics in the United States,National. Available at: https://data.cdc.gov/Vaccinations/COVID-19-Vaccination-Demographics-in-the-United-St/km4m-vcsb/data. Accessed May 11, 2022.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220516005789/en/
Pfizer:
Media Relations
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
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BioNTech SE (BNTX) Gets a Hold Rating from J.P. Morgan
Source: TipRanks
J.P. Morgan analyst Cory Kasimov maintained a Hold rating on BioNTech SE (BNTX – Research Report) today and set a price target of $183.00. The company's shares closed last Monday at $140.32, close to its 52-week low of $121.32. According to TipRanks.com, Kasimov is a 5-star analyst with an average return of 18.2% and a 54.4% success rate. Kasimov covers the Healthcare sector, focusing on stocks such as Ultragenyx Pharmaceutical, BioMarin Pharmaceutical, and Allogene Therapeutics. Currently, the analyst consensus on BioNTech SE is a Moderate Buy with an average price target of $251.89, an 80.5% upside from current levels.
https://www.tipranks.com/news/blurbs/biontech-se-bntx-gets-a-hold-rating-from-j-p-morgan?utm_source=advfn.com&utm_medium=referral
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Can BioNTech's breakout year continue in 2022? Yes, due to COVID vaccine and pipeline
Dec. 29, 2021 11:23 AMBioNTech SE (BNTX)RHHBY, PFEBy: Jonathan Block, SA News Editor
Headquarters of the company Biontech in Mainz, Germany
U. J. Alexander/iStock Editorial via Getty Images
With a year-to-date return of 196% as of yesterday, BioNTech (BNTX -0.8%) has had a spectacular 2021.
Of course, the German biotech's fortunes were made due to its COVID-19 vaccine developed in partnership with Pfizer (PFE -0.4%).
As of Nov. 2, BioNTech and Pfizer delivered 2B COVID doses. The companies say they can deliver up to 4B doses in 2022.
For the nine months ended Sept. 30, BioNTech booked ~€2.6 ($2.9B) in direct COVID vaccine sales.
While revenue from its COVID-19 vaccine will continue to be high in 2022, there is no guarantee that the frenzy of orders will continue at the same level as seen in 2021.
This will likely put pressure on BioNTech to find new revenue streams going forward to avoid relying on its COVID vaccine.
The good news for BioNTech is that it has a healthy pipeline of candidates focused on oncology and infectious diseases that could reap dividends in the coming years.
Its most advanced candidates are mRNA cancer immunotherapies. BNT111 and BNT113, for, respectively, advanced melanoma, and head and neck cancer are both in phase 2. Both utilize the company's FixVac platform of a fixed combination of shared cancer antigens.
BNT111 was buoyed last month after the FDA granted the candidate Fast Track status.
Another mRNA oncology candidate, BNY122 (autogene cevumeran) is also in phase 2 for first-line melanoma and adjuvant colorectal cancer. BioNTech is partnered with Roche's (OTCQX:RHHBY -0.2%) Genentech unit on BNT122.
Check out Seeking Alpha contributor JR Research's recent assessment of BioNTech and whether investors should add shares.
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yes cash cows BNTX
BNTX and MRNA have so much cash !
Time to reward the shareholders with a dividend LOL !
Very nice mick
I picked some also and don’t forget MRNA also !
peeking some today BNTX
BNTX
BioNTech SE
150.11
4.07 (2.79%)
Volume: 742,151
Day Range: 144.74 - 151.45
Bid: 149.90
Ask: 150.13
Last Trade Time: 2:00:50 PM EDT
Total Trades: 9,481
Very nice Mick
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H.C. Wainwright Thinks BioNTech SE’s Stock is Going to Recover • TipRanks • 04/29/2022 10:27:06 AM
Morning Brief: Top Financial Stories Dominating on Thursday, April 28 • Benzinga • 04/28/2022 12:05:17 PM
BioNTech to Report First Quarter 2022 Financial Results and Operational Update on May 9, 2022 • GlobeNewswire Inc. • 04/26/2022 11:00:00 AM
BioNTech SE (BNTX)
138.78 ? -4.62 (-3.22%)
Volume: 783,497 @04/29/22 7:59:20 PM EDT
Bid Ask Day's Range
135.0 138.5 138.31 - 148.78
BNTX Detailed Quote
BioNTech Paves Way for Advanced mRNA-based Vaccines
Source: TipRanks
Biotechnology company BioNTech SE (NASDAQ: BNTX) recently revealed that it has joined hands with a fellow biotechnology company, Matinas BioPharma, to evaluate the combination of mRNA formats and Matinas’ proprietary LNC platform technology. Following the news, shares of the company rose marginally on Monday. The stock pared its gains completely and declined 2.5% to close at $166.28 in the extended trading session. The collaboration will leverage BioNTech’s expertise in mRNA vaccine development and Matinas’ proprietary LNC platform technology to advance novel formulations for mRNA vaccines, including a potential formulation for oral vaccines.
https://www.tipranks.com/news/biontech-paves-way-for-advanced-mrna-based-vaccines?utm_source=advfn.com&utm_medium=referral
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Adding an mRNA vaccine to CAR-T cell therapy could be the key to unlocking activity in solid tumours, according to German biotech BioNTech.
CAR-Ts have revolutionised the treatment of some blood cancers like B cell lymphomas, but have been largely unsuccessful at targeting solid tumours, in part as the cells do not penetrate tumour tissue as effectively as the bone marrow.
BioNTech’s answer to that is to combine an autologous (patient-derived) CAR-T with a tumour-targeted mRNA vaccine that codes for the CAR-T target antigen, attempting to both amplify the response to the cell therapy and stimulate a response by the patient’s immune system.
In a phase 1/2 trial reported at the American Association of Cancer Research (AACR) congress, there were preliminary signs that the approach could work.
BioNTech said its CAR-T (BNT211) and mRNA vaccine (CarVAC) combination – both targeting the cancer-associated antigen claudin-6 – was shown to be safe and well-tolerated in a group of 16 solid tumour patients, with preliminary signs of efficacy.
Patients received the CAR-T alone at ascending doses in the first part of the trial, moving on to combination use with the mRNA vaccine afterwards. It is too soon to see if the combination is working better, but the first results indicate that targeting claudin-6 in patients is a valid strategy to pursue.
Six of 14 evaluable patients with testicular or ovarian cancer achieved a partial response six weeks after treatment, a rate of 43%, with four of the responders getting the CAR-T on its own, while two were also treated with the mRNA shot.
Another five subjects in the study – which also included patients with endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer – had stable disease and shrinking of some target cancer lesions, giving an overall disease control rate of 86%.
The researcher presenting the data at AACR, John Haanen of the Netherlands Cancer Institute, said there was evidence of a “deepening and durability” of the tumour responses over time. With one patient achieving a complete response after 18 weeks. On the other hand, there was also evidence of the treatment effect wearing off in some patients.
“Claudin-6 was never targeted with cellular therapy before, but in this study, the approach is already showing an efficacy that may be better than the data from other CAR-T trials in solid tumours,” he said.
The treatment had manageable side effects, including cases of cytokine release syndrome (CRS) – a known hazard of CAR-T therapy – that resolved after treatment with Roche’s anti-inflammatory drug Actemra (tocilizumab).
Additional data from the ongoing trial will be available later this year, said BioNTech, currently riding high on the success of its COVID-19 vaccine.
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BioNTech partners with Matinas BioPharma on delivery of mRNA vaccines
Apr. 11, 2022 9:45 AM ETBioNTech SE (BNTX)By: Jonathan Block, SA News Editor
mRNA Vaccines
kemalbas/iStock via Getty Images
BioNTech (NASDAQ:BNTX) will collaborate with Matinas BioPharma on the development of new delivery technology for mRNA vaccines, including potential oral vaccines.
Matinas has a proprietary lipid nanocrystal platform technology for intracellular delivery of nucleic acids and small molecules.
Terms call for Matinas will receive an upfront access fee to work exclusively with BioNTech (BNTX), as well as research funding from the German biotech. The companies are also discussing a license agreement for Matinas' platform technology.
Read why Seeking Alpha contributor SM Investor considers BioNTech a buy.
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BioNTech Presents Positive Preliminary Phase 1/2 Data for First-in-Class CAR-T Program BNT211 at AACR
Source: GlobeNewswire Inc.
BNT211 combines two innovative approaches in one regimen, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac) to improve persistence and functionality of the adoptively transferred cells
Treatment with BNT211 alone or in combination with CARVac, currently being tested in a Phase 1/2 Trial in patients with advanced solid tumors, was well tolerated across multiple tumor indications in preliminary data from 16 patients
Preliminary efficacy data showed encouraging signs of clinical activity with a disease control rate of 86% and an overall response rate of 43%
MAINZ, Germany, April 11, 2022 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) presented data from its ongoing first-in-human Phase 1/2 trial evaluating the safety and preliminary efficacy of the Company’s novel CAR-T cell therapy candidate, BNT211, in patients with advanced solid tumors. The preliminary results demonstrated an encouraging safety profile and anti-tumor activity in testicular cancer patients at the first evaluated dose levels of BNT211. The data were presented in the Clinical Trials Plenary Session at the AACR Annual Meeting 2022 by Prof. John Haanen, M.D., Ph.D., Netherlands Cancer Institute (NKI), Amsterdam, Netherlands.
BNT211 is a potential first-in-class therapeutic approach which comprises two drug products, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin-6 (CLDN6) and a CLDN6-encoding CAR-T cell amplifying RNA vaccine (CARVac), which is based on BioNTech’s mRNA-lipoplex technology to improve persistence and functionality of the adoptively transferred cells.
The presentation included data from 16 patients who received CLDN6 CAR-T cells at dose levels 1 (1x107 CAR-T cells) and 2 (1x108 CAR-T cells) alone or combined with CARVac. Tumor indications included testicular cancer (n=8) ovarian cancer (n=4), endometrial cancer, fallopian tube cancer, sarcoma, and gastric cancer (1 patient each). Treatment with CLDN6 CAR-T alone or in combination with CARVac up to dose level 2 was well tolerated and showed encouraging signs of clinical activity. All 16 patients showed robust CAR-T cell expansion 10-17 days after infusion with cell frequencies close to 109 total counts in dose level 2. Adverse events and dose limiting toxicities were manageable; cytokine release syndromes of grade 1 and 2 and one transient occurrence of neurotoxicity grade 1 were observed.
At the first efficacy assessment 6 weeks post infusion, 6 of 14 evaluable patients showed a partial response, and 5 patients had stable disease with shrinkage of target lesions. One patient showed no change from baseline and two patients were progressing. Responses were seen in testicular (n=4) and ovarian cancer (n=2) patients. At 12 weeks, 4 of the 6 patients with a partial response showed deepening and durability of responses with one patient reaching a complete response 18 weeks after infusion. All 4 testicular cancer patients in the higher dose level had disease control and 3 of these patients showed objective responses. In addition, 1 testicular cancer patient showed partial response after infusion of the lowest CAR-T dose level in combination with CARVac. Antitumor activity tended to be higher at the higher CAR-T dose and when combined with the vaccine, with 4 of 5 patients in the CARVac combination group showing a partial response.
“Seeing first anti-tumor effects even at the lowest CAR-T cell dose in this heavily pre-treated patient population is truly remarkable and points to the potential of our CAR design and our CARVac approach,” said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “The results support our assumption that Claudin-6 is a well-suited new tumor target. Bringing these innovations together in one regimen may benefit patients with hard-to-treat solid tumors with an otherwise poor prognosis, such as advanced testicular cancer. Our preliminary data indicate that the successes of CAR-T in hematological cancers may indeed be transferred to solid tumors.”
“Claudin-6 was never targeted with cellular therapy before, but in this study, the approach is already showing an efficacy that may be better than the data from other CAR-T trials in solid tumors,” said John Haanen, M.D., Ph.D. a medical oncologist at the Netherlands Cancer Institute (NKI), Amsterdam, Netherlands, and principal investigator of the study. “While the data are very early, it is remarkable that all patients with testicular cancer showed clinical benefits at dose level 2, and the responses we have observed can be deep, including one ongoing complete remission. I look forward to further evaluating this exciting new modality for solid tumor patients.”
The ongoing Phase 1/2 study (NCT04503278; 2019-004323-20) aims to evaluate the safety and preliminary efficacy of the CLDN6 CAR-T therapy alone and in combination with CARVac in heavily pretreated patients with CLDN6-positive relapsed or refractory advanced solid tumors and is conducted at multiple sites across Germany and the Netherlands. The next data update is expected later this year.
About BNT211
To harness the power of cell therapies for solid cancers and overcoming hurdles to date, BioNTech has combined their CAR-T and FixVac platform technologies to develop a highly tumor-specific CAR-T cell therapy product which is consecutively enhanced by a CAR-T Cell Amplifying RNA Vaccine (CARVac) that is based on BioNTech`s mRNA-lipoplex technology and encodes for the respective CAR-T target antigen. The vaccine has the potential to boost CAR-T activity, thus enabling and maintaining a therapeutic effect even at low CAR-T doses. BNT211 is a CAR-T cell therapy directed against the novel oncofetal antigen Claudin-6 (CLDN6), a target expressed on multiple solid tumors such as ovarian cancer, sarcoma, testicular cancer, endometrial cancer and gastric cancer. The program is currently being evaluated in a first-in-human Phase 1/2 trial as a monotherapy and in combination with a CLDN6-encoding CARVac, aiming to boost persistence and functionality of the CLDN6-CAR-T cells, in patients with CLDN6-positiv relapsed or refractory advanced solid tumors.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer, infectious diseases and other serious conditions. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific checkpoint immuno-modulators, targeted cancer antibodies and small molecules immunomodulators. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech is developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma and Pfizer.
For more information, please visit www.BioNTech.de
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to statements concerning: BioNTech’s CAR-T program candidate BNT211; timing for any data readouts of the Phase 1/2 trial; the registrational potential of any trial we may initiate for BNT211; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs and specifically including, but not limited to, statements regarding timing or plans for initiation of clinical trials, enrollment or submission for and receipt of product approvals with respect to BioNTech’s product candidates; the ability of BioNTech’s mRNA technology to demonstrate clinical efficacy outside of BioNTech’s infectious disease platform; the potential safety and efficacy of our other product candidates; and BioNTech’s anticipated market opportunity and size for its product candidates, the rate and degree of market acceptance of BioNTech’s investigational medicines, if approved. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: discussions with regulatory agencies regarding timing and requirements for additional clinical trials; and the ability to produce comparable clinical results in future clinical trials.
For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
BNTX $$$$
BioNTech gets contract from Germany for mRNA vaccines for pandemic response
Apr. 08, 2022 9:43 AM ETBioNTech SE (BNTX)By: Ravikash, SA News Editor
BioNTech And Pfizer To Begin Clinical Trial For Covid-19 Vaccine
Thomas Lohnes/Getty Images News
BioNTech (NASDAQ:BNTX) said it is one of the companies in Germany to be granted a pandemic preparedness contract by the Germany Federal Ministry of Health.
The company said the framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany.
Under the agreement, BioNTech will reserve and maintain manufacturing capabilities to produce at least 80M mRNA-based vaccine doses per year.
The contract has an initial term of five years.
"There is growing evidence that viral pandemics will continue to pose a public health challenge for years. This contract with the German government will ensure significant supply of vaccine doses to address potential public health threats by 2027,” said BioNTech's Chief Business and Chief Commercial Officer.
BioNTech gets contract from Germany for mRNA vaccines for pandemic response
Apr. 08, 2022 9:43 AM ETBioNTech SE (BNTX)By: Ravikash, SA News Editor
BioNTech And Pfizer To Begin Clinical Trial For Covid-19 Vaccine
Thomas Lohnes/Getty Images News
BioNTech (NASDAQ:BNTX) said it is one of the companies in Germany to be granted a pandemic preparedness contract by the Germany Federal Ministry of Health.
The company said the framework agreement is aimed at pandemic preparedness including manufacturing and supply of mRNA vaccines in emergency situations in Germany.
Under the agreement, BioNTech will reserve and maintain manufacturing capabilities to produce at least 80M mRNA-based vaccine doses per year.
The contract has an initial term of five years.
"There is growing evidence that viral pandemics will continue to pose a public health challenge for years. This contract with the German government will ensure significant supply of vaccine doses to address potential public health threats by 2027,” said BioNTech's Chief Business and Chief Commercial Officer.
Awesome News imo
BNTX $$$$
Which Healthcare Giant Could Deliver Better Returns in 2022?
Source: TipRanks
The COVID-19 pandemic has heightened the focus on healthcare systems, with governments across the globe allocating significant budgets toward drug development and medical facilities. Per the Centers for Medicare & Medicaid Services (CMS), U.S. healthcare spending increased 9.7% to $4.1 trillion in 2020, mainly due to the pandemic. Though the growth rate in national health spending slowed down to 4.2% in 2021, it’s worth noting that this growth was still off the exceptionally high base seen in 2020.
https://www.tipranks.com/news/article/which-healthcare-giant-could-deliver-better-returns-in-2022?utm_source=advfn.com&utm_medium=referral
BNTX $$$$
. New Covid Variant XE Found In UK, More Transmissible Than Omicron: WHO
https://www.ndtv.com/world-news/new-covid-variant-xe-found-in-uk-more-transmissible-than-omicron-who-2858643
Exactly my friend !
Bought in again !
BNTX $$$$
Great earnings for BNTX! The vaccine maker had income of $13.55/share compared to expected $8.16. Revenue of $6.16B. They announced a share buyback and a special cash dividend of $2.23/share. Why would anyone not want to buy this stock?
Agreed. It is hard to believe anyone would even root for this stock let alone buy it. Enemies of freedom and human life
PFE/BNTX submit FDA-EUA request for fourth COVID shot:
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-us-emergency-use-authorization
BIG SPIKE/ BioNTech SE (BNTX)
153.3 ? 17.66 (13.02%)
Volume: 3,920,835 @03/14/22 7:59:53 PM EDT
Bid Ask Day's Range
153.0 154.0 138.69 - 160.3
BNTX Detailed Quote
Thanks Mick
BioNTech SE (BNTX)
134.01 ? -3.26 (-2.37%)
Volume: 1,074,583 @03/11/22 7:59:53 PM EST
Bid Ask Day's Range
133.0 144.72 135.61 - 145.25
BNTX Detailed Quote
BioNTech SE (BNTX)
176.4 ? 1.38 (0.79%)
Volume: 880,607 @02/04/22 7:43:42 PM EST
Bid Ask Day's Range
175.0 178.22 172.2913 - 177.02
BNTX Detailed Quote
PFE/BNTX start phase-1 trial of Omicron vaccine:
https://finance.yahoo.com/news/pfizer-biontech-initiate-study-evaluate-114500326.html
BioNTech and Crescendo Biologics Announce Global Collaboration to Develop Multi-specific Precision Immunotherapies
Source: GlobeNewswire Inc.
Collaboration leverages BioNTech’s proprietary multimodal immunotherapy expertise with Crescendo’s proprietary Humabody® VH platform to develop precision immunotherapies, including mRNA-based antibodies and engineered cell therapies against targets selected by BioNTech
BioNTech will hold exclusive worldwide development and commercialization rights to all immunotherapies arising from the collaboration
Crescendo will receive $40 million upfront, including a cash payment and an equity investment from BioNTech, as well as research funding, and will be eligible to receive development, regulatory and commercial milestone payments up to a total of more than $750 million, plus tiered royalties on global net sales
MAINZ, Germany and CAMBRIDGE, UK, January 10, 2022 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Crescendo Biologics Ltd (“Crescendo”), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announced that they have entered a multi-target discovery collaboration to develop novel immunotherapies for the treatment of patients with cancer and other diseases. The initial term of the discovery collaboration is three years.
Crescendo will contribute its unique, proprietary, transgenic platform to deliver fully human heavy-chain antibody domains (Humabody® VH) against targets nominated by BioNTech. Humabodies represent a novel class of therapeutics that retain the high-affinity binding and specificity of conventional therapeutic antibodies while providing additional advantages such as small size, enhanced tissue and tumor penetration, stability and molecular simplicity due to the lack of a light chain. In particular, the modular nature of Humabodies make them ideally suited for the development of multi-target immunotherapies.
“Crescendo’s platform provides excellent properties for exploiting novel targets and target combinations which we believe has great potential for the development of multi-specific mRNA and engineered cell-based therapies in a variety of disease areas,” said Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We are excited to begin working with Crescendo to further strengthen and expand our multimodal immunotherapy portfolio and deliver breakthrough precision medicines for patients.”
“To collaborate with BioNTech and their world-class team is a transformational opportunity for Crescendo. We are looking forward to further leveraging our clinically validated Humabody VH platform within mRNA therapeutics to develop better treatment options for patients,” said Theodora Harold, Chief Executive Officer at Crescendo Biologics.
Under the terms of the agreement, Crescendo will receive $40 million upfront, including a cash payment and an equity investment from BioNTech, as well as research funding for the period of the collaboration. BioNTech will be responsible for global development and hold exclusive worldwide commercialization rights on any products arising from the collaboration. Crescendo will be eligible to receive development, regulatory and commercial milestones up to a total of more than $750 million, in addition to tiered royalties on global net sales.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
About Crescendo Biologics
Crescendo Biologics is a private, clinical stage immuno-oncology company developing novel, targeted T cell enhancing Humabody® therapeutics.
Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody® for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anti-cancer effect whilst avoiding systemic toxicity, and the clinical programme for CB307 is underway in patients with PSMA positive solid tumours.
The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating fully human VH domain building blocks (Humabody® VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel pharmacology and superior bio-distribution. This can lead to larger therapeutic windows compared to conventional IgG approaches. Humabody®-based formats can also be applied across a range of non-cancer indications.
Beyond Crescendo’s proprietary pipeline, the Company has a global, multi-target discovery and development collaboration with Takeda; a clinical development partnership for CB213 (a PD-1xLAG-3 multi-specific Humabody®) with Cancer Research UK; and an exclusive, worldwide licensing agreement with Zai Lab for ZL-1102 (formerly CB001, an anti-IL-17A targeting Humabody®), which has recently successfully completed a Phase 1 clinical trial.
Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas.
For more information, please visit www.crescendobiologics.com and follow @HUMABODY.
BioNTech Forward-Looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s collaboration with Crescendo Biologics; the ability of Crescendo’s Humabody® VH discovery platform to develop multi-specific immunotherapies, including cell therapies; and the ability of BioNTech to commercialize these immunotherapies, if successfully developed.
Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.
For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” in BioNTech’s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
CONTACTS
BioNTech
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Crescendo Biologics
Michael Booth, CFO
+44 (0)1223 497140
investors@crescendobiologics.com
media@crescendobiologics.com
Instinctif Partners
Melanie Toyne-Sewell, Katie Duffell,
Nathan Billis
+44 (0)20 7457 2020
crescendo@instinctif.com
BNTX $$$$
Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine
Source: GlobeNewswire Inc.
Third mRNA vaccine collaboration between the companies aims to accelerate development of an improved vaccine for shingles, a debilitating, disfiguring and painful disease that affects people all over the world
Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology
Clinical trials are expected to start in the second half of 2022
BioNTech will receive $225 million upfront, including an upfront cash payment of $75 million and an equity investment of $150 million, and will be eligible to receive future approval and sales milestone payments totaling up to $200 million as well as a share of gross profits arising from future product sales
Pfizer will receive an upfront payment of $25 million from BioNTech for its proprietary antigen sequences identified by Pfizer
NEW YORK and MAINZ, Germany, January 5, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new research, development and commercialization collaboration to develop a potential first mRNA-based vaccine for the prevention of shingles (herpes zoster virus, or HZV), a debilitating, disfiguring and painful disease that impacts about one in three people in the United States during their lifetime. The collaboration builds on the companies’ success in developing the first approved and most widely used mRNA vaccine to help prevent COVID-19. This is the third collaboration between Pfizer and BioNTech in the infectious diseases field, following the influenza vaccine collaboration initiated in 2018 and the COVID-19 vaccine collaboration initiated in 2020.
Under the terms of the agreement, the companies will leverage a proprietary antigen technology identified by Pfizer’s scientists and BioNTech's proprietary mRNA platform technology used in the companies’ COVID-19 vaccine. The parties will share development costs. Clinical trials are planned to start in the second half of 2022. Pfizer will have rights to commercialize the potential vaccine on a global basis, with the exception of Germany, Turkey and certain developing countries where BioNTech will have commercialization rights. The companies will share gross profits from commercialization of any product.
“Pfizer and BioNTech co-developed the world’s first mRNA vaccine, providing a well-tolerated and effective tool to help address COVID-19 – the most devastating pandemic in a century – and demonstrating consistent, agile and high-quality manufacturing on an unprecedented scale,” said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development & Medical, Pfizer. “With this agreement, we continue on our journey of discovery together, by advancing mRNA technology to tackle another health challenge ripe for scientific innovation, supported by our world-class manufacturing network.”
“The collaboration aims to develop a new mRNA-based vaccine against shingles, leveraging the expertise and resources of both companies,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Adults aged 50 years and older as well as vulnerable populations like cancer patients are at an increased risk of shingles. Our goal is to develop an mRNA vaccine with a favorable safety profile and high efficacy, which is at the same time more easily scalable to support global access.”
Under the terms of the agreement, Pfizer will pay BioNTech $225 million in upfront payments, including a cash payment of $75 million and an equity investment of $150 million. BioNTech is eligible to receive future regulatory and sales milestone payments of up to $200 million. BioNTech will pay Pfizer $25m for the company’s proprietary antigen technology.
About Shingles (Herpes Zoster Virus)
Shingles (HZV) is a chronic form of the varicella zoster virus (VZV), which causes an initial chickenpox infection. After chickenpox disease, the virus remains dormant in human nerve cells and can re-activate later in life, due to a trigger such as stress or immunocompromise. This attack can lead to extremely painful, disfiguring patches, which may continue to be painful after the episode has resolved, a condition known as postherpetic neuralgia (PHN). In rare conditions, shingles can also lead to facial paralysis, deafness and blindness.
According to the U.S. Centers for Disease Control and Prevention, studies show that more than 99 percent of Americans 40 years and older have had chickenpox, even if they don’t remember having the disease.
While there are currently approved vaccines for shingles, there is an opportunity to develop an improved vaccine that potentially shows high efficacy and better tolerability, and is more efficient to produce globally, by utilizing mRNA technology.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of January 5, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a potential preventative Herpes Zoster Virus (HZV) mRNA vaccine candidate and a strategic research, development and commercialization collaboration between Pfizer and BioNTech for the development of such HZV mRNA vaccine candidate, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for a HZV mRNA vaccine candidate; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether a HZV mRNA vaccine candidate will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a HZV mRNA vaccine candidate; whether the collaboration between Pfizer and BioNTech will be successful; the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, the ability of BioNTech to develop and commercialize a vaccine for the Herpes Zoster Virus (HZV), the ability of BioNTech to achieve the collaboration milestone payments and the timing to commence clinical trials. Any forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these and other risks and uncertainties, see the section entitled “Risk Factors” in BioNTech’s Annual Report on Form 20-F filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
CONTACTS
Pfizer:
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
$$$ BNTX $$$
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older
Source: Business Wire
First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age
Today’s FDA action also reduces time between completion of primary series and booster dose for all eligible individuals, and authorizes a third primary series dose for individuals 5 through 11 years of age with certain kinds of immunocompromise
Pfizer and BioNTech fulfill their goal to deliver 1 billion doses of their COVID-19 vaccine to low- and middle-income countries in 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 12 years of age and older. The booster dose is the same dosage strength (30-µg) as the dose approved in the primary series.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220103005218/en/
A booster dose of the Pfizer-BioNTech COVID-19 Vaccine was previously authorized by the FDA for emergency use after completion of a primary series in individuals 16 years of age and older. The vaccine is also authorized for eligible individuals 18 and older who have completed primary vaccination with a different authorized COVID-19 vaccine.
“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”
“The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”
Real world evidence from the Ministry of Health of Israel on the administration of over 4.1 million third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series revealed no new safety concerns in adolescents 12 through 17 years of age.1
Additional EUA Amendments
Separately, the FDA is also amending the existing EUA to reduce the time for administration of a booster dose from at least six months to at least five months following completion of the primary series for individuals 12 years of age and older. The reduction of time between the primary series is supported by real world evidence from the Ministry of Health of Israel on the administration of third doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 5 months after the primary series, which revealed no new safety concerns in adults.1
Finally, the FDA has expanded the current Emergency Use Authorization to include administration of a third primary series dose at least 28 days following the second dose for individuals 5 through 11 years of age who have who have been determined to have certain kinds of immunocompromise. This authorization is based on information extrapolated from an independent report evaluating safety and effectiveness of a third dose in adults who received solid organ transplants. A third primary dose of the Pfizer-BioNTech vaccine was previously authorized for administration to individuals at least 12 years of age who have been determined to have certain kinds of immunocompromise.
The companies continue to supply the vaccine, including booster doses, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect that today’s news will impact the existing supply agreements in place with governments and international health organizations around the world. As of December 29, 2021, Pfizer and BioNTech have delivered 1 billion doses of the Pfizer-BioNTech COVID-19 Vaccine to low- and middle-income countries. The companies expect to deliver an additional 1 billion doses to these nations in 2022. These doses are part of Pfizer and BioNTech’s previously announced pledge to provide 2 billion doses of the COVID-19 vaccine to low- and middle-income countries between 2021 and 2022.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
U.S. Indication & Authorized Use
HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under EUA to provide:
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
EUA Statement
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATION
Individuals should not get the vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Additional side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Click for
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older)
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of January 3, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including emergency use authorization of a booster dose for individuals 12 years and older in the U.S., reduction of time between completion of primary series and booster dose, authorization of a third primary series does authorized for individuals 5 through 11 years old with certain kinds of immunocompromise, qualitative assessments of available data, potential benefits, expectations for clinical trials, supply agreements with the U.S. government, as well as governments and international health organizations around the world, and the timing of delivery of doses thereunder, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for a potential booster dose, pediatric populations and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant-specific vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer: a planned submission of a supplemental BLA for a potential booster dose of BNT162b2 in individuals 16 years of age and older, a supplemental BLA to support potential full FDA approval of BNT162b2 in individuals 12 through 15 years, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the risk of further widespread use of our vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; decisions by regulatory authorities that may impact labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of our vaccine, including development of products or therapies by other companies; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; disruptions in the relationships between us and our collaboration partners, clinical trial sites or other third-parties; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by BioNTech and third-party providers; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; whether and when additional supply agreements will be reached; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 to BioNTech’s trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
______________________
1 Ministry of Health of Israel. Division of Epidemiology. (December 15, 2021). Corona Vaccine Safety [PowerPoint presentation]. Vaccine Efficacy & Safety Follow-up Committee, Israel. https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_vaccine-safty-15122021.pdf
View source version on businesswire.com: https://www.businesswire.com/news/home/20220103005218/en/
Pfizer:
Media Relations
+1 (212) 733-7410
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de
BNTX $$$$
Same to you and yours
I sure hope so too
Happy New Year 2022 to you and all !
BNTX $$$$
Quote . Can BioNTech's breakout year continue in 2022? I sure hope so
Can BioNTech's breakout year continue in 2022? Yes, due to COVID vaccine and pipeline
Dec. 29, 2021 11:23 AMBioNTech SE (BNTX)RHHBY, PFEBy: Jonathan Block, SA News Editor
Headquarters of the company Biontech in Mainz, Germany
U. J. Alexander/iStock Editorial via Getty Images
With a year-to-date return of 196% as of yesterday, BioNTech (BNTX -0.8%) has had a spectacular 2021.
Of course, the German biotech's fortunes were made due to its COVID-19 vaccine developed in partnership with Pfizer (PFE -0.4%).
As of Nov. 2, BioNTech and Pfizer delivered 2B COVID doses. The companies say they can deliver up to 4B doses in 2022.
For the nine months ended Sept. 30, BioNTech booked ~€2.6 ($2.9B) in direct COVID vaccine sales.
While revenue from its COVID-19 vaccine will continue to be high in 2022, there is no guarantee that the frenzy of orders will continue at the same level as seen in 2021.
This will likely put pressure on BioNTech to find new revenue streams going forward to avoid relying on its COVID vaccine.
The good news for BioNTech is that it has a healthy pipeline of candidates focused on oncology and infectious diseases that could reap dividends in the coming years.
Its most advanced candidates are mRNA cancer immunotherapies. BNT111 and BNT113, for, respectively, advanced melanoma, and head and neck cancer are both in phase 2. Both utilize the company's FixVac platform of a fixed combination of shared cancer antigens.
BNT111 was buoyed last month after the FDA granted the candidate Fast Track status.
Another mRNA oncology candidate, BNY122 (autogene cevumeran) is also in phase 2 for first-line melanoma and adjuvant colorectal cancer. BioNTech is partnered with Roche's (OTCQX:RHHBY -0.2%) Genentech unit on BNT122.
Check out Seeking Alpha contributor JR Research's recent assessment of BioNTech and whether investors should add shares.
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CDC head Walensky says FDA considering COVID booster for 12 to 15-year-olds - CNN
Dec. 29, 2021 8:24 AMBioNTech SE (BNTX)By: Jonathan Block, SA News Editor
Doctor vaccinating a teenage boy
portishead1/E+ via Getty Images
CDC Director Rochelle Walensky says that the FDA is considering amending the Emergency Use Authorization for the Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) vaccine to include boosters for 12 to 15-year-olds.
Speaking on CNN, Walensky said that she is hoping to receive an opinion from the FDA in "the days to weeks ahead."
She added that an OK for vaccine use in under 5-year-olds will not happen in the next month.
The Pfizer/BioNTech vaccine is the only COVID shot authorized for those below 18.
Dear readers: We recognize that politics often intersects with the financial news of the day, so we invite you to click here to join the separate political discussion.
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Pfizer and BioNTech to Provide European Union More Than 200 Million Additional Doses of COMIRNATY® to Help Meet Continued Need for Vaccine Supply
Source: Business Wire
European Commission exercise part of its option for over 200 million additional doses to be delivered in 2022
These doses are in addition to the 450 million doses already planned for delivery in 2022, bringing the total number of vaccine doses in the European Union to more than 650 million
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement has been reached with the European Commission (EC) and its member states to exercise an option to purchase more than 200 million additional doses of COMIRNATY®, the companies’ COVID-19 vaccine. Contractual details are currently being finalized.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211220005525/en/
These 200 million optional doses are in addition to the 450 million doses already planned to be delivered in 2022 based on previously signed agreements. The number of doses to be delivered to the EC member states by the companies in 2022 will now total more than 650 million doses.
This order would also cover potential vaccines adapted to the Omicron variant without additional costs, if a variant vaccine is determined to be needed and subsequently authorized or approved.
Pfizer and BioNTech agreed in May to supply 900 million doses to the European Commission (EC) in 2022 and 2023, with option to request up to an additional 900 million doses.
COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
U.S. Indication & Authorized Use
HOW IS THE VACCINE GIVEN?
The vaccine will be given as an injection into the muscle.
Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 12 years of age and older, a third primary series dose may be administered at least 4 weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals 16 years of age and older
A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under EUA to provide:
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 16 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
EUA Statement
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.
IMPORTANT SAFETY INFORMATION
Individuals should not get the vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Additional side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Click for
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older)
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of December 20, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, supply agreements with the European Commission and the timing of delivery of doses thereunder, a potential variant-specific vaccine for Omicron, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for a potential booster dose, pediatric populations and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant-specific vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine’s benefits outweigh its known risks and determination of the vaccine’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.
BioNTech Forward-looking Statements
This press release contains “forward-looking statements” of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the potential of an Omicron-specific COVID-19 vaccine candidate, the potential timing for the development of an Omicron-specific COVID-19 vaccine candidate, the testing of BNT162b2 against the Omicron variant, the effectiveness of a third booster dose of BNT162b2 to induce protection against Omicron-induced COVID-19 disease, and the timing for assessment of the effectiveness of a variant-specific COVID-19 vaccine, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the risk of further widespread use of our vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; decisions by regulatory authorities that may impact labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of our vaccine, including development of products or therapies by other companies; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; disruptions in the relationships between us and our collaboration partners, clinical trial sites or other third-parties; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine’s formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by BioNTech and third-party providers; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; whether and when additional supply agreements will be reached; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 to BioNTech’s trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.
For a discussion of these and other risks and uncertainties, see BioNTech’s Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC’s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211220005525/en/
Pfizer:
Media Relations
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+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de
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Sylke Maas, Ph.D.
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Investors@biontech.de
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BioNTech is more than a COVID-19 vaccine company - Morgan Stanley
Dec. 16, 2021 12:58 PMBioNTech SE (BNTX)By: Dulan Lokuwithana, SA News Editor
BioNTech And Pfizer To Begin Clinical Trial For Covid-19 Vaccine
Thomas Lohnes/Getty Images News
While COVID-related revenue will remain as its key valuation driver, next year, investors of BioNTech (NASDAQ:BNTX) will start to see the company’s non-COVID pipeline, the analysts at Morgan Stanley argue, initiating its coverage on the stock with an Equal Weight rating.
“BioNTech is more than a COVID-19 mRNA company,” they added, citing its diverse pipeline targeted at oncology and infectious diseases including influenza, melanoma, and head/neck cancer.
As key drivers for its stock, the analysts led by Matthew Harrison term the impact of new variants, requirements for annual boosters, and the company’s efforts to compete with a pan respiratory vaccine. They also highlight a range of readouts scheduled for next year in its oncology pipeline.
However, comparing its market cap to those of Gilead (NASDAQ:GILD), Regeneron (NASDAQ:REGN), and Vertex (NASDAQ:VRTX), the team also argues that the German biotech appears fairly valued despite having a single product with an uncertain long-term outlook. The price target of $294 per share implies a premium of ~2.4% to the last close.
As shown in the diagram below, the Bullish recommendations on BioNTech (BNTX) have gradually increased on Wall Street over the past six months.
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HEALTH AND SCIENCE
Fauci says Covid boosters work against omicron, no need for variant-specific third shot
PUBLISHED WED, DEC 15 2021 12:24 PM EST
UPDATED AN HOUR AGO
Spencer Kimball
@SPENCEKIMBALL
WATCH LIVE
KEY POINTS
White House chief medical advisor Dr. Anthony Fauci said the primary two-dose vaccination series from Pfizer and BioNTech is significantly compromised by omicron.
However, two-doses still offer considerable protection against severe disease, Fauci said.
A booster dose increases protection against symptomatic disease to 75%, Fauci.
AP: Anthony Fauci: Confirmed case of Omicron in U.S. 211201
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, speaks during the daily briefing at the White House in Washington, Wednesday, Dec. 1, 2021.
Susan Walsh | AP
White House chief medical advisor Dr. Anthony Fauci said Wednesday that currently available booster shots work against the omicron variant of Covid-19 and do not need to be adjusted to fight the new, highly contagious strain of the virus at this time.
"Our booster vaccine regimens work against omicron," Fauci told the public during a White House Covid update on Wednesday. "At this point, there is no need for a variant-specific booster."
Fauci said the primary two-dose vaccination series from Pfizer and BioNTech is significantly compromised by omicron, but still offers considerable protection against severe disease. Protection from the two-dose vaccine against infection dropped to 33% compared with 80% before the emergence of omicron. However, two doses are still 70% effective at preventing hospitalization in omicron patients in South Africa, Fauci said.
"Obviously, this is significantly down but there is the maintaining of a degree of protection against hospitalization," Fauci said.
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A booster dose increases protection against symptomatic disease to 75%, Fauci said, citing data from the U.K. Health Security Agency.
Sorry , wrong link before !
Pfizer jabs protect 70% against hospitalization from omicron
A large-scale analysis in South Africa says that two-dose Pfizer/BioNTech vaccination provides just 33% protection against infection by the omicron coronavirus variant but 70% protection against hospitalization
By ANDREW MELDRUM Associated Press
December 14, 2021, 6:01 AM ET
• 4 min read
CDC panel to weigh in on Pfizer's COVID-19 vaccine for younger kidsAn independent CDC advisory panel will vote Tuesday on whether to recommend Pfizer's COVID-19 vaccine for children ages 5 to 11 in the U.S.The Associated Press
JOHANNESBURG -- A two-dose Pfizer/BioNTech vaccination provides just 33% protection against infection by the omicron variant of the coronavirus, but 70% protection against hospitalization, according to a large-scale analysis in South Africa released Tuesday.
The first large-scale analysis of vaccine effectiveness in the region where the new variant was discovered appears to support early indications that omicron is more easily transmissible and that the Pfizer shot isn't as effective in protecting against infection as it was against the delta variant.
The analysis was based on more than 211,000 positive COVID-19 test results, 41% from adults who had received two doses of the Pfizer vaccine. About 78,000 of these positive COVID-19 test results between Nov. 15 and Dec. 7 were attributed to omicron infections. The study was carried out by Discovery Health, South Africa's largest private health insurer, and the South African Medical Research Council.
The study has been carried out in the weeks since omicron was first announced in November by scientists in South Africa and Botswana. The researchers emphasized that its findings are preliminary and not peer reviewed.
The data are gathered from the first three weeks of South Africa’s omicron-driven wave and may change as time passes. South Africa is the first country to experience a surge in COVID-19 driven by the omicron variant.
South Africa has experienced rapid community spread — concentrated in its most populous province, Gauteng — dominated by the omicron variant.
The seven-day rolling average of daily new cases in South Africa has risen over the past two weeks from 8.07 new cases per 100,000 people on Nov. 29 to 34.37 new cases per 100,000 people on Dec. 13, according to Johns Hopkins University. The death rate hasn't increased during that same period.
“Superb genetic surveillance by the Network for Genomic Surveillance in South Africa identified that omicron infection accounts for over 90% of new infections in South Africa, and has displaced the formerly dominant delta variant,” Discovery Health chief executive Dr. Ryan Noach said.
“The omicron-driven fourth wave has a significantly steeper trajectory of new infections relative to prior waves. National data show an exponential increase in both new infections and test positivity rates during the first three weeks of this wave, indicating a highly transmissible variant with rapid community spread of infection,” Noach said.
The result shows that vaccinated individuals who received two doses of the Pfizer vaccine have 33% protection against infection from omicron, relative to those who were unvaccinated in the first weeks of South Africa’s current omicron-driven wave. This represents a significant drop from the 80% protection against infection afforded during the earlier period, probably on the basis of lower antibody susceptibility, following the extensive spike protein mutations in the omicron variant.
Encouragingly though, the result shows that these same vaccinated individuals who received two doses of the Pfizer vaccine have 70% protection against hospital admission in this same time period. This protection against hospital admission is reduced from the highs of 93% in South Africa’s delta-driven variant.
The study shows that the protection against hospital admission is maintained across all ages, in people from 18 to 79 years old, with slightly lower levels of protection for older people, with 67% in people age 60 to 69 and 60% for people age 70 to 79. Protection against admission is also consistent across a range of chronic illnesses including diabetes, hypertension, hypercholesterolemia, and other cardiovascular diseases.
———
The study also found:
1. Omicron poses a higher risk of reinfection. For individuals who have previously had COVID-19, the risk of reinfection with omicron is significantly higher than that of earlier variants.
2. Risk of hospitalization from omicron is lower. Hospital admissions among adults diagnosed with COVID-19 attributed to omicron is 29% lower compared to the COVID-19 wave that South Africa experienced in mid-2020, after adjusting for vaccination status.
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Coronavirus Update
Pfizer’s COVID-19 antiviral proves almost 90% effective in latest trial data, as U.S. passes 50 million confirmed cases of the illness
Last Updated: Dec. 14, 2021 at 10:29 a.m. ET
First Published: Dec. 14, 2021 at 10:28 a.m. ET
By Ciara Linnane
0
California joins New York and others in mandating face masks in public spaces
Pfizer’s antiviral being made at a plant in Germany. HANDOUT/AGENCE FRANCE-PRESSE/GETTY IMAGES
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Pfizer Inc. cheered investors Tuesday with final data from a late-stage trial of its COVID-19 antiviral, that found it reduced the risk of hospitalization or death in high-risk adults by 89% if given shortly after the onset of symptoms, confirming the first set of data released last month.
The antiviral, named paxlovid, is also effective in dealing with the new omicron variant in lab studies, Pfizer PFE, 0.63% said, easing some of the concerns about omicron, which appears to be more transmissible than other variants and offers some resistance to existing vaccines. For now, it remains unclear whether the new variant is more lethal than previous ones, as it spreads in South Africa and Europe and is expected to become the dominant strain in the U.S. in the coming weeks.
“Emerging variants of concern, like omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic,” Pfizer Chief Executive Albert Bourla said in a statement.
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BioNTech was founded in 2008 on the understanding that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
To translate this idea into reality, we have combined ground-breaking research with cutting-edge technologies to develop pioneering therapeutics for cancer and beyond.
As we prove the value of our approach in the clinic, we will continue to build the partnerships,
manufacturing and team required to bring individualized treatments to patients worldwide.
From our roots in Mainz, Germany, we are driven to become the leading global biotechnology company for individualized cancer medicine.
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