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VLA15: Biotech news outlet FierceBiotech reported that the vaccine, VLA15, the only vaccine of its type, could be a game-changer.
(started already 2020/07)
The Vineyard is poised to be a proving ground for an experimental compound to help prevent Lyme disease. Pfizer, the pharmaceutical giant that developed lifesaving COVID-19 vaccines, is working toward a vaccine against Borrelia burgdorferi, the tick-borne bacteria that cause Lyme disease. Pfizer is developing the vaccine with French pharmaceutical company Valneva. Phase 3 trials of the drug will take place on the Vineyard, according to Michael Loberg, president of Vineyard Medical Care and a member of the Tisbury board of health.
https://www.mvtimes.com/2022/07/11/lyme-trials-coming-vineyard/
VLA15: 2022-AUG-06: Final testing for new Lyme disease vaccine seeks RI volunteers
https://eu.providencejournal.com/story/news/healthcare/2022/08/06/potential-lyme-disease-vaccine-ri-volunteers-needed-phase-3-trial/10224259002/
July 2022 update - WHO - Global COVID-19 Vaccination Strategy in a Changing World
https://www.who.int/publications/m/item/global-covid-19-vaccination-strategy-in-a-changing-world--july-2022-update
On COVID-19 vaccine products, fundamental innovation and
development is needed to achieve durable, broadly protective
immunity, including mucosal immunity, to substantially reduce SARS-
CoV-2 transmission. Accumulated evidence indicates that existing
vaccines provide only modest and relatively limited duration of
protection against infection. Reduced transmission will help safeguard
against emergence of new variants of concern and their global waves
of disease with related health and economic consequences. It is key
for such innovations to be accessible in a timely way to all countries
for equity as well as global health and economic security reasons.
European Commission to order 1.25 million doses of Valneva’s whole-virus COVID-19 vaccine VLA2001 in 2022
Saint-Herblain (France), July 20, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announces that the European Commission (EC) has approved an amendment to the Advance Purchase Agreement (APA) it signed in November 2021[1] for Valneva’s inactivated whole-virus COVID-19 vaccine, VLA2001. The amendment will be signed after a mandatory five-day period during which Member States can opt out. Under this amendment, the Member States’ purchases will consist of 1.25 million doses of VLA2001 in 2022, with the option to purchase an equivalent quantity later this year for delivery in 2022. This amendment follows remediation discussions based on the EC’s notice of intent[2] to terminate the initial APA for VLA2001 doses in 2022 and optional doses for 2023.
The first vaccine doses will be delivered to participating EU Member States (Germany, Austria, Denmark, Finland and Bulgaria) in the coming weeks. Valneva will retain inventory for potential additional supply to these EU Member States should demand increase and, in parallel, will aim to deploy approximately eight to ten million doses of remaining inventory into international markets. Given that VLA2001’s shelf life is expected to reach up to 24 months over time, the Company will aim to deploy these doses in the next six to twelve months.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We welcome the fact that the EC has decided not to terminate the APA, although we feel the order volume does not reflect the interest we see from European citizens. Despite this, we have decided to enter into this amendment to make our vaccine available to the Europeans who have been waiting for it. While the pandemic had been declining, the latest COVID-19 wave in Europe clearly underlines the need for alternative vaccines. 15% of Europeans over 18 are not yet vaccinated[3] and we continue to receive messages from Europeans who are awaiting a more traditional vaccine technology. Recent market studies[4] conducted in several EU member states suggest that making our inactivated vaccine available in Europe could increase vaccine uptake and have a meaningful impact on public health.”
In light of the reduced order volume from EU member states, the Company is evaluating the COVID-19 program and associated operations. Valneva continues discussions on potential additional supply and financing agreements with various other countries around the world and will invest in further development of its current or second-generation COVID-19 vaccine only if it reaches an agreement with potential customers and receives the necessary funding over the summer.
Valneva does not expect immediate cash constraints following this change in the EC order and believes that its 2022 revenues could still reach the lower end of its previously communicated guidance[5] based on revenue recognition linked to the EC and UK supply contracts. In light of the amended APA, Valneva has suspended manufacturing of VLA2001 and is assessing its COVID-19 related assets with regard to any potential write-down. The Company will provide a more detailed update on its plans and financial guidance with its first half results on August 11, 2022.
In parallel, Valneva will continue to progress its two late-stage assets: its Lyme disease vaccine candidate, which is partnered with Pfizer and expected to enter its Phase 3 study in the third quarter of 2022, and its single-shot chikungunya vaccine candidate for which the Company expects to commence submission of the Biologics License Application with the US FDA in the second half of 2022. Valneva is also actively working to add new vaccine candidates to its clinical pipeline, both through the advancement of its preclinical assets and potential program acquisitions.
VLA2001 is the first COVID-19 vaccine to receive a standard marketing authorization in Europe[6]. The vaccine was also granted conditional marketing authorization in the United Kingdom[7] and emergency use authorization in the United Arab Emirates[8] and Kingdom of Bahrain[9].
VLA2001: Valneva is expected to be at least as effective ...
Based on data comparing the immune response triggered by COVID-19 Vaccine (inactivated, adjuvanted)
Valneva with that induced by an authorised COVID-19 vaccine, EMA concluded that COVID-19 Vaccine (inactivated, adjuvanted)
Valneva is expected to be at least as effective as the comparator
at protecting against the disease in people aged between 18 and 50 years.
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva
Extracts from Focus.de (2022-JUN-30)
https://www.focus.de/gesundheit/news/erste-standard-zulassung-valneva-vakzin-in-der-eu-zugelassen-was-der-echte-totimpstoff-kann_id_108170542.html
Corona vaccine number six is on the starting blocks.
European institutions recently gave the green light for the inactivated vaccine
from the manufacturer Valneva. The vaccine can therefore
be vaccinated in Germany in the future.
It is the sixth vaccine against the coronavirus in the EU -
and the first standard approval.
The previous vaccines were approved very quickly due to the acute emergency situation of the pandemic, but only "conditionally".
Unlike the previously approved vaccines, Valneva is a dead vaccine.
"VLA2001" is a vaccine with inactivated viruses. It is thus "a classic vaccine technology that has been used
for 60 to 70 years, with proven procedures and very high safety," as the EU Commission told 2021.
The technology is also used in most flu vaccines and many vaccines for childhood diseases,
it said. This makes "VLA2001" the only Corona vaccine based on inactivated viruses currently approved in Europe, he said.
What are the known side effects of Valneva's vaccine?
Valneva also investigated side effects as part of this comparative study.
According to the study, the vaccine was "well tolerated" and "showed a statistically
significant better tolerability profile" compared to the Astrazeneca vaccine.
Does the Valneva vaccine also work against Omikron?
According to the company, the Valneva vaccine also protects against the Omikron variant.
The company announced in January that preliminary laboratory studies showed that three doses of the
vaccine candidate, VLA2001, neutralized the Omikron variant (B.1.1.529 line). According to the results,
100 percent of serum samples tested showed neutralizing antibodies to the delta
variant and 87 percent to the omicron variant.
VLA2001: Valneva Receives Marketing Authorization in Europe for Inactivated Whole-Virus COVID-19 Vaccine VLA2001
https://valneva.com/press-release/valneva-receives-marketing-authorization-in-europe-for-inactivated-whole-virus-covid-19-vaccine-vla2001/
June 24, 2022
VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe
Saint Herblain (France), June 24, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Commission (EC) has granted marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.
With this approval, VLA2001 becomes the first COVID-19 vaccine to receive a standard marketing authorization in Europe. The marketing authorization will cover all 28 European Union Member States as well as Iceland, Liechtenstein, and Norway.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased that the EC granted full marketing authorization for VLA2001, the only inactivated whole-virus COVID-19 vaccine available in Europe. Once again, we have shown that Valneva has the expertise to bring a vaccine all the way from bench to market. Since we began working on VLA2001, we have continued to receive messages from Europeans who are waiting for a more traditional vaccine technology. Now that we have received this full marketing authorization, we hope that the EC and its member states will place orders that reflect this demand. 15% of Europeans over 18 are not yet vaccinated[1], and we believe that making our inactivated vaccine available could increase vaccination coverage and have a meaningful impact on public health.”
The EC’s approval follows recommendations yesterday from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorization. This new marketing authorization in Europe follows conditional marketing authorization in the United Kingdom, which was granted in April 2022[2], and emergency use authorization granted in the United Arab Emirates and Bahrain in May 2022 and March 2022, respectively.
About VLA2001
VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine which has received marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
VAL2001: VAL2001 would NOT be an emergency use authorization (EUA)/EU, but a standard one.
VLA2001: Valneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europehttps://valneva.com/press-release/valneva-receives-positive-chmp-opinion-for-marketing-authorization-of-its-inactivated-covid-19-vaccine-candidate-in-europe/
https://valneva.com/press-release/valneva-receives-positive-chmp-opinion-for-marketing-authorization-of-its-inactivated-covid-19-vaccine-candidate-in-europe/
alneva Receives Positive CHMP Opinion for Marketing Authorization of its Inactivated COVID-19 Vaccine Candidate in Europe
June 23, 2022
Saint Herblain (France), June 23, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization in Europe for Valneva’s inactivated whole-virus COVID-19 vaccine candidate, VLA2001, for use as primary vaccination in people from 18 to 50 years of age.
The European Commission (EC) will review the CHMP recommendation, and a decision on the marketing authorization application for VLA2001 is expected shortly. If granted, this will be the first COVID-19 vaccine to receive a standard marketing authorization in Europe.
The CHMP concluded by consensus after a thorough evaluation that, “the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.”
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are pleased that the CHMP has recommended VLA2001, the only inactivated COVID-19 vaccine candidate in Europe, for full marketing authorization and are now looking forward to receiving marketing authorization from the EC. I would like to personally thank all those who have supported us in this endeavor, as well as everyone at Valneva for all their hard work. We hope that the EC and its member states will recognize the potential advantages of an inactivated vaccine and make a meaningful order, since we have clear evidence that Europeans are seeking a more traditional vaccine technology. Our aim is to further support public health in Europe by providing a new option for the 15% of Europeans over 18 who are not yet vaccinated[1].”
Once granted by the EC, the marketing authorization would be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.
The EMA’s CHMP opinion follows conditional marketing authorization in the United Kingdom, which was granted in April 2022[2], and emergency use authorization granted in the United Arab Emirates in May 2022 and in Bahrain in March 2022.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
Media & Investor Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com
Valneva announces resumption of trading of its ordinary shares on Euronext Paris
https://valneva.com/press-release/valneva-announces-resumption-of-trading-of-its-ordinary-shares-on-euronext-paris-2/
Valneva and Pfizer Announce Closing of Equity Investment
https://valneva.com/press-release/valneva-and-pfizer-announce-closing-of-equity-investment/
Valneva Announces Successful Outcome of its AGM and Appointment of two New Supervisory Board Members
https://valneva.com/press-release/valneva-announces-successful-outcome-of-its-agm-and-appointment-of-two-new-supervisory-board-members/
VLA2001: IDT Biologika production on tack
Despite the fact that the vaccine has still not been approved by the
European Medicines Agency (EMA), production of the Covid-19 vaccine
in Rodleben is currently continuing.
The doses will be made available to Valneva on time,
IDT spokeswoman Corinna Meisel explained.
The company has remained silent about the production quantities from the beginning.
According to MDR information, it should be several million doses.
Whether and how many will ultimately go on the market, however, is currently uncertain.
VLA15: Pfizer will invest €90.5 million in Valneva
https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/
VLA2001 also as Booster/How-To: https://healthalert.gov.bh/en/article/vaccination-and-booster-dose-criteria
VLA2001/UK. Saint-Herblain (France), June 15, 2022 – Valneva SE, (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that it has entered into a settlement agreement with the Government of the United Kingdom (“HMG”) in relation to the termination of the supply agreement for Valneva’s COVID-19 vaccine candidate, VLA2001.
The Company announced on September 13, 2021 that it had received a termination notice from HMG, and the termination, which Valneva accepted on the basis of HMG’s discretionary right to terminate for convenience, became effective on October 10, 2021.
The settlement agreement resolves certain matters relating to the obligations of the Company and HMG following the termination of the supply agreement and in relation to the separate agreement relating to clinical trials of VLA2001 in the United Kingdom, which remains in place.
The Company continues to have certain other obligations pursuant to provisions of the supply agreement that survive its termination.
VLA2001: Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states
Saint-Herblain (France), June 10, 2022 – Valneva SE, a specialty vaccine company, today provides an update on its European inactivated whole-virus COVID-19 vaccine candidate VLA2001.
Following receipt of the European Commission (EC)’s notice of intent to terminate the Advance Purchase Agreement (APA)[1], Valneva proposed a remediation plan, which is now subject to further discussion within the EC and among the participating member states.
Some member states have confirmed their interest in having an inactivated, adjuvanted whole-virus vaccine solution in their portfolio. However, the preliminary, unofficial volume indications received from the EC would not be sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program. This would also impede the future development of the program beyond the current product profile.
If such indications are confirmed, Valneva will not be able to enter into an amendment to the APA that could allow for a reduced order, and the EC is thus likely to terminate the agreement. As a result, Europeans would not have access to Valneva’s inactivated vaccine VLA2001.
VLA1553: Valneva to Present on its Single-Shot Chikungunya Vaccine Candidate, Host Symposium at NECTM8
https://valneva.com/press-release/valneva-to-present-on-its-single-shot-chikungunya-vaccine-candidate-host-symposium-at-nectm8/
Valneva Joins Euronext’s Tech Leaders Index - https://valneva.com/press-release/valneva-joins-euronexts-tech-leaders-index/
VAL15: Valneva/Pfizer - If the Pfizer-Valneva vaccine receives FDA licensing, it will be the first Lyme vaccine on the market in the U.S. in two decades.
In the first round of clinical trials, 246 healthy adults ages 18 to 65 received the vaccine. Pfizer reported it was “safe and well-tolerated across all doses and age groups tested” and “no serious adverse events were observed in any treatment group.” The vaccine is now in the second phase of clinical trials, which expanded the subject group to include pediatric patients ages 5 through 17.
https://bangordailynews.com/2022/05/27/news/pfizer-lyme-vaccine-clinical-trials-joam40zk0w/
VLA1553 - Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate
https://valneva.com/press-release/valneva-successfully-completes-lot-to-lot-consistency-trial-for-its-single-shot-chikungunya-vaccine-candidate/
May 25, 2022
Saint Herblain (France), May 25, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the lot-to-lot Phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The final analysis included six-month follow-up data and confirmed the topline results reported in December 2021.
The VLA1553-302 trial met its primary endpoint, demonstrating that three consecutively manufactured vaccine lots elicited equivalent immune responses measured by neutralizing antibody titer GMT ratios on Day 29 after vaccination.
The trial included 408 participants aged 18 to 45 years. The safety profile shown in study VLA1553-302 was similar to the Phase 3 trial, VLA1553-301[1]. With a 96.0% seroprotection rate at Day 180, the immunogenicity profile from study VLA1553-301 was also confirmed.
Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “We are extremely pleased that the final lot-to lot data confirmed the previously reported topline results. We have now all necessary clinical data to support submission with the US Food and Drug Administration (FDA), which we plan to start later this year. Chikungunya is a major, growing and unmet public health threat, yet no vaccine or specific treatment is currently available to prevent this debilitating disease. We will continue to work assiduously to bring VLA1553 to market as soon as possible.”
Valneva’s chikungunya program was awarded Breakthrough Therapy Designation by the US FDA in July 2021. This milestone followed the US FDA’s Fast Track designation and the European Medicines Agency (EMA)’s PRIME designation which the Company received in December 2018 and in October 2020, respectively. The sponsor of the first chikungunya vaccine Biologics License Application (BLA) to be approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV) [2].
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in 72-92% of humans after 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia, and the virus has spread to more than 100 countries. As of September 2020, there were more than 3 million reported cases in the Americas[3] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.
About VLA1553
VLA1553 is a live-attenuated, single dose investigational vaccine candidate designed to target the chikungunya virus. It has been designed by deleting a part of the chikungunya virus genome.
In March 2022, Valneva announced successful completion of the Phase 3 pivotal trial of VLA1553[4]. The final six-month analysis confirmed the very high level of seroprotection reported from this trial in August 2021. In this double-blind, multi-center, randomized Phase 3 clinical trial, 4,115 participants aged 18 years and above were randomized 3:1 into two groups to receive either 0.5mL of VLA1553 or a placebo. The trial met its primary endpoint, inducing protective CHIKV neutralizing antibody titers in 98.9% of participants 28 days after receiving a single shot (264 of 268 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.2-99.6). The seroprotective titer was agreed with the FDA to serve as a surrogate of protection that can be utilized in a submission for approval of VLA1553 under the accelerated approval pathway. VLA1553 was highly immunogenic, with a GMT of approximately 3,270.
VLA1553 was generally well tolerated among the 3,082 subjects evaluated for safety. An independent Data Safety Monitoring Board, or DSMB, continuously monitored the study and identified no safety concerns. Solicited adverse events were observed, the majority of which were mild or moderate and resolved within 3 days.
Additionally, VLA1553 was shown in the Phase 3 pivotal trial to be highly immunogenic in elderly study participants, who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as an equally good safety profile.
VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for chikungunya vaccines is estimated to exceed $500 million annually by 2032[5].
To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[6]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[7], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.
About Phase 3 study VLA1553-302
The VLA1553-302 clinical lot-to-lot consistency study is a prospective, multicenter, randomized, pivotal Phase 3 study including 408 participants aged 18 to 45 years. Lyophilized VLA1553 were administered as a single intramuscular immunization. Equivalence of immune responses was determined based on neutralizing antibody titers. The primary objective of the study was to evaluate a pair-wise comparison of the 95% Confidence Interval (CI) on the ratio of GMTs on Day 29 after vaccination in the three vaccine lots. The two-sided 95% CI on the GMT ratio should be within 0.67 and 1.5 in order to demonstrate consistency.
Study volunteers were followed for six months after vaccination. Additional information, including a detailed description of the study design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04786444).
EMA accepts filing of marketing authorization application for Valneva’s inactivated COVID-19 Vaccine Candidate
Saint Herblain (France), May 19, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (“EMA”) has accepted the filing of a marketing authorization application (MAA) for Valneva’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization application, the Company confirms it would expect to receive a positive CHMP opinion in June 2022.
If positive opinion is given by the CHMP, the European Commission (EC) will review the recommendation and provide a final decision on the MAA. If granted by the EC, the centralized marketing authorization would be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “The EMA’s acceptance of the filing for VLA2001 is an important step toward product approval. We remain fully committed and dedicated to working jointly with the regulators, the European members states and the European Commission toward making a more traditional and established COVID-19 vaccine technology available to people in Europe.”
NEW: Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine (Dubai, Abu Dhabi, Ajman, Fujairah, Ras Al Khaimah, Sharjah and Umm Al Quwain)
Saint Herblain (France), May 16, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the United Arab Emirates (UAE) granted emergency use authorization for Valneva’s inactivated, adjuvanted COVID-19 vaccine, VLA2001.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this new authorization and would like to thank the UAE for their trust and confidence. As the only dual-adjuvanted, whole-virus inactivated COVID-19 vaccine approved by the UAE Ministry of Health and Prevention, VLA2001 could offer an alternative vaccine solution to people across the Emirates. This is our second approval in the Gulf countries, and we are hoping that further approvals of VLA2001 will follow elsewhere.”
This authorization follows Conditional Marketing Authorization from the UK MHRA[1], which was granted last month, and emergency use authorization from the Bahraini NHRA in March 2022[2].
https://valneva.com/press-release/valneva-receives-emergency-use-authorization-from-the-united-arab-emirates-for-its-inactivated-covid-19-vaccine/
remediation plan <-> EU. intent to terminate the advance purchase agreement
"very funny" that the EU makes most of the problems where others are already granting approvals
Saint-Herblain (France), May 16, 2022 – Valneva SE, a specialty vaccine company, today announced that it has received a notice from the European Commission (“EC”) of intent to terminate the advance purchase agreement (“APA”) for Valneva’s inactivated whole-virus COVID-19 vaccine candidate VLA2001.
The APA provides the EC with a right to terminate the APA if VLA2001 had not received a marketing authorization from the European Medicines Agency (“EMA”) by April 30, 2022. Based on the terms of the APA, Valneva has 30 days from May 13, 2022 to obtain a marketing authorization or propose an acceptable remediation plan.
https://valneva.com/press-release/valneva-receives-notice-of-european-commissions-intent-to-terminate-covid-19-vaccine-purchase-agreement/
postpone PFE+BNTX. The U.S. pharmaceutical company Pfizer and its German partner Biontech will postpone the next delivery of vaccines to the European Union (EU) by three months. According to the companies, in agreement with the European Commission, the doses of vaccine planned for June to August will be delivered only from September to the fourth quarter of this year.
2022-MAY-04 starting heterologous booster trials ...
May 4, 2022
Saint-Herblain (France), May 4, 2022 – Valneva SE, a specialty vaccine company, today announced the initiation of a heterologous booster trial of its inactivated whole-virus COVID-19 vaccine candidate VLA2001. The VLA2001-307 trial will be the Company’s first clinical trial to provide booster data following primary vaccination with an mRNA vaccine or natural COVID-19 infection. Data, if positive, could support potential use as heterologous booster, subject to applicable regulatory recommendations and approvals.
The VLA2001-307 trial is expected to include approximately 150 participants who will receive a VLA2001 booster vaccination at least six months after primary vaccination with a licensed mRNA COVID-19 vaccine or following natural COVID-19 infection. The trial will be conducted in the Netherlands and topline results are expected in the third quarter of 2022.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “This trial is extremely important as it will provide the first booster data in unvaccinated adults following natural COVID-19 infection. It will also provide data on VLA2001’s capability for use as a heterologous booster and could potentially nicely complement the positive homologous booster data we already generated. We would like to thank all those who are demonstrating continued interest in our vaccine; we remain fully committed to bring our inactivated solution to as many people as we can.”
Valneva announced positive homologous booster results at the end of December 2021[1]. The data showed an excellent immune response after a third dose of VLA2001 administered seven to eight months after the second dose of primary vaccination with VLA2001. The third dose of VLA2001 showed a strong boosting effect, increasing levels of binding antibodies against the Wuhan virus 42- to 106-fold, depending on the pre-boosting levels of antibodies. In April 2022, VLA2001 was granted Conditional Marketing Authorization by the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) for primary immunization in adults 18 to 50 years of age[2]. This authorization followed emergency use authorization from the Bahraini NHRA in March 2022[3]. The Company is still in a rolling review process with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) and remains focused on achieving a Conditional Marketing Authorization for VLA2001 in the European Union this quarter.
About Trial VLA2001-307
VLA2001-307 is a multicenter, open-label, single-arm clinical study investigating the safety, tolerability and immunogenicity of a VLA2001 booster vaccination in participants aged 18 years and older. Approximately 150 participants, either generally healthy or with a stable medical condition, will be enrolled in the trial. The VLA2001 booster will be given to adults 6 to 12 months after completion of primary vaccination with an mRNA COVID-19 vaccine or unvaccinated adults 6 to 12 months after PCR confirmation of natural SARS-CoV-2 infection.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.
2022-APR-26 Positive Phase 2 Pediatric Data for Lyme Disease
pdf
https://ml-eu.globenewswire.com/Resource/Download/86a2f1d2-6cea-46f5-83c4-a8c5b936915e
Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme
Disease Vaccine Candidate
• Strong immunogenicity profile observed in study participants aged 5-17 years one
month after the primary vaccination series
• Safety profile observed in pediatric participants similar to previously reported data
in adult participants
• Pediatric population to be included in planned Phase 3 trial – expected to start in Q3
2022, subject to regulatory approval
2022-APR-26 non-dilutive funding: Additional $40 million made available...
pdf https://ml-eu.globenewswire.com/Resource/Download/25530d09-1f9a-4982-8e18-66990f4f50e8
Saint-Herblain (France), April 26, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, today announced an agreement to increase the principal amount of its
existing $60 million debt financing agreement with funds managed by leading US-based healthcare
investment firms Deerfield Management Company and OrbiMed. This extension will provide Valneva
immediate access to $20 million, with an additional $20 million available upon potential conditional
approval of its inactivated COVID-19 vaccine candidate, VLA2001, by the European Medicines
Agency. The increased funding will be used to further invest in R&D, including market access
preparations for Valneva’s chikungunya vaccine candidate, VLA1553.
Peter Bühler, Chief Financial Officer of Valneva, commented, “We are extremely pleased to have
access to additional non-dilutive funding from our existing financial partners. Extension of our loan
provides additional flexibility to execute on our strategy and deliver shareholder value. We
appreciate the continued support from Deerfield and OrbiMed as we pursue expansion of our global
portfolio of marketed vaccines.”
The loan interest rate remains unchanged. The interest-only period has been extended to the third
quarter of 2024, and the loan will now mature in the first quarter of 2027.
In January 2021, Valneva announced an amendment1 to the terms of this debt facility, which was
originally signed in February 20202.
About Deerfield
Deerfield is an investment management firm committed to advancing healthcare through investment,
information and philanthropy.
About OrbiMed
OrbiMed is a leading healthcare investment firm, with $15 billion in assets under management.
OrbiMed invests globally across the healthcare industry, from start-ups to large multinational
corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds.
OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and
Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and
global team resources and support to help build world-class healthcare companies
EMA behaves in a manner LoQ... / Valneva will respond to these requests in the coming days ...
Saint Herblain (France), April 25, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today provided an update on the rolling review process of its inactivated, COVID-19 vaccine candidate, VLA2001, with the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”).
Following last week’s meeting, the CHMP provided another List of Questions (“LoQ”). This LoQ includes requests for additional data and for further justification of a Conditional Marketing Authorization.
Valneva will respond to these requests in the coming days. If the CHMP accepts the submissions, the Company would expect a Conditional Marketing Authorization this quarter.
Valneva continues to believe that its inactivated vaccine meets the conditions for a Conditional Marketing Authorization, including a positive benefit-risk profile. The Company remains focused on achieving a Conditional Marketing Authorization for VLA2001 in Europe after it was granted Conditional Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom (“UK”) two weeks ago[1].
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are disappointed that the EMA has not considered our submissions sufficient to date. We remain fully committed and dedicated to working jointly with the regulators towards a product approval. VLA2001 is the only inactivated COVID-19 vaccine candidate in Europe, and we continue to receive messages every day from people who are looking for a more traditional vaccine approach”.
In its Phase 3 pivotal trial, Valneva demonstrated that two doses of VLA2001 induced superior neutralizing antibody levels and a significantly better tolerability profile compared to another EMA-approved vaccine (AZD1222)[2]. On April 14, 2022, the UK MHRA granted Conditional Marketing Authorization for VLA2001 for primary immunization in adults 18 to 50 years of age[3]. MHRA found that VLA2001 meets the required safety, quality and effectiveness standards. This authorization followed emergency use authorization from the Bahraini NHRA in March 2022[4].
This is a double event.
https://lepetitjournal.com/londres/sante/valneva-premier-vaccin-francais-approuve-au-royaume-uni-335918
The first French vaccine has finally arrived on the market. And its Franco-Austrian manufacturer based in Nantes has just found its first customer: the United Kingdom.
The United Kingdom is further expanding its anti-Covid-19 arsenal by authorizing the French vaccine produced by Valneva. The country is thus adding to an already long list: AstraZeneca, Pfizer, Moderna, Janssen and Novavax.
Contrary to what one might have thought, the first doses will not be delivered to European Union countries, but across the Channel, starting in May. It is indeed the United Kingdom that has accepted, this Thursday April 14, the use of the vaccine of the French laboratory. The British Medicines and Healthcare products Regulatory Agency, the MHRA, says it is "the first in the world to approve it".
While there are three main methods for making a vaccine, the inactivated virus technology was chosen here. This method creates an immune response in patients by injecting them with a whole virus that has been stripped of its ability to cause harm. It is also easy to use because the vaccine developed by Valneva can be stored at the right temperature in simple refrigerators.
Orders for Valneva's vaccines are pouring in from around the world
Franck Grimaud, CEO of the Valneva laboratory, is obviously delighted with this news and the orders that are multiplying. 60 million doses have already been reserved by some 20 European Union member states. The Kingdom of Bahrain has purchased one million doses and numerous advanced contacts are underway with countries in the Middle East, South East Asia and Latin America.
This is a great success story for the company, which has historically been based in Saint-Herblain, near Nantes, and employs some 800 people, including some in a Scottish factory in Livingstone, near Edinburgh.
UK: Covid vaccine approved by regulators - 2022-APR-14
https://www.bbc.com/news/health-61104594
Dr June Raine, MHRA Chief Executive, said:
Our approval of the COVID-19 vaccine made by Valneva today follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.
https://www.gov.uk/government/news/valneva-covid-19-vaccine-approved-by-mhra
Opening today: Valneva > Sweden's first covid vaccine factory
Lena Hallengren inaugurates Sweden's first covid vaccine factory
Published 07 April 2022
On Thursday 7 April, Minister of Social Affairs Lena Hallengren will inaugurate
Sweden's first factory for the production of vaccines against covid-19.
The factory belongs to the vaccine manufacturer Valneva.
The Minister will give the inauguration speech and participate
in a tour of the new Covid vaccine factory.
Valneva's new production plant is the first of its kind in Sweden.
Janet Hoogstraate, CEO of Valneva Sweden, Thomas Lingelbach, CEO of Valneva,
and Hans Wigzell, Professor Emeritus of the Karolinska Institute,
will also attend the inauguration.
The programme starts at 13.00, and the media are welcome to attend.
For more information and interview requests,
please contact press officer Sofia Brändström.
Encephalitis Vaccine Market Size And Forecast
https://www.businessmerseyside.co.uk/encephalitis-vaccine-market-size-scope-and-forecast/
Valneva Sweden has shipped (Bahrain) 2022-MAR-28
Valneva Sweden has now shipped the first doses of its covid-19 vaccine to Bahrain, where the vaccine candidate has received emergency approval.
By Anders Göransson
March 28, 2022 08:26
https://www.lifesciencesweden.se/article/view/842453/valneva_har_gjort_forsta_svenska_leveransen_av_covidvaccin_en_stor_milstolpe
This is a major milestone for us at Valneva and for Sweden in general as it is the first covid-19 vaccine ever manufactured in the country, says Janet Hoogstraate, CEO of Valneva Sweden, in a press release.
Valneva Sweden is a subsidiary of French Valneva SE, whose vaccine candidate, VLA2001, is currently under review by the European Medicines Agency (EMA) for possible marketing authorisation in the EU.
Bahrain granted an emergency use authorisation in early March, becoming the first country in the world to approve the vaccine. An agreement has been signed for the supply of one million doses to Bahrain in 2022 and 2023. The manufacturing will largely take place at Valneva Sweden's facility in Solna, as Life Science Sweden previously reported.
We are extremely pleased to be able to contribute to medical innovation in Sweden and strengthen our reputation as a life science nation. We now look forward to the official opening of our new covid-19 vaccine plant next month," says Janet Hoogstraate, CEO of Valneva Sweden.
The European Commission has also signed an agreement with Valneva for the supply of the company's covid-19 vaccine candidate, subject to EU approval.
Valneva's vaccine candidate is the only inactivated, adjuvanted whole-virus vaccine candidate against covid-19 that is now in clinical trials in the EU. VLA2001 consists of inactivated whole virus particles of SARS-Cov-2 with high S-protein density, in combination with two adjuvants.
Australia 'Unprecedented' Japanese Encephalitis Outbreak
https://www.voanews.com/a/australia-facing-unprecedented-japanese-encephalitis-outbreak/6487573.html
IXIARO
old: https://valneva.com/press-release/valneva-u-s-dod-exercises-first-year-option-on-ixiaro-supply-contract/
+
VLA1601
https://valneva.com/research-development/zika/
VALNEVA MOSKITO GUARD®
https://www.valneva.at/en/moskito-guard
...insect repellent spray protects against mosquitoes, sand flies and other biting insects that can transmit diseases such as malaria, Japanese encephalitis or the Zika virus
open job positions (3/2022): now >50 - https://valneva.com/careers/
Deliver: Austria/EU >> May
"We have submitted all the necessary documents to the EMA and answered all their questions," said Jandl. Accordingly, distribution in Austria would be possible in May.
VLA2001 | Already available in April(?)-ORF/Austria/Covid vaccine from Vienna |
In Vienna, the Austro-French group Valneva is developing a whole-virus vaccine against the coronavirus. The vaccine could be available in the second half of April.
Online 2022/MAR/09, 12:06 p.m. today (update: 12:45 p.m.).
https://wien.orf.at/stories/3146644/
[...]
"I am particularly proud that Valneva is working here in Vienna on such internationally sought-after products as the whole-virus corona vaccine. For me, this proves that the measures taken to support the life sciences industry by the City of Vienna were 100 percent the right move," said Peter Hanke (SPÖ), city councilor for economic affairs, at a press conference on Wednesday.
Valneva maintains the largest of its international sites in Vienna, with more than 250 people working at the Vienna BioCenter. They have not only developed the new vaccine against coronavirus, but also one against cholera or Japanese encephalitis, for example.
VLA1553: Phase 3 COMPLETE against mosquito-borne viral disease.
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate
https://valneva.com/press-release/valneva-successfully-completes-pivotal-phase-3-trial-of-single-shot-chikungunya-vaccine-candidate/
March 8, 2022
VLA1553-301 six-month follow-up completed – all endpoints met
Seroprotection (protective CHIKV neutralizing antibody levels) in 98.9% of participants after one month and 96.3% after six months
Good safety and tolerability profile confirmed
Valneva expects to commence pre-submission process
Saint Herblain (France), March 8, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021. Valneva now expects to commence the pre-submission process with the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.
The VLA1553-301 trial, which enrolled 4,115 adults aged 18 years and above across 44 sites in the U.S., met all primary and secondary endpoints. The final analysis confirmed the very high level of seroprotection, with 98.9% of participants achieving protective levels of chikungunya virus (CHIKV) neutralizing antibodies one month after receiving a single vaccination (263 of 266 subjects from the per-protocol subgroup tested for immunogenicity, 95% CI: 96.7-99.8). The excellent immunogenicity profile was maintained over time, with 96.3% of participants showing protective CHIKV neutralizing antibody titers six months after receiving a single vaccination (233 of 242 subjects from the per-protocol subgroup tested for immunogenicity, 95%CI: 93.1-98.3). The reported levels of seroprotection far exceeded the 70% threshold (for non-acceptance) based on a surrogate of protection agreed with the FDA under the accelerated approval pathway[1].
VLA1553 was also confirmed to be highly immunogenic in elderly study participants (65 years of age or older), who achieved equally high seroprotection rates and neutralizing antibody titers over time as younger adults. A dedicated antibody persistence trial (VLA1553-303) will monitor a subset of participants from study VLA1553-301 for a period of at least five years to confirm the anticipated long-term protection after a single vaccination.
The six-month safety profile was also consistent with previous results across all age groups. VLA1553 was generally well tolerated among the 3,082 subjects evaluated for safety. An independent Data Safety Monitoring Board continuously monitored the study and identified no safety concerns. The majority of solicited adverse events were mild or moderate and resolved within three days. 2.0% of study participants reported severe solicited adverse events, most commonly fever. Approximately 50% of study participants experienced solicited systemic adverse events, most commonly headache, fatigue and myalgia.
Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva commented, “These final pivotal Phase 3 results confirm the compelling profile of our single-shot vaccine candidate across all age groups. Delivering these first-ever final Phase 3 results for a chikungunya vaccine candidate means that we are a step closer to addressing a major, growing and unmet public health threat. We would like to thank everyone who participated in the trial and who continued to advance the trial during the pandemic.”
Valneva previously reported positive topline lot-to-lot manufacturing consistency results for VLA1553[2]. This is one of the standard requirements for vaccine licensure, and final lot-to-lot results are expected in the second quarter of 2022. Valneva also recently initiated a Phase 3 trial in adolescents conducted in Brazil by Instituto Butantan to support the label extension in this age group following a potential initial regulatory approval in adults in the U.S[3]. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), this trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in an endemic region.
Valneva’s chikungunya vaccine program was awarded Breakthrough Therapy Designation by the FDA in July 2021. This followed the FDA Fast Track designation and the European Medicines Agency (EMA)’s PRIME designations, which the Company received in December 2018 and in October 2020, respectively. The sponsor of the first chikungunya vaccine approved in the U.S. will be eligible to receive a Priority Review Voucher (PRV).
About Chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating. There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat. As of September 2020, there were more than 3 million reported cases in the Americas[4] and the economic impact is considered to be significant. The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically. Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high. Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. High risk areas of infection are places where chikungunya virus-carrying mosquitos are currently endemic, including the Americas, parts of Africa, and Southeast Asia.
About VLA1553
VLA1553 is a live-attenuated, single dose vaccine candidate targeting the chikungunya virus, which has spread to over 120 countries. It has been designed by deleting a part of the chikungunya virus genome.
VLA1553 would expand Valneva’s existing commercial vaccines portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations. The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032[5].
To make VLA1553 more accessible to Low and Middle Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement in January 2021 for the development, manufacturing and marketing of VLA1553[6]. The collaboration falls within the framework of the agreement signed between CEPI and Valneva in July 2019[7], which provides funding of up to $23.4 million with support from the European Union’s Horizon 2020 program.
About Phase 3 trial VLA1553-301
VLA1553-301 Phase 3 trial was initiated in September 2020. It is a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 trial evaluating 4,115 participants aged 18 years or above. Lyophilized VLA1553 or placebo were administered as a single intramuscular immunization. The primary objective of the trial was to evaluate the immunogenicity and safety of VLA1553 at one month following a single immunization. Additional information, including a detailed description of the trial design, eligibility criteria and investigator sites, is available at ClinicalTrials.gov (Identifier: NCT04546724).
VLA2001: Authorization from Bahrain: DONE
Saint Herblain (France), March 1, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain has granted emergency use authorization for Valneva’s inactivated, adjuvanted COVID-19 vaccine, VLA2001. This authorization follows a rolling review process with the Bahraini NHRA and reflects the NHRA’s initiative to support the authorization of COVID-19 vaccines.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are extremely pleased with this first authorization and would like to thank the Kingdom of Bahrain for their trust and confidence. We are looking forward to addressing the evolution of the pandemic in the Middle East and starting to deliver our first vaccines in the region. As the only dual-adjuvanted, inactivated COVID-19 vaccine approved in Bahrain, VLA2001 will provide a differentiated vaccine option to the Bahraini population and medical community.”
Valneva signed an advance purchase agreement with the Kingdom of Bahrain in December 2021 for the supply of one million doses of VLA2001. The Company expects to deliver the first shipments of VLA2001 to Bahrain at the end of this month.
Valneva remains focused on achieving additional regulatory approvals of VLA2001. On February 25, 2022, the Company announced that it had received an initial assessment of VLA2001 from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).[1] Based on this assessment, and subject to the CHMP’s acceptance of Valneva’s responses to a list of questions and to the timetable to be proposed by the EMA, Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 in Europe for primary immunization in adults aged 18-55 at the end of the first quarter of 2022.
https://valneva.com/press-release/valneva-receives-emergency-use-authorization-from-bahrain-for-its-inactivated-covid-19-vaccine-vla2001/
03/03/2022 EMA reg. press briefing on COVID-19 live
https://www.ema.europa.eu/en/events/ema-regular-press-briefing-covid-19-15
VLA2001: Valneva Receives Initial CHMP Assessment of its Inactivated, Adjuvanted COVID-19 Vaccine Candidate
February 25, 2022
Saint Herblain (France), February 25, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided an initial assessment of Valneva’s inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Valneva has received a list of questions from the CHMP and is confident that it will be able to respond to these in the coming days. Following the Company’s response, the EMA will provide a timetable towards anticipated conditional approval.
Subject to the CHMP’s acceptance of Valneva’s responses and the EMA’s timetable, Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age at the end of the first quarter of 2022. Following such conditional approval, the Company would expect to deliver the first shipments of VLA2001 to European countries early in the second quarter of 2022.
Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “We are pleased with the initial CHMP assessment and look forward to providing our responses as soon as possible. VLA2001 is the only inactivated COVID-19 vaccine in clinical development in Europe, and this brings us closer to our objective of providing a differentiated vaccine option to the population and physicians who need it. Adults aged 18 to 55 represent the vast majority of unvaccinated people in Europe, and we continue to receive messages every day from many who are looking for a more traditional and established vaccine approach.”
The Company is currently conducting additional clinical studies aiming to gradually expand the label and indications of VLA2001 to further age groups, including for potential use as a booster vaccine in the course of 2022.
Valneva signed an agreement with the European Commission (EC) in November 2021 to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 2022[1]. Valneva has commenced manufacturing for the EC and Bahraini supply contracts and has inventory ready for labelling and deployment upon regulatory approval.
Valneva Awarded Up to £20 Million
by Scottish Enterprise to Advance Vaccine Development
February 21, 2022
Saint Herblain (France), February 21, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its subsidiary Valneva Scotland has been awarded research and development funding of up to £20 million by Scottish Enterprise.
The investment from Scotland’s national economic development agency follows advanced discussions reported on December 23, 2021, and will be comprised of two grants, which build on the agency’s longstanding engagement with Valneva and will benefit the Company’s manufacturing site in Livingston. The grants are expected to be received over the next three years, commencing March 2022.
The first grant of up to £12,500,000 will support research and development related to the manufacture of VLA2001, Valneva’s inactivated, whole virus COVID-19 vaccine candidate. The second grant of up to £7,500,000 will support research and development connected to Valneva’s manufacturing processes for other vaccines.
Valneva’s research and development portfolio includes VLA1553, the Company’s single-shot vaccine candidate against the mosquito-borne viral infection chikungunya, which it also intends to manufacture in Livingston. Valneva reported positive topline Phase 3 results in 2021 for both VLA2001 and VLA1553.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “This investment bolsters Valneva’s longstanding relationship with Scottish Enterprise as well as our position at the forefront of life sciences and vaccine development in Scotland. From the only inactivated, whole virus COVID-19 vaccine candidate in clinical development in Europe to the most clinically advanced vaccine candidate against chikungunya in the world, Scottish Enterprise’s investment will support progress across Valneva’s research and development portfolio – as well as jobs and growth in Scotland. We are grateful to Scottish Enterprise, and to the Scottish Government, for their continuing support.”
Adrian Gillespie, Chief Executive of Scottish Enterprise, commented, “Valneva’s decision to develop and manufacture its COVID-19 vaccine here in Scotland is extremely welcome. It is a huge vote of confidence in our life sciences sector and its highly skilled workforce, with one of the largest and most advanced vaccine manufacturing sites in the world now firmly anchored in Scotland and set to export its life-saving vaccines across the world. We look forward to supporting Valneva’s continued growth in Scotland, and to help it realise its international growth ambitions.”
Ivan McKee, Scottish Government Business Minister, said, “Valneva is a valued contributor to our life sciences sector and the Livingston facility is an important asset, developing and manufacturing vaccines for the prevention and treatment of several infectious diseases. This funding package will support high quality jobs create, drive further research and underpin the company’s operations in Scotland.”
Hannah Bardell, MP for Livingston, added, “I am delighted to see this significant investment in Valneva from Scottish Enterprise. This funding will enable Valneva to continue its expansion in Livingston, securing vital vaccine production capabilities and protecting crucial jobs. My constituency colleagues and I have long championed Valneva’s work and this investment confirms the company’s place at the forefront of Scottish life sciences.”
The grants signed with Scottish Enterprise are tied to the safeguarding and creation of jobs at Valneva’s Livingston site and, before receiving funds, Valneva must provide a legal opinion and a parent guarantee.
VLA15: Valneva and Pfizer Report Positive Phase 2 Data
February 4, 2022
Dose selection complete for planned Phase 3 trial, expected to be initiated in 3Q2022
Sub-analysis compared the immunogenicity of VLA15 in adults 18-65 years of age after administration of two or three primary series doses
Stronger immune response observed in adult participants who received three priming doses vs. two priming doses; pediatric study ongoing with initial data expected in 1H2022
Three-dose priming schedule selected for use in adults moving forward
Saint-Herblain (France) and New York, February 4, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE) today reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in 2022, subject to regulatory approval.
The Phase 2 trial, VLA15-221, compared the immunogenicity of VLA15 after administration of two (at months 0 and 6) or three (at months 0, 2 and 6) primary series doses in groups aged 5-11, 12-17 and 18-65 years. In the sub-analysis of adult participants (18-65 years old) who received VLA15 in either the two-dose schedule (N=90) or the three-dose schedule (N=97), performed one month after the last vaccination dose, VLA15 was found to be immunogenic with both vaccination schedules tested. These data are consistent with the strong immunogenicity profile observed for this age group in previous Phase 2 studies. However, the induction of anti-OspA IgG (anti-outer surface protein A immunoglobulin G) antibody titers was higher in participants who received the three-dose primary series compared to those who received the two-dose primary series, supporting the use of a three-dose primary series schedule in the planned Phase 3 clinical trial. The VLA15-221 trial is ongoing to assess the safety and immunogenicity of VLA15 in 5-17 year olds. Initial pediatric data are expected in the first half of 2022.
The analysis was also consistent with the acceptable safety and tolerability profile observed in previous studies of VLA15. No vaccine-related serious adverse events (SAEs) were observed.
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “I’m very pleased with these results, which are critical for determining the optimal vaccination schedule for our planned Phase 3 trial. In partnership with Pfizer, we are excited to further investigate this vaccine candidate, which will hopefully help provide protection against Lyme disease for both adults and children.”
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer, said: “Lyme disease is increasingly impacting people throughout the northern hemisphere, potentially due to environmental changes and more active outdoor lifestyles. The continued positive data from the VLA15-221 trial support the ongoing development of this vaccine candidate, and we look forward to continuing to work with Valneva to potentially help protect people against Lyme disease.”
About VLA15
VLA15 is the only Lyme disease vaccine candidate currently in clinical development. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. The vaccine covers the six OspA serotypes expressed by Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 has demonstrated strong immunogenicity and safety data in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 20171. Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop VLA15.2
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-data-for-lyme-disease-vaccine-candidate/
Full Year 2021 Revenue and Cash
Total revenues
Total revenues of €348.1 million in 2021 compared to €110.3 million in 2020 – an increase of 216%
Includes €94.8 million of product and other revenues (excluding COVID), at the higher end of the Company’s previously communicated guidance of €85 to €100 million, and
€253.3 million of COVID-related revenues under the terminated UK agreement
Strong cash position
Strong cash position of €346.7 million at end of December 31, 2021
Reflects $209.6 million of combined gross proceeds from Nasdaq Initial Public Offering (IPO) and European placement in May 2021, plus November 2021 follow-on offering, and
Significant pre-payments under the EC COVID-19 vaccine supply agreement
Full year 2022 financial guidance
Total revenues expected between €430 to €590 million, including:
€350 to €500 million of COVID-19 vaccine sales subject to regulatory approvals and deliveries of VLA2001[1],
€60 to €70 million of other vaccine sales
Approximately €20 million of Other Revenues (revenues from collaborations, licensing and services)
Key milestones achieved include:
Lyme Disease Vaccine Candidate VLA15
Further positive Phase 2 results, including booster response
Inactivated COVID-19 Vaccine Candidate VLA2001
Positive pivotal Phase 3 results
Advance Purchase Agreement approved by European Commission (EC) for up to
60 million doses in 2022 and 2023
Initiation of rolling submissions to the European Medicines Agency (EMA) as well as the UK and Bahraini agencies (MHRA and NHRA, respectively)
Positive homologous booster results between seven to eight months after primary vaccination
Confirmed neutralization of Omicron and Delta variants in laboratory studies
Single-Shot Chikungunya Vaccine Candidate VLA1553
Positive pivotal and lot-to-lot Phase 3 results
Raised approximately $210 million
Successful Nasdaq IPO and concurrent private placement in Europe
Successful follow-on equity offering in the US and Europe
not COVID: Adolescent Phase 3 Trial for Chikungunya Vaccine (= VLA1553, not COVID VLA2001)
https://valneva.com/press-release/valneva-announces-initiation-of-adolescent-phase-3-trial-for-its-single-shot-chikungunya-vaccine-candidate/
Juan Carlos Jaramillo, M.D, Chief Medical Officer of Valneva commented, “We are delighted to work with Instituto Butantan and CEPI on this new trial, which represents another major step in the development of this exciting product. We reported compelling pivotal Phase 3 results in adults and in the elderly, and we are looking forward to obtaining results in adolescents. The dreadful impact of the COVID-19 pandemic has underlined the importance of vaccines to combat public health crises. Chikungunya outbreaks have impacted over 120 countries and affected millions, yet no vaccine or specific treatment is currently available to prevent this debilitating disease.”
Prof. Dimas Tadeu Covas, President of Instituto Butantan which sponsors the VLA1553-321 trial, commented, “VLA1553 is currently the most clinically advanced chikungunya vaccine candidate worldwide having successfully completed Phase 3 in adults. Through developing, producing and commercializing Valneva’s chikungunya vaccine, Butantan reinforces even more its engagement to improve public health in developing countries.”
Dr. Melanie Saville, Director of Vaccine Research & Development at CEPI, added, “Today, well over a billion people live in areas where chikungunya outbreaks occur – and climate change could further amplify the threat posed by this debilitating virus. Tremendous progress has been made by our partner, Valneva, to advance its chikungunya vaccine candidate in recent years and I am pleased to see these additional developments, announced today with Instituto Butantan, to evaluate the performance of its vaccine candidate in the adolescent population.”
"...Valneva has already started to build up an Omikron-specific virus bank. We believe that by early March at the latest, we will be at a point where we could theoretically start production of an Omikron-specific vaccine if it were necessary and desired."
Thomas Lingelbach, CEOValneva (2022-JAN-25)
PR. Valneva Advances Booster Phase of Cov-Compare Trial of Its Inactivated COVID-19 Vaccine Candidate
Saint-Herblain (France), January 25, 2022 – Valneva SE, a specialty vaccine company, today announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare. This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results. The data are not intended for the initial regulatory approval process which the Company expects to finalize in the coming weeks.
The trial extension will evaluate a booster dose of VLA2001 in adults, aged 18 and above, who received primary vaccination with two doses of VLA2001, as well as participants, aged 30 and above, who received two doses of AstraZeneca’s (AZD1222). The VLA2001 booster vaccination will be given at least seven months after completion of the primary vaccination series. The trial is currently ongoing in the UK and is supported by the National Institute for Health Research (NIHR). It is expected to provide topline data during the second quarter of 2022.
Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “While we are focused on completing our rolling submissions for initial regulatory approval of VLA2001 in a primary vaccination context, we are working extremely hard in parallel to generate further data for VLA2001 in order to assess the role it could play in a booster context as well. We continue to believe that VLA2001 may play an important role to fight the current pandemic phase and beyond. We would like to thank all those who are demonstrating continued interest in our vaccine, and we remain fully committed to bring our inactivated solution to the market as soon as we can.”
Valneva announced first positive homologous booster results at the end of December 2021[1]. The data showed an excellent immune response after a booster dose of VLA2001 administered seven to eight months after the second dose of primary vaccination. In addition, Valneva plans to initiate a further dedicated heterologous booster only trial of VLA2001 in the coming weeks. Valneva also recently reported laboratory results demonstrating that serum antibodies induced by three doses of VLA2001 neutralize the initial SARS-CoV-2 virus as well as the Omicron and Delta variants[2].
Valneva is continuing to provide data to the European Medicines Agency (EMA) as well as the UK and Bahraini agencies (MHRA and NHRA respectively), and expects to complete these rolling submissions in time to receive potential regulatory approvals in the first quarter of 2022.[3]
About the Booster extension of Phase 3 Cov-Compare Study VLA2001-301
Cov-Compare is a randomized, observer-blind, controlled, comparative immunogenicity study for which Valneva reported positive topline data in October 2021. As part of the study’s booster extension, all participants are offered a third vaccination, except those who already received a licensed COVID-19 vaccine outside of the study. Participants will receive a VLA2001 shot at least seven months after completion of the primary vaccination series with VLA2001 or AZD1222; follow-up visits will be performed 14 days and six months after the booster vaccination. Participants who will not receive a VLA2001 booster vaccination will continue with their scheduled Month 12 follow up visit. In addition to evaluating tolerability of a VLA2001 booster dose, blood samples will be taken for immunogenicity analysis from a subset of adults who received primary vaccination with two doses of VLA2001, as well as from a subset of participants who received two doses of AZD1222 for primary immunization.
About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the ongoing pandemic and potentially later for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).
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