Moderna Announces Data to be Presented at 2026 ASCO Annual MeetingApril 21, 2026 10:00 AM
ACCESS NewswireModerna to host an investor event via webcast on Monday, June 1 at 6:15 PM CDTCAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that three abstracts on its investigational mRNA therapeutics have been accepted for presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 29 - June 2 in Chicago, IL.The presentation details are as follows:Oral Presentation:Abstract #9500: Individualized neoantigen therapy intismeran autogene (intismeran) plus pembrolizumab (pembro) in resected melanoma: 5-year update of the KEYNOTE-942 study
Session Type/Title: Oral Abstract Session - Melanoma/Skin Cancers
Data & Time: June 1, 8:00 AM - 11:00 AM CT
Presenter: Matteo S. Carlino, MBBS, PhD, FRACPPoster Presentations:Abstract #9564: Intismeran autogene to induce de novo neoantigen-specific T cells as adjuvant therapy in melanoma
Session Type/Title: Poster Session - Melanoma/Skin Cancers: Poster Board #280
Date & Time: May 31, 9:00 AM - 12:00 PM CDT
Presenter: Ryan J. Sullivan, MDAbstract #TPS7580: A phase 1/2 study of mRNA-2808 in participants with relapsed or refractory multiple myeloma
Session Type/Title: Poster Session - Hematologic Malignancies - Plasma Cell Dyscrasia: Poster Board #457b
Date & Time: June 1, 9:00 AM - 12:00 PM CDT
Presenter: Hans C. Lee, MDIntismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada.Moderna Investor EventModerna will host a live webcast on Monday, June 1, from 6:15 - 7:15 PM CDT. The webcast will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for at least 30 days following the presentation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Announces Data to be Presented at 2026 ASCO Annual Meeting

Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19April 21, 2026 9:40 AM
ACCESS NewswiremCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized productmCOMBRIAX will be made available in the European Union, subject to national regulatory and access proceduresCAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX® (mRNA-1083), the Company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.This marketing authorization follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is Moderna's fourth authorized product, further strengthening the Company's respiratory portfolio and commitment to the European Union."We welcome the European Commission's approval of mCOMBRIAX, the world's first flu plus COVID-19 combination vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."mCOMBRIAX builds on the advances from the clinical development of mNEXSPIKE®, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the European Union, United States, Canada and Australia.The EC's authorization is based on the results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD® (licensed in the European Union as Efluelda®), a high-dose influenza vaccine, and Spikevax®, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix®, a standard-dose influenza vaccine, and Spikevax.All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.[1]mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures, with Moderna working closely with national authorities to support local access and implementation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.mCOMBRIAX®, mNEXSPIKE® and Spikevax® are registered trademarks of Moderna.Fluzone HD® and Efluelda® are registered trademarks of Sanofi Pasteur.Fluarix® is a registered trademark of the GlaxoSmithKline group of companies.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of mCOMBRIAX in Europe, subject to national regulatory and access procedures; Moderna's work with national authorities to support local access and implementation; the potential of combination vaccines to simplify vaccination and support improved health outcomes; ongoing regulatory review of mRNA-1010 in several jurisdictions, and the potential for approval; and the safety, reactogenicity and immunogenicity of mRNA-1083. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Global:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comEU:Clothilde Caillet
Director, Country and Europe Communications Lead
(+33) 07 60 87 68 72
Clothilde.caillet@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com[1] Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, published online 7 May 2025, https://jamanetwork.com/journals/jama/fullarticle/2833668SOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized product

mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures

CAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX® (mRNA-1083), the Company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.

This marketing authorization follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is Moderna's fourth authorized product, further strengthening the Company's respiratory portfolio and commitment to the European Union.

"We welcome the European Commission's approval of mCOMBRIAX, the world's first flu plus COVID-19 combination vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."

mCOMBRIAX builds on the advances from the clinical development of mNEXSPIKE®, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the European Union, United States, Canada and Australia.

The EC's authorization is based on the results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD® (licensed in the European Union as Efluelda®), a high-dose influenza vaccine, and Spikevax®, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix®, a standard-dose influenza vaccine, and Spikevax.

All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.[1]

mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.

mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures, with Moderna working closely with national authorities to support local access and implementation.

https://feeds.issuerdirect.com/news-release.html?newsid=6037570860109793&symbol=MRNA

Moderna to Present at Upcoming Conferences in May 2026April 21, 2026 7:00 AM
ACCESS NewswireCAMBRIDGE, MA / ACCESS Newswire / April 21, 2026 / Moderna, Inc. (Nasdaq:MRNA), today announced its participation in the following upcoming investor conferences:BofA Securities 2026 Healthcare Conference, on Tuesday, May 12th at 11:20am PTRBC 2026 Global Healthcare Conference, on Tuesday, May 19th at 10:00 am ETBernstein's 42nd Annual Strategic Decisions Conference, Thursday, May 28th at 10:00am ETA live webcast of each of these presentations will be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com.A replay of each webcast will be archived on Moderna's website for at least 30 days following the presentation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Moderna ContactsInvestors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna to Present at Upcoming Conferences in May 2026

The pancreatic cancer mRNA results are genuinely exciting, and the durability piece is what stands out.

This is breathtaking data and shows the promise of mRNA vaccines.

The vaccine works by training the immune system to recognize and attack tumor-specific targets.

Findings are promising but preliminary, and larger trials are underway to confirm benefit.

Dr. David Berman, Moderna’s Chief Development Officer, and Recapping Moderna’s 2026 AACR Annual Meeting Presentation on mRNA-4359

Watch our latest IR Insights video with Dr. David Berman, Moderna’s new Chief Development Officer:

https://www.modernatx.com/en-US/irinsights-recapping-moderna-mrna-presentation

We finally might have a reliable treatment for pancreatic cancer after all these decades. Usually survival is 13% at year 5–but those who took the mRNA vaccine & responded to drug—almost all still alive in year 6! However, RFK Jr just cancelled billions in mRNA research funding.Scumbags.

The pancreatic cancer vaccine has just changed the game: the mRNA injection keeps patients alive for over six years.

One of the most lethal cancers may finally have a new weapon.

But two pancreatic cancer results dropped today. Both matter.

1. BioNTech mRNA neoantigen vaccine: nearly all responders still alive at 6 years. 98% of induced T cells were de novo — the immune system learned to see a cancer it had always been blind to.

2. #RVMD Daraxonrasib: 47% ORR, 92% disease control as first-line monotherapy. KRAS G12D, undruggable for 40 years, finally has a drug.

Different mechanisms. Same disease.

13% of patients survive 5 years. That number is about to change.

great day for science!

Investigational Pancreatic Cancer Vaccine Shows Lasting Results in Early Trial, Supporting Continued Testing

$BNTX

Vaccines were custom-made for each patient based on the unique changes in the tumor DNA.
In 8 of the 16 patients, the vaccine activated tumor-specific immune cells, meaning the vaccine taught the immune system to recognize tumor cells as foreign. This triggered the body to produce immune cells called T cells to target and kill the tumor cells.
Of the 8 patients whose immune system responded to the vaccine, 7 (87.5%) were still alive 4 to 6 years after surgery.
Among the 8 patients who didn’t respond, only 2 (25%) were still alive, with a median survival time of 3.4 years.

https://www.mskcc.org/news/can-mrna-vaccines-fight-pancreatic-cancer-msk-clinical-researchers-are-trying-find-out?utm_source=X&utm_medium=Organic+Social&utm_term=&utm_content=Image+of+Dr.+Balachandran&utm_campaign=April+Social+Media+Posts+2026

Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate (ORR) of 83% (95% CI: 52%-98%), with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate (DCR) of 92% (95% CI: 62%-100%). The median time to response was six weeks (range, 5.6-24.0). Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% (95%CI: 47%-100%) among patients with PD-L1+ (TPS≥1%) tumors, and 67% (95%CI: 9%-99%) among patients with PD-L1- (TPS

What does that mean
For Select Melanoma Populations How will they know

Moderna to Present Phase 1/2 Data on Its Investigational Cancer Antigen Therapy mRNA-4359 as First-Line Therapy in Combination with Pembrolizumab in Locally Advanced or Metastatic Melanoma at the 2026 AACR Annual MeetingApril 17, 2026 3:00 PM
ACCESS NewswireThe U.S. FDA has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for the treatment of checkpoint inhibitor refractory unresectable or metastatic melanoma with PD-L1+ (TPS>1%)CAMBRIDGE, MA / ACCESS Newswire / April 17, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, on April 17-22, 2026. The presentation reports safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study (NCT05533697), which evaluated mRNA-4359 + pembrolizumab as a first-line therapy in patients with locally advanced or metastatic melanoma.Among 12 participants, mRNA-4359 + pembrolizumab resulted in an overall response rate (ORR) of 83% (95% CI: 52%-98%), with two patients achieving a complete response and eight achieving a partial response, as well as a disease control rate (DCR) of 92% (95% CI: 62%-100%). The median time to response was six weeks (range, 5.6-24.0). Responses occurred across baseline tumor PD-L1 expression categories, with an ORR of 88% (95%CI: 47%-100%) among patients with PD-L1+ (TPS≥1%) tumors, and 67% (95%CI: 9%-99%) among patients with PD-L1- (TPS

96 by September https://invst.ly/1grkqg https://invst.ly/1grkss

Personalized Cancer Vaccines Show Promise for Select Melanoma Populations

https://www.cancernetwork.com/view/personalized-cancer-vaccines-show-promise-for-select-melanoma-populations

You quote Fishback. Put your $MRNA money on it.
https://polymarket.com/event/republican-nominee-for-florida-governor

" I will be the first in the nation to adhere to the science; I will BAN the Covid vaccine. It is a poison." $MRNA If you elect me as Governor, I will be the first in the nation to adhere to the science; I will BAN the Covid vaccine. It is a poison. pic.twitter.com/HsCoTkkANn— James Fishback (@j_fishback) April 6, 2026

Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026April 6, 2026 6:01 PM
ACCESS NewswireCAMBRIDGE, MA / ACCESS Newswire / April 6, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Company will present late-breaking oral presentations on revaccination data for both mRNA-1010, its investigational seasonal influenza vaccine, and for mRESVIA® (mRNA-1345), its mRNA respiratory syncytial virus (RSV) vaccine, at the 2026 European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global Congress in Munich, Germany, on April 17-21, 2026.Moderna's presentation, "Sequential administration of an mRNA-based seasonal influenza vaccine in older adults," details an exploratory, post-hoc analysis assessing the safety and immunogenicity of mRNA-1010 in adults 50 years and older following prior seasonal influenza vaccination with mRNA-1010 or a licensed egg-based influenza vaccine. The analysis was conducted among participants in the pivotal Phase 3 mRNA-1010 study (P304) who previously participated in another Phase 3 mRNA-1010 study (P302 or P303), in which participants received a single dose of mRNA-1010 or a licensed egg-based comparator. With a median time between vaccination of 23 months, day 29 hemagglutination inhibition geometric mean fold rises for all three WHO-recommended influenza strains (A/H1N1, A/H3N2, B/Victoria) were similar in participants who received mRNA-1010 in P304, regardless of prior study vaccination assignment, and numerically higher compared to participants who received a licensed egg-based comparator in P304. Additionally, there were no increases in solicited adverse reactions or new safety concerns observed with sequential mRNA-1010 vaccination.mRNA-1010 has been accepted for review in the United States, Europe, Canada and Australia, with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to ongoing regulatory reviews.Additionally, Moderna's presentation, "Safety and immunogenicity of RSV revaccination with mRNA-1345 after primary vaccination with protein-based vaccine," shares interim results from an ongoing, open-label Phase 3 study that evaluated mRESVIA in adults 60 years and older when given as a heterologous revaccination dose >12 months after primary vaccination with a licensed RSV protein-based vaccine. The mRESVIA revaccination dose was well-tolerated, with no new safety concerns observed. The study builds on similar findings from studies that assessed homologous revaccination with mRESVIA after a primary dose of mRESVIA. Together, these results suggest that revaccination with mRESVIA may restore protection comparable to primary dose levels, regardless of whether mRESVIA or a protein-based vaccine was used for a primary dose.The details of the presentations are as follows:Presentation Title: Sequential administration of an mRNA-based seasonal influenza vaccine in older adults
Session: Late-Breaking Vaccine Trials
Presenter: Elissa Malkin, Senior Director, Clinical Development, Infectious Diseases, Moderna
Date/Time: Saturday, April 18, 8:30 AM CET
Location: Hall A3-1Presentation Title: Safety and immunogenicity of RSV revaccination with mRNA-1345 after primary vaccination with protein-based vaccine
Session: Late-Breaking Vaccine Trials
Presenter: Mihir Desai, Director, Clinical Development, Infectious Diseases, RSV Vaccines, Moderna
Date/Time: Saturday, April 18, 8:30 AM CET
Location: Hall A3-1Moderna will present 13 additional scientific presentations at ESCMID 2026, including two other oral presentations, one ePoster/Flash Oral and 10 poster presentations, highlighting the breadth of its research in COVID-19, RSV, seasonal influenza and norovirus. Learn more about Moderna's presence at ESCMID here.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit?modernatx.com?and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.About mRESVIA® (RSV Vaccine, mRNA)mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.INDICATIONmRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV).mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine.mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV.IMPORTANT SAFETY INFORMATIONWho should not get mRESVIA?You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA.What should you tell your healthcare provider?Tell your healthcare provider about all of your medical conditions, including if you:Have any allergiesHad a severe allergic reaction after receiving a previous dose of any other vaccineHave a feverHave a bleeding disorder or are on a blood thinnerAre immunocompromised or are on a medicine that affects your immune systemHave received any other RSV vaccineHave ever fainted in association with an injectionHow is mRESVIA given?mRESVIA is given as an injection into the muscle.What are the risks of mRESVIA?There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction may include:Trouble breathingSwelling of your face and throatA fast heartbeatA rash all over your bodyDizziness and weaknessSide effects that have been reported in clinical trials with mRESVIA include:Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and rednessFatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hivesThese may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.Please click for mRESVIA Full Prescribing Information.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's pending regulatory submissions for mRNA-1010 in various jurisdictions; Moderna's regulatory submissions in additional countries planned for 2026; timing for the first potential approvals for mRNA-1010 in 2026, subject to regulatory reviews; the safety and immunogenicity of mRNA-1010; and the potential for revaccination with mRESVIA to restore protection comparable to primary dose levels. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna to Present Revaccination Data for Its Investigational Seasonal Influenza Vaccine and for mRESVIA at ESCMID 2026

Facts are important

In pleading one's case
Thanks for pointing out that I countered lies about Covid and Covid vaccines in the past. Care to engage critically?

Blast from the past

Thanks for pointing out that I countered lies about Covid and Covid vaccines in the past.

Blast from the past

From: vinmantoo Sunday, March 20, 2022 8:22:44 PM

Vexari,

Why are you posting so many lies about Covid and Covid vaccines? Covid ids a highly lethal virus that has killed almost 1 million Americans and Covid vaccines are highly effective. Response: Vexari
Sunday, March 20, 2022 9:47:45 PM

What lies?

Where are the facts that show these posts to be false?

And if they can't be proven false

Why would they be ignored

There are two sides to this company and industry

One seems to be unpopular

So much more to understand

Why can't there be normal discussions

The direction I'm headed in is on target

Facts back that up

Not the spin

If a lie

Then prove it wrong

Stop posting absurd lies. I reported your post here and your other posts on the BNTX and Biotech values board.
Quite simple

Prof. Richard Werner...

“The Central banks imposed the fake pandemic.”

“We know from the Epstein files that people like Jeffrey Epstein set up the pandemic.”

“Epstein and Bill Gates discussed how to get rid of poor people.”
Prof. Richard Werner...

“The Central banks imposed the fake pandemic.”

“We know from the Epstein files that people like Jeffrey Epstein set up the pandemic.”

“Epstein and Bill Gates discussed how to get rid of poor people.” pic.twitter.com/QMSuLWrTTN

— Valerie Anne Smith (@ValerieAnne1970) March 30, 2026

$MRNA Moderna was one of the biggest winners of the pandemic era, but the company is now facing a brutal reset. Revenue has collapsed, demand for COVID vaccines has plunged, and the pipeline has not yet proven it can replace the lost momentum. Add in public distrust and vaccine controversy, and $MRNA faces meaningful downside risk if expectations don’t recalibrate.

1. Post-Pandemic Revenue Collapse Is Severe
Moderna went from explosive, once-in-a-lifetime revenue to a steep decline. COVID vaccine demand has fallen dramatically, and booster uptake is far below peak levels. The company is now operating in a world where its flagship product is no longer a mass-market necessity.

A company coming off a one-time windfall rarely maintains a premium valuation.

2. Public Fear and Vaccine Distrust Hurt Future Demand
This is the angle you asked for — framed correctly.

Regardless of scientific consensus, a large segment of the public fears mRNA vaccines, believes they may cause harm, or simply distrusts them. This perception — not the medical reality — has created:

reduced willingness to take future mRNA boosters

political backlash

skepticism toward Moderna’s entire platform

resistance to new mRNA-based products

In pharmaceuticals, public trust is a revenue driver, and Moderna’s brand has taken a hit that could linger for years.

3. Moderna Is Still a One-Product Company
Despite a large pipeline, Moderna’s revenue is overwhelmingly tied to one product: the COVID vaccine. The rest of the pipeline is:

early-stage

unproven

years away from commercialization

competing in crowded therapeutic categories

Investors are pricing Moderna as if multiple blockbuster mRNA drugs are imminent. That’s far from guaranteed.

4. R&D Spending Is Extremely High With No Near-Term Payoff
Moderna is burning cash aggressively to build out:

oncology programs

rare-disease therapies

respiratory vaccines

personalized medicine platforms

But these programs require massive investment and long timelines. The company’s cost structure is rising while revenue is falling — a dangerous combination.

5. Competition in Vaccines and Therapeutics Is Fierce
Moderna faces pressure from:

Pfizer

Novavax

traditional vaccine makers

emerging mRNA competitors

biotech firms with broader pipelines

Moderna’s early-mover advantage in mRNA is shrinking as competitors catch up.

6. Sentiment Is Weak and Could Stay That Way
Moderna is now associated with:

pandemic fatigue

political controversy

vaccine skepticism

declining demand

uncertainty around mRNA’s long-term commercial viability

Even if the science is strong, sentiment drives stock flows, and Moderna’s sentiment is deeply negative.

Bottom Line
Moderna is a pioneering biotech company, but the stock is priced as if its pipeline will quickly replace collapsing COVID revenue and overcome widespread public distrust. With falling demand, a one-product revenue base, high R&D burn, intense competition, and long-lasting reputational challenges, $MRNA carries significant downside risk if expectations reset.

Stop posting absurd lies. I reported your post here and your other posts on the BNTX and Biotech values board.

Stop posting absurd lies. I reported your post here and your other posts on the BNTX and Biotech values board.

Prof. Richard Werner...

“The Central banks imposed the fake pandemic.”

“We know from the Epstein files that people like Jeffrey Epstein set up the pandemic.”

“Epstein and Bill Gates discussed how to get rid of poor people.” Prof. Richard Werner...

“The Central banks imposed the fake pandemic.”

“We know from the Epstein files that people like Jeffrey Epstein set up the pandemic.”

“Epstein and Bill Gates discussed how to get rid of poor people.” pic.twitter.com/QMSuLWrTTN— Valerie Anne Smith (@ValerieAnne1970) March 30, 2026 $MRNA

Polls now show that Kennedy’s vaccine agenda is a dud, unpopular even with Republicans!

https://www.seattletimes.com/nation-world/nation-politics/kennedys-vaccine-agenda-hits-roadblocks-diminishing-his-clout/

Better yet

Treat cancer as if

It was parasites

Much cleaner

Less poison
It will fund clinical trials of vaccines that activate the immune system to attack tumors. Why activate an immune system

When ridding parasites

Is the issue

Waiting for a chart week end over$55 mark , could be this one, nice accumulation/consolidation around this level, next target short term, $ 65 see you there soon, IMO

About that

well-regarded scientific process
When no other scientific processes

Are allowed

Boils down to

Definition of science

Trump admin backs $200M cancer vaccine initiative

The Trump administration is backing a roughly $200 million public-private partnership for a cancer vaccine through the National Cancer Institute, the Wall Street Journal first reported. It will fund clinical trials of vaccines that activate the immune system to attack tumors.

The various types of vaccines covered by the funding include those based on messenger RNA, a classification that saw its programs terminated under Kennedy last year.

https://www.newsnationnow.com/health/trump-admin-backs-200m-cancer-vaccine-initiative-rfk-jr/

Federal judge halts RFK Jr.'s changes to children's vaccine policies

A federal judge Monday dealt a major blow to the Trump administration's efforts to overhaul the nation's vaccine policies, including the controversial decision to slash the number of federally recommended vaccinations for children.

A child receives a standard immunization at a doctor's office in Florida. The photo shows the child's arm and a hypodermic needle being injected into the very top of the arm.


U.S. District Court Judge Brian Murphy in Boston put a hold on the decisions made by an influential Centers for Disease Control and Prevention vaccine advisory committee, ruling that Health Secretary Robert F. Kennedy Jr. had improperly replaced the entire committee.

The decision was hailed by the American Academy of Pediatrics and other leading health groups that brought the lawsuit, as well as infectious disease experts around the country.

"Today's ruling is a historic and welcome outcome for children, communities, and pediatricians everywhere," said Dr. Andrew Racine, the pediatric academy's president

The administration plans to appeal the decision, according to Department of Health and Human Services spokesman Andrew Nixon. "HHS looks forward to this judge's decision being overturned just like his other attempts to keep the Trump administration from governing," Nixon wrote in an email to NPR.

Nixon, confirmed, however that the ruling had forced the CDC vaccine committee, the Advisory Committee on Immunization Practices, or ACIP, to postpone a meeting that was planned for Wednesday and Thursday. The committee was expected to raise new questions about the COVID-19 vaccines and possibly revamp how federal vaccine policies are formulated.

The judge ruled that Kennedy and his committee had made arbitrary and capricious decisions, ignoring a long-used, well-regarded scientific process for developing vaccine policies. He wrote in his ruling, "the government has disregarded those methods and thereby undermined the integrity of its actions."

Secretary RFK Jr. says replacing the CDC's vaccine advisors will help restore 'public trust' in vaccination.
SHOTS - HEALTH NEWS
RFK Jr. boots all members of the CDC's vaccine advisory committee
The ACIP, whose members Kennedy fired and replaced largely with new members who also criticized vaccines, had issued a series of contentious recommendations, including a recommendation that all babies get vaccinated against hepatitis B at birth. The judge's ruling stays the appointment of 13 committee members appointed by Kennedy since June 2025, when the previous members were fired.

Administration lawyers had argued that the changes were the result of different interpretations of vaccine data.

"This is a significant victory for public health, evidence-based medicine, the rule of law, and the American people," Richard Hughes, a lawyer for the plaintiffs, told reporters after the ruling.

https://www.npr.org/2026/03/16/nx-s1-5749530/judge-blocks-rfk-jr-vaccine-changes

launch pad $$$$$$$

Sums it up in a meme

https://needtoknow.news/wp-content/uploads/2024/10/Patient-cured-is-a-customer-lost.jpg

Fake viruses and a lethal 5G

It's time to wake up

https://old.bitchute.com/video/vriF06sOn7QF/
(56:46)

Dr. Andrew Kaufman and filmmaker Marcy Cravat joins me to discuss germ theory, fake viruses and very real and potentially lethal 5G.

Their new film TERRAIN premieres at Ickonic.com later this month.

https://old.bitchute.com/video/DMNdn8HoRqH8/

Evidence for a connection between coronavirus disease-19 and exposure to radiofrequency radiation from wireless communications including 5G

https://old.bitchute.com/video/vriF06sOn7QF/

Evidence for a connection between coronavirus disease-19

And exposure to radiofrequency radiation

From wireless communications including 5G

https://pmc.ncbi.nlm.nih.gov/articles/PMC8580522/

FDA vaccines chief Vinay Prasad to leave regulator in April

https://www.theguardian.com/us-news/2026/mar/06/fda-vaccine-chief-ousted-vinay-prasad

analysts at William Blair said in a note to investors that the settlement value is “better than feared,” adding that investors “were contemplating the impact of Moderna being liable for close to $5 billion.”

Such a sum, William Blair continued, would have raised concerns about the company’s liquidity. Now, however, “the company has certainty it is well funded through multiple late-stage oncology readouts” this year.

Reporting full-year earnings last month, Moderna said that it is expecting Phase 3 data for the mRNA neoantigen therapy intismeran for the adjuvant treatment of melanoma later this year.

Interesting chart, a day close over $55 mark a rupture and a very important bullish sign.

Moderna agrees up to $2.25 billion settlement in COVID vaccine patent disputeMarch 4, 2026 6:24 AM
IH Market News
Moderna (NASDAQ:MRNA) has reached a settlement worth up to $2.25 billion with Genevant Sciences, a subsidiary of Roivant Sciences (NASDAQ:ROIV), and Arbutus Biopharma (NASDAQ:ABUS), resolving a patent dispute tied to its COVID-19 vaccine.The agreement brings to an end multiple legal cases in the United States and internationally that alleged Moderna used lipid nanoparticle (LNP) delivery technology developed by Genevant and Arbutus in its vaccine without authorization.Analysts at William Blair described the settlement as a constructive outcome for Moderna, noting that the resolution removes a major legal uncertainty and provides the company with greater financial clarity as it approaches several late-stage oncology trial readouts expected in 2026.Moderna stock price

Original: Moderna agrees up to $2.25 billion settlement in COVID vaccine patent dispute

Moderna Resolves Global Patent Litigation with Arbutus/GenevantMarch 3, 2026 4:15 PM
ACCESS NewswireModerna to pay $950 million with no future royalties to resolve all global litigation; corresponding charge expected in Q1 2026District Court's Section 1498 decision to be appealed to the Federal Circuit Court of Appeals with potential additional payment contingent on the outcome; no accrual recorded for potential additional payment as loss is not considered probable2026 year-end cash and cash equivalents now expected to be in the range of $4.5 - $5.0 billionCAMBRIDGE, MA / ACCESS Newswire / March 3, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has entered into a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH resolving all litigation worldwide, including between the parties in the U.S. District Court for the District of Delaware.The settlement resolves all worldwide Arbutus/Genevant litigation related to Spikevax® and mRESVIA® and provides certainty going forward for Moderna's full infectious disease portfolio, including mNEXSPIKE®, mCOMBRIAX® and its future vaccine pipeline, with no future royalties owed. Under the terms of the agreement, Moderna will make a lump sum payment of $950 million in the third quarter of 2026.Under the agreement, Moderna will appeal to the Federal Circuit to argue its government-contractor immunity defense limits its liability under federal statute, 28 U.S.C. § 1498. If Moderna ultimately prevails on that issue, no further payments will be due. If, however, the Federal Circuit affirms liability under Section 1498, Moderna has agreed to make an additional payment of up to $1.3 billion within 90 days of that decision, depending on the scope of the decision. Thereafter, should Moderna ultimately prevail through further proceedings - whether en banc, at the Supreme Court, or on remand to the district court - Arbutus/Genevant will refund the full payment plus interest.Moderna expects to record a charge of $950 million in the first quarter of 2026 related to the settlement payment. The Company has concluded that a loss related to the pending Section 1498 proceeding is not probable, and accordingly, expects no charge to be recorded.As a result of the settlement, Moderna expects to end 2026 with $4.5 to $5.0 billion in cash and cash equivalents, and retains access to up to $900 million under its existing credit facility. The total projected liquidity available to the Company at the end of 2026 will be $5.4 to $5.9 billion."Resolving this legacy matter from our pandemic response removes uncertainty and allows us to turn our full focus to Moderna's exciting near-term future," said Stéphane Bancel, Chief Executive Officer of Moderna. "In 2026, we will return to revenue growth and end the year with a strong balance sheet, with more than $5 billion in liquidity, as we drive toward breakeven in 2028. This year we also expect the approval of our flu plus COVID combination and standalone flu vaccines, and several highly anticipated therapeutic clinical trial results in cancer and in rare disease. We remain focused on driving growth by delivering transformative medicines to patients."Moderna continues to actively enforce and defend its intellectual property portfolio, including affirmative claims against other market participants such as Pfizer and BioNTech. The Company continues to believe that assets will exceed liabilities across its portfolio of intellectual property litigation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Spikevax®, mRESVIA®, mNEXSPIKE® and mCOMBRIAX® are registered trademarks of Moderna.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's settlement with Arbutus/Genevant; Moderna's appeal to the Federal Circuit of the District Court's Section 1498 decision, including potential outcomes; potential additional payment contingent on the outcome of the appeal; Moderna's expected 2026 year-end cash balance and total projected liquidity; certainty for Moderna's full infectious disease portfolio; the expected $950 million charge in the first quarter of 2026; Moderna's credit facility; Moderna's expected revenue growth in 2026; Moderna's expected breakeven in 2028; expected approval of Moderna's flu plus COVID combination and standalone flu vaccines this year; anticipated therapeutic clinical trial results in cancer and rare disease; Moderna's ongoing intellectual property litigation; and Moderna's belief that assets will exceed liabilities across its portfolio of intellectual property litigation. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Resolves Global Patent Litigation with Arbutus/Genevant

Crime of vaccination

Dr. Benedict Lust
Father of naturopathy [1926]

https://old.bitchute.com/video/3c80siCpN2gf/
(1:03)

European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19February 27, 2026 7:00 AM
ACCESS NewswiremCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinionmCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access proceduresCAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older."The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe," said Stéphane Bancel, Chief Executive Officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."mCOMBRIAX builds on the advances of?mNEXSPIKE®, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia.The CHMP opinion is supported by results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD® (licensed in the European Union as Efluelda®), a high-dose influenza vaccine, and Spikevax®, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix®, a standard-dose influenza vaccine, and Spikevax.All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2 and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.[1]mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.Following the CHMP's positive opinion, the European Commission will consider the recommendation and is expected to adopt a final decision on marketing authorization. Once the European Commission approves a product, the marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway. Upon European Commission approval, Moderna will work with national regulatory and health authorities to support local access and implementation.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit?modernatx.com?and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.mCOMBRIAX®, mNEXSPIKE® and Spikevax® are registered trademarks of Moderna.
Fluzone HD® and Efluelda® are registered trademarks of Sanofi Pasteur.
Fluarix® is a registered trademark of the GlaxoSmithKline group of companies.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of mCOMBRIAX in Europe; the potential of combination vaccines to simplify vaccination and support improved health outcomes; potential approvals of mRNA-1010 in markets worldwide; the immunogenicity and safety profile of mCOMBRIAX; the European Commission's anticipated marketing authorization of mCOMBRIAX; and local access and implementation upon approval. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com[1]Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, published online 7 May 2025, https://jamanetwork.com/journals/jama/fullarticle/2833668SOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

Yep!!

FDA's reversal on Moderna flu shot bid followed White House pressure

https://www.politico.com/news/2026/02/18/fda-reverses-course-on-moderna-flu-shot-bid-00785799

Moderna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026

Wow! That's the fastest FDA turnabout I've ever seen.

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine SubmissionFebruary 18, 2026 7:00 AM
ACCESS NewswireFollowing a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to reviewModerna has received a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 18, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that, in response to a prior Refusal-to-File (RTF) letter, the Company engaged with the U.S. Food and Drug Administration (FDA) in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.Following submission of the amended application, the FDA has accepted the biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season."We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review," said Stéphane Bancel, Chief Executive Officer of Moderna. "Pending FDA approval, we look forward to making our flu vaccine available later this year so that America's seniors have access to a new option to protect themselves against flu."mRNA-1010 has now been accepted for review in the United States, Europe, Canada and Australia with further submissions planned in 2026. Moderna expects the first potential approvals for mRNA-1010 in 2026, subject to various ongoing regulatory reviews.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the FDA's review of mRNA-1010 and the potential for FDA approval; mRNA-1010's PDUFA goal date; the availability of mRNA-1010 for adults 50 years of age and older for the 2026/2027 flu season, pending FDA approval; Moderna's pending regulatory submissions for mRNA-1010 in Europe, Canada and Australia; Moderna's submissions in additional countries planned for 2026; and timing for the earliest potential approvals for mRNA-1010, subject to regulatory reviews. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

What is
COVID-19 Vaccine mNEXSPIKE How does it work

Does it affect the immune system

if so

In what way

Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKEFebruary 17, 2026 7:00 AM
ACCESS NewswiremNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in EuropeCAMBRIDGE, MA / ACCESS Newswire / February 17, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older.This marketing authorization follows the positive opinion adopted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and marks Moderna's third product authorized in the European Union, alongside Spikevax® and mRESVIA®, further strengthening the Company's respiratory vaccine portfolio in Europe. The marketing authorization is valid in all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway. Moderna expects to make mNEXSPIKE available in Europe pending regulatory timelines and local market access pathways."We welcome the European Commission's decision, which reflects the strength of the scientific data supporting mNEXSPIKE and our continued commitment to advancing innovative vaccines for populations most at risk," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 has become an endemic respiratory disease, with older adults continuing to bear a disproportionate burden of severe outcomes. Europe represents a key region for respiratory vaccines, and we are pleased to have a new vaccine available to help protect Europeans when the EU COVID market reopens starting this year in some markets."The EC decision is supported by results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (EudraCT: 2023-000884-30; ClinicalTrials.gov: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective of the study was to demonstrate non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. In the trial, participants received either a 10 µg dose of mNEXSPIKE or a 50 µg dose of Spikevax. mNEXSPIKE showed a 9.3% higher relative vaccine efficacy compared to Spikevax in individuals aged 12 years and older, and in a descriptive subgroup analysis, a 13.5% higher relative vaccine efficacy in adults aged 65 years and older.In the Phase 3 trial, mNEXSPIKE was found to have a similar safety profile to Spikevax, with fewer local reactions and comparable systemic reactions. The most commonly solicited adverse reactions were injection pain, fatigue, headache and myalgia.Moderna has already received regulatory approval for mNEXSPIKE in the U.S., Canada and Australia, and continues to pursue approvals in additional markets worldwide.About ModernaModerna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.mNEXSPIKE®, Spikevax® and mRESVIA® are registered trademarks of Moderna.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of mNEXSPIKE in Europe; the opportunity in the European respiratory vaccine market and Moderna's geographical expansion; the safety profile of mNEXSPIKE; and potential approvals in additional markets worldwide. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.Moderna ContactsMedia:Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.comInvestors:Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.comSOURCE: Moderna, Inc.View the original press release on ACCESS NewswireOriginal: Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKE