Latest news with #mRNA-1018
Indianapolis Star
2 days ago
- Health
- Indianapolis Star
Moderna Announces Update on Investigational Pandemic Influenza Program
Phase 1/2 H5 avian flu vaccine study shows positive interim results Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines CAMBRIDGE, MA / ACCESS Newswire Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype. The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines. 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.' The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline. The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting. Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company's strategic commitment to pandemic preparedness. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the clinical development of mRNA-1018, the safety and immunogenicity data from the Phase 1/2 study; the cancellation of the development contract for Moderna's pandemic flu program by the U.S. Department of Health and Human Services; and the exploration of alternative paths for development of the vaccine program. 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, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at 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 Contacts Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire
Miami Herald
29-05-2025
- Business
- Miami Herald
Moderna Announces Update on Investigational Pandemic Influenza Program
Phase 1/2 H5 avian flu vaccine study shows positive interim results Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype. The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines. "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program," said Stéphane Bancel, Chief Executive Officer of Moderna. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats." The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline. The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting. Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company's strategic commitment to pandemic preparedness. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the clinical development of mRNA-1018, the safety and immunogenicity data from the Phase 1/2 study; the cancellation of the development contract for Moderna's pandemic flu program by the U.S. Department of Health and Human Services; and the exploration of alternative paths for development of the vaccine program. 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, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at 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 Contacts Media:Chris RidleyGlobal Head of Media Relations+1 Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 SOURCE: Moderna, Inc.
The Hindu
29-05-2025
- Health
- The Hindu
U.S. Government cancels $766 million Moderna contract to fight pandemic flu
The Trump administration has cancelled $766 million awarded to drugmaker Moderna Inc. to develop a vaccine against potential pandemic influenza viruses, including the H5N1 bird flu. The company said it was notified Wednesday (May 28, 2025) that the Health and Human Services Department had withdrawn funds awarded in July 2024 and in January to pay for the development and purchase of its investigational vaccine. The funds were awarded through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics. The new vaccine, called mRNA-1018, utilises the same technology that enabled the rapid development and rollout of vaccines to combat COVID-19. Health Secretary Robert F. Kennedy Jr. has expressed deep scepticism regarding mRNA vaccines, despite real-world evidence that the vaccines are safe and have saved millions of lives. The cancelation came as Moderna announced positive interim results from an early-stage trial of the vaccine that targeted H5 bird flu virus, tested in 300 healthy adults. 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis," the company said in a statement. H5N1 bird flu viruses spread from wild birds into cattle in the U.S. last year, infecting hundreds of animals in several states. At least 70 people in the U.S. have been sickened by bird flu infections, mostly mild. One person died. Scientists fear that continued mutation of the virus could allow it to become more virulent or more easily spread in people, with the possibility that it could trigger a pandemic. Moderna received $176 million in July 2024 and $590 million in January. The January award would have supported a late-stage clinical trial that could have determined the vaccine's efficacy against pandemic viruses, including bird flu, a company spokesman said.
Yahoo
29-05-2025
- Business
- Yahoo
Moderna, Inc. (MRNA) Reports Strong H5 Avian Flu Vaccine Data Despite HHS Funding Cut
Moderna, Inc. (NASDAQ:MRNA) announced today that its investigational H5 avian influenza vaccine, mRNA-1018, has shown promising interim results in a Phase 1/2 clinical trial involving 300 healthy adults. The vaccine, which uses Moderna, Inc. (NASDAQ:MRNA)'s mRNA technology, demonstrated a rapid, potent, and durable immune response. Three weeks after the second dose, nearly 98% of participants reached antibody levels considered protective, with titers rising over 44-fold from baseline. The vaccine was generally well-tolerated, with most side effects being mild to moderate, and no serious safety concerns reported. A scientist studying a petri dish with magnifying glass in a laboratory setting. Despite these encouraging results, MRNA revealed that the U.S. Department of Health and Human Services (HHS) has decided to terminate its award for late-stage development and the right to purchase pre-pandemic influenza vaccines. This unexpected move introduces uncertainty for the program's future. Moderna, Inc. (NASDAQ:MRNA)'s CEO, Stéphane Bancel, emphasized the importance of mRNA technology in pandemic preparedness and stated the company will seek alternative paths for advancing the H5 vaccine. Additional data from the study will be presented at an upcoming scientific conference. MRNA remains committed to developing solutions for emerging health threats and will continue to pursue options for the H5 program's late-stage development and manufacturing. While we acknowledge the potential of MRNA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MRNA and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
29-05-2025
- Business
- Business Insider
Moderna confirms HHS to terminate flu vaccine award
Moderna (MRNA) announced positive interim data from a Phase 1/2 clinical study evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype. The company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services; however, on Wednesday Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines. 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,' said Stephane Bancel, Chief Executive Officer of Moderna. 'These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.' The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition antibody titers greater than or equal to1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers greater than or equal to1:40 with a 44.5-fold increase of titers from baseline. The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting. Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company's strategic commitment to pandemic preparedness.
