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Medscape
03-06-2025
- Health
- Medscape
Could One Shot Replace Flu and COVID-19 Vaccines?
A novel multicomponent messenger RNA (mRNA) vaccine, mRNA-1083, demonstrated noninferiority to standard influenza and COVID-19 vaccines in adults aged 50 years or older, eliciting higher immune responses against most influenza strains (A/H1N1, A/H3N2, B/Victoria, and B/Yamagata) and SARS-CoV-2 ( Omicron XBB.1.5), according to a pivotal phase 3 study. METHODOLOGY: The mRNA-1083 is an investigational, multicomponent vaccine that combines the components of a hemagglutinin-based influenza vaccine (mRNA-1010) and a second-generation SARS-CoV-2 vaccine encoding the spike glycoprotein's N-terminal and receptor-binding domains. Researchers present interim findings of a phase 3 trial that assessed the immunogenicity and safety of this vaccine in adults aged 50 years or older across the United States, enrolling participants between October 19, 2023, and November 21, 2023. They randomly assigned 8061 participants to receive either the mRNA-1083 vaccine plus placebo or the active comparator vaccines for seasonal influenza or COVID-19. Participants were stratified into those older than 65 years (n = 4017; 54.2% women) and those aged 50-64 years (n = 3998; 58.8% women). The primary objective was to demonstrate the noninferiority of humoral immune responses — measured by antibody levels — to mRNA-1083 vs active influenza and COVID-19 vaccines against vaccine-matched strains, 29 days post-vaccination. TAKEAWAY: The mRNA-1083 vaccine demonstrated noninferiority to the active comparator vaccines against the four influenza strains and SARS-CoV-2 in both age groups, as determined by a 97.5% CI lower bound greater than 0.667 for the geometric mean ratio and more than −10% for the seroconversion rate difference. In adults aged 50-64 years, mRNA-1083 elicited superior immune responses to all four influenza strains relative to the active comparator influenza vaccines, whereas in adults aged 65 years or older, superiority was observed for three strains (A/H1N1, A/H3N2, and B/Victoria). Most local and systemic adverse reactions were grade 1 or 2 across vaccine groups. Grade 4 adverse reactions, all of which were systemic events (fever), were reported by two participants in each age group. In both age groups, no severe or serious adverse events or adverse events of special interest were deemed vaccination-related. No deaths or cases of myocarditis or pericarditis were reported. IN PRACTICE: 'As such, an annual vaccination campaign with a multicomponent vaccine could occur during the seasonal period when the burden of respiratory hospitalizations is the greatest, while allowing for a standalone COVID-19 vaccine option for additional doses or if the vaccine is updated in the interim should any antigenically divergent strain emerge,' the authors wrote. SOURCE: This study was led by Amanda K. Rudman Spergel, MD, Moderna Inc., Cambridge, Massachusetts. It was published online on May 7, 2025, in JAMA . LIMITATIONS: The efficacy of mRNA-1083 was not established in the study and requires further investigation. Although the diversity of the study population mirrored that of the general US population, the results may not be generalizable to other geographic areas. DISCLOSURES: This study was funded by Moderna, Inc. Many authors were employees of Moderna and may hold stock or stock options.
Economic Times
29-05-2025
- Business
- Economic Times
Big blow to Moderna vaccine projects as Trump cancels over $700 million funding
The Trump administration has slashed $766 million allocated in funding to Moderna Inc., an American biotech and pharmaceutical company responsible for developing vaccines. Moderna was tasked to make vaccines against potential pandemic influenza viruses, as well as the H5N1 bird flu. This comes at a time when a new Covid strain has sparked concerns in the US. Tired of too many ads? Remove Ads Trump cancels contract Moderna's award Tired of too many ads? Remove Ads The Trump administration cancelled more than $700 million award to Moderna to develop an mRNA vaccine for bird flu in humans, the company announced Wednesday. It has also cancelled the right to purchase shots, according to the January, Moderna was awarded $590 million by the Biden administration to advance the development of its bird flu vaccine, and support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. This was in addition to the $176 million granted last year by the US Department of Health and Human Services for the advanced development and testing of a pre-pandemic mRNA vaccine targeting H5N1 avian influenza, Moderna announced plans to consider alternative options for the vaccine's late-stage development and production. But the company said it would explore alternatives for further developing and manufacturing the secretary Robert F. Kennedy has expressed his concerns regarding the company's vaccines despite evidence that vaccines developed by Moderna are safe and have saved millions of lives before. '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," said the company in a statement as reported by AP. Using the same technology used to develop and roll out vaccines during the Covid-19 pandemic, Moderna has developed a new vaccine called reported positive early stage data on the mRNA vaccine, saying clinical testing in roughly 300 adults was found to be generally well-tolerated. Participants achieved 98% immunity within three weeks of the second dose of the vaccine, the company said."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," Moderna CEO Stéphane Bancel said in a statement. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."Meanwhile, a new and highly contagious Covid-19 variant, labeled NB.1.81, has emerged in the United States. First detected in late March and early April among international travelers, the variant has since been reported in several states, including New York, Ohio, California, Rhode Island, Hawaii, Washington, and a related concern, last year saw the H5N1 bird flu virus jump from wild birds to cattle, resulting in infections among hundreds of animals across multiple states. Seventy people fell ill with the flu, and one fatality was reported. Scientists continue to warn that ongoing mutations or evolution of the virus could increase its severity and potentially trigger a pandemic.
Time of India
29-05-2025
- Business
- Time of India
Big blow to Moderna vaccine projects as Trump cancels over $700 million funding
The Trump administration has slashed $766 million allocated in funding to Moderna Inc., an American biotech and pharmaceutical company responsible for developing vaccines. Moderna was tasked to make vaccines against potential pandemic influenza viruses, as well as the H5N1 bird flu. This comes at a time when a new Covid strain has sparked concerns in the US. Tired of too many ads? Remove Ads Trump cancels contract Moderna's award Tired of too many ads? Remove Ads The Trump administration cancelled more than $700 million award to Moderna to develop an mRNA vaccine for bird flu in humans, the company announced Wednesday. It has also cancelled the right to purchase shots, according to the January, Moderna was awarded $590 million by the Biden administration to advance the development of its bird flu vaccine, and support the expansion of clinical studies for up to five additional subtypes of pandemic influenza. This was in addition to the $176 million granted last year by the US Department of Health and Human Services for the advanced development and testing of a pre-pandemic mRNA vaccine targeting H5N1 avian influenza, Moderna announced plans to consider alternative options for the vaccine's late-stage development and production. But the company said it would explore alternatives for further developing and manufacturing the secretary Robert F. Kennedy has expressed his concerns regarding the company's vaccines despite evidence that vaccines developed by Moderna are safe and have saved millions of lives before. '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," said the company in a statement as reported by AP. Using the same technology used to develop and roll out vaccines during the Covid-19 pandemic, Moderna has developed a new vaccine called reported positive early stage data on the mRNA vaccine, saying clinical testing in roughly 300 adults was found to be generally well-tolerated. Participants achieved 98% immunity within three weeks of the second dose of the vaccine, the company said."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," Moderna CEO Stéphane Bancel said in a statement. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats."Meanwhile, a new and highly contagious Covid-19 variant, labeled NB.1.81, has emerged in the United States. First detected in late March and early April among international travelers, the variant has since been reported in several states, including New York, Ohio, California, Rhode Island, Hawaii, Washington, and a related concern, last year saw the H5N1 bird flu virus jump from wild birds to cattle, resulting in infections among hundreds of animals across multiple states. Seventy people fell ill with the flu, and one fatality was reported. Scientists continue to warn that ongoing mutations or evolution of the virus could increase its severity and potentially trigger a pandemic.
Bloomberg
26-02-2025
- Business
- Bloomberg
Trump Team Weighs Pulling Funding for Moderna Bird Flu Vaccine
US health officials are reevaluating a $590 million contract for bird flu shots that the Biden administration awarded to Moderna Inc., people familiar with the matter said. The review is part of a government push to examine spending on messenger RNA-based vaccines, the technology that powered Moderna's Covid vaccine. The bird flu shot contract was awarded to Moderna in the Biden administration's final days, sending the company's stock up 13% in the two days following the Jan. 17 announcement.
