A combination COVID flu vaccine is apparently one step closer to being commercialized.
Moderna, which has the experimental vaccineannounced Monday that mRNA-1083 achieved a better immune response than other vaccines in Phase 3 clinical trials.
The combination vaccine includes mRNA-1010 (Moderna's seasonal flu vaccine candidate) and mRNA-1283 (the company's “next generation vaccine”). Covid-19 vaccine candidate”), according to a company press release.
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“These data serve as a milestone in the industry's push for a combination vaccine against influenza and COVID-19 that could change the way we approach the respiratory disease season,” said Francesca Ceddia, Chief Medical Affairs Officer at Moderna, in a statement to Fox. News Digital.
With this new announcement from Moderna, a combination COVID flu vaccine is one step closer to hitting the market. (iStock)
“With mRNA-1083, we may be able to not only provide the convenience of double protection in one shot, but also provide improved immunity compared to current standalone vaccines against the two respiratory diseases that place the greatest burden on healthcare systems. she continued.
“Our hope is that with greater convenience comes greater compliance – promoting public health and reducing the number of serious outcomes from COVID-19 and influenza.”
According to the company's press release, Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine.
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Moderna's Phase 3 trial was a randomized, double-blind study that included two independent groups, each consisting of 4,000 adults.
One group consisted of adults of the same age 65 and olderwhich compared the experimental vaccine to Fluzone HD, an improved flu vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine, the release said.
Moderna announced Monday that mRNA-1083 achieved a better immune response than other vaccines in Phase 3 clinical trials. (REUTERS/Brian Snyder)
The second group, consisting of adults 50 to 64 years old, compared mRNA-1083 with Fluarix, a standard-dose flu vaccine, and Spikevax.
In both groups, mRNA-1083 resulted in “statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2 and B/Victoria) and against SARS-CoV-2,” the release said.
“One can never predict rare side effects.”
Amrie Grammer, a Virginia-based immunologist who previously worked at the National Institutes of Health, was not involved in the research or vaccine development but commented on the findings.
“Moderna's results from their Ph3 NCT06097273 trial indicate that the double SARS-CoV-2/flu immunization is no less effective than two single shots,” Grammer told Fox News Digital.
In both groups, mRNA-1083 resulted in “statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2 and B/Victoria) and against SARS-CoV-2.” (iStock)
“This makes it easier for more Americans to protect themselves from these two serious infections, especially those 65 and older who are at greatest risk for COVID and flu-related deaths,” she continued.
“Ninety percent of deaths from COVID and 70% to 85% of deaths from flu in 2023 were people over 65.”
“This is especially good news for people who are wary of too many vaccines, even if they believe in them.”
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, was also not involved in the process but shared insights.
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“Moderna has been working to combine a vaccine to combat both the latest subvariant of the coronavirus and the flu strain of the year,” he told Fox News Digital.
“The Phase 3 clinical trials look excellent – safe and effective, with more antibodies against both than either immunization given separately.”
Overall, the experimental vaccine showed an “acceptable tolerability and safety profile,” Moderna said. (iStock)
The effectiveness is likely due to the vaccine “waking up” the immune system to both viruses at the same time, creating a stronger, more varied and longer-lasting response, Siegel said.
“This is especially good news for people who are wary of too many vaccines, even if they believe in them,” he said.
“The most commonly requested side effects were injection site pain, fatigue, muscle pain and headache.”
“This inclusion creates a 'two-for' option and should be a useful tool, especially if GPs have easy access to it.”
Overall, the experimental vaccine showed an “acceptable tolerability and safety profile,” Moderna said.
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“The most commonly requested side effects were injection site pain, fatigue, muscle aches and headaches,” the release said.
As Grammer noted, Moderna's Phase 3 trial included thousands of people with a “modest profile of side effects, but rare side effects can never be predicted.”
As of May 2022, only about 23% of U.S. adults are aware of the COVID vaccines, according to data from the CDC. (Julian Stratenschulte/dpa)
Siegel also agreed with the vaccine's safety profile.
“Contrary to some public statements, this has been shown to be generally a very safe technology, although it does cause short-term side effects such as a sore arm and, in rare cases, slightly more pronounced or longer lasting ones,” he told Fox NewsDigital. .
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Only about 23% of U.S. adults are up to date on COVID vaccines as of May 2022, according to data from the Centers for Disease Control and Prevention (CDC).
Flu vaccination coverage for adults was about 47% in January 2024, according to the CDC.
The effectiveness is likely due to the fact that the vaccine “wakes up” the immune system to both viruses at the same time, a doctor noted. (iStock)
Looking ahead, Moderna plans to present and submit Phase 3 clinical data for publication.
“Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference and submit it for publication,” the press release said. “The company will engage with regulators about next steps.”
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Both Novavax and Pfizer-BioNTech are also conducting ongoing clinical trials of SARS-CoV-2/flu vaccines, Grammer points out.
“Our Phase 3 combination study in COVID-19 and influenza is on track to start in the second half of this year,” a Novovax spokesperson told Fox News Digital.
“A single combination vaccine visit creates a convenience that we believe can translate into improved vaccination rates, especially among older adults, who are most at risk.”
Fox News Digital reached out to Pfizer for comment.
