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Moderna's New Flu-COVID Combi MRNA Vaccine Outperforms Separate Shots In Trials

Pharmaceutical company Moderna has announced that a combination vaccine it has been developing against flu and COVID-19 has performed well so far in Phase 3 trials. The data are yet to be submitted for publication in a peer-reviewed journal, but the company says their combi vaccine has produced stronger immune responses than the already-licensed vaccines it was compared to.

Moderna became a household name thanks to the success of its mRNA vaccine against COVID-19. Along with the Pfizer/BioNTech mRNA vaccine, it remains a cornerstone of the public health response to the pandemic, with the architects of the technology behind them winning a Nobel Prize.

While other vaccines played their part in gaining control of the spread of COVID, some – like the AstraZeneca vaccine – are now being withdrawn, while the mRNA vaccines continue to be updated to match the latest variants.

But COVID-19 is not the only threat out there, and a number of research projects are currently looking to apply mRNA vaccines to other diseases, including cancer. When it comes to respiratory pathogens, a clear target would be influenza. There are around a billion cases of seasonal flu annually and hundreds of thousands of deaths, not to mention the ever-present Damocles' sword of a possible future pandemic.

Influenza viruses and SARS-CoV-2 (the virus behind COVID-19) share a tendency to mutate rapidly. That's why regular booster shots are recommended for COVID and why the seasonal flu shot is updated every year. Moderna's combi vaccine seeks to put both shots into one handy package.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said CEO Stéphane Bancel in a statement.

The combi vaccine, called mRNA-1083, incorporates a candidate vaccine for seasonal flu (mRNA-1010) and Moderna's latest COVID-19 vaccine (mRNA-1283). The Phase 3 clinical trial, which is still ongoing, has recruited two cohorts of approximately 4,000 adults each.

The first cohort are all aged 65 and over. Participants have been randomly assigned to receive either mRNA-1083, or a combination of Moderna's current COVID vaccine (Spikevax®) and a licensed flu vaccine called Fluzone HD®.

The second cohort are aged between 50 and 64. In this group, participants have either received mRNA-1083 or a combination of Spikevax and a standard flu vaccine (Fluarix®).

Moderna reports that the immune response elicited by mRNA-1083 was stronger than that produced by the separate vaccines against SARS-CoV-2 and three different flu strains: H1N1, H3N2, and B/Victoria. MRNA-1083 was also found to be safe, and the majority of side effects experienced were mild and similar to those caused by the separate vaccines. The most common side effects were pain at the injection site, fatigue, muscle aches, and headache.

Moderna now plans to present the data at a medical conference and hopes to publish the findings in a peer-reviewed journal.

"Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine," said Bancel. "Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health."

Moderna's Flu & Covid-19 Combination Vaccine Succeeds In Phase 3 Clinical Trial

Vaccination against seasonal respiratory viruses requires patients to receive a shot for each pathogen. Moderna is a step closer to offering a combination vaccine that protects against both influenza and Covid-19 with a single injection.

Moderna announced on Monday that mRNA-1083, its experimental combination vaccine for flu and Covid-19, elicited higher immune responses compared to individual vaccines currently available to protect against infection from both pathogens. The Cambridge, Massachusetts-based company said it plans to present the full Phase 3 results at an upcoming medical conference and submit them for publication. The company added it will also speak with regulators about the combination vaccine's next steps.

The combination vaccine is a pairing of two experimental Moderna vaccines, mRNA-1010 for seasonal influenza and mRNA-1283 for Covid-19. Spikevax, Moderna's first Covid-19 vaccine, requires ultra-cold storage. By contrast, mRNA-1283 is designed to be stable at refrigerator temperatures. Tested separately, the Moderna flu and Covid-19 vaccines have each demonstrated positive Phase 3 results.

The results announced Monday are from a Phase 3 test that evaluated the combination shot in two groups of about 4,000 adults each. In the group of adults age 65 and older, mRNA-1083 was compared to the co-administration of two commercially available products, the Sanofi flu vaccine Fluzone and Moderna's Spikevax. The second group consisted of adults age 50-64. It compared mRNA-1083 to GSK's flu vaccine Fluarix and Spikevax.

The trial is a non-inferiority study — the main goal is to show that mRNA-1083 works at least as well as the comparator vaccines. The combination shot more than met that goal. Results from both groups showed mRNA-1083 elicited statistically significantly higher immune responses against the H1N1, H3N2, and B/Victoria influenza strains compared to the co-administered commercially available vaccines. The combination shot also led to higher immune responses against SARS-CoV-2 compared to Spikevax.

Moderna said mRNA-1083 showed an acceptable tolerability and safety profile with low-grade adverse reactions that were consistent with those associated with the commercially available vaccines used in the trial. These reactions included injection site pain, fatigue, muscle ache, and headache.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Moderna CEO Stéphane Bancel said in a prepared statement.

Moderna's mRNA-1083 is the most advanced of the company's combination vaccine programs. A flu, Covid-19, and respiratory syncytial virus (RSV) combo shot, named mRNA-1230, is in Phase 1 testing. The RSV component of that combination vaccine is mResvia (formerly mRNA-1345), a vaccine that received FDA approval in late May for use in adults age 60 and older. Moderna is offering this new RSV vaccine in pre-filled syringes. Also in early-stage clinical development are the flu and RSV vaccine candidate mRNA-1045, and the RSV and human metapneumovirus vaccine candidate mRNA-1365.

[Update: The following two paragraphs added with analyst comments.] In a note sent to investors, William Blair analyst Myles Minter wrote that combination vaccines will help Moderna differentiate from competitors and are a key piece to Bancel's stated goal of breaking even by 2026. William Blair believes mRNA-1083 will receive regulatory approval, and when combined with pre-filled syringe formulations, it offers a differentiated and convenient vaccine option with the potential to reduce the cost of goods and improve vaccine efficiency and efficacy.

"The key question for us is how much of the flu vaccination market Moderna can now capture with a combination vaccine, given the vast discrepancy between Covid and flu vaccination rates, or if this combination approach will just cannibalize the company's existing Covid-19 business," Minter said.

Photo: Adam Glanzman/Bloomberg, via Getty Images

COVID-flu Combo Vaccine Shows 'positive' Results In Phase 3 Trials, Moderna Says: A 'two-for' Option

A combination COVID-influenza vaccine is apparently one step closer to hitting the market.

Moderna, which is developing the experimental vaccine, announced Monday that in phase 3 clinical trials, mRNA-1083 achieved a better immune response than other vaccines.

The combination vaccine includes mRNA-1010 (Moderna's vaccine candidate for seasonal influenza) and mRNA-1283 (the company's "next-generation COVID-19 vaccine candidate"), according to a press release from the company.

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"This data serves as a milestone for the industry's pursuit of a flu and COVID-19 combination vaccine, which could change the way we manage the respiratory illness season," Francesca Ceddia, chief medical affairs officer at Moderna, said in a statement to Fox News Digital. 

A combination COVID-influenza vaccine is one step closer to hitting the market with this new announcement from Moderna. (iStock)

"With mRNA-1083, we may be able to not only offer the convenience of dual protection in a single shot, but we also may offer enhanced immunity compared to today's standalone vaccines against the two respiratory diseases with the largest burden on health care systems," she continued.

"Our hope is that with improved convenience comes improved compliance — helping to advance public health and lower rates of severe outcomes related to COVID-19 and flu."

Moderna is the only company with a positive phase 3 flu and COVID combination vaccine, according to the company's press release.

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Moderna's phase 3 trial was a randomized, double-blinded study that included two independent groups, each consisting of 4,000 adults.

One group included adults age 65 and older, who compared the experimental vaccine to Fluzone HD, an enhanced influenza vaccine, and Spikevax, Moderna's currently licensed COVID-19 vaccine, the release stated.

Moderna announced Monday that in phase 3 clinical trials, mRNA-1083 achieved a better immune response than other vaccines. (REUTERS/Brian Snyder)

The second group, which included adults 50 to 64 years old, compared mRNA-1083 to Fluarix, a standard dose influenza 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," according to the release.

"One can never predict rare adverse events."

Florida State Surgeon General Dr. Joseph A. Ladapo, who was not involved in the vaccine trial, shared his reaction in an exclusive statement to Fox News Digital.

"I've made it clear why the mRNA COVID-19 vaccines are not appropriate for human use, and researchers will continue to uncover additional concerns and adverse events caused by these mRNA shots," he said.

Florida State Surgeon General Dr. Joseph A. Ladapo, who was not involved in the vaccine trial, shared his reaction in an exclusive statement to Fox News Digital. (Paul Hennessy/SOPA Images/LightRocket)

"Combining this unsafe product with any vaccine is a mistake, and a disservice to public health."

Amrie Grammer, a Virginia-based immunologist who previously worked with the National Institutes of Health, was not involved in the trial or the vaccine development but commented on the findings.

"Moderna's results from their Ph3 NCT06097273 trial indicate that the dual SARS-CoV-2/influenza 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 simpler for more Americans to protect themselves from these two serious infections, especially those 65 and older who are most at risk for COVID- and flu- related deaths," she continued.

"Ninety percent of deaths from COVID and 70% to 85% of deaths from the flu in 2023 were in those 65 and older."

"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 trial but shared insights. 

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"Moderna has been working on combining a vaccine to fight both the latest coronavirus subvariant and the year's flu strain," he told Fox News Digital. 

"The phase 3 clinical trials look excellent — safe and effective, with more antibodies made against both than when either immunization is given alone."

Overall, the experimental vaccine showed an "acceptable tolerability and safety profile," Moderna stated.  (iStock)

The effectiveness is likely due to the vaccine "waking up" the immune system to both viruses at the same time, causing a stronger, more varied and more durable response, according to Siegel.

"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 solicited adverse reactions were injection site pain, fatigue, myalgia and headache."

"This shot creates a 'two-for' option and should be a useful tool, especially if primary care physicians have ready access to it."

Overall, the experimental vaccine showed an "acceptable tolerability and safety profile," Moderna stated. 

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"The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache," per the release.

As Grammer pointed out, Moderna's phase 3 trial included thousands of people with a "modest adverse event profile, but one can never predict rare adverse events."

As of May 2022, only some 23% of U.S. Adults are up-to-date on COVID vaccines, according to data from the CDC. (Julian Stratenschulte/dpa)

Siegel also chimed in on the vaccine's safety profile.

"Contrary to some public pronouncements, this has been shown to be an overall very safe technology, though it does cause short-term side effects, like sore arm and, rarely, something more pronounced or long-lasting," he told Fox News Digital.

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As of May 2022, only some 23% of U.S. Adults are up-to-date on COVID vaccines, according to data from the Centers for Disease Control and Prevention (CDC).

Flu vaccine coverage for adults was around 47% as of January 2024, per the CDC.

The effectiveness is likely due to the vaccine "waking up" the immune system to both viruses at the same time, a doctor noted. (iStock)

Looking ahead, Moderna plans to present the phase 3 clinical data and submit it for publication.

"Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication," the release stated. "The company will engage with regulators on next steps." 

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Both Novavax and Pfizer-BioNTech also have ongoing clinical trials of SARS-CoV-2/influenza vaccines, Grammer pointed out.

"Our Phase 3 COVID-19-influenza combination study is on track to start in the second half of this year," a spokesperson from Novavax told Fox News Digital. 

"A single combination vaccine visit creates a convenience that we believe can translate into improved vaccination rates, especially in older adults, who are most at risk."

Fox News Digital reached out to Pfizer for comment.

Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.Rudy@fox.Com.

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