Health
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.”
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.
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 Novovax 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.
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The latest COVID-19 vaccine (2024-2025) has been linked to fewer serious heart-related events among U.S. veterans.
New research confirmed a small reduction in COVID-related cardiovascular events, or COVID-19-associated MACE, due to the vaccine.
MACE (major adverse cardiovascular events) is a composite measure of serious heart-related outcomes. It typically includes cardiovascular death, heart attack and stroke, and may also include hospitalization for heart failure.
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Using health records from the U.S. Department of Veterans Affairs, the researchers compared two groups of veterans — one that received the COVID and flu vaccine on the same day (nearly 350,000 people) and another group that received only the flu vaccine (nearly 700,000 people).
For people older than 75, vaccine effectiveness against COVID-associated MACE was 50.7%. (iStock)
Out of more than one million veterans studied, the average age was about 70 and 92% were male, according to a press release.
Within about eight months, the results showed that those who received the 2024-2025 COVID vaccine had a lower risk of COVID-associated major cardiovascular events, with a relative vaccine effectiveness of 37.7%.
The COVID vaccine was linked to a 57.9% lower risk of cardiovascular death, 38.5% lower risk of heart attack and 41.9% lower risk of hospitalization for heart failure, the researchers stated. The result for stroke was not statistically significant.
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The benefit was greatest among adults ages 75 and older and those with underlying health conditions. In people over 75, the vaccine was 50.7% effective at preventing COVID-associated MACE.
As the study was observational, it could not prove cause and effect between the COVID-19 vaccine and lower risk of cardiovascular events, but only highlighted an association.
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Dr. Glenn Hirsch, cardiologist at National Jewish Health in Denver, Colorado, called these results “not overall surprising” in an interview with Fox News Digital.
After eight months, those who received the 2024-2025 COVID vaccine had a lower risk of COVID-associated major cardiovascular events. (iStock)
“This result is consistent with previous studies of the COVID-19 vaccine and other vaccines against infectious diseases [in] preventing cardiovascular events, including heart attack, cardiovascular cause of death or hospitalizations,” he said.
Acute inflammation in the body from infections like COVID-19 increases the risk of cardiovascular events and can cause further complications, according to the doctor.
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“This can lead to a higher risk of blood clotting, but can also make arterial plaques susceptible to rupture, which then leads to clot formation to heal a ruptured plaque,” he said. “This clotting can cause a near-total or complete occlusion of an artery, leading to these cardiovascular events.”
“Vaccines either prevent infection or reduce the severity of infection and subsequent inflammation, lowering the cardiovascular risk.”
Acute inflammation in the body from infections like COVID-19 can increase the risk of cardiovascular events, the study suggests. (iStock)
Despite the positive outcome, the overall benefit of the vaccine in this study was less than in previous studies, according to Hirsch, who was not involved in the research.
This could be due to the lower severity of illness seen in more recent COVID-19 variants, as well as immunity from prior infections among unvaccinated people, he noted. There has also been a decline in COVID testing, making it more difficult to link cardiovascular events to the virus.
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“The bottom line [is] that there is still evidence of benefit from COVID-19 vaccination like many other infectious disease vaccinations, and people should be encouraged to discuss these with their healthcare team annually,” Hirsch advised.
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“This is an observational trial and there can always be some confounding after necessary statistical adjustments and other potential benefits or harms, including adverse effects from vaccines that were not investigated in this study,” he added.
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A former “Real Housewives of Beverly Hills” star is speaking out about a fresh wave of health issues.
Brandi Glanville, 53, has been speaking publicly about ongoing swelling, lumps and paralysis of her face since 2023.
At the time, the reality star shared that she believed she had been infected with a parasite during a trip to Morocco, Fox News Digital previously reported.
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After the initial diagnosis, she suspected she contracted a parasite in Morocco and said she could feel it moving within her face.
Brandi Glanville attends the grand opening of Beverly Hills Rejuvenation Clinic West Hollywood in West Hollywood, Calif., on April 25, 2024. (Paul Archuleta/Getty Images)
Glanville was first diagnosed with stress-induced angioedema, a sudden swelling of the deeper layers of the skin and mucous membranes, according to Cleveland Clinic.
Angioedema “is a reaction similar to hives that affects deeper layers of the skin. It can appear with hives or alone,” Mayo Clinic states.
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Most recently, in a June 18 episode of her podcast “Brandi Glanville Unfiltered,” Glanville revealed that doctors discovered a “benign tumor” in one of her facial lymph nodes.
The reality star, who has previously speculated that a parasite may be contributing to her facial symptoms, said the finding could help explain the swelling and fluid buildup she has experienced and noted that she has had a lump in her face for “years.”
Brandi Glanville, 53, has been speaking publicly about ongoing swelling, lumps and paralysis of her face since 2023. (Mega/GC Images)
“I don’t know what’s wrong with me, guys. I thought I was fixed, and then it happened again and now it’s sinking in again,” Glanville said in another June podcast.
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“It could be why the fluid is going around my face and why I’m having a hard time,” she added.
While benign tumors of the face have been known to arise from fat tissue, blood vessels, skin structures, salivary glands or lymphatic tissue, Glanville has not publicly disclosed the specific type of diagnosis she received.
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Prior to learning of the tumor, Glanville said she saw dozens of doctors and spent over $100,000 trying to pinpoint the source of the issue.
Brandi Glanville shares images of painful facial burns caused by Nair hair removal cream in a viral TikTok video. (Brandi Glanville/TikTok)
The reality star emphasized that the tumor is “not cancerous.”
“I haven’t had a face lift yet!” she added.
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Glanville also said she suspected her ruptured breast implants could have played a role in her health issues, claiming the leaking silicone had clogged her lymph nodes.
Fox News Digital reached out to Glanville for comment.
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