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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As colorectal cancer (CRC) is now the leading cause of cancer death in adults under 50, a new report reveals some surprising shifts in the incidence of the disease.
Although rates of CRC have been declining among seniors, those 65 and under are facing a rise in diagnoses, according to a report titled Colorectal Cancer Statistics, 2026, from the American Cancer Society.
Adults 65 and younger comprise nearly half (45%) of all new colorectal cancer cases — a significant increase from 27% in 1995, states the report, which was published in CA: A Cancer Journal for Clinicians.
The disease is rising fastest among adults 20 to 49 years old, at a rate of 3% per year.
Colorectal cancer is now the leading cause of cancer death in adults under 50. (iStock)
Among adults 50 and under, 75% of colorectal cancers are diagnosed at an advanced stage. Half of the diagnoses in that age range are made between the ages of 45 and 49. Although that age group is eligible to receive routine screenings, just 37% do so.
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The report also revealed that rectal cancer is on the rise, now accounting for about one-third (32%) of all CRC cases — an increase from 27% in the mid-2000s.
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“After decades of progress, the risk of dying from colorectal cancer is climbing in younger generations of men and women, confirming a real uptick in disease because of something we’re doing or some other exposure,” said Rebecca Siegel, senior scientific director, surveillance research at the American Cancer Society and lead author of the report, in a press release.
Among adults 50 and under, 75% of colorectal cancers are diagnosed at an advanced stage. Half of the diagnoses in that age range are made between the ages of 45 and 49. (iStock)
“We need to redouble research efforts to understand the cause, but also circumvent deaths through earlier detection by educating clinicians and the general public about symptoms and increasing screening in people 45-54 years.”
It is projected that 158,850 new cases of colorectal cancer will be diagnosed this year, and that the disease will cause 55,230 deaths, per the report.
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More than half of CRC cases can be linked to high-risk behaviors, the researchers said. Those include lack of nutrition, high alcohol consumption, smoking, lack of exercise and obesity.
“These findings further underscore that colorectal cancer is worsening among younger generations and highlight the immediate need for eligible adults to begin screening at the recommended age of 45,” said Dr. William Dahut, chief scientific officer at the American Cancer Society.
When the disease is caught at a local (early) stage, the five-year survival rate is 95%. (iStock)
“The report also shines a light on the crucial importance of continued funding for research to help discover new therapies to treat the disease and advance patient care.”
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When the disease is caught at a local (early) stage, the five-year survival rate is 95%, the report stated.
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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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