United States: US federal regulators seek further data about the protection provided by newly developed COVID-19 flu combination vaccines made from messenger RNA antibodies.
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Modern Researchers at vaccine producer Moderna released a paper Wednesday showing that their new combination vaccine stimulated more robust immune responses to COVID-19 and multiple flu strains above individual shots in people aged 50 and up.
Patients who received the vaccine experienced pain near the injection site, combined with fatigue and headaches as side effects.
A summary of trial data came from Moderna for the 8,000-person study, which was conducted independently.
The mRNA technique powers approved COVID-19 and RSV vaccines, though it remains unapproved for flu vaccines.
Moderna estimates mRNA technology will produce flu vaccines faster than time-consuming methods based on eggs and cell culture production systems.
Moderna researchers reported that the new combo shot generated a stronger immune response against COVID-19 and most strains of flu than existing standalone shots in people 50 and older. Side effects were injection site pain, fatigue and headaches. https://t.co/xtMXMrxgjl
— WPRI 12 (@wpri12) May 7, 2025
According to researchers, the JAMA publication detailed how a combination vaccine could potentially boost vaccination numbers.
According to Dr. Greg Poland, who studies vaccine responses at the Mayo Clinic outside the research team, the combined vaccine approach shows insufficient evidence of public acceptance.
The all-year presence of COVID-19 poses complications for vaccine timing to maintain robust protection as the flu virus spreads in traditional seasonal patterns, according to experts.
Dr. Poland desires to see research demonstrating the effectiveness of the new combination vaccine in preventing cases of infection and hospitalizations.
After collecting blood samples from participants at day 29, researchers measured their antibody levels, which indicated brief disease protection.
Moderna postponed its vaccine approval target for 2026 when the Food and Drug Administration demanded direct measures instead of antibody measurements last week.
“I agree in this case with the FDA that efficacy data are important to see,” Poland stated.
Researchers needed evidence to show the depth of disease protection provided by the vaccine.