A new flu vaccine took a step closer to being launched on the US market this Thursday, after federal health advisors recommended approval of the first vaccine made with the same mRNA technology that was key to ending the COVID-19 pandemic.
The Food and Drug Administration (FDA) is evaluating Moderna’s new vaccine, called mFlusiva, for older Americans ahead of the winter flu season.
Moderna is seeking full approval for use of the vaccine in people ages 50 to 64, along with authorization for use in people ages 65 and older, while it conducts additional testing.
The FDA’s independent advisory committee evaluated Moderna’s studies of the vaccine and voted unanimously that its benefits appear to outweigh any risks for both age groups. The FDA will consider that recommendation when making a final decision in early August.
Tens of thousands of Americans die from the flu each year, and older adults are among the most vulnerable. There are already several types of flu vaccines available in the U.S., including three specifically recommended for people 65 and older.
However, vaccines made with Nobel Prize-winning mRNA technology are made faster than other types, something experts say could be useful if the flu virus, which constantly changes shape, mutates in such a way that new doses need to be produced suddenly to counter it.
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“Having this technology puts us in a better position to be prepared for emerging strains in the future,” said Dr. Flor Muñoz-Rivas, from Texas Children’s Hospital, one of the FDA advisors.
In a study of 40,000 people ages 50 and older, Moderna’s mRNA vaccine reduced flu cases by about 27% compared to those who received another commonly used brand of vaccine.
In a smaller study of people 65 and older, Moderna’s vaccine also generated a strong protective immune response compared to a high-dose flu vaccine already recommended for that age group.
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The data showing strong immune reactions “was very compelling,” said FDA adviser Dr. Anna Durbin of Johns Hopkins University, adding that “the vaccine looks very promising”.
Moderna’s Dr. Rituparna Das told panel members that the company’s ability to quickly manufacture mRNA vaccines that closely match the latest flu strains could prevent thousands of hospitalizations among older Americans.
Severe flu cases in the United States tend to increase in years when the flu vaccine does not match the circulating virus well.
Moderna representatives noted that flu strains for each fall’s vaccines are now chosen several months ahead of the annual update of the formula for COVID-19 vaccines, which are mostly mRNA-based, and there may be a mismatch if the flu virus mutates after the formula has been made.
At the meeting, Dr. Timothy Brennan, an FDA vaccine evaluator, suggested that the agency was willing to approve the vaccine for older adults before the next flu season, even though more information is needed about its use in frail older people or people with weakened immune systems.
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If approved, Moderna plans to conduct the mandatory next-stage study, which will include 400,000 people age 65 and older; Half will be given the mRNA vaccine and the rest will be given one of the current vaccines specific to older people. This study is planned to be repeated during two flu seasons.
Moderna’s data showed no major safety concerns, although the vaccine did cause some temporary reactions, such as pain at the injection site, fever, headache, tiredness and aches. These last reactions are common in various vaccines, but occurred a little more frequently than with current flu vaccines. The FDA noted that this is typical for mRNA vaccines.
Those temporary reactions may be a sign that “your immune system is responding,” said Dr. Hayley Gans, a pediatrician at Stanford Medicine and an FDA advisor, who stressed that it will be important to explain this to those who receive the vaccine.
Earlier this year, Moderna data was at the center of a highly unusual public controversy, as a top FDA official at the time blocked the company’s application for its vaccine, the first of its kind.
Then-vaccine chief Dr Vinay Prasad, who was at the center of the controversy, said the company should have compared its vaccine to a high-dose flu vaccine recommended for older people, rather than a standard-dose brand. It was a sign of increased FDA scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.
Moderna challenged that decision, noting that FDA staff had approved the design of that main study and citing a smaller, independent study comparing the mRNA vaccine to a high-dose vaccine for older people. Days after the dispute, the FDA accepted Moderna’s request.
Modern is also studying the vaccine in younger adults and plans to conduct an independent study in youth ages 9 to 17 this fall.
