The FDA head has called into question whether the agency will approve and authorize the Covid-19 vaccine for the winter.
In August 2024, the United States Food and Drug Administration approved the updated ARNM COVID vaccine to protect current variants and also approved an updated Novavax vaccine.
The FDA curator, Dr. Marty Makary, however, has shown doubts about whether this is necessary for the 2025-2026 season.
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“We are taking a look. I can’t comment on any specific application. As you know, we have a lot of applications for these reinforcement shots,” Makary told CBS News on Tuesday, according to the departure.
In August 2024, the United States Food and Drug Administration approved the updated ARNM COVID vaccine to protect current variants and also approved an updated Novavax vaccine. (Istock)
“I think there is a data gap. And I think instead of allowing this gap to be filled with opinions, I would like to see some good data,” he added.
Makary also mentioned a “public trusted problem” about covid promoters, emphasizing that many health workers chose to receive them last season.
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The head of the FDA has also expressed concern about the lack of data supporting the Covid Vaccine of Novavax, asking for more studies on its effectiveness before passing it.
“The great study of Novavax 2020-2021 excluded people with natural immunity in Covid. Today, there is a wide population immunity and the big question is: it provides a benefit?” He said in an interview with Inside Medicine on Tuesday.
The FDA curator, Dr. Marty Makary, has shown doubts about whether this is necessary for the 2025-2026 season. (Getty’s pictures)
“Without a study of the new formulation and product, we cannot give an honest and evidence -based answer to this question.”
Novavax published an update on Tuesday on its FDA application website for an additional clinical trial.
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“It’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, we need to know if they work today to be able to recommend them,” Makary told CBS News on Tuesday.
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Disease control and prevention centers (CDC) have also been considered to reduce recommendations for generalized cucid vaccines from 2025-2026.
Disease control and prevention centers (CDC) have also been considered to reduce recommendations for generalized cucid vaccines from 2025-2026. (Reuters/Ruvic Dado/Illustration/File Photo)
In a April report, the agency presented three options for Covid Boosters: to maintain the “ universal vaccine policy ” for everyone 6 months and more, to recommend them only to groups with a high risk of severe diseases or to use recommendations based on the risk of up to 64 years of age and then move to universal recommendations at the age of 65.
The main risk factors for severe diseases are to advance age, underlying medical conditions and pregnancy, according to the CDC.
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