Annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a policy shift unveiled Tuesday by the Trump administration.<\/p>\n
Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they\u2019d continue to use a streamlined approach that would make vaccines available to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.<\/p>\n
But the FDA framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million adults.<\/p>\n
The upcoming changes raise questions for people who may still want a fall COVID-19 shot but don\u2019t clearly fit into one of the categories.<\/p>\n
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\u201cIs the pharmacist going to determine if you\u2019re in a high-risk group?\u201d asked Dr. Paul Offit, a vaccine expert at Children\u2019s Hospital of Philadelphia. \u201cThe only thing that can come of this will make vaccines less insurable and less available.\u201d<\/p>\n
The framework is the culmination of a series of recent steps scrutinizing the use of COVID shots.<\/p>\n
For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immune protection as the previous year\u2019s version.<\/p>\n
But the FDA\u2019s new guidance appears to be the end of that approach under Health Secretary Robert F. Kennedy, who has filled the FDA and other health agencies with outspoken critics of the government\u2019s handling of COVID shots, particularly their recommendation for young, healthy adults and children.<\/p>\n
Tuesday\u2019s update, written by FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, criticizes the country\u2018s \u201cone-size-fits-all\u201d approach and states that the U.S. has been \u201cthe most aggressive\u201d in recommending COVID boosters, when compared with European countries.<\/p>\n
\u201cWe simply don\u2019t know whether a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine will benefit from the seventh dose,\u201d they wrote.<\/p>\n
Outside experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccinations or whether they should be recommended for people at increased risk. An influential panel of advisers to the Centers for Disease Control and Prevention is set to debate that question next month.<\/p>\n
The FDA framework announced Tuesday appears to usurp that advisory panel\u2019s job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.<\/p>\n