Washington (AP) – COVVI-19 annual plans For young adults and healthy children will no longer be Systematically approved Under a new major change of policy unveiled Tuesday by Trump administration.
Senior officials for Food and Drug Administration Presented with new requirements for access to annual coastal plans, saying that they would continue to use a rationalized approach that would continue to offer them to adults aged 65 and over as well as younger children and adults with at least one health problem that endangers them.
But the FDA framework urges companies to carry out important and long studies before modified vaccines can be approved for healthier people. In a framework Posted Tuesday in the New England Journal of MedicineAgency officials said the approach may still maintain the annual vaccinations available between 100 million and 200 million people.
The upcoming changes raise questions for people who may still want a COVVI-19 autumn shot but do not clearly enter one of the categories.
AB AP: The new Trump vaccine policy limits access to the coast
Lisa Dwyer of AP reports that there are new requirements for hairstyle vaccines for healthy adults and children.
“Will the pharmacist determine if you are in a high-risk group?” Asked Dr. Paul Offer, a vaccination expert at the Children’s Hospital in Philadelphia. “The only thing that can result will make vaccines less assurable and less available.”
The frame is the culmination of a Recent steps seriesballot The use of counted plans and raising major questions about the wider availability of vaccines under President Donald Trump. It was published two days before the first meeting of FDA external vaccine experts under the Trump administration.
Last week, the FDA granted the complete approval of the COVVI-19 vaccine from Novavax But with major restrictions on who can get it – and Tuesday’s advice reflect these restrictions. The approval came after Trump’s nominees canceled the previous plans of FDA scientists to approve the fire without restrictions.
Pfizer and Moderna, which make the most used COVI-19 vaccines, did not immediately comment.
For years, federal health officials have told most Americans to wait for annual updates to COVVI-19 vaccines, similar to the annual flu vaccine. As with the flu vaccines, so far, the FDA has approved updated coated shots when manufacturers provide evidence that they arouse as much immune protection as the version of the previous year.
But the new FDA directives seem to be the end of this approach under Health Secretary Robert F. Kennedy Jr.Who has completed the FDA and other health agencies with frank criticism of the government of the government of the co -via plans, in particular their recommendation for young adults and healthy children. Under federal procedures, the FDA publishes new directives in the form of a project and allows the public to comment before finalizing its plans. The publication of Tuesday’s policy in a medical journal is very unusual and could arise for federal procedures, according to FDA experts.
Tuesday update, written by FDA Commissioner Marty Makary And The head of the FDA Vinay Prasad vaccineCriticized the United States’s approach to “one-sized” and declares that the United States has been “the most aggressive” to recommend coastal boosters compared to European countries.
“We simply do not know if a 52-year-old healthy woman with a normal BMI who had covid-19 three times and received six previous doses of a COVVI-19 vaccine will benefit from the seventh dose,” they wrote.
Makary and Prasad have recommended that companies study people not tried at high risk for six months, assigning them at random to obtain a vaccine or placebo and follow -up of results with particular attention to serious illnesses, hospitalization or death.
Experts say that there are legitimate questions about the amount that everyone still benefits from annual vaccination vaccination or if they should be recommended for increased risks.
An influential panel of Centers for Disease Control and Prevention is planned to debate vaccines that should be recommended to groups.
The FDA’s announcement seems to usurp this work of the Advisory Committee, said Offer. He added that CDC studies have clearly indicated that the recall doses offer protection against light to moderate disease for four to six months after the shot even in healthy people.
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