New Trump vaccine policy limits access to Covid recordings

Washington (AP) – Annual Covid 19 shots It will no longer be for healthy younger adults and children approved routinely Under a large new political shift that was presented on Tuesday by The Trump administration.

Top officials for the Food and Drug Administration They contained new requirements for access to annual covid recordings and said that they would continue to use an optimized approach that would continue to offer 65 adults and older than children and younger adults with at least one health problem that they take with a higher risk.

However, the FDA frame calls on companies to carry out large, lengthy studies before the vaccines can be approved for healthier people. In a frame Published on Tuesday in the New England Journal of MedicineOfficials from the agency said that the approach could still provide annual vaccinations for 100 million and 200 million people.

The upcoming changes raise questions for people who may still want an autumn-Covid 19 shot, but do not clearly fit into one of the categories.

“Will the pharmacist determine whether you are in a high -risk group?” asked Dr. Paul Offit, a vaccine expert at the children's hospital in Philadelphia. “The only thing that can get from it makes vaccines less insurable and less available.”

The frame is the highlight of A Series of the latest stepscheck The use of Covid shots and the major questions about the more comprehensive availability of vaccines under President Donald Trump. It was published two days before the first meeting of the FDA's external vaccine experts under the Trump administration.

Last week the FDA Gave the full approval of the Novavax Covid 19 vaccine But with great restrictions on who can get it – and the instructions on Tuesday reflect these restrictions. After Trump, the FDA's former plans to approve the shot without restrictions had overridden.

Pfizer and Moderna, which make the most commonly used COVID 19 vaccines, did not immediately comment.

For years, federal health officers have asked most Americans to expect annual updates for COVID 19 vaccines, similar to annual flu vaccination. Just like with flu vaccine, the FDA has approved updated covid recordings if the manufacturers provide evidence that they trigger as much immune protection as the version of the previous year.

But the new guidance of the FDA seems to be the end of this approach Health Minister Robert F. Kennedy Jr.who filled the FDA and other health authorities with pronounced critics of dealing with Covid shots by the government, in particular the recommendation for young, healthy adults and children. As part of the federal procedure, the FDA publishes new guidelines in a design form and enables the public to comment on comment before completing its plans. According to the FDA expert, the publication of the guidelines on Tuesday in a medical journal is very unusual and could carry out the federal procedures.

Tuesday update, written by von von FDA Commissioner Marty Makary And FDA vaccine leader Vinay Prasadcriticized the approach of the United States “one-sized” and explains that the United States has recommended “most aggressive” Covid booster compared to European countries.

“We just don't know whether a healthy 52-year-old woman with a normal BMI who had Covid-19 three times and received six earlier doses of a Covid 19 vaccine from which seventh dose will benefit,” she wrote.

Makary and Prasad recommended that companies who were not classified with high risk for six months to investigate them to become vaccine or placebo and to pursue results with particular attention to serious illnesses, hospital stays or deaths.

Experts say that there are legitimate questions of how much each of the annual covid vaccination is still benefiting or whether they should be recommended for people with increased risk.

An influential body of consultants at the centers for the control and prevention of diseases will discuss which vaccines should be recommended for which groups.

The announcement of the FDA seems to have to overurp this mandate of the advisory committee, said Offit. He added that CDC studies have made it clear that booster sockets after the shot offer protection against slight to moderate diseases even in healthy people four to six months after the shot.

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