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New FDA restrictions will make COVID-19 vaccines only available to elderly and people with medical conditions
Large, lengthy studies will be needed for the agency to approve boosters for healthy adults and children, regulators said.
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A new mandate from the U.S. Food and Drug Administration will likely impede healthy adults and children from getting COVID-19 shots this fall.
The vaccines will only be available to adults over 65 and to people older than 6 months old who have at least one medical condition that puts them at risk for severe COVID. The FDA will now "demand robust, gold-standard data" on the efficacy of yearly vaccine updates â in the form of large clinical trials â before approving them for people at "low risk" of COVID, agency officials announced in a paper published in the New England Journal of Medicine on Tuesday.
MORE:Â New ways to test for prostate cancer are being developed to help with early detectionThis is a major shift from recent years in which updated COVID shots have been available once drugmakers give evidence that they provide as much protection as the previous year's vaccines. Between 100 million and 200 million Americans will have access to COVID vaccines, according to the paper, but it is unclear how people who don't fall under that age and health criteria will be able to get them.
The Centers for Disease Control and Prevention's list of risk factors for severe COVID include cancer, asthma, HIV and other chronic diseases. It also includes obesity, pregnancy and depression. But some health experts are worried about how vaccine eligibility will be determined under the new framework.
"Is the pharmacist going to determine if you're in a high-risk group?â Dr. Paul Offit, a vaccine expert at Children's Hospital of Philadelphia, asked in an Associated Press story. âThe only thing that can come of this will make vaccines less insurable and less available."
Requiring lengthy studies before approving updated vaccines for healthy people "will provide information that is desperately craved by health care providers and the American people," FDA Commissioner Marty Makary and the FDA's new vaccine regulator Vinay Prasad wrote in the New England Journal of Medicine.
"We simply donât 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. This policy will compel much-needed evidence generation," Makary and Prasad wrote.
The new framework falls in step with Health and Human Services Secretary Robert F. Kennedy Jr.'s longtime anti-vaccine and anti-mRNA â the technology used to develop COVID vaccines â stance. In May 2021, Kennedy filed a petition requesting the FDA revoke authorization for COVID vaccines and refrain from approving them in the future.Â
The new guidelines don't make sense from a public health standpoint, Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, told the New York Times.
"This is overly restrictive and will deny many people who want to be vaccinated a vaccine," Durbin said.
For the week ending May 10, 0.5% of all deaths nationwide were due to COVID, according to the CDC. In Philadelphia, there were three deaths and nearly 100 hospitalizations because of the disease in March, the most recent statistics available.
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