The agency is changing the type of evidence it will accept from vaccine manufacturers to approve updated Covid-19 shots, Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary said in an editorial published Tuesday in the New England Journal of Medicine.
Stricter FDA policy for Covid vaccines: 10 points
-The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy Americans under 65. Critics said the move will make access difficult for people who are not high risk but want to be vaccinated against the disease.
-The new strategy would continue the current vaccine approval process for people ages 65 and older and younger people with health problems that put them at high risk, according to an article published Tuesday in The New England Journal of Medicine.
ALSO READ: Trump’s One big, Beautiful bill: When will no tax on tips, overtime, Social Security start?
-Top FDA officials have introduced a new framework for approving COVID-19 vaccines. Under this plan, booster shots will be made available to Americans aged 65 and older, as well as to adults and children over 6 months old who have at least one condition that heightens their risk of developing severe COVID-19.
-The FDA framework, published Tuesday in the New England Journal of Medicine, urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people, reports news agency AP. It is in contrary from the previous federal policy recommending an annual COVID shot for all Americans six months and older.
-Vinay Prasad, the controversial director of the Center for Biologics Evaluation and Research, described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.
-The nation’s leading pediatrics group said FDA’s approach will limit options for parents and their children. “If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary of the American Academy of Pediatrics.
-According to provisional data from the Centers for Disease Control and Prevention, over 47,000 Americans died from causes related to COVID-19 last year. In two-thirds of those cases, the virus was identified as the primary cause of death, while in the remaining cases, it was a contributing factor.
-The new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr. scrutinizing the use of COVID shots and raising questions about the broader availability of vaccines. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under Trump.
ALSO READ: Donald Trump’s tax on imported goods is a blow to income tax relief? Check details
-Last week, the FDA granted full approval to Novavax’s COVID-19 vaccine, but with significant restrictions on eligibility — restrictions that were echoed in Tuesday’s guidance. The decision followed an intervention by Trump-appointed officials, who overruled FDA scientists’ initial plans to approve the vaccine without limitations.
-For years, federal health officials have advised most Americans to anticipate yearly COVID-19 vaccine updates, much like the annual flu shot. As with flu vaccines, the FDA has so far approved updated COVID vaccines as long as they provide immune protection comparable to the prior year’s formulation.
(With inputs from AP)
