New Trump Vaccine Policy Limits Access to COVID Shots; FDA Plans to Restrict Annual COVID-19 Shots To Over-65s, and other C-Virus related stories
New Trump vaccine policy limits access to COVID shots:
Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are healthy
The Trump administration said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else — raising questions about whether some people who want a vaccine this fall will be able to get one.
Top officials for the Food and Drug Administration laid out new requirements for access to updated COVID shots, saying they’d continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.
But 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. In the paper and a subsequent online webcast, the FDA’s top vaccine official said still, more than 100 million Americans still should qualify for what he termed a booster under the new guidance.
Dr. Vinay Prasad described the new approach as a “compromise” that will allow vaccinations in high-risk groups while generating new data about whether they still benefit healthier people.
“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA’s handling of drug and vaccine approvals.
It’s unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don’t clearly fit into one of the categories.
“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”
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. —>READ MORE HERE
FDA plans to restrict annual COVID-19 shots to over-65s, officials say:
Healthy Americans under 65 who want an annual COVID vaccine will be out of luck under a new Food and Drug Administration policy unveiled Tuesday.
Under the plan, the FDA will allow seniors and other high-risk populations to receive annual COVID shots, but will hold off on approving them for anyone else until more robust testing is done.
“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted,” read the new framework, published in the New England Journal of Medicine. FDA Commissioner Dr. Martin Makary and vaccine division chief
Dr. Vinay Prasad revealed the plan two days before the Centers for Disease Control and Prevention convenes its first meeting of vaccine experts to determine COVID-19 booster shot approvals for the fall.
The CDC panel was set to determine which COVID-19 vaccines should be used and which populations should get them.
“As always, the FDA will evaluate individual applications on a case-by-case basis and will evaluate the benefit–risk balance of each regulatory submission,” Makary and Prasad wrote, adding that they wanted vaccine manufacturers to track individuals over six months after administering the shot. —>READ MORE HERE
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