Republic file photo Pfizer and its partner BioNTech asked the Food and Drug Administration to authorize an additional booster dose of their COVID-19 vaccine for seniors.
Bartholomew County health officials said they are taking a wait-and-see approach after the Trump administration said it plans to limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.
Earlier this week, top officials for the Food and Drug Administration laid out new standards for 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, The Associated Press reported.
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.
“I think it is going to be wise to wait and see what takes place over the next few weeks with the FDA in their final decision-making process,” said Bartholomew County Health Officer Dr. Brian Niedbalski. “There is a large fraction of people who have risk factors in the general population, so they thankfully will still qualify for vaccination. Others will likely need to be assessed on an individual basis.”
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, according to wire reports.
It’s a stark break from the previous federal policy recommending an annual COVID shot for all Americans six months and older, according to wire reports. In the paper and a subsequent online webcast, the FDA’s top vaccine official said 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 “reasonable compromise” that will allow vaccinations in high-risk groups to continue 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.
However, what the upcoming changes will mean for individuals who wish to receive a fall COVID-19 booster but fall outside the eligibility categories remains uncertain.
“Is the pharmacist going to determine if you’re in a high-risk group?” Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told the AP. “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.
Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year, according to wire reports. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest. Among them were 231 children whose deaths were deemed COVID-related, 134 of them where the virus was the direct cause — numbers similar to yearly pediatric deaths from the flu.
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, according to wire reports. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under Trump.
