The changes that Donald Trump is implementing in American society also affect the health sector. The Trump administration has announced that it will limit the approval of seasonal Covid-19 vaccines to older individuals and other high-risk groups, as reported by AP. The reason cited is that they will wait for more data on how they affect healthy or middle-aged populations before making the doses available. This new approach raises doubts about whether some individuals who want a vaccine this fall will be able to obtain it.
Senior officials from the Food and Drug Administration (FDA) have set new requirements for access to updated Covid vaccines, stating that they will continue to use a streamlined approach to make them available to adults aged 65 and older, as well as to children and young adults with at least one high-risk health condition.
However, the FDA framework, published on Tuesday in the New England Journal of Medicine, urges companies to conduct large and prolonged studies before modified vaccines can be approved for healthier individuals. In the article and in a subsequent webcast, the FDA's top vaccine official stated that over 100 million Americans could qualify for what he referred to as a booster under the new guidance.
Doctor Vinay Prasad described the new approach as a "compromise" that will allow vaccinations in high-risk groups while new data is generated on whether vaccines still benefit healthier individuals.
"For many Americans, we simply do not know the answer as to whether they should receive the seventh, eighth, ninth, or tenth Covid-19 booster," explained Prasad, who joined the FDA earlier this month. Previously, Prasad spent over a decade in academia, frequently criticizing the FDA's handling of drug and vaccine approvals.
It is unclear what the upcoming changes mean for individuals who may still want a Covid-19 vaccine in the fall but do not clearly fit into one of the categories.
Provisional data from the Centers for Disease Control and Prevention show that over 47,000 Americans died from Covid-related causes last year. The virus was the underlying cause for two-thirds of those cases and was a contributing factor for the rest. Among them, there were 231 children whose deaths were considered Covid-related, with 134 of them where the virus was the direct cause, figures similar to annual pediatric deaths from the flu.
The FDA's new approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr., examining the use of Covid vaccines and raising significant questions about broader vaccine availability. It was published two days before the first meeting of external vaccine experts at the FDA during the second term of President Donald Trump.