FDA No Longer Recommends COVID Vaccine For Healthy Babies

Via Headline USA,

The U.S. government no longer recommends the COVID-19 vaccine for healthy babies thanks to new guidelines from the Trump administration, which said Tuesday it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else.

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.

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. 

Previously, federal policy recommended an annual COVID shot for all Americans six months and older. 

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.

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.

Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. The virus was the underlying cause for two-thirds of those and it was a contributing factor for the rest.

Health experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended only for people at increased risk.

In June, an influential panel of advisers to the CDC is set to debate which vaccines should be recommended to which groups.