FDA Delays Decision on COVID Vaccine for Young Kids

Citing new data, FDA delays decision on early childhood COVID vaccination

(RxWiki News) Health officials have delayed their decision on whether young children should get the COVID-19 vaccine.

Pfizer recently announced that it was seeking approval of its COVID-19 vaccine for use in children between 6 months and 4 years old. The vaccine is already approved for children who are 5 years old and older.

But the US Food and Drug Administration (FDA) announced that it was going to delay its advisory committee meeting, where the childhood COVID vaccination issue was going to be discussed.

The FDA said it was delaying the decision on the vaccine because Pfizer had submitted new data that the agency needed more time to consider.

"The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children," said Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press statement. "In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to get vaccinated or receive a booster dose when eligible."

Pfizer is engaged in an ongoing clinical trial of its vaccine in young children. As new data emerges from that study, the company must submit it to the FDA.

Recently, the FDA said, Pfizer submitted data about the possibility of a third dose in what has been the two-doze Pfizer series for kids. The agency said that this new information should be a factor in whether the vaccine is approved for use in young children.

That is why the FDA postponed the Vaccines and Related Biological Products Advisory Committee meeting, which had been scheduled for Feb. 15. The FDA had not announced a new meeting time as of the time of publication.

If you suspect that your young child may have COVID-19, seek immediate medical care.

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Review Date: 
February 15, 2022