FDA to revise Pfizer’s COVID-19 vaccine recommendations after allergic reactions

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WASHINGTON – The United States Food and Drug Administration (FDA) said Thursday it was working with Pfizer to revise an information sheet for recipients of the Pfizer-BioNTech COVID-19 vaccine after two people had allergic reactions .

The two people, both health workers, were vaccinated in Alaska and one of them had a severe or “anaphylactic” reaction resulting in hospitalization.

Doran Fink, Deputy Director of the Vaccines Division of the FDA, said, “All of these people have been treated with proper medical intervention and luckily all are recovering or recovering.

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“We anticipate that there may be additional reports, which we will quickly investigate.”

He added that US authorities, including the Centers for Disease Control and Prevention, were investigating the two cases and working with Britain to better understand two similar cases that occurred there.

“While the totality of the data at this time continues to support vaccinations under the Pfizer EUA (Emergency Use Authorization), without further restrictions, these cases underscore the need to remain vigilant during the early phase. of the vaccination campaign, ”said Fink.

A vial of the Pfizer-BioNTech COVID-19 vaccine at Royal Victoria Hospital, Belfast, December 8, 2020 (Liam McBurney / Pool via AP)

To that end, he said, “The FDA is working with Pfizer to further revise the fact sheets and prescribing information for their vaccines to draw attention to the CDC’s guidelines for post-treatment monitoring. vaccination and management of immediate allergic reactions. ”

The review will include the current warning for people with a history of allergic reactions to vaccine ingredients to avoid getting the vaccine at this time.

It will also include the warning that facilities where vaccines are administered should ensure that medical treatment for the management of severe allergic reactions is immediately available.

Fink added that if Moderna were granted emergency use authorization, it would have similar warnings.

Both of these vaccines are based on mRNA (messenger ribonucleic acid) technology, which had never before been approved in a vaccine.

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