- The Washington Times - Thursday, December 17, 2020

The Food and Drug Administration is meeting with outside experts Thursday to debate whether a coronavirus vaccine from Moderna should be approved for emergency use.

The session should pave the way for the Massachusetts company to join Pfizer in the early phase of the campaign, though the panel is grappling with reports of allergic reactions in a handful of early recipients in Alaska and the U.K.

Bartlett Regional Hospital in Juneau said two workers had adverse reactions shortly after receiving the Pfizer vaccine this week. One female worker felt flush and had shortness of breath, even though she doesn’t have a history of allergies.

Local media reports said the worker was treated with epinephrine for anaphylaxis. She is recovering and still enthusiastic about the vaccine, but won’t receive the second dose.

A second worker had a milder reaction on Wednesday and fully recovered.



“As we continue to investigate and evaluate the data we will consider whether additional recommendations need to be made,” Doran Fink, a deputy director in the FDA’s vaccines division, told the advisory panel.

Two British workers had severe allergic reactions to the vaccine last week, although both had a history of allergy issues and carried EpiPens.

It’s unclear what caused the reactions to the Pfizer version, which is the first to win approval in the West.

Participants in human trials were excluded from phase 2 and phase 3 trials if they had a history of severe adverse reactions to vaccines or any component of the investigational vaccines.

“We don’t yet have all the details of the report from Alaska about a potential serious allergic reaction but are actively working with local health authorities to assess,” Pfizer said in an emailed statement. “We will closely monitor all reports suggestive of serious allergic reactions following vaccination and update labeling language if needed. The prescribing information has a clear warning/precaution that appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.”

Both the Pfizer and Moderna shots use a platform known as “messenger RNA” but the makeup of the bubble of fat, or lipid nanoparticle, that surrounds the RNA differs between the versions and could be a factor in Thursday’s discussion.

Moderna requested emergency use authorization from the FDA on Nov. 30, after human trials showed it was nearly 95% effective.

Like the Pfizer shots, it requires a second dose weeks later, although the gap is 28 days compared to Pfizer’s 21.

Federal officials say they’ll start to ship 6 million doses of Moderna’s version this weekend if regulators give the go-ahead, boosting early efforts to inoculate health workers and nursing home residents and staff.

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