A Food and Drug Administration advisory panel endorsed the Moderna vaccine for emergency use after a daylong debate on Thursday, a move that should accelerate the immunization campaign.
Moderna requested emergency use authorization from the FDA on Nov. 30, after human trials showed it was nearly 95% effective, putting it on par with a vaccine from Pfizer that’s being used now.
The Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention, to begin using the vaccine.
Federal officials say they’ll start to ship 6 million doses of Moderna’s version this weekend if regulators give the official go-ahead in the coming hours or days, boosting supply as hospitals inoculate their workers and nursing homes protect their residents and staff.
Like the Pfizer shots, the Moderna vaccine uses “messenger RNA” and requires a second dose weeks later. The second Moderna dose is given 28 days later, compared to 21 days for Pfizer’s.
Early shipments of the Pfizer vaccine have gone smoothly, though there have been a handful of reports of allergic reactions to the Pfizer shots.
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 experience 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, is recovering, and is still enthusiastic about the vaccine, though she 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.
The Centers for Disease Control and Prevention describes allergic reactions as a “common concern” for vaccine providers though says these reactions are uncommon and anaphylaxis following vaccines is rare, occurring at a rate of approximately one per million doses for many vaccines.
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 vaccine, which is the first to hit the market 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.”
Vaccines are being shipped while the coronavirus rages across the country and sets single-day records for cases, hospitalizations and deaths.
The rate of new cases appears to have leveled off a bit but remains elevated, at over 200,000 reported infections per day. Hospitalizations have reached 113,000, taxing doctors and nurses, and the U.S. has recorded an average of 2,500 deaths per day over the past week.
Overseas, President Emmanuel Macron of France tested positive for the virus after feeling some symptoms. He will self-isolate for seven days.
European Commission President Ursula von der Leyen said the first round of vaccinations in the European Union will begin Dec. 27-29.
Meanwhile, Germany remains in a lockdown that extends through early January, shuttering its popular Christmas markets.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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