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FDA advisory committee today is expected to scrutinize Moderna on vaccine reaction 

The FDA is recommending surveillance of Bell's palsy after four Moderna trial participants developed the temporary facial paralysis.

Susan Morse, Managing Editor

Sandra Lindsay, a critical care nurse at Long Island Jewish Medical Center, receives the first Pfizer-BioNTech vaccine in the U.S. on Dec. 14. (Photo courtesy Northwell Health)Sandra Lindsay, a critical care nurse at Long Island Jewish Medical Center, receives the first Pfizer-BioNTech vaccine in the U.S. on Dec. 14. (Photo courtesy Northwell Health)

In its review of the Moderna COVID-19 vaccine, the Food and Drug Administration's advisory committee today is expected to question the Bell's palsy reaction in four of its trial participants.

The FDA is recommending surveillance of Bell's palsy after three Moderna trial participants who received the vaccine and one who got a placebo developed the temporary facial paralysis that causes drooping on one side of the face.

"FDA will recommend surveillance for cases of Bell's palsy with deployment of the vaccine into larger populations," according to an FDA briefing document released prior to today's FDA advisory committee review.

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The Moderna review follows a serious allergic reaction to the Pfizer-BioNTech vaccine by an Alaskan healthcare worker on Tuesday night. 

Unlike two British healthcare staffers who had a history of allergic reactions and had serious reactions after receiving the Pfizer-BioNTech vaccine, the female employee of Bartlett Regional Hospital in Juneau reportedly had no history of allergies and had never experienced the life-threatening anaphylaxis. The Alaskan woman was expected to be released after being hospitalized overnight, according to NBC News.

BELL'S PALSY CONCERNS

The Pfizer-BioNTech vaccine also showed a small number of vaccine trial participants developed Bell's palsy. 

Last Thursday, during review of the Pfizer-BioNTech vaccine, advisory committee members raised concern about the FDA briefing document showing a small number of reported cases of Bell's palsy, but members said there was an insufficient number of cases or evidence to show a correlation to the vaccine. 

The Moderna briefing is also ambiguous as to a possible correlation.

"Currently available information is insufficient to determine a causal relationship with the vaccine," the FDA briefing document said.

In one case of Bell's palsy in the vaccine group, a 67-year-old female with diabetes was hospitalized for stroke due to new facial paralysis 32 days after vaccination, the report said. This case was reported as resolving. 

Another Bell's palsy case in the vaccine group occurred 28 days after vaccination in a 30-year-old female who reported an upper respiratory infection 27 days prior to onset of her facial paralysis. This case was reported as resolved. 

An additional case of Bell's palsy in the vaccine group occurred 22 days after vaccination in a 72-year-old female; this event was still ongoing at the time of the safety report. 

The case in the placebo group, reported as resolving, occurred 17 days post injection in a 52-year-old-male. 

"Causality assessment is confounded by predisposing factors in these participants," the report said. "However, considering the temporal association and biological plausibility, a potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out." 

WHAT'S HAPPENING TODAY

The Food and Drug Administration's Vaccines and related Biological Products Advisory Committee will review the Moderna vaccine today as it did for the Pfizer-BioNTech vaccine last Thursday.

The advisory committee is expected to take a vote by the end of day on whether to recommend emergency use authorization for the Moderna vaccine to the FDA and if approved, distribution would begin this month.

Twenty million doses of the Moderna vaccine could be delivered by the end of the month, along with additional doses of the Pfizer-BioNTech vaccine, which began going out to frontline healthcare workers in the U.S. on Monday, according to Operation Warp Speed officials who spoke on Tuesday.

Operation Warp Speed's chief advisor Dr. Moncef Slaoui commended the effectiveness of the vaccine, at 94.5%.

Onset of efficacy is very fast after immunization, at 65% on day 28 after the first of two required doses, Slaoui said Tuesday. Data on the efficacy of the second dose will be available in a few weeks, he said.

VACCINE UPDATE

As of Tuesday, all of the Pfizer-BioNTech vaccine that had been expected to be delivered, has been delivered, according to Health and Human Services Secretary Alex Azar.

Frontline workers were the first to get the vaccine, followed by residents of long-term care facilities.

Distribution to long-term care facilities has begun, with most going out on Monday, December 21. Operation Warp Speed is expected to deliver 2 million doses of the Pfizer-BioNTech vaccine to 1,100 long-term care facilities.

"We are on track with all of the deliveries," said General Gustave F. Perna, chief operations officer for Operation Warp Speed.

CVS and Walgreens are helping to lead the effort, according to Perna. The Centers for Disease Control and Prevention is collaborating with 19 pharmacy chains to enable states to access the vaccine for distribution.

Perna said FedEx and UPS, which are delivering the vaccines, have also demonstrated professionalism in doing their jobs.

"It's a whole of America approach," Perna said.

Next in the drug portfolio is the Johnson & Johnson vaccine, which is closing recruitment of its Phase 3 trial. If all goes well, doses may start being distributed in February and March.

AstraZeneca's vaccine is still in the pipeline, with Phase 3 trial recruitment to end by the end of this year.

ANTIBODY TREATMENTS

The FDA has also authorized antibody treatments to help prevent hospitalization from COVID-19. They are available to individuals 65 and older who have comorbid conditions and have tested positive.

Operation Warp Speed has allocated 330,000 doses of the therapeutics to all states and territories but so far, usage has been disappointing, officials said Tuesday.
 
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com