Pfizer Shot Effective, Safe, FDA Staff Says Before Meeting

The coronavirus vaccine made by Pfizer Inc. and its German partner BioNTech SE is highly effective in preventing Covid-19 and there are no safety concerns that would prevent it from being granted an emergency-use authorization, according to a report by staff of the U.S. Food and Drug Administration.

The report offers a first look at the U.S. review of the vaccine ahead of a public meeting Thursday of outside advisers to the agency. The FDA could clear the shot shortly after the meeting, with as many as 6.4 million doses immediately available to kick off a vast immunization effort designed to end a pandemic that has killed more than 283,000 Americans.

The findings, posted on the agency’s website Tuesday, echoed previously disclosed data from the companies that showed the vaccine was 95% effective in preventing symptomatic Covid-19. It also said that two months of trial data revealed no significant safety issues.

Pfizer requested an emergency authorization in the U.S. on Nov. 20. Regulators in the U.K. approved the vaccine earlier this month, and on Tuesday, the National Health Service there launched an ambitious vaccination campaign that will begin with tens of thousands of people over the age of 80 in the coming days. The shot is also under review in the European Union.

Pfizer shares gained 1.2% to $41.76 at 9:40 a.m. in New York. So far this year, the stock has climbed 13%.

The vaccine uses technology called messenger RNA that transforms the body’s cells to fight the virus. Moderna Inc. also makes an experimental Covid-19 vaccine based on messenger RNA, and FDA advisers will meet next week to consider whether it should receive emergency authorization.

In their report, FDA staff wrote that analyses “showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe Covid-19.” Common side effects included injection-site reactions, fatigue and headache.

There isn’t enough data on children younger than 16 to determine whether it will work in pediatric populations, FDA staff said. Data is also insufficient to make any determinations about pregnant, lactating or immunocompromised people.

Among participants in the Pfizer clinical trial who didn’t show signs of Covid-19 infection during vaccination, there were eight virus cases within the group who received the shot and 162 in those who got a placebo, according to the report. The vaccine is a two-dose regimen, with the second dose given 21 days after the first. The shot was about 89% effective after the first dose, FDA staff found.

Six people died in the clinical trial of almost 44,000 participants, two in the group that received the vaccine and four in the placebo group. The two in the vaccine group were older than 55. One died of cardiac arrest 62 days after vaccination and the other from arteriosclerosis, a condition where blood vessels can harden with age, three days after vaccination.

“All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate,” the report said.

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