The Pfizer-BioNTech COVID-19 vaccine is entering the final phase of review before the U.S. government decides whether to allow millions to get the shots.
The Food and Drug Administration posted a positive review of the vaccine on Tuesday and will hold a public hearing today. Next week, it will do the same thing for Moderna’s coronavirus vaccine candidate.
The agency’s scientific review is a key step — not just for the U.S., but for countries around the world weighing whether to begin using a vaccine.
Teams of FDA scientists scrutinize tens of thousands of pages of technical data provided by the companies, focusing on vaccine effectiveness, safety, side effects and the manufacturing process needed to ensure the quality and consistency of the doses.
Up until now, Pfizer and its partner BioNTech had only released minimal results about their vaccine’s safety and performance in company press releases. The details have yet to be reviewed and published in a medical journal.
Health Canada has been receiving what it calls a rolling submission of data from the company, paving the way for its authorization in Canada on Wednesday. Britain and Bahrain previously approved it, with vaccinations in the United Kingdom having begun earlier this week.
WATCH l Dr. Supriya Sharma of Health Canada speaks to The National about the approval:
Today, a group of about two dozen outside experts weighs in on the FDA’s findings and gives its own assessment. The panellists have expertise in vaccines, infectious diseases and medical statistics. The FDA is not required to follow their advice, though it usually does.
The daylong event also gives the agency a chance to pull back the curtain on its review process and try to assure the public that the vaccine was independently vetted. That confidence will be critical for the country’s largest-ever vaccination effort. The meeting concludes with the panel’s non-binding vote on whether the vaccine should be authorized for use in the U.S.
“It’s both the transparency and the actual data that I think will be very important,” said Stephen Hahn, the FDA commissioner. “What are experts outside the agency asking? I think that will be very informative for the American people.”
READ | FDA briefing document: Pfizer-BioNTech vaccine data:
There is no deadline for a ruling, but the FDA’s Dr. Peter Marks, the leader of the FDA’s biologics centre, said he hoped a decision on the Pfizer vaccine could come by the following week.
Health Secretary Alex Azar said Wednesday that the decision could come “in a matter of days,” though the White House is likely eager to have the vaccine approved as soon as possible, given the toll the virus has taken in the U.S.
The U.S. topped 3,000 deaths Wednesday in what is a single-day record, according to the COVID Tracking Project. New cases per day have rocketed to more than 200,000 on average, and the number of patients in hospital with COVID-19 stood at almost 105,000 on Tuesday, another all-time high.
If the FDA gives the thumbs-up, it would still only allow limited use in certain high-risk groups because final-stage studies are not yet complete.
This comes under the FDA’s “emergency use authorization,” which is used to speed up the availability of medical products during a health crisis.
The deployment of a vaccine would ultimately be up to officials in the 50 states. Some governors and other state officials complained in the spring of a lack of coherence and guidance from the federal government, which resulted in bidding wars for scarce personal protective equipment.
Vaccine hesitancy will also be an issue. About 50 per cent of Americans will take the new coronavirus vaccine, according to The Associated Press-NORC Center for Public Affairs Research survey released this week. About 25 per cent of U.S. adults aren’t sure if they want to get vaccinated, taking a wait-and-see approach.
Separately, the president of the Uniformed Firefighters Association told CNN this week that in an internal poll answered by 25 per cent of the workforce, 55 per cent of firefighters in the Fire Department of New York answered No to the question of whether they would take the vaccine if offered by their employer.