A nurse holds a phial of the Pfizer-BioNTech Covid-19 vaccine at the Royal Free hospital in London on December 8, 2020 at the start of the UK's biggest ever vaccination programme. AFP / POOL / Jack Hill
Pfizer Inc. and BioNTech SE’s vaccine is highly effective in preventing Covid-19 and there are no safety concerns that would prevent the shot from being granted an emergency-use authorization, according to a report by staff of the U.S. Food and Drug Administration.
The FDA staff 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 agency could move to clear the shot shortly after the meeting.
The report, posted on the agency’s website Tuesday, echoed previously disclosed findings 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 emergency authorization of the Covid-19 shot in the U.S. on Nov. 20. Regulators in the U.K. approved it earlier this month, and on Tuesday, the National Health Service there launched an ambitious immunization campaign that will begin with vaccinating tens of thousands of people over the age of 80 in the coming days. Pfizer’s shot is also under review in the European Union.
The vaccine uses technology called messenger RNA that transforms the body’s cells to fight the virus. It also requires special freezers to keep. Moderna Inc. also makes an experimental Covid-19 vaccine that is based on messenger RNA, and FDA advisers will meet next week to consider whether it should receive emergency authorization.
Pfizer has said the shot protected people of all ages and ethnicities. Side effects included headache and fatigue.
If Pfizer’s vaccine is cleared, Trump administration officials have said it could begin to be distributed within 24 hours, with as many as 6.4 million doses immediately available. Between Pfizer and Moderna’s vaccines, 40 million doses are expected to be available by the end of the year, enough for 20 million people to get the two-shot regimen.
The Trump administration is confident that the U.S. will have enough supply to eventually vaccinate everyone, a senior administration official said Monday on a call with reporters, though only the shots made by Pfizer and Moderna are expected to be cleared by the FDA this month. The U.S. also has agreements to get shots from AstraZeneca Plc, Johnson & Johnson and others.
