The United Kingdom on Wednesday became the first country to approve a Covid-19 vaccine developed by Pfizer and its partner BioNTech, a decision that will likely put pressure on the Food and Drug Administration to move swiftly to do the same.
The vaccine is also the first to run the gauntlet of clinical studies normally required for approval. Russia and China have authorized vaccines without Phase 3 clinical trial data.
The fact that the U.K. approved a vaccine developed by an American company — in partnership with a German one — before the United States could pour fuel on the already tense relationship between President Trump and the FDA, which has taken a more deliberative process in reviewing vaccine data.
Over the course of the pandemic, Trump has often used his bully pulpit — and Twitter account — to pressure the agency, and the FDA has taken several steps that critics worried were politically motivated, including granting emergency use authorizations to hydroxychloroquine, an old malaria drug, and convalescent plasma, a blood product, as treatments for Covid-19 despite a lack of evidence that either is effective. The authorization for hydroxychloroquine was later rescinded.
The controversy over the earlier decisions and the pressure from the White House led to fears that the FDA would be forced to authorize Covid-19 vaccines without a proper review. As a result, the agency has taken pains to be transparent about its review processes and insisted decisions would be made by career staff.
But the result has been impatience at the White House. On Tuesday, the news site Axios reported that White House chief of staff Mark Meadows summoned Stephen Hahn, the FDA commissioner, to explain why the agency hadn’t already moved to authorize the Pfizer/BioNTech vaccine, or another vaccine developed by the biotechnology firm Moderna.
Both the Pfizer/BioNTech and Moderna vaccines have been shown in large trials to reduce the risk of developing symptomatic Covid-19 infection by more than 90%. But full details on both trials have been made available only by press releases, not in medical journals.
The FDA normally conducts the most rigorous reviews of medical products in the world, re-analyzing the databases from clinical trials and conducting its own reviews of the safety and efficacy of products, as well as independent statistical reviews of their clinical trials.
A key part of that process is scheduled for Dec. 10, for the Pfizer/BioNTech vaccine, and Dec. 17, for the Moderna vaccine. That is when an FDA advisory panel of outside experts is scheduled to go over the data in meticulous detail in a public meeting. These advisory panels are not necessary for an emergency use authorization, as opposed to a full approval, but it is extremely unlikely that the FDA would issue a decision without waiting for the meetings to occur.
Throughout the vaccine development process, there have also been concerns that things were moving too quickly. For instance, a group of academic experts wrote an open letter to Pfizer, asking the drug giant to collect more safety data on its vaccine before submitting to the FDA. Those data have now been collected.
Unlike regulators in the U.K. and some other countries, however, the FDA has not taken the data for the new vaccines on a rolling basis.
Recently, there has been disagreement between federal officials about how quickly after the Dec. 10 advisory panel an emergency use authorization could occur. The director of the Centers for Disease Control and Prevention, Robert Redfield, has said that such a decision could occur almost immediately after the panel. But Peter Marks, who heads the FDA center responsible for the decision, has said instead that the decision would happen within “a few weeks.”