The Food and Drug Administration (FDA) released an analysis of pharmaceutical company Pfizer’s COVID-19 vaccine data on Thursday morning. According to the report, the FDA has no specific concerns that would prevent authorization of the vaccine.
Pfizer’s vaccine has not yet received an Emergency Use Authorization (EUA), which would allow medical professionals to administer it outside of clinical trials. The FDA’s vaccine advisory committee—a panel of outside experts—is set to meet on Thursday to determine how the agency should proceed. Depending on how conclusively the group is able to determine the vaccine’s safety and efficacy based on Pfizer’s clinical trial data, it could take days or weeks for the FDA to move forward with authorizing the vaccine. While the FDA isn’t required to follow the recommendations that result from these committee reviews, it usually does.
The analysis released on Tuesday support’s Pfizer’s previous claims of 95 percent efficacy for the vaccine, which is currently being considered for use in patients age 16 and up. While many patients in clinical trials experienced side effects like headaches, muscle pain, and fatigue, serious reactions were rare. You can see a breakdown of the results of the trial, which included 44,000 people, in this interactive graphic by The Washington Post.
Pfizer’s vaccine requires two doses taken 21 days apart to achieve 95 percent efficacy, but the current clinical data suggests a single dose may provide more than 80 percent efficacy. More research is needed to understand how much protection a single dose can offer, which will be important in understanding how well the vaccine will work in practice—it’s likely that many patients will fail to get their second dose, or fail to do so within the recommended window. The FDA will also need more research in order to approve the vaccine for children, pregnant people, and those with compromised immune systems. Clinical trials will continue to collect data even if the vaccine is given EUA status.
The United Kingdom became the first country to approve Pfizer’s vaccine several days ago. On Tuesday morning, it was administered to a patient for the first time outside of clinical trials. The patient, named Margaret Keenan, turns 91 next week. The UK has ordered 40 million doses of the vaccine (enough for 20 million people, about a third of the nation’s population), and has acquired 800,000 doses for the country’s first wave of inoculations.
The US has secured 100 million doses of the new vaccine, which will be enough to inoculate 50 million of the nation’s about 331 million people. The Trump Administration reportedly turned down a deal for a larger order of doses in July. Whichever vaccines the US ends up relying on, their distribution will be a long and complicated process.