The Food and Drug Administration (FDA) has confirmed Pfizer’s coronavirus vaccine to be safe and effective. In documents published ahead of an advisory meeting Thursday to consider emergency use of the vaccine, the FDA said the pharmaceutical company’s Covid-19 vaccine candidate offers protection after the first dose and that data from the vaccine’s trial appears to meet the standard for an emergency use authorization.
The 53-page document, which contains analysis from both federal regulators and Pfizer on data from the company’s Phase 3 clinical trial, noted that the vaccine was 82% effective after the first dose and that the effectiveness appears to be the same across all age groups, racial and ethnic minorities, and people with underlying conditions. The Pfizer vaccine calls for two doses, three weeks apart, with the FDA adding that two doses of the vaccine were “highly effective” in preventing confirmed cases of Covid-19 at least seven days following the second dose. The FDA has indicated that it would authorize a vaccine that’s safe and at least 50% effective. The Tuesday-released documents also noted that two months of follow-up on participants in the trial provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].”
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“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency wrote.
The documents were released ahead of a planned meeting Thursday of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, an advisory that will vote on whether to advise the agency to grant emergency use authorization of the vaccine in the U.S. During the meeting, Pfizer will present the safety and efficacy data for its vaccine candidate and answer questions from experts. The FDA is expected to follow the panel’s recommendations. James Hildreth, a member of the FDA’s vaccine advisory committee, recently indicated that vaccine distribution could occur as early as Friday of this week “if the FDA commissioner decides to issue approval.”
Pfizer’s vaccine has already been rolled out in the United Kingdom, with a 90-year-old woman named Margaret Keenan becoming the first in the world to receive a Covid-19 vaccine outside of trial. Pfizer’s vaccine, according to NBC News, may come with side effects including fatigue, fever, headaches, muscle, and joint pain. Four cases of Bell’s palsy, a condition that causes weakness in the facial muscles, were also identified in participants who received the vaccine.
