Pfizer Vaccine Receives Full FDA Approval
September 3, 2021
This week, the US Food and Drug Administration gave its full approval of the COVID-19 Pfizer/BioNTech vaccine for all people ages 16 and older.
This is the first Covid vaccine to receive FDA approval. The vaccine has been available since December 11th, 2020, and since release has undergone the FDA’s review of the quality, safety, and effectiveness. According to the FDA’s website, the vaccine has been distributed under a EUA which is something used during a public health emergency by the FDA to help prevent, diagnose, and treat diseases. The EUA was based on a randomized, controlled, and blinded clinical trial to produce a vaccine that combats the Coronavirus Pandemic. The FDA reviewed new and updated information from the continuing trial and used the information to grant its approval. The trial followed the effectiveness of the vaccine by ensuing 20,000 placebo recipients ages 16 and up. It followed the safety of the vaccine by evaluating 22,000 vaccinated people and 22,000 who received a placebo and were 16 years or older. The clinical trial showed that the vaccine was 91% effective and more than half of clinical trial recipients have been followed up on their safety and continue to be evaluated. The most common side effects that have been reported by clinical trial participants is pain, redness and swelling at the vaccination site, fatigue, headache, muscle or joint pain, chills, and fever.
While the vaccine can cause uncomfortable side effects, it has been effective in preventing infection of Covid-19, and when infected more extreme outcomes such as hospitalization and death. The FDA will continue to monitor the side effects and long-term health and safety concerns as that information is not yet available for the vaccine and a warning about the risks and the lack of knowledge about the long-term effects is included in the Comirnaty Prescribing Information.
For more information about the vaccine and finding a vaccination site near you visit https://www.vaccines.gov/search/
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