Pfizer COVID-19 Vaccine Granted Full FDA Approval

Posted on: August 25, 2021 - 1:15pm
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On August 23, 2021, the U.S. Food and Drug Administration (FDA) issued full approval to the Pfizer-BioNTech COVID-19 vaccine, which will now be marketed as Comirnaty. The FDA has been issuing Emergency Use Authorizations (EUA) for COVID-19 vaccines based on the urgent need created by the pandemic and the vaccine’s extensive safety and efficacy data. With the FDA granting full approval for a COVID-19 vaccine, East Hartford residents can be even more confident that the COVID-19 vaccines work and are safe.

FDA’s full approval of the first COVID-19 vaccine, which required additional safety and efficacy data beyond what was provided for the EUA, is an important milestone that should reassure anyone who has concerns about getting vaccinated. On top of the rigorous testing and trials that went into Emergency Use Authorization of the Pfizer vaccine, the FDA has now completed additional analysis of the effectiveness and safety data from tens of thousands of clinical trial participants, as well as the analysis of real-world safety data.

All of the COVID-19 vaccines authorized or approved in the U.S. are extremely safe and effective, based on extensive clinical trials and the fact that nearly 200 million Americans have received at least one shot. The Moderna and Johnson & Johnson vaccines will continue to be safely administered through emergency use authorization as the FDA reviews data about their real-world use. The Pfizer COVID-19 vaccine was the first vaccine to receive emergency authorization, which is why it is the first to have enough data to receive full approval. It does not mean anything about the safety and effectiveness of either the Moderna or Johnson & Johnson vaccine. Moderna has also submitted an application for full approval of its COVID-19 vaccine, and the FDA is currently reviewing that data.

With increasing rates of COVID-19 infection, hospitalization, and deaths across the country, the East Hartford Health Department would like to emphasize that it is more important than ever for all eligible people to get vaccinated. To view a schedule of upcoming clinics in the Town of East Hartford, click here.

For additional questions and answers regarding FDA approval, please visit the Public Health Communications Collaborative. To speak with a public health nurse, contact the East Hartford Health Department at 860-291-7324.