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FDA Grants Full Approval to Pfizer Covid-19 Vaccine

August 23, 2021

The Food and Drug Administration (FDA) granted full approval for the Pfizer Covid-19 vaccine for individuals 16 and older on Monday, Aug. 23.  Until now, the Pfizer vaccine was available under an Emergency Use Authorization.  
In a news release, the FDA emphasized that all Covid-19 vaccines available in the U.S. have met the agency’s rigorous scientific standards for emergency use. The Pfizer vaccine received full approval because additional clinical trials involving tens of thousands of participants demonstrated that the Pfizer vaccine meets the high standards for safety and effectiveness that the FDA requires of an approved product.  The FDA is reviewing Moderna’s application for full approval of its Covid-19 vaccine and Johnson and Johnson is also expected to apply for full approval.
“If you have delayed getting a Covid-19 vaccine until it received full FDA approval, I strongly urge you to get the Pfizer vaccine as soon as possible,” said Susan Breen, MS, RN, the City’s interim Chief Public Health Officer. She noted that over 83,000 residents have already received at least one dose of the Covid-19 vaccine.
The Emergency Use Authorization will continue to cover use of the Pfizer vaccine for teens age 12–15 and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Clinical trials are ongoing with these groups to collect the data necessary for full approval.
To find out where to get vaccinated in Cambridge, visit the Massachusetts Department of Public Health’s vaccine website.

Suzy Feinberg, MPH
Public Information Officer

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