FDA Grants First COVID-19 Vaccine Approval to Pfizer-BioNTech

FDA

The initial COVID-19 vaccine with full Food and Drug Administration (FDA) capitulation was awarded to Pfizer-BioNTech for people 16 and comparison on Aug. 23, 2021. Pfizer is in joining with other vaccines as a initial COVID-19 vaccine subjected to a full examination by a United States regulator; it will be marketed as Comirnaty (Koe-mir’-na-tee).

Health officials trust full capitulation of a Pfizer vaccine competence remonstrate people who are wavering about being vaccinated. In June, a formula of a Kaiser Family Foundation check indicated that 31 percent of unvaccinated people would be some-more expected to get a shot once one is entirely authorized by a FDA.

FDAActing FDA Commissioner Janet Woodcock explained, “While this and other vaccines have met a FDA’s rigorous, systematic standards for puncture use authorization, as a initial FDA-approved COVID-19 vaccine, a open can be really assured that this vaccine meets a high standards for safety, effectiveness, and production peculiarity a FDA need of an authorized product.”

Pfizer-BioNTech stays accessible for girl 12-15 underneath puncture use authorisation (EUA) and, as of Aug 12, for a third sip “in certain immunocompromised individuals, specifically, plain organ transplant recipients or those who are diagnosed with conditions that are deliberate to have an homogeneous turn of immunocompromise,” according to a FDA. While a group authorized Moderna as a third sip for these individuals, a evaluators dynamic there is no need for others to need a upholder shot during this time.

As of 6 a.m. EDT on Aug 22, 171 million Americans had been entirely vaccinated — 51.5 percent.

Written by Cathy Milne-Ware

U.S. Food Drug Administration: Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
U.S. Food Drug Administration: FDA Approves First COVID-19 Vaccine
NPR: Pfizer’s COVID Vaccine Gets Full Approval From The FDA; by Scott Hensley
Beckers Hospital Review: States ranked by commission of race entirely vaccinated: Aug. 23; by Katie Adams

Featured and Top Image Courtesy of Jamie Bernstein’s Flickr Page – Creative Commons License
Inset Image by Edwin J. Torres/ NJ Governor’s Office Courtesy of Phil Murphy’s Flickr Page – Creative Commons License

FDA Grants First COVID-19 Vaccine Approval to Pfizer-BioNTech combined by Cathy Milne-Ware on Aug 23, 2021
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