Pfizer COVID-19 vaccine gets full FDA approval

Published 9:00 pm Monday, August 23, 2021

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The Pfizer-BioNTech COVID-19 vaccine has received full approval from the Food and Drug Administration for people ages 16 and up, likely paving the way for more businesses and organizations to mandate the vaccine for their workers.

The vaccine is still available under an emergency use authorization for those ages 12 to 15, and for third dose vaccinations for immunocompromised people.

Pfizer’s COVID-19 vaccine will now be marketed as Comirnaty, according to the FDA.

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“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”

Woodcock said the approval puts the U.S. one step closer to changing the course of the pandemic for the better.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some,” Woodcock said, “the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”

In a statement, Virginia vaccine coordinator Dr. Danny Avula said the state department of health is pleased with the announcement.

Nearly 5.5 million Pfizer doses have been administered in the state since late December 2020, and more than 200 million have been administered across the country.

“The science is clear that this is a safe and effective vaccine that is highly effective in preventing infection by the SARS-CoV-2 virus and subsequent variants,” Avula said, “and in preventing serious illness that could result in hospitalization and/or death.”

Rates for all people fully vaccinated in Western Tidewater ranges from just over 39% in Southampton County to nearly 48% in Surry County, with Suffolk at 43.3%.

Virginia has also updated its COVID-19 cases by vaccination status dashboard, with the state health department saying it wants to more accurately represent the impact of vaccinations on infection rates in the state.

It says the primary change will be in reporting rates of infection, hospitalizations and deaths by vaccination status — fully vaccinated, partially vaccinated and unvaccinated. It will also report cases, hospitalizations and deaths among those who are fully vaccinated at the state and health region levels.

Between Jan. 17 and Aug. 14, 252,938 people had COVID-19-like symptoms or tested positive, with just 10,712 infections (0.2%), 404 hospitalizations (0.009%) and 83 deaths (0.0018%) reported in the same time period among the 4.7 million state residents who are fully vaccinated. Unvaccinated people have gotten COVID-19 at a rate of 12.5 times higher than those who are fully vaccinated.

From Jan. 17 through Aug. 14 in the Eastern Region, which includes all of Western Tidewater —  there have been 1,941 infections, 85 hospitalizations and 23 deaths.

Virginia’s updated system allows for COVID-19 cases from the Virginia Electronic Disease Surveillance System to be automatically matched with immunization records in the Virginia Immunization Information System, where all COVID-19 vaccinations are recorded. The state health department was previously doing this match by hand.