• Tue. Sep 21st, 2021

Pfizer’s COVID-19 vaccine granted full approval from the FDA

By: Scripps National

The Food and Drug Administration on Monday issued full approval to the two-dose Pfizer COVID-19 vaccine.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” acting FDA Commissioner 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.”

While the Pfizer vaccine has been widely available to all Americans older than 12 for the last few months, it was only available under an emergency use authorization order.

Top health officials in the U.S. hope that granting full approval to the Pfizer vaccine will alleviate the fears among those who remain hesitant about getting a shot.

Full approval also opens the door for more government departments and businesses to issue vaccine mandates. For example, the Pentagon earlier this month said it would require all military members to get vaccinated by Sept. 15, though Sec. of Defense Lloyd Austin said he would issue an order making the shots mandatory “immediately upon licensure” by the FDA.

Two other COVID-19 vaccines — the two-dose Moderna vaccine and the single-dose Johnson & Johnson shot — are still widely available in the U.S. under emergency use authorization.

The full approval of the Pfizer vaccine comes amid a spike in COVID-19 cases, hospitalizations and deaths caused by the more contagious delta variant. Health experts say that the current spike is driven by those who remain unvaccinated.

All three COVID-19 vaccines have proven to be safe and highly effective in fighting severe and deadly cases of the virus. Earlier this month, the CDC reported that 99.99% of fully vaccinated people had avoided a severe or deadly COVID-19 infection.

This story is breaking and will be updated.

Reposted with permission from WCPO 9 Cincinnati.