September 23, 2021, Thursday
Nepal 1:37:26 pm

US regulators give full approval to Pfizer COVID vaccine

The Nepal Weekly
August 25, 2021

The United States Government gave full approval to Pfizer’s COVID-19 vaccine Monday, potentially boosting public confidence in the shots and instantly opening the way for more universities, companies and local governments to make vaccinations mandatory.

The Pentagon promptly announced it will press ahead with plans to pressurize members of the military to get vaccinated amid the battle against the extra-contagious delta variant. The University of Minnesota has said it will require its students get the shot, as did Louisiana’s major public universities, including LSU, though state law there allows broad exemptions.

More than 200 million Pfizer doses have been administered in the U.S. under emergency provisions — and hundreds of millions more worldwide — since December. In going a step further and granting full approval, the Food and Drug Administration cited months of real-world evidence about having extremely rare serious side effects.

The formula, jointly developed with Germany’s BioNTech, will be marketed under the brand name Comirnaty. Moderna has also applied to the FDA for full approval of its vaccine. Johnson & Johnson, maker of the third option in the U.S., said it hopes to do so later in the year.

Just over half of the U.S. population is fully vaccinated. Vaccinations in this country bottomed out in July at an average of about a half-million shots per day, down from a peak of 3.4 million a day in mid-April. As the delta variant fills hospital beds, shots are on the rise again, with a million a day given Thursday, Friday and Saturday.

Full approval of Pfizer vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” pointed out Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. That should help “anyone who still has concerns gain confidence” in the shots.

Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s OK to make the vaccine mandatory by mid-September or once the FDA grants final approval, whichever comes first. On Monday, after the FDA acted, the Pentagon said guidance on vaccinations will be worked out and a timeline will be provided in the coming days.

The approval also opened the way for swift action by colleges to require vaccines and solidified the legal ground for hundreds of universities that have already issued mandates for students and staff.