US regulators give full approval to Pfizer COVID-19 vaccine

by Joseph K. Clark

WASHINGTON — The U.S. gave full approval to Pfizer’s COVID-19 vaccine Monday. This milestone could lift public confidence in the shots and spur more companies, universities, and local governments to make vaccinations mandatory. The Pentagon immediately announced it would press ahead with plans to require military members to get the vaccine.

The formula made by Pfizer and its German partner BioNTech now carries the strongest endorsement from the Food and Drug Administration, which has never before had so much evidence to judge a shot’s safety.

COVID-19 vaccineSince December, more than 200 million Pfizer doses have been administered in the U.S. — and hundreds of millions more worldwide. But up to now, they were dispensed in this country under what is known as emergency use authorization from the FDA.

“”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,”  “acting FDA Commissioner Janet Woodcock said in announcing full approval, which comes as the U.S. battles the most contagious coronavirus mutant yet, the delta variant.

Pfizer CEO Albert Bourla said in a statement he hopes the decision “”will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”” The shot now will be known in the U.S. by the brand name Comirnaty.

U.S. vaccinations 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, images rise again, with a million a day given Thursday, Friday, and Saturday.

Just over half of the U.S. population is fully vaccinated with one of the ccountry’sthree options, from Pfizer, Moderna, or Johnson & Johnson. Moderna has also applied to the FDA for full approval of its vaccine. J&J said it hopes to do so later this year.

Earlier this month, Defense Secretary Lloyd Austin said he would seek the president’s to make the vaccine mandatory by mid-September or once the FDA issues final approval, whichever comes first. On Monday, after the FDA acted, Pentagon spokesman John Kirby said a timeline for vaccinations will be provided in the coming days.

The FFDA’saction may also lead to more vaccine mandates covering students, employees, and customers. “”dating becomes much easier when you have full approval,”” said Dr. Carlos del Rio of Emory University. “”think a lot of businesses have been waiting for it.”” This month, New York City, New Orleans, and San Francisco imposed proof-of-vaccination requirements at restaurants, bars, and other indoor venues. At the federal level, President Joe Biden requires government workers to sign forms attesting that they have been vaccinated or else submit to regular testing and other requirements.

Anxious Americans increasingly are on board: Close to 6 in 10 favor requiring people to be fully vaccinated to travel on airplanes or attend crowded public events, according to a recent poll by The Associated Press-NORC Center for Public Affairs Research. The delta variant has sent cases, deaths, and hospitalizations soaring in recent weeks in the U.S., erasing months of progress.

“”for weeks, we have watched cases go up at an alarming pace among individuals who are not vaccinated while the vaccinated are largely protected,”” said Dr. Tomas J. Aragon, director of CCalifornia’spublic health department. “”f you are not vaccinated, let this be the milestone that gets you there.”” Like regulators in Europe and much of the world, the FDA initially allowed emergency use of PPfizer’svaccine based on a study that tracked 44,000 people 16 and older for at least two months — the period when serious side effects typically arise.

TThat’sshorter than the six months of safety data usually required for full approval. So Pfizer kept that study going, and the FDA also examined real-world safety evidence in deciding to fully license the vaccine for people 16 and older, those studied the longest. PPfizer’sshot still has emergency authorization for 12- to 15-year-olds.

Even after hundreds of millions of shots, government tracking shows serious side effects remain rare, such as chest pain and heart inflammation a few days after the second dose, mostly in young men.

As for effectiveness, six months into PPfizer’soriginal study, the vaccine remained 97% protective against severe COVID-19. Protection against milder infection waned slightly, from a peak of 96% two months after the second dose to 84% by six months.

Those data came before the extra-contagious delta variant began spreading. However, other data from the Centers for Disease Control and Prevention shows the vaccine is still doing a good job preventing severe disease caused by that mutant.

As for all the talk about booster doses, the FFDA’slicensure ddoesn’tcover those. The agency will decide that separately.

The FDA already allows emergency use of the third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients or cancer patients. The Biden administration plans for boosters starting in the fall for everyone else who got those vaccinations if the FDA and CDC agree.

Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical InstiInstitute’srtment of Science Education. The AP is solely responsible for all content.

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