WASHINGTON (AP) \u2014 The U.S. gave full approval to Pfizer\u2019s COVID-19 vaccine on Monday, a milestone that may help lift public confidence in the shots as the nation battles the most contagious coronavirus mutant yet.<\/p>\n\n\n\n
The vaccine made by Pfizer and its 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\u2019s safety. More than 200 million Pfizer doses already have been administered in the U.S. \u2014 and hundreds of millions more worldwide \u2014 since emergency use began in December.<\/p>\n\n\n\n
\u201cThe 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,\u201d said acting FDA Commissioner Janet Woodcock. \u201cToday\u2019s milestone puts us one step closer to altering the course of this pandemic in the U.S.\u201d<\/p>\n\n\n\n
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said in a statement he hoped the decision \u201cwill help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.\u201d<\/p>\n\n\n\n
U.S. vaccinations bottomed out in July. As delta fills hospital beds, shots are on the rise again \u2014 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 country\u2019s three options, from Pfizer, Moderna or Johnson & Johnson.<\/p>\n\n\n\n
The FDA\u2019s action also may spur more vaccine mandates by companies, universities and local governments. This month New York City, New Orleans and San Francisco all imposed proof-of-vaccination requirements at restaurants, bars and other indoor venues. At the federal level, President Joe Biden is requiring government workers to sign forms attesting that they\u2019ve been vaccinated or else submit to regular testing and other requirements.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
\u201cMandating becomes much easier when you have full approval,\u201d said Dr. Carlos del Rio of Emory University. \u201cI think a lot of businesses have been waiting for it.\u201d<\/p>\n\n\n\n
The FDA, like regulators in Europe and much of the world, initially allowed emergency use of Pfizer\u2019s vaccine based on a study that tracked 44,000 people 16 and older for at least two months \u2014 the time period when serious side effects typically arise.<\/p>\n\n\n\n
That\u2019s shorter than the six months of safety data normally 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. Pfizer\u2019s shot still has emergency authorization for 12- to 15-year-olds.<\/p>\n\n\n\n
Even after hundreds of millions of shots, serious side effects \u2014 such as chest pain and heart inflammation in teens and young adults \u2014 remain exceedingly rare, the FDA said.<\/p>\n\n\n\n
As for effectiveness, six-month tracking of Pfizer\u2019s original study showed 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.<\/p>\n\n\n\n
Those data came before the extra-contagious delta variant began spreading, but 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.<\/p>\n\n\n\n
As for all the talk about booster doses, the FDA\u2019s licensure doesn\u2019t cover those. The agency will decide that separately.<\/p>\n\n\n\n
The FDA already is allowing emergency use of a third dose of either the Pfizer or Moderna vaccine for people with severely weakened immune systems, such as organ transplant recipients who don\u2019t respond as strongly to the usual two shots. For everyone else who got those vaccinations, the Biden administration is planning ahead for booster starting in the fall \u2014 if the FDA and CDC agree.<\/p>\n\n\n\n
Also still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying youngsters, with data expected in the fall.<\/p>\n\n\n\n
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