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U.S. regulators give full approval to Pfizer's COVID-19 vaccine

The U.S. gave full approval to Pfizer's 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.

Posted: Aug 23, 2021 8:43 AM
Updated: Aug 23, 2021 2:10 PM

WASHINGTON (AP) — The U.S. 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 require members of the military to get vaccinated amid the battle against the extra-contagious delta variant. Louisiana State University likewise said it will demand its students get the shot.

More than 200 million Pfizer doses have been administered in the U.S. under special 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 that serious side effects are extremely rare.

President Joe Biden said that for those who hesitated to get the vaccine until it received what he dubbed the “gold standard” of FDA approval, “the moment you’ve been waiting for is here.”

“Please get vaccinated today,” he said.

Pfizer CEO Albert Bourla called the FDA's action “an important milestone that I think will unlock some of the more skeptical minds.”

Pfizer said the U.S. is the first country to grant full approval of its vaccine, in a process that required a 360,000-page application and rigorous inspections. Never before has the FDA has so much evidence to judge a shot's safety.

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 this 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's COVID-19 vaccine means it meets the same “very high standards required of all the approved vaccines we rely on every day,” said 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.

LSU, with over 30,000 students, acted amid a surge in Louisiana that has repeatedly broken records for the number of people hospitalized with COVID-19. Some major college systems such as the University of Minnesota said they were waiting for FDA approval before making vaccinations mandatory. But some states forbid universities to require shots, including Texas and Florida.

“Mandating becomes much easier when you have full approval,” said Dr. Carlos del Rio of Emory University. “I think a lot of businesses have been waiting for it.”

On the same day the FDA decision came down, New York City announced that all public school teachers and other staffers will have to get vaccinated.

Earlier 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, Biden is requiring 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 fly 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. Deaths are running at about 1,000 a day on average for the first time since mid-March, and new cases are averaging 147,000 a day, a level last seen at the end of January.

“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 California’s public health department. “If you are not vaccinated, let this be the milestone that gets you there.”

The FDA, like regulators in Europe and much of the rest of the world, initially allowed emergency use of Pfizer’s vaccine based on a study that tracked 44,000 people 16 and older for at least two months — the time period when serious side effects typically arise.

That’s 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.

Pfizer’s shot will continue to be dispensed to 12- to 15-year-olds under an emergency use authorization, until the company files its its application for full approval.

Normally, doctors can prescribe FDA-approved products for other reasons than their original use. But FDA's acting Commissioner Dr. Janet Woodcock strongly warned that the Pfizer vaccine should not be used “off-label” for children under 12 — a warning echoed by the American Academy of Pediatrics.

Both Pfizer and Moderna have vaccine studies underway in youngsters, and they are using lower doses than those available for people 12 and older.

Pfizer's Bourla said he expects study results from 5- to 11-year-olds by the end of September, but data for those younger than 5 will take a couple of months.

Also, Woodcock said health providers are offering COVID-19 vaccines under agreements with the government that should preclude using Monday's approval as a pretext for offering booster shots to the general population.

Currently, the FDA has authorized third doses of either Pfizer's or Moderna's vaccine only for certain people with severely weakened immune systems, such as organ transplant recipients. For everyone else, the Biden administration is planning for boosters starting in the fall. But the FDA is evaluating that question separately.

In reaching Monday's decision, the FDA said serious side effects remain very 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 Pfizer’s original 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 findings came before the 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.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 692029

Reported Deaths: 8118
CountyCasesDeaths
Hennepin1420361857
Ramsey59138950
Dakota52802499
Anoka48675484
Washington31035311
Stearns25220241
St. Louis20709336
Scott19922146
Wright18796163
Olmsted16101111
Sherburne13732104
Carver1228652
Clay928595
Rice9218124
Blue Earth883747
Crow Wing7961102
Kandiyohi750289
Chisago725258
Otter Tail680795
Benton6577101
Mower570538
Winona561352
Goodhue557680
Douglas543684
Itasca527671
Beltrami521172
McLeod513464
Steele512821
Isanti497170
Morrison473363
Nobles453850
Becker445859
Polk439975
Freeborn434140
Lyon399854
Carlton395659
Nicollet384747
Pine379526
Mille Lacs360360
Brown354244
Cass350835
Le Sueur345930
Todd328434
Meeker311049
Waseca294725
Martin268733
Wabasha24734
Dodge24655
Hubbard238541
Roseau235924
Houston207416
Redwood204042
Renville202548
Fillmore200810
Pennington193622
Wadena189426
Faribault182825
Sibley178810
Cottonwood178524
Chippewa172739
Kanabec167029
Aitkin157338
Watonwan156711
Rock141819
Jackson135412
Pope13478
Yellow Medicine127020
Pipestone125526
Koochiching122319
Stevens121611
Swift118819
Murray116610
Marshall105818
Clearwater105418
Lake93021
Wilkin90314
Lac qui Parle87024
Mahnomen7069
Big Stone7014
Grant6958
Norman6739
Lincoln6624
Kittson53722
Unassigned50993
Red Lake4937
Traverse4325
Lake of the Woods4124
Cook2140

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 438547

Reported Deaths: 6420
CountyCasesDeaths
Polk69441683
Linn26618363
Scott23312265
Black Hawk19397338
Woodbury17483233
Johnson1698692
Dubuque14775221
Pottawattamie13369186
Dallas13048102
Story1211448
Warren707893
Webster6479103
Cerro Gordo6370105
Clinton635898
Des Moines618084
Muscatine5985109
Marshall586981
Sioux547676
Jasper532076
Lee529084
Wapello5230128
Buena Vista479442
Marion464086
Plymouth442185
Henry351341
Jones341159
Bremer331365
Washington330454
Crawford326844
Carroll326553
Benton325756
Boone318636
Mahaska282754
Dickinson276547
Kossuth257471
Clay255629
Jackson253844
Tama246073
Hardin244547
Buchanan244238
Delaware240143
Cedar228025
Fayette227945
Page225724
Wright221741
Winneshiek219237
Hamilton216752
Harrison205476
Madison199920
Clayton199758
Floyd195742
Butler191936
Poweshiek188837
Mills188225
Iowa185927
Cherokee184740
Allamakee181152
Jefferson178238
Lyon178041
Calhoun172213
Hancock170336
Winnebago170131
Cass164356
Louisa161651
Grundy161335
Appanoose158149
Shelby156539
Emmet153241
Franklin152224
Humboldt151626
Union149937
Sac147922
Mitchell146143
Guthrie142132
Chickasaw141618
Palo Alto134527
Clarke130226
Montgomery127940
Keokuk121332
Monroe118733
Howard118422
Ida109838
Davis105025
Greene103012
Pocahontas102623
Monona99034
Lucas98523
Adair97734
Worth9558
Osceola84717
Decatur76710
Fremont76511
Van Buren75221
Taylor73412
Wayne66323
Ringgold63027
Audubon60114
Adams4254
Unassigned270
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