FDA approves COVID booster shots for elderly, high risk

More regulatory hurdles remain in place.

Posted: Sep 22, 2021 8:38 PM

(ASSOCIATED PRESS) - The U.S. moved a step closer Wednesday to offering booster doses of Pfizer’s COVID-19 vaccine to senior citizens and others at high risk from the virus as the Food and Drug Administration signed off on the targeted use of extra shots.

The FDA authorized booster doses for Americans who are 65 and older, younger adults with underlying health conditions and those in jobs that put them at high risk for COVID-19. The ruling represents a drastically scaled back version of the Biden administration’s sweeping plan to give third doses to nearly all American adults to shore up their protection amid the spread of the highly contagious delta variant.

However, more regulatory hurdles lie ahead before the dispensing of boosters can begin.

Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when. And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence.

The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.

The FDA decision Wednesday was expected after the agency’s own panel of advisers last week overwhelmingly rejected the Biden plan. The panel instead recommended boosters only for those most vulnerable to severe cases of COVID-19.

FDA acting commissioner Dr. Janet Woodcock said in a statement that the FDA authorization would allow for boosters in health care workers, teachers, grocery workers and those in homeless shelters or prisons.

"As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Woodcock said.

Under the FDA authorization, vaccinated Americans are eligible for a third dose six months after receiving their second Pfizer shot. That's different than the Biden proposal announced in August, which called for boosters after eight months.

“Today’s FDA decision is a major step forward in our effort to provide Americans with additional protection from COVID-19,” White House press secretary Jen Psaki tweeted Wednesday night. “We have been preparing for weeks to administer booster shots to eligible Americans and are ready to do so following CDC’s final recommendation later this week.”

The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC convenes its own experts.

The CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters. On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death. On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes.

Ultimately the committee must decide who is considered at high enough risk for an extra dose. Data provided by Pfizer and the Israeli government suggests a strong case for boosters in people 65 and older, but there is less evidence that extra shots provide much benefit for younger people with underlying health conditions.

Several CDC advisers agreed boosters are also important for keeping health care workers on the job.

“We don’t have enough health care workers to take care of the unvaccinated,” said Dr. Helen Keipp Talbot of Vanderbilt University. “They just keep coming.”

The CDC has already said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

The World Health Organization and other global health advocates are opposed to wealthy nations dispensing a third round of shots when poor countries don’t have enough vaccine for their first doses. And many independent scientists say that the vaccines continue to perform well against the worst effects of COVID-19 and that their ability to curb the overall trajectory of the epidemic is uncertain.

U.S. regulators will decide at a later date on boosters for people who have received the Moderna or Johnson & Johnson vaccines. They indicated the Pfizer shots would not be recommended for people who got a different brand of vaccine initially.

The across-the-board rollout of boosters proposed by the White House was supposed to have begun this week. Some questioned whether President Joe Biden had gotten ahead of the science by announcing his plans before government regulators had reached any conclusions.

Despite the resistance in recent days, some top U.S. health officials said they expect boosters to eventually win broader approval in the coming weeks or months. Dr. Anthony Fauci said over the weekend that “this is not the end of the story.”

Other administration officials noted that the FDA decision covers tens of millions of Americans and that seniors and other high-risk groups would have been the first to get boosters even if extra shots had been authorized for the entire population. Seniors were in the first group of Americans eligible for vaccination last December.

The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking.

The U.S. is dispensing around 760,000 vaccinations per day on average, down from a high of 3.4 million a day in mid-April. About 180 million Americans are fully vaccinated, or 64% of those who are eligible.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 895229

Reported Deaths: 9462
CountyCasesDeaths
Hennepin1749772017
Ramsey722701040
Dakota66032572
Anoka62513568
Washington39357355
Stearns32821275
St. Louis28761399
Wright25354211
Scott25329181
Olmsted21750127
Sherburne18478126
Carver1629166
Clay11923103
Blue Earth1126366
Rice11234138
Crow Wing11003122
Chisago974676
Kandiyohi9660106
Otter Tail9611126
Benton8815124
Beltrami801794
Goodhue786596
Douglas7689100
Itasca752796
Mower721349
Winona702756
McLeod694483
Isanti681383
Steele669431
Morrison663479
Becker620873
Polk591684
Freeborn550846
Carlton529474
Nobles521654
Lyon518761
Mille Lacs516573
Nicollet510960
Pine500641
Cass491252
Todd483642
Brown465057
Le Sueur445933
Meeker422357
Martin378143
Wabasha366010
Waseca365132
Dodge351511
Hubbard349848
Roseau307931
Fillmore299115
Wadena298239
Redwood277845
Houston266817
Renville264151
Faribault253032
Pennington247529
Sibley246917
Kanabec241536
Cottonwood225032
Chippewa216342
Aitkin215850
Pope203210
Watonwan194920
Yellow Medicine185423
Rock174728
Swift169322
Koochiching168123
Stevens164511
Jackson159216
Clearwater155720
Marshall151122
Murray150911
Pipestone148329
Lake129824
Lac qui Parle120025
Wilkin119416
Mahnomen104714
Norman10389
Grant9719
Big Stone9365
Lincoln8705
Kittson71523
Red Lake70710
Traverse5996
Unassigned572124
Lake of the Woods5235
Cook3020

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 516453

Reported Deaths: 7289
CountyCasesDeaths
Polk80319799
Linn32142424
Scott26637292
Black Hawk21974378
Woodbury20490258
Johnson19778105
Dubuque18515241
Pottawattamie15890213
Dallas15320113
Story1380258
Warren8450104
Cerro Gordo7964123
Clinton7725114
Webster7326122
Des Moines7098105
Marshall669093
Muscatine6645117
Wapello6441144
Jasper619591
Sioux610177
Lee5908105
Marion557897
Buena Vista502149
Plymouth488388
Henry418655
Benton404859
Jones404862
Bremer395372
Washington391463
Boone389739
Carroll367755
Mahaska365365
Crawford353747
Dickinson314655
Jackson307747
Buchanan305741
Clay295536
Delaware294654
Kossuth289077
Fayette286353
Hardin284353
Tama279777
Page272533
Wright266149
Cedar265527
Hamilton259857
Winneshiek258143
Floyd255449
Clayton244459
Poweshiek237243
Madison234525
Harrison234379
Cass233466
Butler232744
Iowa229634
Jefferson223043
Mills220930
Winnebago215938
Hancock214639
Cherokee211347
Lyon206142
Appanoose205357
Allamakee203955
Calhoun196919
Shelby196442
Union191141
Humboldt185130
Grundy183637
Franklin183029
Mitchell182043
Chickasaw178922
Emmet178246
Louisa176953
Sac171026
Guthrie168137
Montgomery161745
Clarke160829
Keokuk150839
Palo Alto150532
Howard146824
Monroe142739
Ida130141
Greene127517
Davis124625
Lucas124426
Monona122939
Worth12139
Pocahontas120724
Adair114337
Osceola104818
Decatur101913
Taylor98514
Fremont95913
Van Buren93222
Wayne84525
Ringgold76729
Audubon74917
Adams5748
Unassigned480
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