Next on FDA's agenda: Booster shots of Moderna, J&J vaccines

With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.

Posted: Oct 12, 2021 8:58 AM

WASHINGTON (AP) — With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it's their turn.

Federal regulators begin tackling that question this week.

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.

After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director.

The process is meant to bolster public confidence in the vaccines. But it has already led to conflicts and disagreements among experts and agencies.

For example, last month the CDC advisory panel backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems. But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

Some health experts fear the back-and-forth deliberations are muddling the public effort to persuade the unvaccinated to get their first shots. They worry that the talk of boosters will lead people to wrongly doubt the effectiveness of the vaccines in the first place.

As the FDA's panel meets to review the Moderna and J&J vaccines, its decisions this time are likely to be even more complicated, with experts discussing whether a third Moderna shot should contain just half the original dose and what’s the best timing for a second shot of the single-dose J&J vaccine.

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have not endorsed so far.

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

The two initial Moderna shots contain 100 micrograms of vaccine each. But the drugmaker says 50 micrograms ought to be enough for a booster for healthy people.

A company study of 344 people gave them a 50-microgram shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster even triggered a 42-fold rise in antibodies able to target the extra-contagious delta variant.

Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.

As for people who got the J&J vaccine, the company submitted data to the FDA for different options: a booster shot at two months or at six months. The company did not signal its preference.

J&J released data in September showing that a booster given at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection.

Even without a booster, J&J says, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the U.S.

Scientists emphasize that all three vaccines used in the U.S. still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection may wane.

In one recent study, researchers compared about 14,000 people who had gotten their first Moderna dose a year ago with 11,000 vaccinated eight months ago. As the delta variant surged in July and August, the more recently vaccinated group had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

Still, medical experts continue to debate the science and rationale for giving extra shots to those who already have significant protection.

The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing signs of waning protection and the then-surging delta variant. But they were rebuffed by many experts who said there is little data showing whether such broad use would stop breakthrough infections or curb the overall trajectory of cases.

While the FDA and CDC ultimately scaled back use of Pfizer boosters, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.

They point to data from Israel showing lower rates of infections and severe disease among people who received a third Pfizer shot.

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 921249

Reported Deaths: 9678
CountyCasesDeaths
Hennepin1797812046
Ramsey744701052
Dakota68081589
Anoka64523585
Washington40846364
Stearns33805283
St. Louis29764413
Scott26116187
Wright26105223
Olmsted22502130
Sherburne19117128
Carver1677569
Clay12183107
Blue Earth1154270
Rice11505139
Crow Wing11275124
Chisago999580
Kandiyohi9861108
Otter Tail9860129
Benton9098126
Beltrami819598
Goodhue816899
Douglas7929101
Itasca777299
Mower736349
McLeod718284
Winona711658
Isanti704785
Steele689234
Morrison675380
Becker630474
Polk606187
Freeborn564847
Carlton549875
Mille Lacs535179
Lyon530961
Nobles526954
Nicollet525661
Pine517943
Cass503253
Todd494143
Brown471760
Le Sueur460534
Meeker435459
Martin388244
Wabasha377410
Waseca375933
Dodge364312
Hubbard356049
Roseau318631
Fillmore307415
Wadena304740
Redwood282145
Houston272417
Renville269851
Faribault259435
Sibley254417
Pennington253430
Kanabec251837
Cottonwood231232
Aitkin223751
Chippewa221242
Pope209410
Watonwan200021
Yellow Medicine189223
Rock178229
Koochiching177825
Swift173423
Stevens169311
Jackson161716
Clearwater158721
Marshall154222
Murray152711
Pipestone150529
Lake133624
Lac qui Parle123525
Wilkin121516
Mahnomen106414
Norman10569
Grant101810
Big Stone9555
Lincoln8885
Kittson73623
Red Lake71610
Traverse6076
Unassigned569124
Lake of the Woods5265
Cook3131

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 527597

Reported Deaths: 7379
CountyCasesDeaths
Polk81677809
Linn32838430
Scott27126295
Black Hawk22334382
Woodbury20736263
Johnson20150108
Dubuque18996243
Pottawattamie16215214
Dallas15573115
Story1398059
Warren8637107
Cerro Gordo8141125
Clinton7928115
Webster7419124
Des Moines7153106
Marshall675494
Muscatine6717117
Wapello6546145
Jasper630591
Sioux622477
Lee5977106
Marion567697
Buena Vista503449
Plymouth493388
Henry427155
Benton414760
Jones413564
Bremer403873
Boone397042
Washington395464
Carroll373355
Mahaska372366
Crawford355647
Jackson324047
Dickinson317555
Buchanan312743
Delaware303255
Clay297636
Kossuth293477
Fayette290356
Hardin289253
Tama282878
Page276133
Wright270050
Cedar269527
Winneshiek267744
Hamilton262757
Floyd261049
Clayton252360
Poweshiek242043
Harrison240979
Madison237425
Butler237346
Cass235667
Iowa234336
Jefferson228544
Mills225330
Hancock222840
Winnebago222339
Cherokee217347
Appanoose210157
Lyon209842
Allamakee209456
Calhoun199519
Shelby199542
Union197141
Unassigned18890
Humboldt188231
Franklin188031
Grundy186137
Chickasaw184522
Mitchell184343
Emmet180146
Louisa178653
Sac175626
Guthrie169338
Clarke163629
Montgomery163146
Keokuk152639
Palo Alto152332
Howard150624
Monroe144340
Ida134141
Greene128818
Davis126825
Lucas126127
Monona124940
Worth12309
Pocahontas122125
Adair118239
Osceola105718
Decatur104813
Taylor100914
Fremont98913
Van Buren95922
Wayne86125
Ringgold78429
Audubon77617
Adams5869
Rochester
Cloudy
31° wxIcon
Hi: 46° Lo: 29°
Feels Like: 22°
Mason City
Partly Cloudy
27° wxIcon
Hi: 51° Lo: 28°
Feels Like: 19°
Albert Lea
Cloudy
28° wxIcon
Hi: 47° Lo: 28°
Feels Like: 23°
Austin
Clear
28° wxIcon
Hi: 47° Lo: 29°
Feels Like: 20°
Charles City
Partly Cloudy
28° wxIcon
Hi: 51° Lo: 28°
Feels Like: 20°
Tracking cold and snow for next week
KIMT Radar
KIMT Eye in the sky

Community Events