FDA advisers unanimously recommend booster doses of Johnson & Johnson's Covid-19 vaccine

The FDA will now consider the committee's advice. Then the US Centers for Disease Control and Prevention's vaccine advisers will be asked to consider it.

Posted: Oct 15, 2021 11:52 AM

By Maggie Fox, CNN

(CNN) -- Vaccine advisers to the US Food and Drug Administration voted unanimously Friday to recommend a booster dose of Johnson & Johnson's vaccine at least two months after people get the first dose.

The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-0 to recommend the extra dose for all recipients of the J&J Janssen vaccine, 18 and older. They asked to simplify the original question being posed by the FDA, which had asked the committee to say whether the data showed that waiting six months or longer after getting the first shot would provide an even stronger immune response.

The FDA will now consider the committee's advice. Then the US Centers for Disease Control and Prevention's vaccine advisers will be asked to consider it.

Johnson & Johnson says studies have shown boosting at two or six months can bring that effectiveness up to 94% and it says its effectiveness does not wane over time in the same way that effectiveness from Pfizer's vaccine does.

But the Johnson & Johnson vaccine has not been shown to be as protective as either the Pfizer or Moderna vaccines, noted VRBPAC chair Dr. Arnold Monto, a professor of public health and epidemiology at the University of Michigan. "So there is some urgency here to do something," he told the meeting.

And the CDC's Dr. Amanda Cohn told the meeting that various studies suggested real-world efficacy of J&J's vaccine was anywhere between 50% and 68%.

"Regardless of whether or not there been waning or this is the true effectiveness after a single dose, the effectiveness or protection of a single dose of the J&J vaccine is not equivalent to protection at this time with either two doses of an mRNA vaccine and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine," Cohn said.

Members of the committee said while there was not much data to show whether the efficacy of the Janssen vaccine was waning -- or was strong to begin with -- they agreed people should be given the opportunity for a booster. "I would say I agree a second dose booster is needed to boost immunity back to the 90-plus range," Dr. Archana Chatterjee, a pediatric infectious diseases expert at Rosalind Franklin University in Chicago, said before the vote.

The FDA has already given EUA to a booster for Pfizer's vaccine for people who are six months out from their first two shots who are also either 65 or older or who are at least 18 and have a higher risk of severe disease because of pre-existing conditions or because of work or living conditions.

And Americans are already flocking to get those boosters. Data from the US Centers for Disease Control and Prevention show close to 5% of fully vaccinated people -- about 9 million people -- have received booster shots.

On Thursday, VRBPAC members voted unanimously to recommend booster doses of Moderna's vaccine to the same groups.

If the FDA gives emergency use authorization to Moderna or Johnson & Johnson boosters, CDC vaccine advisers will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation. CDC's Advisory Committee on Immunization Practices is scheduled to discuss boosters on October 21.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 387485

Reported Deaths: 5116
CountyCasesDeaths
Multnomah59768836
Washington41571393
Marion39592504
Clackamas32426376
Lane29856354
Jackson24672350
Deschutes23182185
Umatilla15087180
Linn14488178
Douglas13236286
Josephine10057240
Yamhill9665142
Klamath8979145
Polk813698
Benton605137
Malheur591586
Coos5573106
Columbia423855
Jefferson416865
Lincoln357252
Union336854
Crook330156
Wasco314846
Clatsop258335
Baker217531
Tillamook214345
Hood River211337
Morrow197025
Curry190136
Harney119332
Grant108314
Lake104016
Wallowa74713
Sherman1903
Gilliam1844
Wheeler1141
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California Coronavirus Cases

Data is updated nightly.

Cases: 5060048

Reported Deaths: 74129
CountyCasesDeaths
Los Angeles152429427102
San Diego4047084319
Riverside3849455306
San Bernardino3718825944
Orange3329505675
Sacramento1674002423
Kern1565171781
Fresno1558992246
Santa Clara1511691922
Alameda1246581500
San Joaquin1070001833
Ventura1036461188
Contra Costa1032921045
Stanislaus912991413
Tulare856141082
San Francisco56614669
San Mateo56058629
Monterey52340625
Solano47422356
Santa Barbara47035548
Merced44807664
Sonoma42912412
Placer41881468
Imperial38128769
Kings35038358
San Luis Obispo31294358
Madera26005311
Shasta25917440
Butte25295309
Santa Cruz22028222
Yolo21451257
Marin18342248
El Dorado18166161
Sutter14494181
Napa13372104
Yuba1070088
Tehama10230129
Humboldt10043117
Nevada9914103
Mendocino848894
Lassen792355
San Benito775977
Tuolumne767790
Lake6990110
Amador573766
Siskiyou470954
Glenn455136
Calaveras435685
Del Norte371242
Colusa323519
Inyo254345
Plumas19127
Mono18294
Mariposa156718
Trinity98817
Modoc7475
Unassigned2430
Sierra2170
Alpine1060
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