Johnson & Johnson Covid-19 vaccine is safe and effective, FDA analysis finds

In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use...

Posted: Feb 24, 2021 10:03 AM
Updated: Feb 24, 2021 4:00 PM

In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization -- another step toward the authorization of a third shot for the United States.

The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single-dose vaccination and 66.1% at least 28 days after vaccination, according to the analysis, which is meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee.

The committee is an independent group that determines if the vaccine works and if it's safe. After the group meets Friday, it will make its authorization recommendation to the FDA, which typically follows the recommendation.

Any time it approves or authorizes a vaccine, the FDA releases an analysis of the clinical trial data that the company has submitted. What the FDA found in the trial data looked good.

'There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,' the analysis said.

In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is 'consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.'

Seems to work against variants

The Johnson & Johnson Covid-19 vaccine seems to work better than initial data showed against the virus variant first identified in South Africa.

The variant, which is thought to be more contagious, currently makes up the majority of cases in South Africa and has been found in several countries now, including in the United States.

According to the FDA analysis, the vaccine showed a 64% efficacy rate in South Africa. That's seven points higher than the interim data that was released by the company in January. Since that time, J&J did some additional sequencing of the cases in the study, and determined that more of them were caused by a variant that could be included in its analysis. Nearly 95% of the cases in the study came from the variant, according to the addendum to the FDA analysis.

'The fact that the numbers came up a little bit, once they fully analyzed the data from the time of the initial press release, shows that it's not that different against the South African variant,' said Dr. Philip Grant, who was the lead investigator on the Stanford University arm of the J&J vaccine trial. 'I think it's going to have to be looked at more carefully, in terms of which vaccines are most effective in different locations.'

The vaccine has a 72% efficacy rate in the US and a more than 68% rate in Brazil at protecting people from mild to severe/critical disease.

The vaccine offered nearly 86% protection against severe forms of the disease in the US, nearly 82% in South Africa and nearly 88% in Brazil.

Current Covid-19 vaccines made by Pfizer and Moderna are also thought to have good efficacy against the variants.

Experts have said variants may fuel a surge of cases in the spring in the US, and say that's one reason why it's important to get as many people vaccinated as quickly as possible.

'We'll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,' Dr. Aditya Gaur said, a co-lead investigator on the J&J trial at St. Jude in Memphis. 'But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.'

May prevent asymptomatic infections

The briefing document also hints that the J&J vaccine may prevent Covid-19 infection without symptoms starting at about four weeks.

A January study from the US Centers for Disease Control and Prevention have shown that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease -- not just keep the vaccinated from getting sick.

The clinical trial looked for asymptomatic infections among the volunteers at several points after they had been vaccinated. The trial found that the vaccine had 'modest' protection against asymptomatic infection from day one through day 29, but after that, it seemed to offer protection.

When the volunteers were checked for coronavirus antibodies at 71 days after they had gotten the vaccine, it seemed about 74% effective against asymptomatic infections.

'The news about asymptomatic infectious is very encouraging, with all the caveats,' said Grant.

The document says these findings should be 'interpreted with caution' and additional research is needed, since the follow-up time is limited and the number of volunteers in this sample was comparatively small, so 'definitive conclusions cannot be drawn at this time.'

Gaur said there is definitely a 'signal here to see that there is efficacy of the vaccine against asymptomatic infection,' and he agrees it requires more follow-up studies.

A 'favorable safety profile'

The analysis of safety data through January, found that the most common side effects associated with the vaccine were pain at the injection site, headache, fatigue and muscle pain.

There appeared to be more incidents related to blood clotting and ringing in the ears among those who received the vaccine compared with those who didn't, but the FDA notes, 'Data at this time are insufficient to determine a causal relationship between these events and the vaccine.'

Overall, non-fatal serious adverse events were infrequent, according to the briefing document, and there were no reported cases of anaphylaxis following vaccination.

With the Moderna and Pfizer Covid-19 vaccines, there have been a handful of severe allergic reactions, but this has been an extremely rare outcome. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.

As of February 5, there were seven Covid-19-related deaths in the placebo group in the J&J trial and no Covid-19-related deaths in the vaccine group.

The experts think this analysis is a good sign that the US could have another vaccine soon.

'I would be very surprised if they don't approve this,' said Dr. Jeffrey Carson, the lead investigator for the Rutgers arm of the J&J vaccine trial. 'The safety parameters look really good and the overall efficacy is over their criteria of 50% without a lot of serious side effects.'

And what that means, the experts said, is that people should get a Covid-19 vaccine -- any vaccine that's available -- as soon as they can.

'Given the effectiveness data that's being shared with the vaccines that are available, in assuming this one gets approved, what we all should be seeking is a vaccine, not trying to look at, which one's better because it's just very, very nuanced,' Gaur said. 'They're all giving protection against the severe spectrum of the illness.'

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: 520452

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
Unassigned40470
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
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