FDA vaccine advisers recommend authorization of Johnson & Johnson's coronavirus vaccine

Vaccine advisers to the US Food and Drug Administration voted Friday to recommend the agency grant emergency use authorization to Johnson & Johnson's coronavirus vaccine.

Posted: Feb 26, 2021 5:37 PM
Updated: Feb 27, 2021 8:41 AM

Vaccine advisers to the US Food and Drug Administration voted Friday to recommend the agency grant emergency use authorization to Johnson & Johnson's coronavirus vaccine.

The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend EUA of the vaccine in people 18 and older.


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Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, head of the FDA's vaccine decision, said EUA would come quickly.

'The U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution,' they said in a joint statement after the vote.

The vaccine will become the third authorized for use in the United States. It will be the first one-shot vaccine, and one that can be stored in regular refrigerators, making it easier to distribute than the Pfizer/BioNTech and Moderna vaccines, which are more delicate and require two doses.

The vaccine, made by Johnson & Johnson's vaccine arm, Janssen, was tested in advanced clinical trials in more than 44,000 people in the US, South Africa and Latin America. Globally, it showed an overall efficacy of 66% in preventing moderate-to-severe disease. In the US, this efficacy was 72% and it was 85% effective in preventing severe disease. No one who got the vaccine died of Covid-19 during the trial.

Top US health officials have said vaccination is the best way to bring the coronavirus pandemic under control. The virus has infected more than 28 million Americans and killed more than half a million.

'We urgently need more vaccines under EUA to protect the millions of Americans who remain at risk,' Dr. Greg Poland, head of the Mayo Clinic's Vaccine Research Group, told the meeting.

'We need a vaccine that can be quickly mass produced,' Poland told Friday's meeting. 'We'd want to see a reasonable duration of efficacy and protection,' he added. 'The Janssen vaccine candidate checks nearly all the boxes.'

How the vaccine works

Members of the committee said they had few doubts about their decision.

'I think it's a relatively easy call. It clearly gets way over the bar and it's nice to have a single-dose vaccine,' Dr. Eric Rubin, editor in chief of the New England Journal of Medicine and a professor at the Harvard TH Chan School of Public Health, said after the vote.

Several members stressed the urgency of fighting a pandemic that has killed more than half a million Americans.

'We are still in the midst of a deadly pandemic. There is a shortage of vaccines that are currently authorized and I think authorization of this vaccine will help meet the need at this moment,' said Dr. Archana Chatterjee, vice president for medical affairs at Rosalind Franklin University in Chicago.

'There's an urgency to get this done. We're in a race between the virus mutating, new variants coming out that can cause further disease and stopping it,' added Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri Kansas City school.

'We need to get this vaccine out. I do believe the evidence supports its safety and effectiveness.'

Janssen's vaccine is different from the Pfizer and Moderna vaccines, which are made using a new technology that employs genetic material called messenger RNA or mRNA. Janssen's vaccine uses a common cold virus called adenovirus 26. It has been genetically engineered so that it cannot replicate in the body. Instead, it infects a few cells in the arm when injected, carrying the genetic code for a small part of the coronavirus. Those cells then produce material that looks like pieces of the virus to the immune system, stimulating an immune response.

It's an older vaccine technology. 'The military has used adenovirus vaccines a lot,' Dr. Arnold Monto, an epidemiologist at the University of Michigan's School of Public Health who chairs the VRBPAC, said during the meeting.

Although the Johnson & Johnson vaccine does not appear to have the astonishing 94% to 95% efficacy of the Pfizer and Moderna vaccines, researchers told the VRBPAC committee that it was tested at a different time -- when more virus was circulating and after new variants had arisen that have the ability to evade some of the immune response. Although they were not able to show that these variants were responsible for the apparent lower efficacy of Johnson & Johnson's vaccine, they told the committee it could have been a factor.

What happens next

If the FDA issues an EUA, it could come as soon as Friday night. It's up to the US Centers for Disease Control and Prevention to decide whether the vaccine should actually be given to Americans. The CDC's Advisory Committee on Immunization Practices (ACIP) has scheduled a meeting for Sunday to take up the question. ACIP will vote on Sunday afternoon on whether the CDC should OK the vaccine's distribution and may also designate priority groups.

The CDC director, Dr. Rochelle Walensky, will then give the final go-ahead.

The US federal government says it's ready to distribute about 4 million doses of the vaccine immediately.

Dr. Anthony Fauci, the chief medical adviser to the White House and director of the National Institute of Allergy and Infectious Diseases, has said Americans should not try to pick and choose vaccines but rather, get whichever vaccine is available.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 766351

Reported Deaths: 13965
CountyCasesDeaths
Marion1052671804
Lake568691028
Allen42858698
St. Joseph37286568
Hamilton37260426
Elkhart29729470
Tippecanoe23441230
Vanderburgh23153404
Porter19568327
Johnson18807391
Hendricks18059321
Madison13518345
Clark13502198
Vigo12817255
LaPorte12558224
Monroe12529178
Delaware11124198
Howard10654237
Kosciusko9751123
Hancock8734149
Bartholomew8256157
Warrick8053157
Floyd8005181
Grant7349181
Wayne7234201
Boone7173105
Morgan6904142
Marshall6329116
Dubois6270118
Cass6085111
Dearborn600078
Noble597890
Henry5944111
Jackson515677
Shelby509897
Lawrence4914127
Gibson461596
Montgomery457592
Clinton454555
DeKalb453685
Harrison452476
Whitley415345
Huntington414081
Steuben410260
Miami405073
Jasper400455
Knox388091
Putnam384662
Wabash368783
Adams352256
Ripley351071
Jefferson341586
White339354
Daviess3089100
Wells302781
Greene292985
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Fayette285864
Posey280935
Scott278758
LaGrange277172
Clay273148
Washington253537
Randolph247583
Jennings238649
Spencer237931
Fountain234850
Starke229959
Owen222259
Sullivan219543
Fulton207845
Jay202832
Carroll197122
Orange190956
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Parke154816
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Blackford137832
Pulaski123648
Newton123036
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Brown105943
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Martin92515
Warren87715
Switzerland8328
Union73510
Ohio58311
Unassigned0428

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1122647

Reported Deaths: 20467
CountyCasesDeaths
Franklin1302911493
Cuyahoga1171502259
Hamilton823481259
Montgomery534491059
Summit488581014
Lucas43734832
Butler39936614
Stark33800937
Lorain25996509
Warren24896312
Mahoning22685612
Lake21457396
Clermont20368260
Delaware19120138
Licking16842227
Trumbull16786491
Fairfield16762207
Medina15832276
Greene15499254
Clark14339308
Portage13417218
Wood13338201
Allen12043245
Richland11726213
Miami10998228
Wayne9251227
Columbiana9196236
Muskingum9119137
Pickaway8738123
Tuscarawas8714254
Marion8703140
Erie8126166
Ashtabula7272179
Hancock7044134
Ross7012165
Geauga6948153
Scioto6679108
Belmont6210179
Lawrence5917104
Union590449
Jefferson5723162
Huron5630122
Sandusky5482130
Darke5436130
Seneca5376128
Washington5362111
Athens526560
Auglaize507087
Mercer490685
Shelby481297
Knox4609112
Madison447266
Ashland443198
Defiance438499
Fulton435775
Putnam4351104
Crawford4110111
Brown409662
Preble3946107
Logan391679
Clinton389266
Ottawa375581
Highland365068
Williams356478
Champaign348360
Guernsey330254
Jackson321254
Perry298350
Morrow294643
Fayette288250
Hardin279165
Henry276967
Coshocton272561
Holmes2725102
Van Wert251665
Adams249258
Gallia249250
Pike244637
Wyandot235257
Hocking222663
Carroll201249
Paulding179442
Meigs151040
Noble137739
Monroe137545
Harrison115238
Morgan111524
Vinton87217
Unassigned03
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