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: 704632

Reported Deaths: 13211
CountyCasesDeaths
Marion961411718
Lake51322943
Allen39040670
Hamilton34368405
St. Joseph33865539
Elkhart27197431
Vanderburgh22050394
Tippecanoe21725212
Johnson17475374
Porter17240298
Hendricks16754310
Clark12663190
Madison12321337
Vigo12172244
Monroe11417166
LaPorte10841204
Delaware10325184
Howard9629211
Kosciusko9098113
Hancock7954139
Bartholomew7867155
Warrick7680155
Floyd7543176
Wayne6887198
Grant6773171
Boone6524100
Morgan6379138
Dubois6074117
Marshall5770108
Dearborn568576
Cass5678102
Henry5569100
Noble539383
Jackson492869
Shelby478295
Lawrence4336118
Gibson427789
Harrison427570
Clinton417753
Montgomery417286
DeKalb407984
Huntington377480
Whitley376339
Miami371765
Knox365789
Steuben363357
Putnam352360
Jasper347546
Wabash347377
Adams337852
Ripley333468
Jefferson312180
White307854
Daviess289399
Wells285581
Decatur278592
Fayette277162
Greene270485
Posey268433
Scott260853
Clay253044
LaGrange252170
Randolph234680
Washington230631
Spencer227531
Jennings224747
Fountain208245
Sullivan207542
Starke202652
Owen191956
Fulton190939
Jay185829
Carroll185620
Perry179736
Orange176753
Rush170624
Vermillion165943
Franklin165635
Tipton160943
Parke144316
Blackford133331
Pike130234
Pulaski113245
Newton103034
Brown99740
Crawford97514
Benton96413
Martin82515
Warren79315
Switzerland7698
Union69710
Ohio55711
Unassigned0408

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1050112

Reported Deaths: 18991
CountyCasesDeaths
Franklin1219281356
Cuyahoga1067232069
Hamilton780741168
Montgomery49976996
Summit45252909
Lucas39984765
Butler37678570
Stark31385895
Lorain24111473
Warren23864293
Mahoning20869583
Lake19963362
Clermont19423229
Delaware18002130
Licking16109207
Fairfield15676197
Trumbull15553460
Medina14839259
Greene14643236
Clark13602293
Wood12733185
Portage12353196
Allen11312229
Richland11025198
Miami10525214
Muskingum8702127
Wayne8556209
Columbiana8535226
Pickaway8429121
Tuscarawas8370240
Marion8365135
Erie7554154
Hancock6694123
Ross6693146
Geauga6532146
Ashtabula6470165
Scioto6286101
Belmont5610158
Union557447
Lawrence5465102
Jefferson5303147
Huron5298114
Darke5268121
Sandusky5171120
Seneca5108120
Washington5073107
Athens500656
Auglaize475184
Mercer471184
Shelby455890
Knox4380108
Madison421559
Putnam420799
Ashland412688
Fulton409167
Defiance400896
Crawford3866101
Brown386055
Logan372876
Preble369898
Clinton360560
Ottawa356578
Highland346359
Williams324974
Champaign319257
Jackson307951
Guernsey306149
Perry289649
Fayette277348
Morrow274639
Hardin264164
Henry263566
Coshocton258857
Holmes253099
Van Wert238862
Gallia233346
Pike232931
Adams227852
Wyandot226953
Hocking208959
Carroll189147
Paulding168638
Meigs141538
Noble132837
Monroe128841
Morgan106623
Harrison105236
Vinton81414
Unassigned02
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