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.


FOX 55: Tracking the COVID-19 Vaccine

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: 1011197

Reported Deaths: 16524
CountyCasesDeaths
Marion1359292129
Lake666181167
Allen58254802
Hamilton46498467
St. Joseph44559617
Elkhart36044510
Vanderburgh32333481
Tippecanoe28037260
Johnson25196446
Hendricks23960360
Porter22985367
Madison18820410
Clark18609253
Vigo17530303
Monroe15319200
LaPorte15230252
Delaware15127264
Howard14801290
Kosciusko12410149
Hancock11773176
Bartholomew11695180
Warrick11305189
Floyd11138215
Wayne11023253
Grant10131220
Morgan9506177
Boone8965116
Dubois8281131
Henry8252153
Dearborn823493
Noble8064106
Marshall7981135
Cass7556123
Lawrence7479172
Shelby7216119
Jackson700990
Gibson6614115
Harrison651892
Huntington6447100
Knox6427106
DeKalb6363100
Montgomery6293112
Miami595298
Putnam584179
Clinton579271
Whitley568455
Steuben566876
Wabash5363104
Jasper536180
Jefferson513297
Ripley501987
Adams483777
Daviess4684115
Scott439875
Greene427296
Clay426960
Wells426088
White420964
Decatur4177104
Fayette407387
Jennings390262
Posey377544
LaGrange361778
Washington360451
Randolph3476100
Spencer340743
Fountain336160
Sullivan330852
Starke319171
Owen315571
Fulton313468
Orange295064
Jay285546
Franklin266443
Perry265752
Rush263832
Carroll262434
Vermillion259854
Parke232029
Pike229643
Tipton229059
Blackford195042
Pulaski184657
Crawford160125
Newton159848
Benton151217
Brown147047
Martin139319
Switzerland135311
Warren121416
Union107216
Ohio84613
Unassigned0544

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1524169

Reported Deaths: 23955
CountyCasesDeaths
Franklin1646591696
Cuyahoga1468932459
Hamilton1056051431
Montgomery742551279
Summit620221111
Lucas56539917
Butler51696718
Stark468601064
Lorain35783585
Warren32903377
Mahoning30927693
Clermont28271330
Lake27179448
Delaware24263164
Licking24027294
Trumbull22993561
Fairfield22438247
Greene22414326
Medina22149313
Clark19920354
Richland18643292
Portage18073252
Wood17505224
Allen16054279
Miami15627306
Muskingum14890185
Columbiana14153274
Wayne13852271
Tuscarawas12777311
Marion12016180
Scioto11497162
Pickaway11386142
Erie10951184
Ross10614203
Ashtabula9809204
Lawrence9783153
Hancock9741155
Belmont9333209
Geauga9008157
Jefferson8600199
Huron8427143
Union822259
Washington8114144
Sandusky7875151
Athens779579
Knox7766144
Darke7695158
Seneca7405145
Ashland6993130
Auglaize681799
Shelby6540115
Brown640091
Crawford6292130
Defiance6241105
Mercer617893
Fulton605196
Highland602899
Guernsey596371
Madison595678
Logan594596
Clinton585193
Preble5730125
Putnam5354110
Williams530888
Perry519863
Champaign514273
Jackson512473
Ottawa490586
Coshocton488383
Morrow460558
Pike435067
Fayette430363
Hardin420780
Gallia419367
Adams417995
Van Wert374082
Henry366972
Holmes3653125
Hocking357582
Wyandot325262
Carroll304365
Paulding280747
Meigs267251
Monroe216254
Noble201247
Morgan194333
Harrison182646
Vinton167225
Unassigned05
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