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 coronav...

Posted: Feb 26, 2021 2:35 PM

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.

If the FDA acts on the recommendation -- and it's expected to do so quickly -- 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

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.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 177134

Reported Deaths: 2467
CountyCasesDeaths
Multnomah35310570
Washington23704229
Marion20393299
Clackamas15557204
Lane11802144
Jackson10077129
Umatilla800083
Deschutes731272
Linn422263
Yamhill413675
Klamath357159
Polk348452
Malheur343358
Josephine310062
Douglas306566
Benton277719
Jefferson207732
Coos198631
Columbia156126
Union141824
Lincoln130520
Wasco130428
Hood River113529
Morrow108415
Clatsop9078
Crook89519
Baker86714
Curry6049
Tillamook5883
Grant4304
Lake4177
Harney3156
Wallowa1585
Gilliam571
Sherman571
Wheeler261
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3725088

Reported Deaths: 61193
CountyCasesDeaths
Los Angeles122999823702
Riverside2976314547
San Bernardino2951314569
San Diego2756313681
Orange2692584902
Santa Clara1173792019
Kern1080611333
Sacramento1017871651
Fresno1007681650
Alameda856521477
Ventura803601002
San Joaquin717351334
Contra Costa67157782
Stanislaus606491035
Tulare49443831
Monterey43301364
San Mateo41251560
San Francisco36117529
Santa Barbara33926445
Solano32086243
Merced31289453
Sonoma29734312
Imperial28024719
Kings22781245
Placer21957283
San Luis Obispo20991257
Madera16301240
Santa Cruz15719204
Marin13868227
Yolo13581200
Shasta11747219
Butte11619196
El Dorado9797109
Napa971579
Sutter9299109
Yuba612744
San Benito598863
Lassen567924
Tehama544556
Nevada448975
Tuolumne408664
Mendocino399647
Humboldt365938
Amador363146
Lake341843
Glenn235925
Colusa220416
Calaveras206252
Siskiyou196521
Inyo141838
Del Norte12907
Mono12744
Plumas6936
Modoc4904
Mariposa4297
Trinity3985
Sierra1100
Alpine880
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