J&J’s 1-dose shot cleared, giving US 3rd COVID-19 vaccine

Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.

Posted: Feb 27, 2021 5:32 PM
Updated: Feb 27, 2021 8:05 PM

The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.

Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.

The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85% protective against the most severe COVID-19 illness, in a massive study that spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.

“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health, told The Associated Press Saturday. “The most important thing we can do right now is to get as many shots in as many arms as we can.”

J&J initially is providing a few million doses and shipments to states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.

J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization. The company aims to produce about 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.

“This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis,” President Joe Biden said in a statement. “But I want to be clear: this fight is far from over,” he added, encouraging people to stick with masks and other public health measures.

On Sunday, a U.S. advisory committee will meet to recommend how to prioritize use of the single-dose vaccine. And one big challenge is what the public wants to know: Which kind is better?

“In this environment, whatever you can get — get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks.

Data is mixed on how well all the vaccines being used around the world work, prompting reports in some countries of people refusing one kind to wait for another.

In the U.S., the two-dose Pfizer and Moderna shots were 95% protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85% against severe COVID-19 dropped to 66% when moderate cases were rolled in. But there’s no apples-to-apples comparison because of differences in when and where each company conducted its studies, with the Pfizer and Moderna research finished before concerning variants began spreading.

NIH’s Collins said the evidence shows no reason to favor one vaccine over another.

“What people I think are mostly interested in is, is it going to keep me from getting really sick?” Collins said. “Will it keep me from dying from this terrible disease? The good news is all of these say yes to that.”

Also, J&J is testing two doses of its vaccine in a separate large study. Collins said if a second dose eventually is deemed better, people who got one earlier would be offered another.

The FDA cautioned that it’s too early to tell if someone who gets a mild or asymptomatic infection despite vaccination still could spread the virus.

There are clear advantages aside from the convenience of one shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who are spending months on fishing vessels — communities where it’s hard to be sure someone will come back in three to four weeks for a second vaccination.

The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.

“We’re chomping at the bit to get more supply. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were readying electronic health records, staffing and vaccine storage in anticipation of offering J&J shots soon.

The FDA said studies detected no serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache.

An FDA fact sheet for vaccine recipients says there is “a remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines. Such reactions are treatable, and vaccine recipients are supposed to be briefly monitored after the injection.

The vaccine has been authorized for emergency use in adults 18 and older for now. But like other manufacturers, J&J is about to study how it works in teens before moving to younger children later in the year, and also plans a study in pregnant women.

All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that coats it. But they’re made in very different ways.

J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along. It’s the same technology the company used in making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.

The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless spike copies.

The AstraZeneca vaccine, already used in Britain and numerous other countries, is finishing a large U.S. study needed for FDA clearance. Also in the pipeline, Novavax uses a still different technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a British study suggesting strong protection.

Still other countries are using “inactivated vaccines,” made with killed coronavirus by Chinese companies Sinovac and Sinopharm.

___

Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Huntsville/Redstone
Partly Cloudy
51° wxIcon
Hi: 65° Lo: 46°
Feels Like: 51°
Decatur
Partly Cloudy
52° wxIcon
Hi: 65° Lo: 43°
Feels Like: 52°
Huntsville/Madison
Partly Cloudy
47° wxIcon
Hi: 65° Lo: 44°
Feels Like: 45°
Decatur
Clear
52° wxIcon
Hi: 66° Lo: 46°
Feels Like: 52°
Fort Payne
Mostly Cloudy
54° wxIcon
Hi: 65° Lo: 44°
Feels Like: 54°
WAAY Radar
WAAY WAAY-TV Cam
WAAY Temperatures

Alabama Coronavirus Cases

Cases: 522131

Reported Deaths: 10790
CountyCasesDeaths
Jefferson754831494
Mobile39111799
Madison34084500
Tuscaloosa25396444
Montgomery24037573
Shelby23210242
Baldwin20714302
Lee15614166
Calhoun14350311
Morgan14164273
Etowah13696348
Marshall12007220
Houston10408279
Elmore10018203
Limestone9858148
Cullman9507191
St. Clair9478236
Lauderdale9271233
DeKalb8760183
Talladega8122173
Walker7146276
Autauga6760106
Jackson6760110
Blount6529133
Colbert6234132
Coffee5431113
Dale4779111
Russell430939
Franklin420982
Chilton4114110
Covington4068115
Tallapoosa3915148
Escambia390374
Dallas3525150
Chambers3516122
Clarke347260
Marion3072100
Pike306576
Lawrence296295
Winston273272
Bibb256361
Marengo248461
Geneva246275
Pickens233259
Barbour227155
Hale218675
Butler213168
Fayette209460
Henry188144
Cherokee182744
Randolph177241
Monroe172740
Washington165338
Macon156148
Clay150155
Crenshaw149557
Cleburne146741
Lamar139734
Lowndes137353
Wilcox124727
Bullock121940
Conecuh109528
Perry107626
Sumter103232
Coosa99428
Greene91434
Choctaw58824
Out of AL00
Unassigned00

Tennessee Coronavirus Cases

Cases: 830484

Reported Deaths: 12049
CountyCasesDeaths
Shelby927281585
Davidson87309923
Knox49411623
Hamilton43254481
Rutherford41816420
Williamson27237214
Sumner23155339
Montgomery19075224
Wilson17979224
Out of TN1794598
Unassigned16655134
Sullivan16096287
Blount14963194
Bradley14518147
Washington14129242
Sevier13116174
Maury13021168
Putnam11155173
Madison10771240
Robertson9567127
Anderson8599171
Hamblen8478170
Greene7715152
Tipton7216102
Coffee6824121
Dickson6724109
Cumberland6555127
Carter6443156
Bedford6409127
Gibson6387144
McMinn634295
Roane6174102
Jefferson6061121
Loudon601169
Lawrence578686
Hawkins5766106
Monroe570295
Warren550881
Dyer5357104
Franklin508388
Fayette490377
Obion449996
Cocke442998
Cheatham442254
Rhea430375
Lincoln429563
Marshall410358
Campbell408462
Weakley401962
Giles393998
Henderson372475
Macon357376
Carroll357182
White353968
Hardin349166
Hardeman345863
Lauderdale314244
Henry311875
Marion308346
Claiborne305573
Scott305145
Overton296360
Wayne294234
Hickman279645
McNairy276754
DeKalb274953
Smith273938
Haywood268161
Grainger258449
Trousdale248722
Morgan245539
Fentress238046
Johnson230238
Bledsoe209411
Chester209351
Crockett200948
Polk199024
Unicoi194149
Cannon188831
Union185634
Grundy177232
Humphreys173621
Lake169526
Sequatchie166428
Benton162940
Decatur157338
Lewis155726
Meigs134123
Stewart130028
Jackson129635
Clay109031
Houston108333
Perry105728
Moore99717
Van Buren83421
Pickett75624
Hancock54712

Community Events