Johnson & Johnson's Covid-19 vaccine gets emergency use authorization from FDA

The US Food and D...

Posted: Feb 27, 2021 6:21 PM
Updated: Feb 28, 2021 8:53 AM

The US Food and Drug Administration authorized Johnson & Johnson's Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that 'checks nearly all the boxes.'

With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can't come soon enough.

'A third safe and effective vaccine is very welcome news,' Andy Slavitt, the White House's senior for Covid Response, tweeted on Friday.

The vaccine, made by Janssen, J&J's vaccine arm, is safe and effective, and it's considered flexible. It's a single dose, and it doesn't require special storage.

The vaccine is authorized for people ages 18 and older.

'We need a vaccine that can be quickly mass produced,' Dr. Greg Poland, head of the Mayo Clinic's Vaccine Research Group, said Friday. 'We'd want to see a reasonable duration of efficacy and protection.

'The Janssen vaccine candidate checks nearly all the boxes.'

The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.

'One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue,' Dr. Paul Offit, a vaccine adviser to the FDA, told CNN's Wolf Blitzer on Friday.

The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.

Overall, non-fatal serious adverse events were infrequent, according to the FDA's analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.

More research is needed, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections.

A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease -- not just keep the vaccinated from getting sick.

With so much positive data, an independent group of advisers voted unanimously on Friday to recommend the emergency use authorization of the J&J vaccine.

'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, a member of the committee who is also the editor in chief of The New England Journal of Medicine and a professor at the Harvard T.H. Chan School of Public Health, said after the vote.

There is some concern that because the public has heard that the shot is only 72% protective in the US, and the Pfizer and Moderna Covid-19 vaccines are about 95% protective, some will think this is a 'second class' vaccine, but the experts say those numbers are highly misleading.

'It's difficult to make an apples-to-apples comparison between vaccines authorized based on data collected before new variants are believed to have been in widespread circulation,' said Sarah Christopher, the policy advocacy director at the National Women's Health Network. Christopher spoke during the public comment section of the FDA's advisory meeting on Friday.

The Pfizer and Moderna Covid-19 vaccines were tested earlier in the pandemic when there were fewer known variants. FDA research found that the majority of the cases that happened during the South African part of the J&J trial came from a newer and possibly more contagious variant.

Public health experts say people should take whatever shot is first available to them.

'If I had a J&J vaccine available today and a Moderna vaccine available tomorrow, I would be happy to take the J&J today. I don't feel like I would need to wait. They are all terrific vaccines for the things that we care about,' Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.

Experts have said variants may fuel a surge of cases in the spring in the US, and say that's one reason why it's important to get as many people vaccinated as quickly as possible.

'We'll be seeing how much of an impact the variants have and how best these vaccines can address them, whether it will be booster doses, or other vaccines,' said Dr. Aditya Gaur, a co-lead investigator on the J&J trial at St. Jude in Memphis. 'But I think one could not have asked for better from this first round of vaccine development from a standpoint of how quickly it has happened and how quickly it has started to roll out around the world.'

On Sunday, the CDC's Advisory Committee on Immunization Practices, known as ACIP, will meet to set the guidelines for who should get the vaccine. Their vote is scheduled for 3 p.m. ET.

From there, the much needed vaccine could start rolling out to vaccine centers around the country.

While the initial supply is limited -- the company says it only has about 4 million doses of its vaccine ready to ship 'immediately' -- it should have 20 million ready by the end of March.

The advancement of the Johnson & Johnson coronavirus vaccine is 'really good news for the world,' Dr. Francis Collins, director of the National Institutes of Health, told CNN's Wolf Blitzer on Friday. Even with cases in the US declining recently, the pandemic is far from over. 'The best way to get done is with this vaccine being added to the others.'

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 497790

Reported Deaths: 9917
CountyCasesDeaths
Harrison34102530
DeSoto31839398
Hinds31837622
Jackson24314377
Rankin21881388
Lee15427234
Madison14525279
Jones13772241
Forrest13412250
Lauderdale11937314
Lowndes10934185
Lamar10470135
Pearl River9431237
Lafayette8454138
Hancock7697126
Washington7365156
Oktibbeha7111129
Monroe6727174
Warren6642176
Pontotoc6609101
Neshoba6606205
Panola6460131
Marshall6386132
Bolivar6266145
Union596094
Pike5784152
Alcorn5633101
Lincoln5417134
George491879
Scott470998
Tippah465381
Prentiss464181
Leflore4627143
Itawamba4596104
Adams4570119
Tate4546109
Copiah445191
Simpson4421116
Wayne438572
Yazoo438586
Covington427394
Marion4216107
Sunflower4215104
Coahoma4115104
Leake407787
Newton380879
Grenada3692108
Stone358464
Tishomingo356391
Attala330289
Jasper328265
Winston313191
Clay306375
Chickasaw296767
Clarke290694
Calhoun277945
Holmes266987
Smith262550
Yalobusha232647
Tallahatchie225251
Walthall217763
Greene215548
Lawrence211140
Perry204755
Amite203954
Webster201645
Noxubee185340
Montgomery179056
Jefferson Davis170642
Carroll167438
Tunica158639
Benton147438
Kemper141241
Choctaw133026
Claiborne131237
Humphreys129038
Franklin119128
Quitman106227
Wilkinson104539
Jefferson94234
Sharkey64020
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 812694

Reported Deaths: 15142
CountyCasesDeaths
Jefferson1139601904
Mobile721751321
Madison51923685
Shelby37240339
Baldwin37044538
Tuscaloosa34902599
Montgomery33919719
Lee23122240
Calhoun22125469
Morgan20620370
Etowah19739496
Marshall18238298
Houston17288405
St. Clair15897337
Cullman15297290
Limestone15178198
Elmore15038284
Lauderdale14125294
Talladega13692271
DeKalb12554258
Walker11069364
Blount10081174
Autauga9883146
Jackson9776177
Coffee9176188
Dale8856180
Colbert8781200
Tallapoosa7032195
Escambia6725127
Covington6672179
Chilton6580160
Russell624758
Franklin5927105
Chambers5558142
Marion4952126
Dallas4854199
Clarke472681
Pike4716105
Geneva4558126
Winston4461101
Lawrence4252117
Bibb421686
Barbour355374
Marengo333989
Monroe329962
Randolph324763
Butler323994
Pickens313581
Henry310565
Hale308787
Cherokee299457
Fayette290579
Washington250851
Cleburne245958
Crenshaw243375
Clay239767
Macon230662
Lamar215446
Conecuh185351
Coosa177738
Lowndes173161
Wilcox167038
Bullock151744
Perry138040
Sumter131138
Greene125544
Choctaw86627
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A cold front passing through our area overnight will bring into our area some of the coolest temperatures of the season so far. We will see most of the highs this weekend only in the upper 60s to lower 70s. While overnight lows will drop off down into the 40s Saturday night.
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