FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization

[Becky1951]

FDA says Johnson & Johnson Covid-19 vaccine meets requirements for emergency use authorization

(CNN)In an analysis released Wednesday, the US Food and Drug Administration said the Johnson & Johnson Covid-19 vaccine has met the requirements for emergency use authorization.

The efficacy of the Johnson & Johnson vaccine against moderate to severe/critical Covid-19 across all geographic areas was 66.9% at least 14 days after the single dose vaccination and 66.1% at least 28 days after vaccination, a new analysis meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee said.

"There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection," the analysis said.

In a briefing document, the FDA said that it has reviewed the data for the vaccine and has determined that it is "consistent with the recommendations set forth in FDA's guidance Emergency Use Authorization for Vaccines to Prevent COVID-19."

An independent group of FDA advisers, the Vaccines and related Biological Products Advisory Committee, will consider the documents and make a recommendation about whether the Covid-19 vaccination should be authorized. The committee meets on Friday.

https://amp.cnn.com/cnn/2021/02/24/health/johnson-vaccine-fda-analysis/index.html

 

[Aunt Marg]

I trust nothing the FDA washes their hands in.

https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted

 

[Becky1951]

I trust nothing the FDA washes their hands in.

https://ethics.harvard.edu/blog/risky-drugs-why-fda-cannot-be-trusted

The FDA approved the other Covid vaccines.

I hope they approve this one. It's only 66.1% effective but compared to the flu vaccine that is 40-60% effective that's good enough for me.

This vaccine uses the old tried and true way of being developed. It's not the mRNA technology.

Also it's one shot. It doesn't need extreme freezing temperatures to be shipped or stored.

I hear you about the FDA, my daughter in law's father worked for the FDA for years.

 

[MrPants]

As more and more vaccines become approved and available, I wonder if there will be a choice as to which vaccine you can get when your turn comes around or if vaccination places will just carry one brand? If I did have a choice, not sure which I would go with. Probably Pfizer or Moderna as they seem to have the best efficacy ratings.

 

[Sunny]

When I was lucky enough to get my appointment, the online appointment program did mention that it would be Pfizer. I guess if someone has some reason not to want a particular brand, they can shop around until they find the brand they like somewhere else. Most people are so happy to get an appointment at all that they don't know or care what lab made the vaccine. They are all approved, effective, and safe.*

*Obviously, I'm assuming the hospital or health facility scheduling the vaccinations is being recommended by the state or county health department, not some back-alley practitioner.

 

[Jules]

66% for moderate to severe cases doesn’t suit me. No thanks, but I may not be able to have any say. We’ve such limited supplies in Canada.

 

[garyt1957]

I remember seeing something about the JnJ vaccine that quoted the 66% efficacy but then went on to explain how it actually was quite more? I could have read it here for that matter. If you know of the post I'm talking about please let me know. It was the reason I decided I wanted the JnJ vac, good efficacy and better long term study.

 

[Becky1951]

I remember seeing something about the JnJ vaccine that quoted the 66% efficacy but then went on to explain how it actually was quite more? I could have read it here for that matter. If you know of the post I'm talking about please let me know. It was the reason I decided I wanted the JnJ vac, good efficacy and better long term study.

FDA analysis finds Johnson & Johnson COVID vaccine is safe and effective

The Food and Drug Administration's staff released a briefing document on Wednesday endorsing Johnson & Johnson's one-shot coronavirus vaccine as safe and effective.

The latest: Assuming the FDA issues an emergency use authorization "without delay," meaning as soon as this weekend, White House coronavirus coordinator Jeff Zients said J&J will have 3 million to 4 million ready for distribution next week.

What's next: An FDA advisory panel will meet Friday to review the briefing document and vote on whether to recommend an emergency use authorization (EUA). The FDA will then decide on whether to accept the recommendation and issue the EUA, clearing the way for distribution in the U.S. to begin.

Details: The shot was found to be 66.9% effective against moderate to severe/critical COVID-19 cases 14 days after vaccination, and 66.1% effective after 28 days. Against severe/critical cases, the vaccine was 76.6% effective after 14 days and 85.4% effective after 28 days.

• A large clinical trial showed no COVID-19 hospitalizations or deaths 28 days after patients received the vaccine.

• "The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA," FDA staff wrote.

The FDA analysis also offered a breakdown of the efficacy of the vaccine in Brazil and South Africa, where more contagious variants of the coronavirus have been dominant.

• United States:

• Moderate to severe/critical: 72%

• Severe/critical: 85.9%

• South Africa:

• Moderate to severe/critical: 64%

• Severe/critical: 81.7%

• Brazil:

• Moderate to severe/critical: 68.1%

• Severe/critical: 87.6%

Between the lines: Unlike Moderna and Pfizer's vaccines, which are the only two candidates that have received EUAs, the J&J vaccine is administered as a single dose and does not need to be stored at ultra-low temperatures — meaning the logistics for mass distributions would be far simpler.

The big picture: The U.S. government has struck an agreement with J&J to provide 100 million doses by the end of June.

• More than half of the J&J doses sold thus far are destined for the developing world, with 500 million doses purchased by the global COVAX initiative and 120 million by the African Union.


https://www.axios.com/johnson-fda-analysis-33162951-9b5d-41e5-8d74-3c9bfdebd87f.html