FDA Revokes Authorization of J&J's Covid Vaccine as Demand Wanes

[BumRushDaShow]

Source: Bloomberg

US regulators revoked emergency authorization for Johnson & Johnson’s Covid-19 vaccine after the company’s Janssen unit requested its withdrawal.

Janssen informed the Food and Drug Administration that shots bought by the government had expired and there was no demand for the product in the US, the regulator said in a statement released last week. “FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization,” according to the statement. The company “does not intend to update the strain composition of this vaccine to address emerging variants.”

J&J’s single-dose vaccine faced problems early on following manufacturing hiccups and cases of a rare and potentially deadly clotting disorder slowed its roll out in early 2021. Demand has since remained subdued compared with more popular shots from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE.

The decision shouldn’t affect people who’ve received Janssen’s shot as part of their Covid vaccine regimen, according to Joshua Sharfstein, dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health.

Read more: https://www.bloomberg.com/news/articles/2023-06-05/fda-revokes-authorization-of-j-j-s-unpopular-covid-vaccine?srnd=premium

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Just heard this on the radio this afternoon (Bloomberg report)

From the press release mention -

FDA News Release
FDA Roundup: June 2, 2023

(snip)


On Thursday, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. On May 22, Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for this vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants.

(snip)

FDA revocation letter (PDF) - https://www.fda.gov/media/169003/download

[underpants]

1. My first shot.

At the Richmond racetrack. Incredible operation.

[Freddie]

2. Mine too

A mass inoculation event for all school district employees in my county. I’ve gotten all of them since except the latest, waiting for DH to turn 65 in July and we’ll get it together.

[BumRushDaShow]

3. One of my uncles

who is homebound, was given the J&J one as it was easier to deal with as a single-dose vaccine, making it ideal for nursing staff to administer in a single home visit.

[MayReasonRule]

4. I Got J&J - Oozing Rash Over 2/3rds Of My Body - Blood Pressure Spiked To 217/185

Almost killed me. The rash lasted for over three months. It took over two years for the scarring to fade as my skin healed.

I still take blood pressure medication to this day as a result.

I got J&J because the risk profile at the time appeared to be lower than the other available vaccines.
I tested the hypothesis at my earliest convenience and found out. Holy Shit was I wrong!!!
It's the only COVID vaccine I have received as a result.

Cheers to still being here!!!

[BumRushDaShow]

5. That was one that used a more "traditional" vaccine platform rather than mRNA

and was similar to the one that was created by AstraZeneca (both having used an adenovirus for delivery) that resulted in similar issues for some.

The AZ one, which is what was predominately used in Europe and other places around the world, had not been approved here in U.S. (although both AZ and Janssen's (J&J) had attempts at being manufactured here).

[MayReasonRule]

6. Yep, That's Precisely The Case

Just really glad that I survived the ordeal.

[BumRushDaShow]

7. The alternative

could have been actually contracting a pretty lethal variant of COVID-19 but glad you at least recovered from those vaccine effects.

[MayReasonRule]

8. Agreed! I Was Vaccinated September of 2021 - Caught COVID July of 2022 - It Was Horrible!

And thank-you for that kind comment!

Hard to imagine I would have stayed out the hospital, much less survived if my immune system had no prior attenuation.
I stay grateful for what I have, and grateful for what I don't.

Anytime I get caught up in myself and spinning, I contact other folks and just ask 'em how the hell things are going in their world. Inevitably, before I get off the phone I'm already grateful for the problems that I don't have, and it gives me perspective on my own personal difficulties.

I remain grateful that I survived both the vaccination, and a round of COVID. I knew a couple of folks that didn't survive the vaccine, but many more that didn't survive one round of COVID.

I count myself a fortunate man.

Laissez bon temps rouler y'all, the only moment to ever live is now!
Life... Swallow it down... what a jagged little pill!