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BumRushDaShow

(128,969 posts)
Mon Oct 4, 2021, 05:44 PM Oct 2021

Reuters: J&J to seek U.S. FDA authorization of booster shot this week - NYT

Since this "hasn't happened yet" I don't have it in LBN but am posting here because I know there are DUers who received the Janssen (J&J) shot and have been wanting to know what is going on. The original story is in the NYT but I found a non-paywall site to post this.

October 4, 202112:41 PM EDTLast Updated 5 hours ago
United States
J&J to seek U.S. FDA authorization of booster shot this week - NYT
Reuters


Oct 4 (Reuters) - Johnson & Johnson (JNJ.N) is planning to ask U.S. federal regulators this week to authorize a booster shot of its COVID-19 vaccine, the New York Times reported on Monday, citing officials familiar with the company's plans. While scientists are divided over the need for booster shots when so many people in the United States and other countries remain unvaccinated, the Biden administration announced the push for an extra dose in August as part of an effort to shore up protection against the highly transmissible Delta variant.

The U.S. Food and Drug Administration (FDA) last week scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization for a booster shot of J&J's vaccine. Over 15 million Americans have received J&J's vaccine, which is administered as a single dose, according to the latest data from the Centers for Disease Control and Prevention.

The healthcare conglomerate last month said an additional second shot of its vaccine given about two months after the first increased its effectiveness to 94%, compared with 70% protection with the single dose. J&J declined to comment on the NYT report and pointed to its press release dated Sept. 21, saying the company has submitted available data to the U.S. health regulator and intends to submit the data to other regulators.


More: https://www.reuters.com/world/us/jj-seek-us-fda-authorisation-booster-shot-this-week-nyt-2021-10-04/


NYT article referenced

Johnson & Johnson will seek F.D.A. authorization for a booster shot.


Johnson & Johnson is planning to ask U.S. regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least older adults and others in high-risk groups need more protection. Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe Covid-19.

The Food and Drug Administration on Friday scheduled an Oct. 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of the vaccine. That is part of a broader effort by the government to shore up the protection provided by all three vaccines. Regulators last month authorized a booster shot for many recipients of Pfizer-BioNTech’s vaccine and are contemplating doing the same this month for recipients of Moderna’s.

The fact that the advisory committee meeting on Johnson & Johnson was scheduled even before the company filed an application to the Food and Drug Administration reflects a particular sense of urgency in the Biden administration to provide more protection to recipients of that vaccine. Although the federal government has emphasized for months that all three vaccines are highly effective, a recent study by the Centers for Disease Control and Prevention found that Johnson & Johnson’s single-dose vaccine was only 71 percent effective against hospitalization from Covid, compared with 88 percent for Pfizer-BioNTech’s vaccine and 93 percent for Moderna’s.

“Real-world data suggest that the two-dose Moderna and Pfizer-BioNTech mRNA vaccine regimens provide more protection” than the single dose of Johnson & Johnson, the researchers said. Other research found that Johnson & Johnson recipients were more likely to have breakthrough infections or symptomatic Covid than recipients of the other two vaccines. Johnson & Johnson cites some studies with better results: A study of nearly two million people, funded by the company, estimated that the vaccine was 81 percent effective against hospitalization. Other research suggests that protection from Johnson & Johnson’s vaccine does not wane over time like protection from Pfizer-BioNTech’s vaccine. Nonetheless, Johnson & Johnson now appears to agree with federal officials that a single shot of its vaccine is not enough.

(snip)

— Sharon LaFraniere

More: https://www.nytimes.com/live/2021/10/04/world/covid-delta-variant-vaccine/johnson-johnson-will-seek-fda-authorization-for-a-booster-shot


(NYT had a short article)
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Reuters: J&J to seek U.S. FDA authorization of booster shot this week - NYT (Original Post) BumRushDaShow Oct 2021 OP
Thank you for posting this. bamagal62 Oct 2021 #1
You are welcome BumRushDaShow Oct 2021 #4
No thank you raptor_rider Oct 2021 #2
There are ongoing mix/match studies set up by NIH that started over the summer BumRushDaShow Oct 2021 #5
I wonder how much testing they are doing for people with specific illnesses? StarryNite Oct 2021 #8
When I listened to the last meetings off FDA's VRBPAC and CDC's ACIP BumRushDaShow Oct 2021 #9
Thank you for the link. StarryNite Oct 2021 #10
You are welcome BumRushDaShow Oct 2021 #11
That's good. WTF is Moderna doing? ananda Oct 2021 #3
Moderna already asked. LisaL Oct 2021 #6
Moderna only submitted their booster EUA request on September 1st BumRushDaShow Oct 2021 #7
Thank you. It looks like Moderna's in the FDA pipeline. ananda Oct 2021 #12
You're welcome BumRushDaShow Oct 2021 #13

BumRushDaShow

(128,969 posts)
4. You are welcome
Mon Oct 4, 2021, 06:47 PM
Oct 2021

I know there are folks on DU who had the J&J shot and one of my uncles did as well, as he is home bound and that was the easiest way to deal with getting him vaxxed.

raptor_rider

(1,014 posts)
2. No thank you
Mon Oct 4, 2021, 06:44 PM
Oct 2021

The vax messed up my MELD score. Vaxxed in April, got Covid in August. Dr has it in my file for no boosters. Why take a stupid shot that does not work that messed up my progress on my liver that I’ve made in the past 6 years? Huge pass with this bitch…

BumRushDaShow

(128,969 posts)
5. There are ongoing mix/match studies set up by NIH that started over the summer
Mon Oct 4, 2021, 06:50 PM
Oct 2021

Am not sure how long they them to go before going ahead and recommending a mix for "boosters" (or "3rd doses" )... maybe at least 6 months? But hopefully it will be soon since there are various other trials going on around the world (e.g., with AstraZeneca's) that have shown no problems with mixing them with a mRNA vaccine dose.

StarryNite

(9,444 posts)
8. I wonder how much testing they are doing for people with specific illnesses?
Mon Oct 4, 2021, 07:34 PM
Oct 2021

They can't test for all of them.

Anyway, I'm a J&J girl, no liver issues, and I'm waiting to see how this goes.

BumRushDaShow

(128,969 posts)
9. When I listened to the last meetings off FDA's VRBPAC and CDC's ACIP
Mon Oct 4, 2021, 07:52 PM
Oct 2021

I think they were limiting the types of conditions that people had for certain trials but I think they had a mix of people with the more typical underlying conditions like hypertension, COPD, etc.

CDC has a page that was directed to clinicians regarding what to look for if considering doing a booster for a patient - https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#underlying-conditions

StarryNite

(9,444 posts)
10. Thank you for the link.
Mon Oct 4, 2021, 09:01 PM
Oct 2021

Also over time as more people get them trends will start to show up. We're all different. This takes time.

BumRushDaShow

(128,969 posts)
11. You are welcome
Mon Oct 4, 2021, 09:14 PM
Oct 2021

and definitely agree - and particularly in the case of the Janssen (J&J) vaccine since there were less shots of that given out and the earliest were done several months after the earliest Pfizer and Moderna shots. So it will take time to see how that plays out... although many have correlated it with the AstraZeneca shot which used a similar technology and is so far, the most widely distributed vaccine in the world. Scientists and physicians have done similar correlations between Pfizer and Moderna since they both use mRNA tech.

BumRushDaShow

(128,969 posts)
7. Moderna only submitted their booster EUA request on September 1st
Mon Oct 4, 2021, 07:04 PM
Oct 2021

vs Pfizer submitting theirs back in May, so there are a couple months behind.

I think the main reason was that Moderna submitted for a 1/2 dose (50ug) for a true "booster" vs doing a 3rd full dose of 100ug of the active entity.

It sounded like whatever happens at the upcoming October 15th meeting, they may broach the EUA request for Moderna (hopefully), although they took about 3 months for review of Pfizer's (that got approved in August).

As a note - I am a Moderna too but studies have shown that Moderna's did not have the same type of efficacy drop that Pfizer's had. They aren't sure whether it was because Moderna's shot had 3 times the amount of active ingredient when compared to Pfizer's or whether it was due to Moderna's time between doses being longer than Pfizer's or there is some other reason (perhaps how the mRNA candidate was designed).

The last meeting had a slide in one of the slide decks that showed this -

ananda

(28,860 posts)
12. Thank you. It looks like Moderna's in the FDA pipeline.
Tue Oct 5, 2021, 10:52 AM
Oct 2021

I hope it gets approved soon.

And I'm glad Moderna has such strong effectiveness.

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