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Fri Oct 15, 2021, 12:35 PM

FDA panel recommends a booster shot of Johnson & Johnson vaccine for people 18 and older

Source: Washington Post

A panel of outside experts advised the Food and Drug Administration on Friday to authorize a booster dose of the Johnson & Johnson coronavirus vaccine for people 18 and older, at least 2 months after the first shot. The unanimous recommendation will now be taken up by the FDA, which is expected to make a decision within days — a decision that will clarify the path forward for the 14 million people in the United States who have received the Johnson & Johnson vaccine, many of whom have felt left behind.

With many more people vaccinated with messenger RNA vaccines, there have been far more studies of the real-world performance of those vaccines, and the companies that make those vaccines — Pfizer-BioNTech and Moderna — have pushed more aggressively toward boosters. The vote was in favor of the Johnson & Johnson booster, despite experts’ hesitation about the “scant” amount of data. There were only 17 people included in an analysis of the effect of boosting people after six months.

Johnson & Johnson recipients are a small fraction of the nation’s vaccinated population, and they received a vaccine that provides less complete protection against infection than the messenger RNA vaccines. A Centers for Disease Control and Prevention analysis showed that rates of covid-19 and deaths were significantly lower for people vaccinated with any of the three vaccines available in the United States. But the analysis found that while the Johnson & Johnson vaccine offered a strong shield of protection, it was somewhat weaker than the other products.

Another recent study found that all three vaccines were protective against hospitalization, but that Johnson & Johnson offered the weakest protection — 71 percent, compared with 93 percent protective for Moderna and 88 percent protective for Pfizer-BioNTech. “We have shown how the [Johnson & Johnson] covid-19 vaccine could help the U.S. further protect individuals from covid-19, by optimizing immune responses, increasing protection from symptomatic infection, preparing for future variants of concern and potentially helping to reduce transmission,” said Johan Van Hoof, global therapeutic area head of vaccines for Janssen, a division of Johnson & Johnson.

Read more: https://www.washingtonpost.com/health/2021/10/15/johnson-and-johnson-booster-shot-fda/



They are on break at the moment and ready to discuss mix and match.



(note - the original question was to have a "1a and 1b" (if/then) part but they opted to just do the general question for the vote)

17 replies, 1672 views

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Reply FDA panel recommends a booster shot of Johnson & Johnson vaccine for people 18 and older (Original post)
BumRushDaShow Oct 15 OP
underpants Oct 15 #1
durablend Oct 15 #2
MontanaMama Oct 15 #3
StarryNite Oct 15 #4
BumRushDaShow Oct 15 #6
hamsterjill Oct 15 #8
FoxNewsSucks Oct 15 #5
BumRushDaShow Oct 15 #9
hamsterjill Oct 15 #10
BumRushDaShow Oct 15 #13
regnaD kciN Oct 15 #15
hamsterjill Oct 15 #16
hibbing Oct 15 #7
BumRushDaShow Oct 15 #11
hibbing Oct 15 #12
BumRushDaShow Oct 15 #14
GPV Oct 15 #17

Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 12:38 PM

1. Yes!

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 12:40 PM

2. Get it done, FDA

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 12:42 PM

3. I've definitely felt left behind.

I'm ready!

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 12:48 PM

4. There were only 17 people included in an analysis of the effect of boosting people after six months.

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Response to StarryNite (Reply #4)

Fri Oct 15, 2021, 01:03 PM

6. It's probably because they didn't get original EUA approvel until the end of February

and they were focusing on "1-dose" vs "2-dose" as a "selling point". So they had to pull out some trial people to go through this.

However I think they may actually have much more and they dumped a pile on FDA and FDA has admitted that they haven't had chance to go through it all (and indicated it would take "months" ). Both CDC & FDA have observational study data related to those vaccinated with the Janssen vaccine that was useful for decision-making in any case.

So I think the Committee recommendations were more along the line of thinking that Janssen's (J&J) probably should have been a "2-dose" when compared to the 2-dose mRNA ones (although FDA only requires "at least 50% efficacy" in general for ANY vaccine), and it was "not a good look" when comparing theirs to the others. I.e., a "70+% (1-dose) vs a 90+% (2-dose) efficacy. I.e., it's not really a "fair comparison".

On the other hand, I think Janssen was trying to "promote" this as a "single shot", which would be beneficial for a number of populations (including those difficult to reach for a 2nd dose) to give them some type of good protection from moderate to severe COVID-19 infection. I know here in Philly, they were actually giving Janssen's vaccine to many in the transient population to give them something as protection and not worry about trying to find them again to get a 2nd dose, which would be the case for the mRNA vaccines. One of my uncles, who is home bound, got that vaccine for a similar reason - hard to get to.

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Response to StarryNite (Reply #4)

Fri Oct 15, 2021, 01:20 PM

8. Sure seems like a small study doesn't it?

n/t

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 01:02 PM

5. I'm not sure why it's such a mystery

If I recall correctly from the 60's, we had to get a second shot of most of the vaccines we were required to get for school. And sometimes another a few years later. It's the same vaccine science J&J used for covid, so a second shot shouldn't be unexpected.

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Response to FoxNewsSucks (Reply #5)

Fri Oct 15, 2021, 01:28 PM

9. The thing is - as an infant or child

*someone* brought you in and you did what you were told and got the booster. And additionally in those cases, those vaccines had efficacy last a number of years vs this when they are seeing waning after 6 months.

So this is more like the flu vaccine where as adults, it would normally be considered "optional" and many many people "opt out" of the flu vaccine. Of course due to the severity of COVID-19, we have seen less "opting out" of people who are not "anti-vax", and mandates for the hesitant or anti-vaxxers to get them done to help reduce the spread.

An "adult" vaccine series like the shingles vaccine or pneumonia vaccine, would probably be closer to the "childhood" vaccines in terms of giving a longer term immunity.

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Response to BumRushDaShow (Reply #9)

Fri Oct 15, 2021, 01:36 PM

10. Well said.

And more and more will “opt out” as more and more shots are needed.

I am a total needle phobe. It’s not funny and it’s not something casual. I had nightmares. I got the “one and done” because of just that. Being one and DONE.

I, personally, will suffer through and do as my doctor recommends as to a booster. But there will be people who ultimately just say “enough” with this.

Less than half of the population gets a flu vaccine.

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Response to hamsterjill (Reply #10)

Fri Oct 15, 2021, 01:49 PM

13. I think it is a shame

that because of the "technical" criteria that FDA has always had for approving vaccines - that a vaccine be "at least 50% effective" - and that we had this wild huge efficacy out of the mRNA vaccines (a tech being used for the very first time population-wide), and then trying to compare that with a more "traditional" vaccine, you get a more negative "public perception" of it.

We are lucky every year to actually hit even "60% effective" for the annual flu shot (some years its been almost a near miss with 40%), so even what Janssen's vaccine is getting with a single shot at the upper 70s to near 80% with a single shot, is pretty amazing. Plus the data they were showing today, indicated that after that 1st dose, the efficacy generally lasted longer than the others before waning, once it hit its highest point, however what knocked it down, like what knocked down the others, was Delta.

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Response to hamsterjill (Reply #10)

Fri Oct 15, 2021, 04:14 PM

15. I'm much the same re needle phobia...

...and picked the Janssen because of that. In truth, though, what helped me out the most was using EMLA numbing cream, prescribed by my doctor -- I hardly felt a thing. I wish this better known by and easier to get among the general public; in the U.K., at least, it's over-the-counter, while it requires a prescription here.

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Response to regnaD kciN (Reply #15)

Fri Oct 15, 2021, 04:16 PM

16. I'm familiar with it.

I’m glad you found something that helped.

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 01:16 PM

7. Why can't those with J & J get the other ones?

I received the J & J, would I become magnetized or grow a horn out of my head if I went and tried to get the other two shot vaccination? I was notified I could get a vaccine and at that point in time I was ecstatic about it. I will get the J & J booster when I can, just curious about why I can't get the other now?


Side note, 18 years and this is my 9,000 post, I need get busy posting!

Peace

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Response to hibbing (Reply #7)

Fri Oct 15, 2021, 01:37 PM

11. They are discussing the results of their mix/match studies right now

The NIH mix/match presentation (slide deck) can be reviewed here (PDF) - https://www.fda.gov/media/153128/download

They haven't yet approved doing that however. Remember that the only vaccine has "full approved" (Biologic License Agreement) is Pfizer's, where the others are still under EUA. In fact as I type this, one of the members doesn't feel there should even be an EUA to "mix/match" - it's more to confirm whether it is safe to do so or not. And he's now comparing it to how they change the flu vaccine every year.

It is highly highly unusual that the general public gets to see the "sausage-making" of vaccines (just like watching Congress going through the markups and "sausage-making" to draft bills). It's because of the severity of this pandemic that we are even seeing this kind of news coverage.

And congrats on the 9,000!!


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Response to BumRushDaShow (Reply #11)

Fri Oct 15, 2021, 01:48 PM

12. Thanks for the info n/t

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Response to hibbing (Reply #12)

Fri Oct 15, 2021, 01:50 PM

14. You are welcome!

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Response to BumRushDaShow (Original post)

Fri Oct 15, 2021, 08:47 PM

17. Woohoo!

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