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JNJ vaccine FDA review / authorization materials

https://www.fda.gov/media/146267/download

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The J&J vaccine is about to emerge.

Third US vaccine could raise question: Which shots are best?

Here is a lift:

The J&J shot was tested in the U.S., Latin America and South Africa at a time when more contagious mutated versions of the virus were spreading. That wasn’t the case last fall, when Pfizer and Moderna were wrapping up testing, and it’s not clear if their numbers would hold against the most worrisome of those variants.

Personally, I’m leaning in favor of this J&J vaccine. Hope I can obtain it.

Yes, just having to take the one vaccine sounds like a winner. DH & I took the maderna 2/18 & must return 3/18 for second dose.

I like that the J&J vax was subjected to scrutiny more recently than others. No casting aspersions or blame. Trump was far out ahead on vax developments generally. You cannot blame his team because the variants only came into being later. But I still like that, because J&J was a bit behind, they had testing opportunities to which the earlier players never had access.

The fact the earlier players now view as necessary need to develop add-ons to cover the new strains says a lot.

JNJ will be providing 100M doses in the US as part of Warp Speed, but they have had production issues and are behind schedule by several months. The upshot of this is they probably won’t be available in any real amount til April with the 100M expected by end of Q2.

That said, the company currently has a limited number of doses to contribute to the effort to step up the country’s vaccine rollout. It will be April before J&J begins to have substantial amounts of vaccine to feed into the distribution pipeline, Moncef Slaoui, former co-chair of Operation Warp Speed, said earlier this year.

JNJ is an adenovirus vector, so if you wanted a more traditional vaccine technology, that would be a reasonable view to choose them over PFE or MNRA. 1 shot is simpler too, although for all of these immunity builds up over time and the best results they quote are after 1-2 months post vaccine not unlike the 2 shot ones with a 5-6 week time frame for full vaccination.

However, in terms of their efficacy stats, I think this JNJ one looks 2nd tier to me behind PFE, MRNA, or NVAX, where we saw 95% efficacy numbers against the 72% seen for JNJ in the US (avoiding the variant issues that result in their lower foreign trial arm stats). JNJ confounds direct comparison by quoting their efficacy stats against moderate or severe disease (bad enough you have trouble breathing or worse), leaving out the mild cases (ie symptoms + PCR positive, but no need for hospitalization).

They did include a secondary analysis including mild cases, which showed overall trial efficacy in the high 60%’s, not broken down by region, but this was similar to their overall efficacy quoted for moderate/severe so I conclude they are likely similarly effective against mild as they are for the worse cases and hence a fair bit less good than the other vaccines. See page 29 from the FDA presentation I linked above.

Everything we’ve seen shows good but not quite as good vaccine efficacy against the major variants, and given all these vaccines are spike protein based off the Wuhan Classic version, I expect they will fair similarly. Yes, there have been more cases / lower efficacy, but the vast majority of those cases caused by variants in vaccinated people have been in the mild category.

My area is still offering homeless people priority over those who lie about their health issues, and I’m not yet bothering to lie about either of these so I won’t have to make the choice yet to the extent one was offered. But if I had a choice, I’d take one of the higher performing ones (PFE, MRNA, NVAX) over the lesser ones (AZN, JNJ). I suspect any of them will, after appropriate time to build your immunity, prevent the vast vast majority of all serious cases in both the original and variant strains, so in that sense any of these vaccines are still good ones.

JNJ recap

Backup link

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I’m pretty sure I’ve said all along that “6 feet” is an arbitrary fallacy. That there’s far too much situational context in determining the appropriate distance of separation. And some (not sure if you were one) rejected that, insisting that 6-feet is based on established science and I’m dumb and ignorant to say otherwise.

If you don’t think Vit D is reasonably effective / protective against covid, take the other side of these guys $100k wager and take your view to the bank.

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PFE trials are running for the age 12-15 group and they’re starting up the age 5-11 group. Results expected by EOY.

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School for me but not for thee, the CA Teachers Union edition.

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Not to worry. There might be a way!

Don’t like Trump at all, but this is nonsense. When the guy didn’t take the vaccine in December, he was criticized. Upon finding out that he got the vaccine in January, he’s criticized again.

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And he didn’t get it on medical advice too! Those critics sure can’t “follow the science” if it meant anything he did might have been correct.

Trump’s decision to quietly accept the vaccine, without public fanfare, stands in stark contrast to his successors and predecessors. President Joe Biden and Vice President Kamala Harris were each vaccinated on live television in December.

Former Presidents Barack Obama, George W. Bush and Bill Clinton volunteered in December to get their Covid-19 vaccine on camera to increase public confidence in the vaccine’s safety. Former President Jimmy Carter has also been inoculated to fight the virus.

I have to say when I saw all those old folks lining up to offer to get it on TV, it just seemed they were pulling rank to get it early. I mean, you could put me on TV if I could get mine sooner than whatever drug addict they’re busy setting up a special distribution center for in the hood.

And of course for both Trumps, having already had it, there’s a whole lot less reason to think you’d benefit from the vaccines anyway, given you’re likely to get much broader spectrum immunity from the whole virus than just the spike part. Getting the vaccine after you had the virus seems to me like he did it as a leadership thing so he could tell others they should from a personal perspective. If I’d been sick, I definitely wouldn’t take the presumably rare but unknown long term vaccine risks on top of having already gotten whatever long term covid risks by actually being sick.

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It looks like straightforward reporting. Why do you call it criticism?

https://www.washingtonpost.com/health/2021/03/02/merck-johnson-and-johnson-covid-vaccine-partnership/

A well deserved vote of no confidence in the JNJ production, having MRK do more of it. JNJ has had a number of delays.

What makes you think it was secret?? Inside info??