FDA approves Pfizer's covid vaccine

There has already been CDC guidance that immune-compromised people should get third shots so for those folks it’s not even “off-label”. But for the rest of us… it’s an interesting possibility.

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What’s next? Are you going to tell me that it is not called the Foxconn iPhone?

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Citron Yam?
Manic Tyro?
Trymonica?

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Once it’s just buying the doses I don’t think operation warp speed has any meaning. It’s just the name of buying them. It didn’t make the approval any quicker. They did take a stack of cash from the German government to develop the vaccine though.

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It does, though. Operation warp speed money allowed them to be in the EUA program that was specifically authorized for them. If they didn’t sell the doses to the US at the discount rate, they would have been ineligible for the EUA under law. EUA’s REQUIRED acceptance of Operation Warp Speed guidelines. Which is what Pfizer said.

It’s listed in the FDA Fact Sheet

WHAT IF I AM IMMUNOCOMPROMISED?

If you are immunocompromised, you may receive a third dose of the vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate.

There’s also an additional paragraph on Myocarditis and Pericarditis, eua for 12 to 15 year olds and a bunch of stuff on branding. Also, the word “approved” is liberally sprinkled throughout.

My cousin’s doctor pushed an extra dose on him recently so he could fly to a large social gathering in another state. Fun times.
Meanwhile, the majority of humans on this planet have never been given a chance at a first dose of any covid vaccine and the damn patent waver they were promising to keep us from going berserk all year is still crickets.
Ain’t gonna lie - my blood boils every time I read about you all getting third shots when the problem in the US is that people won’t get the first one even having it around the corner for free.
And then I simmer down and think, “well, Hell. If I was in their shoes living with social breakdown on an order recently unimaginable, and every way we’d imagine the pandemic puttering out is cruelly rejected by stubborn dill holes, I’d get a booster, too. Anything I could to keep as protected as possible.”
But public policy needs to address this. If the world doesn’t get shots the waves will just keep coming one after the other.

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Even writing that makes me feel dirty, like trying to do a cryptic crossword.

:joy:

Yes, I feel @theophrastus is spot on. I would now take any bet that they puzzled this thing together from those words, and then thought: “heureka! this sounds like community, we are geniuses!!”

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One of the reasons that i asked was because of what you said.
Since it was authorized to be market, i assumed that it could be sold to private individuals, and i was wondering how it would affect the distribution to the third world (i’m waiting for the second dose of pfizer’s vaccine, but the delay is caused by a certain asshole not related to this).

I completely agree with everything you said, and i was a bit worried about how my city/state are allowing a lot of activities that were restricted.
But, i was surprised to find that my state already applied at least the first dose to around 74 % of the population, my city has a similar rate and they also claim that it means that over 95 % of the eligible people took at least one dose.

I thought we would have a similar rejection rate as the us, since we also had some idiots propagating the anti-vax bullshit (i’m not sure about demonstrations, but i think that it happened at some point, but it was smaller than the ones in europe).
And, it got me less anxious and more hopeful that there is a lower chance that another mutation will appear in the third world, because it seems that the anti-vax are more a us (or western) problem, and even that might not hold for too long after other countries show great results after a massive vaccination.

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It’s just a really, really drunk guy trying to say “community responsibility.” It makes perfect sense! (/s)

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In this case, the patents are not the speedbump. The problem is that mRNA vaccines are very difficult to manufacture. The mRNA itself is straightforward, but the formulation is difficult. The mRNA has to make it through the cell membrane to do anything and that is accomplished by trapping the mRNA molecules in lipid nanoparticles, which is not simple to do and has been difficult to scale up. It requires specialized equipment that takes time and know-how to set up.

The only companies with the capability to help are already working with Moderna and/or Pfizer/BioNTech to speed up production. There are currently no generic companies anywhere close to being able to produce an viable mRNA vaccine. They might be able to pull off J&J or AZ, but a quick look at Emergent BioSolutions reveals why I am not sold on generic vaccine manufacturers.

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I’m not sure if it’s more reassuring or depressing to be reminded that sometimes, our problems aren’t due to Late Stage Capitalism, human cussedness, etc., but because some things just are genuinely that hard to fix.

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Don’t you fret - Nearly everyone in the developing world will be perfectly happy with a Sputnik/Astra Zeneca/ Sinopharm/ Covishield/ Sinovac/Cansino type vaccine with their 80-95% effective rate and simpler refrigeration requirements.

Here in Argentina they got two generic labs up and running in a few month’s time (one for Astra Zeneca, one for Sputnik - both send samples from every batch back to the parent company for QA and none have failed yet). Once Gamalya institute and Oxford/AZ had approved the deals, local investment paid for extra equipment and the conversion of the labs that had been producing other vaccines for decades into covid vaccine producers was simple and fast.

So surely if there were no legal hurdles to that same financing, because no laws were being broken, there’d be little in the way.
Meanwhile, India is already one of the world’s largest vaccine producers and pharmaceutical industry giants, could easily have been pumping out millions of doses a month since early this year.
I think that if you take a moment to reflect between, “let’s wait a year or two so that we can eventually get people in the developing world vaccines with supposed 98% effective rate” (except not for Delta, but whatever) and “lets get the whole world vaccinated now with something that has 85% effective rate” the more responsible option is evident.

Bill Gates’ talking point about how ‘the poor widdles wouldn’t be able to make vaccines anyway so why disincentivize Big Pharma?’ is wrongheaded - if we were so inept, why not waive the patent, avoid controversy, and still not harm shareholders (since nothing would come of it)?

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More acceptance? Nah, just more goalpost shifting now that they can’t play the “something something experimental vaccine” card.

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But this one isn’t!
mRna vaccines are new, and cool that they proved effective in this case, despite the logistical nightmare of the super-low temps required for storage and transport, but there are many old school vaccines which have demonstrated great effectiveness and have been in use around the world since the beginning.
Furthermore, I’m not sure about the ‘colossal’ difficulty in setting up a mRna lab anyway - i have read Cory link to informed assertions to the contrary, FWIW.

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Oh FFS. It’s not “experimental”, it’s under an emergency use authorization. The whole “experimental” wording is just a ploy by the right to muddy the waters and create FUD.

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Read the top comment + replies on Cory’s article… the commenter is pretty harsh, but the cited article completely hand-waves away the formulation and cold-storage issues. The article’s authors never even mention microfluidics, which is pretty problematic. I do think the authors have a reasonable argument for the potential of this technology, but the fact is that we are currently riding the bleeding edge of what is currently possible at the formulation step. The authors will probably be right for the next health emergency that is amenable to mRNA vaccines, though.

That is good. Out of those two, I hope you got the AZ shot. I do have a bit of a bias in that the only authorities I take seriously with regards to efficacy are the EMA and the FDA.

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AIUI, and I’m definitely no expert, the science behind Sputnik is good, but the actual vaccine suffers from problems w. production and quality assurance, in no small part because of the endemic Russian corruption.

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That’s a pretty damning bias and reason enough for me to disengage with your reasoning on anything that has to do with Health for the Global South.
FFS - Do you really think that infection rates wouldn’t have already unmasked any of these supposedly sleazy ineffective ‘fake phase 3’ vaccines?
The effectiveness and quality has stood up. I’m angry just reading your flippant dismissal of the lifelong work of so many meticulous members of the international scientific community.

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I don’t know anything about QA problems with Sputnik, but the science is good. In the beginning of the existence of vaccines for covid, the Gamalaya Institute was one of the first able to get the promised doses out to customers, when Pfizer and Moderna and AZ were backlogged. Recently there have been serious delays in shipments of second doses, so your comment on production issues (at least in the last 2-3 months) is correct. In many cases, countries are opting for mix and max doses to make up the shortage in the second component. Apparently, there is no drop in effectiveness and may even be a gain, though time will tell.

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