Public health announcement: the vaccines have annoying side effects but...

Yeah

But it does look promising in that to date, we do not seem to have many If any Guillain- Barre syndromes but we cannot say they will not happen. That is one of the main concerns because it is very hard to predict since it is an immune response


https://www.nature.com/articles/nrneurol.2014.121

That is a really good article on GB syndrome and I am absolutely sure if you have further questions CF can answer them in even greater detail

 

I think you are confused and responding to some other post.

 

Wasn’t that the Trump plan? Isn’t that still the Trump plan?

 

Oh, no need for a last word in the sense of contesting what you are saying; you are basically right; I acknowledge it. I mean, I'm very invested in improving the number of people who will accept the vaccine (as of the latest polls, 58% seem to now want it, reversing the trend, once it got approved in the UK; we need more; it would be lovely to hit 70% although it's an uphill battle; for the flu shot we get just some 45%), so maybe I'm a bit bold in trying to reassure people. For good reason, I guess. There is an excellent possibility that this mRNA platform is God's Gift to Mankind and unlike the whole virus vaccines of the past, we won't see any serious reactions. But you are right that I can't guarantee it. I do believe that if it happens, it will be very rare. I mean, there is always the possibility of ADE (which stands for Antibody-Dependent Enhancement) and frankly, I don't like to talk about it... it will spook people and decrease the acceptance of the vaccine, resulting in MORE deaths.

My friend 557 knows that when I'm talking vaccines with the lay population, I kind of... er... avoid the topic of ADE. Darn. Now you made me say it... LOL. But, we haven't had any ADE cases yet, with the mRNA vaccines, so maybe we won't.

 

Well, I partially disagree with you on this. OK, we got things a bit abbreviated in the fact that the FDA asked for 2 months after the first dose, to observe for mid-term adverse reactions, and it could have been more than that. Especially, the REGULAR approval process asks for at least one year of observation for mid- and long-term adverse reactions and for stability of the immunity. So, if you look at this, then you might say that the Covid-19 vaccines cut corners.

But see, there is a reason why there is something called an EUA (Emergency Use Authorization) - the operative word being Emergency. When the situation is dire and people are dying all over the place, the FULL approval process is not required. What is required is to say that the vaccine or medication is more likely than not to be efficacious and safe. That's why the FDA set the efficacy threshold at 50%, and the adverse reaction observation at 2 months. This is NOT out of the ordinary for an EUA. That's exactly the spirit of an EUA.

If we were to wait 10 more months to reach one year, we'd have maybe another 500,000 dead people... and we might discover, say, 4 or 5 serious / fatal adverse reactions. Uh, no. We can't afford that. That would be absurd. Like you said, we do not have the luxury of time. And it would make no sense whatsoever to proceed like this. It would be a grave ethical mistake to deny this vaccine to the population for 10 more months, based on some hypothetical reaction that hasn't materialized in phase 3.

The REGULAR process is for other stuff... Say, you have 10 different statins, safe and efficacious, doing their job, and a pharma company makes an 11th one. Sure, let's use the REGULAR process and verify safety over one year or more. Meanwhile nobody is dying of dyslipidemia any more often than the usual slow death toll of this condition, and the other 10 drugs that are in the market are available and perfectly good.

Now, if we had NO statins in the market and dyslipidemia were a sort of acute illness that caused in a short period hundreds of thousands of cardiovascular deaths (as opposed to being a decades-long slow killer chronic condition), then an EUA would be appropriate, to deal with it as soon as possible, and then subsequent statins might be looked at more carefully and with longer scrutiny.

See, if the FDA approves the Pfizer and Moderna products, followed by the AstraZeneca, the Jansen, and the Novavax ones, on bases of EUA, they will CONTINUE to look at the track record of these vaccines, and won't issue a FULL authorization until one year goes by. And if some serious issue pops up, it's just as easy for the FDA to just yank out the EUA, like we saw for hydroxychloroquine. HCQ was approved (wrongly, in my opinion, and this is not Monday Morning Quarterbacking; I always thought so) but then as the lack of efficacy and the QTc prolongation issues got more and more evident, the FDA cancelled the EUA.

I mean, that EUA for HCQ was a lot more absurd. It was done out of political pressure, in my opinion. There has never been enough evidence to say that HCQ was more likely than not to be efficacious and safe for Covid-19. But curiously enough, all the people who keep doubting the vaccine, were perfectly fine with HCQ's EUA... Go figure. HCQ didn't save anyone, and killed a bunch of people... but sure, let's do an EUA. Now, the vaccines are very efficacious and very safe... a true life-saver... and people say "I won't accept it; I'm no guinea pig!"

This shows once more how people react to this with emotions (and politics) rather than logics.

 

Certainly the Transverse Myelitis case that was seen in the Oxford/AstraZeneca trial has me spooked, as it is even more serious than Guillain-Barré. So far so good for the mRNA vaccines, though. Fingers crossed.

Now, another aspect to consider is that virus infections THEMSELVES can and do cause Guillain-Barré Syndrome. For example, Zika (which is caused by a flavivirus) is notorious for causing two issues: microcephaly AND GBS. The very Moderna company doing this Covid-19 vaccine, has two other products, the mRNA-1706, and the mRNA-1325, which intend to prevent Zika, that is, these vaccines would theoretically decrease the incidence of GBS.

Now, look at this, Bowerbird. This paper actually disputes the notion that vaccines, INCLUDING the influenza one, increase the incidence of GBS:

https://pubmed.ncbi.nlm.nih.gov/31858323/

"No increased risk of GBS was detected for vaccination against hepatitis B, influenza, hepatitis A, varicella, rabies, polio(live), diphtheria, pertuss(acellular), tetanusis, measles, mumps, rubella, Japanese Encephalitis, and meningitis vaccines. Adjusted ORs for the recurrence of GBS after vaccination among paediatric and adult population were 0.85 (95% CI 0.07-9.50) and 1.18 (95% CI 0.49-2.65), respectively. In this large retrospective study, we did not find evidence of an increased risk of GBS and its recurrence among either paediatric (≤ 18 years) or adult (> 18 years) individuals within the 180 days following vaccinations of any kind, including influenza vaccination."

And then, look at this one: actually, in this meta-analysis, the risk of GBS was REDUCED by 88% after influenza vaccines!

https://pubmed.ncbi.nlm.nih.gov/32230964/

"The primary result of our meta-analysis pointed to no risk of vaccine-associated GBS, as documented by a pooled ES of 1.15 (95% CI: 0.97-1.35). Conversely, an obvious high risk of GBS was observed in patients with previous influenza-like illness (ILI), as demonstrated by a pooled ES of 9.6 (95% CI: 4.0-23.0) resulting from a supplementary analysis. While the meta-analysis did not confirm the putative risk of vaccine-associated GBS suggested by many epidemiological studies, vaccination against seasonal influenza reduced the risk of developing ILI-associated GBS by about 88%."

Both these studies are from 2020. So, we may be seeing the consensus about GBS and vaccines shifting, now.

 

Correction for post #30 above: the FDA-required period of observation is 2 months after the SECOND dose of the vaccine, not the first one as typed above, by mistake.

 

Sure, if your "news" comes from leftist propaganda...

 

Trump realizes his supporters are becoming anti-vax, he is trying to get them to take it, even trying to call it the Trump vaccine, guess we will see if that works

 

Uh oh, 80 million people won't want the "Trump Vaccine." Trumpcare.

 

the 80 million know Trump had nothing to do with the vaccine, but if it gets Trump supporters to take it, let them think it

 

Yes, I'm just trying to use some humor. Not very successfully, I see.
Now, even though I'm ferociously anti-Trump and voted for Biden precisely due to Trump's mismanagement of the pandemic, I do give credit to him for the Warp Speed initiative. While Pfizer was able to do R&D without Warp Speed (Pfizer has a market value of 210 billion dollars and makes 54 billion dollars annually), Moderna would NOT have finished up just one week later, if not for Warp Speed. Even their scientists - Moderna hired 100 scientists with Warp Speed funds. And Pfizer alone won't be able to get everybody vaccinated. We'll need the Moderna product too. And AstraZeneca's if they can get passed their hurdles. And Jansen. All three benefited from Warp Speed. And Novavax which only indirectly did. But yes, Warp Speed did expedite R&D and production for some of the vaccines, and did even more: while Pfizer will use its own distribution network, Moderna will use Warp Speed for distribution. Warp Speed even got a contract with Corning to supply the special glass for the vials (glass that can withstand rapid shifts from ultra-cold to room temperature without shattering). The bottom line is that Warp Speed did a lot of good, and I do congratulate the president for it. I remember, when Trump was insisting that we needed the vaccine in less than one year, that what people told him that it wasn't possible was unacceptable, I thought, what a moron, he doesn't know that it is impossible. Well, it turns out that it wasn't impossible, and if Trump didn't take a no for an answer and didn't deep pushing, sure, we'd have Pfizer, but not much more than that.

 

do not disagree, but Trump trying to steal the credit is insane to me, even calling it the Trump vaccine, he has played down the virus and not even been to a task force meeting in 5 months

 

Bush, Clinton and Obama will all get the vaccine in public to show their confidence it is safe