Pfizer documents released under court order

[nonethewiser]

I'd normally agree with that, but.....what booster number are we onto now?

Will be getting 5th soon & hopefully more if virus stays around.

 

[trophywench]

Neither of us is sufficiently aged to get our 4th.

 

[Bruce Stephens]

New paper from editor of the British Medical Journal on trials.

The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).

Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials

Introduction: In 2020, prior to COVID-19 vaccine rollout, the Coalition for Epidemic Preparedness Innovations and Brighton Collaboration created a priority list

papers.ssrn.com

There've been a couple of what seem to me to be careful criticisms of this preprint: https://respectfulinsolence.com/2022/06/29/peter-doshi-vs-covid-19-vaccines-the-latest-round/

Studies show that the benefits of COVID-19 vaccines outweigh their risks; preprint claiming to show otherwise is flawed

Multiple peer-reviewed published studies have shown that the benefits of COVID-19 vaccination outweigh its risks. While some COVID-19 vaccines are associated with a risk of heart inflammation while others are associated with a risk of blood clots, the same risks are much higher following...

healthfeedback.org

 

[Dave_Z1a]

Its all about the money.

 

[Bruce Stephens]

I'd normally agree with that, but.....what booster number are we onto now?

As I understand it the consensus is that these are really safe vaccines, and there's no significant risk in having extra doses. Also, it seems generally accepted that it's sensible to regard three doses as the normal series (so our first "booster" probably should just be regarded as the third dose).

UKHSA shows a consensus of vaccine effectiveness in https://assets.publishing.service.g...83443/Vaccine-surveillance-report-week-24.pdf (Table 3, page 13, in particular the Pfizer section).

From that it looks to me like 2 or 3 doses are about as good as each other in preventing hospitalisations once you're after 6 months. (So there's a reasonable argument that actually 2 doses is fine, really.)

But before 6 months you get somewhat better protection against symptomatic infection so an extra dose is likely to do something to help. And if you're higher risk, it's probably worth having one. I find it hard to understand why the government is still pretending it's not going to offer another dose more widely: sickness is obviously causing some of the workforce issues and another dose would help (if only for half a year), and maybe it would help a bit with stress on hospitals (though for the moment C19 isn't that big a part of the problem).

 

[Bruce Stephens]

The paper in the BMJ said this

It's not "in the BMJ". It's a preprint, and one author is an editor at the BMJ.

I'd assume any doctor would assess the risk/reward of precribing any medicine based on the presenting illness.

Absolutely, but (as the criticisms say, and as I commented) this was during the trial when prevalence wasn't all that high.

If you want to know about the vaccines now, look at the evidence now that they've been given to billions of people.

 

[Bruce Stephens]

Its all about the money.

For India I suspect money is a big part of it, yes. Not just the money they'd need to pay to Pfizer, but the money they'd need to spend on the infrastructure to deliver the vaccine. Probably doable in cities, but would be more challenging outside.

The idea that Pfizer was turning down 1.3 billion customers seems a bit silly: these vaccines are hard to produce and there were regular delays even in supplying US and Europe. I presume India wanted to know how to make it themselves (since they make much of the world's vaccines) and that discussion was a part of the conflict too since Pfizer (and Moderna) haven't been very proactive about sharing that expertise even under license.

My guess is this demand for evidence on safety is as much a distraction as anything.

 

[Bruce Stephens]

The paper (by the BMJ chap) (and this thread) is about the trials, which is the basis for the emergency use authorisation.

In that case it's much too late. Even if we believe it makes sense (and I don't, for the reasons given) that's long ago. We have much better experience of how the vaccines work now.

 

[Bruce Stephens]

It seems it was also about giving indemnity to the manufacturers, which India didn't want to do.

Could be, or maybe that was at least partly leverage: if you manufacture it in India (or teach us how to) maybe we can do a deal.

Given that India is a massive manufacturer of vaccines, and especially once they'd seen that vaccines were effective I'm sure they wanted to manufacture their own rather than having to buy them from foreign firms. (Same for Russia and China.)

(This idea that there's some horrible secret, that the Pfizer vaccines are killing more people than they save and it's all being hushed up, is just a silly conspiracy.)

 

[Bruce Stephens]

We also know how well our innate/acquired immune system works too. If one has had covid, this changes the context too of the risk vs reward.

Sure, but there's no need to rely on it: recovery from infection can give you good protection (though it may not, and there's some signs that recovery from Omicron doesn't give such good protection), but recovery from infection followed (a few months later) by vaccination is vastly better. So people should get vaccinated.

Infection is risky: you can die, and (for the survivors) you may be harmed in the long term by the infection (or from your immune system's response to the infection). Vaccination is a safer way to gain that adaptive immune response. And vaccination followed by recovery from infection also seems to provide a very good immune response (better than either alone and (according to one small study) perhaps better than recovery followed by vaccination). So people should get vaccinated.

 

[Bruce Stephens]

These vaccines, from what I understand, do not prevent infection, hence why UK hospitals are now bringing back masks and social distancing.

They do not. (I'm not aware of any vaccines that do.)

They do reduce the risks once one has been infected. They reduce the time that someone is infected.

Thus, getting vaccinated when previously having had covid would be an unnecessary risk?

No! Vaccination after recovery produces better protection. And the risks of vaccination are really low.

 

[Bruce Stephens]

"The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively)."

What would be the basis for recommending a vaccine for those who had already had covid given the above statement?

1. I don't think the statement is true. See the criticisms of the preprint. Do we really think it'll pass peer review and be published? (Would an "editor of the BMJ" write in such a vaccine-critical way if there weren't really solid data? He's done it before, repeatedly.)
2. We don't need to rely on what happened during the trials. Lots more people have been infected since then, and lots more people have received doses of these (and other) vaccines.

 

[Bruce Stephens]

So Tim Spectors statement on This Morning with Dermot O'Leary last year can't of been true?

"Vaccines are very effective at both stopping you getting the virus and also reducing the amount of virus that you get so that it's much harder to transmit it in those "few" people that do get it once they've been vaccinated".

As opposed to the guest prior to Tim (Bev Turner) who said "it does not stop you catching or passing on the virus".

Yes, I'd say the first part of his statement isn't true except short term (for 3-6 months after the last dose). However, given that the vaccines do reduce the severity of infection (and the length) I think it's true that they reduce transmission. I think there are some studies looking at how much they reduce transmission but I don't remember the results.

As I understand it the theory (supported by evidence from this virus and previous ones) is that you can get high levels of antibodies for 3-6 months after a vaccine dose (or infection) and the antibodies can provide some protection against infection. And apparently (according to the SIREN study) that was effective (for that limited period) at least for earlier variants (I think the study hasn't reported on Omicron yet).

Bev Turner's comment is true but deliberately deceptive. The vaccines do not "prevent" those things, but they do reduce them somewhat. She's pretending (as other anti-vaccination advocates do) that these things are either perfect or useless.

 

[Bruce Stephens]

This paper now appears to have been peer reviewed and published?

So it appears. Still looks useless to me for all the reasons the preprint does.

 

[Dave_Z1a]

Its not a vaccine, it does not fit the scientific definition of one. There is big trouble ahead with this.

 

[Bruce Stephens]

Its not a vaccine, it does not fit the scientific definition of one. There is big trouble ahead with this.

Alternatively, the mRNA vaccines are vaccines. We just had too specific definitions (now extended to cover them). And (most likely in my opinion) they're as safe as they seem and the technology will be used for other vaccines including for some which seemed not practical before.