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Pfizer Covid vaccine approved for use next week in UK

bbc.com

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Re: Pfizer Covid vaccine approved for use next week in UK

#641

Post by johnisgood »

statquontrarian wrote: post #457
shusson wrote: post #71

Out of curiosity, how do people on HN rate the risk of long term side-effects?

This is a good summary paper with some safety concerns: https://www.nature.com/articles/nrd.2017.243.pdf?origin=ppub > A possible concern could be that some mRNA-based vaccine platforms 54,166 induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity 167,168 . Thus, identification of individuals at an increased risk of autoimmune reactions…

I have an autoimmune disease and I sit a lot. So I guess I will say no to the vaccine?

Re: Pfizer Covid vaccine approved for use next week in UK

#642

Post by spuz »

gns24 wrote: post #312
spuz wrote: post #305

Earlier quoted context omitted.

This doesn't matter though. The results are still valid.

No, the results are not valid, or at least not in a useful way. The group who have received the wrong dose isn't a random sample from the treatment group, so we don't know whether it's more effective or not. It could even be less so. I don't know what the regulator will do about this situation; it's clear that the vaccine is effective in at least one of the dosing regimes administered, but being entirely certain as t…

My understanding is that the results are still useful and can be include in the statistical analysis. This is what I heard form the BBC's Newscast podcast

https://www.bbc.co.uk/sounds/play/p08ztv8h (starts around 7:30)

Professor Jennifer Rogers (clinical trial statistician):

> "There was some planned dosing differences anyway but this one happened by accident. Now that doesn't mean these results are completely invalid - doesn't mean that at all. You can make changes to your protocol and you can make changes to what you're gonna analyse all the way up until you actually see your data.... If you haven't seen what the data looks like, you are allowed to make changes to your protocols and it is quite common, it does happen that people make changes as to what they're going to analyse.

> "So this change was carried out with discussion with the regulators so it was all fine..."

Now I tried to find the same information reported online and I found this from the same Professor:

https://spectator.com.au/2020/11/what-we-know-so-far-about-t...

> It is perfectly acceptable to make changes to the protocol prior to database lock, so the protocol could have been updated to include this additional analysis (the point of closing a database is to ensure a trial can remain blind, meaning researchers can’t carry out ad-hoc analysis or potentially selectively report results before proper analysis takes place). However, according to version 14 of the protocol, dated 9 November 2020, the primary analysis was set to be the efficacy of two doses of vaccine (across both half and full dose), with secondary analyses being the efficacy of at least one full dose and efficacy of two full doses of vaccine. Efficacy of half dose with a full dose booster was not considered as a secondary analysis in the protocol and so could be an ad-hoc analysis post database lock.

So I'm not actually sure whether AstraZeneca announced the change to their analysis before or after they started looking at their results. If they announced they were going to include the half-doses before database lock then they can use them as valid results.

Re: Pfizer Covid vaccine approved for use next week in UK

#643

Post by jccooper »

swalsh wrote: post #331
jakozaur wrote: post #19

In terms of rollout. UK is the ideal country to be the first: 1. Heavily impacted by Covid-19. 2. Centralised health care system makes it easier to compare results and efficiency. E.g. it's UK which figured out that dexamethasone is efficient against Covid https://www.who.int/news/item/16-06-2020-who-welcomes-prelim... 3. Developed country with great logistics.

In a recent article about the Moderna vaccine, it was mentioned that the actual development only took 2 days.... and it was done in January! Given how short of a time it took to actually develop this thing, could we have drastically sped up this process by maybe being a bit more risky with the trials? At this point ~1.5 million people have died from the virus. I've really struggled with this knowledge that we've had…

Efficacy (the main thrust of Phase 3 trials) could be sped up and made more thorough by deliberately exposing participants. I think one could argue that deliberate exposure and waiting around for enough people to be "naturally" exposed are pretty equivalent in terms of end results, but that's not a winning argument so far. Might be harder to recruit when you know you're definitely getting exposed vs. no change in risk from the no-action option.

But that does presume your methods of exposure are equivalent to what's happening in the real world, both in terms of method and dose. And those are both open questions here and could have bearing on efficacy.

Re: Pfizer Covid vaccine approved for use next week in UK

#644

Post by svrb »

fabian2k wrote: post #57
waihtis wrote: post #20

Not sure why the posts asking for vaccine risks are getting downvoted. Pandemrix, the vaccine for swine flu, caused a notable amount of narcolepsy cases in recipients here in FIN (notable here meaning the amount of yearly cases spiked by 3-4x) and as with anything that's taken quick to market there has to be some risk of overlooking some tail events somewhere. It's not an anti-vaccine attitude, just healthy skepticis…

You have to compare the risks to the risks of the disease and the likelyhood of contracting that disease. And for COVID-19 the risks are very high. It doesn't make much sense to me to trade the very high known risks of COVID-19 against the relatively low risk of rare side effects in a vaccine. These vaccines have been tested in ~40,000 people each, so we do know quite a bit about their safety. The fatality rate of CO…

> And for COVID-19 the risks are very high.

Do you have an actual source for that? People keep repeating it over and over but I've seen no evidence that COVID-19 carries particularly high risk compared to other infectious diseases.

Re: Pfizer Covid vaccine approved for use next week in UK

#645

Post by rootusrootus »

tzs wrote: post #329

There are two challenges I haven't seen talked about a lot. 1. I expect that there will be a lot of people who think that once they get the shot, they can immediately stop wearing masks and practicing social distancing. The rollout to the general public will need to be combined with extensive efforts to make sure people know that it takes time for a vaccine to actually provide protection. In the case of this one, it…

I do not see an easy answer. We could wait until we have 600 million doses on hand, to limit the crossover time when part of the population is vaccinated and part is not. But people will be dying every day in the meantime. But if we start rolling the vaccine out, there will be a significant number of people who will stop wearing a mask as soon as they get the first shot. And probably a bunch of people who will stop because they figure this means the pandemic is basically over.

What I don't think is realistic at all is expecting the population as a whole to continue to wear masks until everyone is vaccinated, and then just everyone goes back to normal at once. Like it or not, this just isn't how it will play with most regular people. People are itching to be done with 2020 and the pandemic, they just gave up their Thanksgiving, they're about to give up their Christmas gatherings, it won't take much to push people over the edge into throwing up their hands and saying "all done!"

Re: Pfizer Covid vaccine approved for use next week in UK

#646

Post by majewsky »

svrb wrote: post #639
majewsky wrote: post #206

Earlier quoted context omitted.

Not a doctor, just a member of a risk group. The continued spread of Covid poses a rather high risk to me, both because of mortality and because of potential long-lasting aftereffects ("Long Covid"). Even if the vaccine turns out to have longterm side effects, I find it very unlikely that those will be more significant than Long Covid. Therefore the risk tradeoff makes any vaccine a complete no-brainer to me.

What about people in the risk group(s) for vaccine side-effects? E.g., people with autoimmune issues. Does their safety matter less than yours? (Assuming you're advocating for vaccinating others; if you're just advocating for vaccinating yourself and yourself only, then carry on.)

I'm also in the autoimmune-disorder bucket. From what I understand, Covid also triggers plenty autoimmune issues, so the risk assessment does not change in a significant way.

Re: Pfizer Covid vaccine approved for use next week in UK

#647

Post by JamisonM »

warmwaffles wrote: post #638
JamisonM wrote: post #518

Earlier quoted context omitted.

For me personally the unknowns of such a new virus mean that the existence of the case studies would be enough to be concerned. And the strongest case is made by the fact that this virus' closest relative known to infect humans has caused lasting damage to people with cases that lead to hospitalization: https://www.nature.com/articles/d41586-020-02598-6 "Evidence from people infected with other coronaviruses suggests…

The corona virus it self has been around for a long time. The strains we are seeing now are newer obviously. But it's known virus.

This is a confusing series of statements, what do you mean?

Re: Pfizer Covid vaccine approved for use next week in UK

#648

Post by andybak »

ApolloFortyNine wrote: post #626
andybak wrote: post #198

Earlier quoted context omitted.

I thought it would be useful to dig out some numbers here: https://en.wikipedia.org/wiki/Pandemrix > The increased risk of narcolepsy due to vaccination was 1 in 18400 or 0.005% https://www.nhs.uk/news/cancer/swine-flu-deaths-examined/ seems to state an infection fatality rate of the 2009 H1N1 of 0.026%

The "issue" I've heard with simply referencing fatality rates is that the fatality rate does not equally apply to all age groups/risk factors. So anyone under 30 has a dramatically lower chance of dying due to covid, and therefore would likely have a higher risk of a serious side effect when compared to the risks of contracting covid. It's an interesting dilemma, for the good of public health you have to have certain…

Not sure if you intended to reply to me as my comment was about H1N1 (which I think had an age bias in the other direction)

Re: Pfizer Covid vaccine approved for use next week in UK

#649

Post by statquontrarian »

johnisgood wrote: post #641
statquontrarian wrote: post #457

Earlier quoted context omitted.

This is a good summary paper with some safety concerns: https://www.nature.com/articles/nrd.2017.243.pdf?origin=ppub > A possible concern could be that some mRNA-based vaccine platforms 54,166 induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity 167,168 . Thus, identification of individuals at an increased risk of autoimmune reactions…

I have an autoimmune disease and I sit a lot. So I guess I will say no to the vaccine?

You should talk to a doctor. I doubt there are any blanket statements that apply.

Re: Pfizer Covid vaccine approved for use next week in UK

#650

Post by svrb »

majewsky wrote: post #646
svrb wrote: post #639

Earlier quoted context omitted.

What about people in the risk group(s) for vaccine side-effects? E.g., people with autoimmune issues. Does their safety matter less than yours? (Assuming you're advocating for vaccinating others; if you're just advocating for vaccinating yourself and yourself only, then carry on.)

I'm also in the autoimmune-disorder bucket. From what I understand, Covid also triggers plenty autoimmune issues, so the risk assessment does not change in a significant way.

At this point, the autoimmune dangers of vaccines are well understood but the autoimmune dangers of COVID-19 aren't. Doesn't that mean it's safer to avoid the vaccine, until that situation changes? In fact it's exactly the opposite of what many people here are saying, considering only themselves and not others, but using their own logic!
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