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Pfizer submits Covid vaccine to FDA for approval, to distribute in December

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Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#81

Post by derwiki »

lmilcin wrote: post #52
Neil44 wrote: post #37

This will save lives. However I imagine most people will end up getting the Oxford vaccine, that doesn't have the storage requirements or need a second dose and is a fraction of the cost.

Well, I wouldn't be so happy. Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die. On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily. We don't know yet if there are complications from the vaccine. It is not possible to judge long term eff…

Being a coder and not a biologist, I asked a friend who regularly works with drug companies on FDA approval. I asked what the risks could be of a vaccine that was “rushed” through. In his opinion, there was virtually no risk of the vaccine actively causing harm. The biggest risk is giving people a vaccine they think is effective but isn’t and they contract the virus.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#82

Post by tuna-piano »

fy20 wrote: post #64
nojito wrote: post #34

Earlier quoted context omitted.

>Other vaccines have been pulled from the market for safety reasons This isn't true at all. There has been 2 voluntary recalls due to manufacturing issues which not led to any health problems.

It's worth thinking about how many more people will die without the vaccine as well. The RotaSheild vaccine had major side effects 1 or 2 out of 10000 people, that's better than the current estimate death rate of COVID-19.

Agree for short term effects, even for young people. Due to the trial size, I think we can be confident that if there are any short-term safety issues with this vaccine they are extremely rare.

1,769 people 25-34 have died of Covid this year. There are 23m people in that age range. .0077% have died. If the vaccine had an adverse effect at a similar rate as covid has killed young people, we'd expect it should have showed in the trials in 1-3 people.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#83

Post by kube-system »

pritovido wrote: post #49
DSingularity wrote: post #3

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?

For me the testing process feels painful and slow. I believe the best way to know the illness is through controlled infection of volunteers. I would have volunteered myself. I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. If people can risk their own lives for the adrenaline rush, I don't know why they can't risk their lives for the improvement of all humanity.

There are plenty of people who are willing to risk their own life for controlled infection trials.

The issue is finding professionals and professional institutions willing to risk the lives of others to administer those trials.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#84

Post by usrusr »

pritovido wrote: post #49
DSingularity wrote: post #3

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?

For me the testing process feels painful and slow. I believe the best way to know the illness is through controlled infection of volunteers. I would have volunteered myself. I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. If people can risk their own lives for the adrenaline rush, I don't know why they can't risk their lives for the improvement of all humanity.

> I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics.

Those are more risks of a quick end doing something you love, which is much more attractive than a risk of ruining a long life ever after, which being on the wrong end of a failed medical experiment very much is. If we somehow had cultural conventions and processes about controlled opt-out from life then this might be different, but we don't. I don't know how those cultural mechanisms would look and I don't know if they would even be possible without doing more harm than good, but I do know that we clearly don't have them.

But the real issue with challenge trials is that they just don't tell you that much as the trial group would undoubtedly be extremely biased. Basic validation can be done in a dish, in programmerese that's the suite of unit tests, and it can be done well enough to skip from safety tests (that don't involve the virus) right to observed staged deployment. The main thing challenge tests would add is that they would be a big lure for reckless people who try to be faster by skimping on the initial dish tests that are the majority of development (the equivalent of skipping unit tests).

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#85

Post by tekstar »

derwiki wrote: post #81
lmilcin wrote: post #52

Earlier quoted context omitted.

Well, I wouldn't be so happy. Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die. On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily. We don't know yet if there are complications from the vaccine. It is not possible to judge long term eff…

Being a coder and not a biologist, I asked a friend who regularly works with drug companies on FDA approval. I asked what the risks could be of a vaccine that was “rushed” through. In his opinion, there was virtually no risk of the vaccine actively causing harm. The biggest risk is giving people a vaccine they think is effective but isn’t and they contract the virus.

What was rushed through? The messaging from my government (not US) has been that approval process rules have not been changed.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#86

Post by DSingularity »

usrusr wrote: post #55
DSingularity wrote: post #3

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?

Basically because the mechanisms this generation of vaccine consist of are much less complex than any before. Historically, vaccines were huge biological black boxes with all kinds of biomachinery inside that weren't understood at all, that weren't even known . Vaccines were routinely developed, purely by clever trial and error search strategies long before any of their actual mechanisms were understood. In particula…

Thank you! Did not know that this vaccine was simpler than past vaccines.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#88

Post by lmilcin »

iakh wrote: post #79
lmilcin wrote: post #52

Earlier quoted context omitted.

Well, I wouldn't be so happy. Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die. On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily. We don't know yet if there are complications from the vaccine. It is not possible to judge long term eff…

[flagged]

Hey. I am not anti vaccine. Your comment is uninformed in that you did not read my comment with comprehension and that you don't understand what stupid stuff anti-vaxxers are serving.

My kids are all vaccinated and so am I and I don't suggest to people to not vaccinate.

I am just trying to cool down the too happy thinking that the vaccine is some magical tool that automatically causes problems to go away with no risk.

In particular, we don't yet know how long the effects of vaccine will persist, we don't know of long term side effects (and even very small amount of side effects multiplied by 7B people is a problem) and we don't know WHEN it is going to be feasible to vaccinate everybody. Remember, it is going to be pricey and many people will choose not to vaccinate for financial or other reasons.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#89

Post by xiphias2 »

refurb wrote: post #61
gvv wrote: post #29

Well just like I don't immediately update to the latest OS I think I'll wait for the beta testing to happen :)

As someone who has some experience with clinical trials and drug approvals, I'd be quite comfortable taking the vaccine. A clinical trial size of 40,000 (20,000 receiving the vaccine) is way larger than a lot of other drugs that people are comfortable taking. Is there zero risk of serious side effects? Of course not, there never is. But the trial gives enough data to say the risk is worth the benefit. Edit: The FDA h…

It also depends on the known safety profile. With AstraZeneca some people already have to take pain medications after taking the vaccine...I wouldn't be comfortable putting using that vaccine without much wider testing. Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from.

Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December

#90

Post by White_Wolf »

aviraldg wrote: post #57
lmilcin wrote: post #52

Earlier quoted context omitted.

Well, I wouldn't be so happy. Think about it. Out of million people only small percentage would become infected with covid and of that, only small percentage would die. On the other hand, vaccine must be distributed to everybody. Alternatively to people who, by occupation, have to contact many other people, daily. We don't know yet if there are complications from the vaccine. It is not possible to judge long term eff…

Is there an example of a vaccine in history that produced no initial side effects but only very long term side effects (ie. several years later)?

2009-2010 GSK H1N1 - settled by the gov of multiple EU countries https://www.cdc.gov/vaccinesafety/concerns/history/narcoleps...
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