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

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441–446 of 446 posts

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

#441

I have a friend who is very anxious about how quickly these vaccines were developed. What can I tell them to reassure them that it is safe?

This NYT article clicked with me: https://outline.com/bVnccw If our best and brightest doctors are opting to get the vaccines for themselves, I feel safe doing the same - it's probably the most clear and obvious signal we're going to get.

This is a game of probability of which risk is greater: covid or vaccine? So, a doctor that has a great chance to get covid it's worth to use the vaccine even if it has risks. For me that I have low probability to get covid (I try to be very careful) it's not worth to have the vaccine risks.

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

#442

Now we (average folks) only have to wait 6 months (minimum). So don't hold your breath. This is kinda good news though.

There’s plenty of fear montering going around so many people don’t actually want to be vaccinated. Your turn may come sooner than expected.

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

#443
post #61

Earlier quoted context omitted.

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…

can you give an example of popular drugs that have been approved with smaller trials?

I haven't dug into the older approvals of Lipitor into a ton of detail, but you can find them on the FDA website.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ev...

It looks like the initial approval of Lipitor was in the hundreds of patients. Now, statins were brand new and not used really broadly. Pfizer did a ton of follow up studies, but looking at the most current label.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/02...

The two biggest trials, ASCOT and CARDS, which measured improvements in mortality (needed to be big trials to measure any difference), they were ~10,000 and ~2,000 patients each.

So suffice to say, Lipitor, which is used in a massive population, has probably been tested, in clinical trials, on a total number of patients comparable to the Pfizer Covid vaccine trial. Obviously the duration of the Lipitor trials were much longer and there a massive body of clinical data from actual use, but it at least gives you some perspective on numbers.

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

#444
post #416

Earlier quoted context omitted.

From reading the abstract, that study comes to the interesting finding that with a highly effective vaccine, it is better to vaccinate the YOUNG first, to reduce the spread.

What about... workers in the cafeteria who handle our food, cashiers at supermarkets and waiters who bring food over to you. I'm shocked most of the papers I'm reading don't mention these folks who are at the very intersection of our daily lives!

Probably too late for anybody's interest, but the risk of getting this from food is suspected to be incredibly low. Droplets being inhaled, entering through the eyes, or nasal mucous membranes are the likely real threats.

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

#445

Earlier quoted context omitted.

You (or rather the writer of that news piece) apparently confused antibodies and immunity. Not only are antibodies not the only mechanism of the adaptive immune system, T cells are harder to test for but equally important. Also it's normal that the body doesn't keep them around indefinitely after an exception. It creates memory cells and quickly recreates antibodies and T cells when needed. There is evidence that rei…

You're right, but are there any peer reviewed papers that back up your argument? > The paper you've linked mentions four cases. Those are confirmed cases. That doesn't mean there's only 4 total.

I don't know if there are any papers for Covid in particular but it's how the immune system works in general. AFAIK there is no reason to assume it Covid differs in that respect.

> Those are confirmed cases. That doesn't mean there's only 4 total.

I'm sure there are more, but how many? There have been hundreds of millions of infections (according to the WHO). If there are a few dozen or even a thousand reinfections among them, it's not a phenomenon we need to worry about.

We could assume that reinfections are common even without any evidence for or against, but then we are playing something akin to Pascal's wager. Also, I think if reinfections were common, by now we would very likely have evidence for that by now.

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

#446

Earlier quoted context omitted.

I'll let you test it for me and find out what the long term effects are.

Go ahead and keep doubting science. I hope that you are hunkering down in the interim and not a mask-denier.

Who said anything about doubting science or masks? Come on
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