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Pfizer Covid vaccine approved for use next week in UK

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

#331

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 a vaccine which it turns out is 95% effective for practically the entire course of the pandemic at at this point... and our conservative "moral" process was to let 1.5 million people die while we vet it.

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

#332
post #86

Earlier quoted context omitted.

The regulators have had the data for a while now They've had some of the data for a while. Pfizer didn't finish their analysis of the Phase 3 data until close to their EUA submission on Nov 20th.

To be clear, the complete dataset and approval application was not delivered to the EMA by Pfizer until Monday. You can't expect a regulatory approval in two days - it takes longer to even read the complete application.

I have zero insight into what was shared when, but I'm assuming if Pfizer completed their primary analysis in time for the Nov 20th FDA submission, they could have shared that with the EMA at that point. So somewhat of a rolling review (submit data to regulator as it becomes available).

But yes, you are correct, the EMA has specific requirements for it's submission and if they haven't received it until Monday, it's going to take a while to review it, even on an expedited basis.

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

#333
post #182

This should really be called the BioNTech or even "Mainz" vaccine (similar to the "Oxford" one), but Germany is terrible at this kind of marketing

In Germany it is mostly referred to as the BioNTech vaccine. I think it's more about international publications being more likely to use the name they recognize or think their audience will recognize. Most everyone is going to know Pfizer and Oxford respectively. Internationally Mainz isn't exactly a famous city, nor is AstraZeneca a well-known pharmaceutical company.

AstraZeneca is as well known as Pfizer, they are big pharma after all, the subset of people who know about Pfizer and not AstraZeneca is going to be quite small.

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

#334
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…

3. Vaccinated people can still be carriers of the virus and infect others who aren't vaccinated yet. As you point out in #1, vaccinated people still need to practice social distancing and wear masks.

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

#335
post #307

Earlier quoted context omitted.

You asked what "people on HN" think which is not exactly the top way to fish out experts.

If an expert read that, they would likely respond, citing why they are an expert. So I think it’s as good a way as any on hn.

If you hold a strawpoll of everyone around, then you may get an expert. But you will also primarily get non-experts, which is the problem and what headmelted is pointing out. If expert opinions are desired, why not ask for that? The non-expert opinions are already abundant, vocal, and ready to spread misinformation. shusson was not soliciting only expert opinions or even primarily expert opinions, whether that was intentional or not.

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

#336
post #331

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…

To be fair, a lot more than 1.5 million people could have died if there were delayed adverse affects of the vaccine and we'd already done a mass rollout. I think it's probably good that we put it through a proper trial process.

Also, we'd still have had to wait for production ramp up which I believe has been done in parallel to the testing, so it may not have saved that much tie.

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

#337
post #313

Earlier quoted context omitted.

This doesn't explain why it will benefit someone. The text is alarmingly vague.

> Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible (...)

Presumably one could get re-infected after vaccination, too, isn't that how vaccines work? I.e. they try to simulate as close as possible a real prior infection.

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

#338
post #94

Earlier quoted context omitted.

We all are still waiting peer-reviewd scientific papers instead of press releases....

Medical isn't constrained to science. Healthcare professionals are allowed to use tradition, authority, and Art in combination with science. It's mind boggling to Engineers to hear this, but Medicine is older than the scientific method and physicians used Regulatory capture to prevent competition. I'd love a science based healthcare alternative.

Science doesn't have all the answers. My partner recently got into a heated debate with a pharmaceutical company she was working for because they wanted something added to their standards of care document for a rare genetic disorder they developed a therapy for.

She couldn't find a study to backup the claims that the medical team wanted to make in the document, but the lead doctor said that if this wasn't included, the patients would suffer and ultimately die.

So she said "you need to prove this in a study so it can be included, otherwise you put the company at risk". To which the doctor said "We could do that, but it would take 3-4 years, and in the mean time, the patients we're caring for would go back home, the doctors would be missing the one key piece of advice, and then they'll all suffer and die".

Science is slow. People are dying now.

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

#339
post #273

Earlier quoted context omitted.

>How are they going to check if the manufacturer fudged the report? Run the experiment themselves again in 20 days? Site and document inspections.

What site? Just pick one of the over 150 trial sites at random? What are they going to see that they couldn’t have seen a month ago?

You'd fit right in with the folks that approved thalidomide.

"Why worry about something that isn't going to happen?"

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

#340
post #95

Earlier quoted context omitted.

UK Gov originally published this as the priority interim list [1] - * older adults’ resident in a care home and care home workers * all those 80 years of age and over and health and social care workers * all those 75 years of age and over * all those 70 years of age and over * all those 65 years of age and over * high-risk adults under 65 years of age * moderate-risk adults under 65 years of age * all those 60 years…

In Denmark where I live, a large proportion of infected people are age 20-29, and I wonder if it would make sense to vaccinate them first when you get to "rest of the population". Even though they have a smaller risk of getting seriously ill, that could be an effective way to lower transmission. That is: 1. Immunize the age group that is dominating in the hospitalization statistics, then 2. Immunize the age group is…

Because A.) Approx 1 20yo in a million will have life threatening complications. Plus B.) there are a lot more of them than their (are people who have non-negligible chance of dying + people around those with non-negligible chance of dying).
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