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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

#72

Earlier quoted context omitted.

It's been almost two weeks. That's more than enough time to read thousands of pages if they are literally the most important thousands of pages in the world right now.

What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?

Add to that the fact that the whole world is watching, and hundreds of thousands of lives are at stake

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

#73
post #37

Amazing that people will be getting vaccinated against coronavirus before the year is out. Is there any evidence of whether these vaccines prevent transmission of the virus yet? Or so far do we just know that they protect the person who is vaccinated?

If you're not actually infected, i.e. you're protected, you don't spread the virus. I'm not aware of a disease for which this isn't true, that vaccinated people can be carriers.

Vaccines that prevent disease symptoms but don't completely prevent infection are definitely a thing (they're said to confer "non-sterilizing immunity," vs. "sterilizing immunity" which prevents both infection and disease). The inactivated polio vaccine (the injectable one that's used in the US) is an example of such a vaccine. The oral polio vaccine, which is the main one used in the developing world, interestingly does confer sterilizing immunity, but with the tradeoff that sometimes it also causes polio.

At least in the US, the explicit target endpoint for FDA approval was just prevention of disease, not prevention of infection, and the phase III trials for both the Moderna and Pfizer/BioNTech trials were only designed to assess this criterion: they only tested symptomatic people, so it's entirely possible (though not that likely given animal model observations, etc.), that infections were just as common in the treatment groups as control groups, but they just never developed symptoms and so were never tested. More research will be needed to ascertain which kind of immunity is being conferred.

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

#74
post #64

Earlier quoted context omitted.

My 85 year old grandparents are excited, they get to hold their great grand children again. They’d be first in line if they could be.

Aside from hospital workers they're likely to be pretty high on the list, if my understanding is correct.

The FDA already recommended (it's not binding) that front-line healthcare workers and seniors in long-term care are the first wave of 20M people (40M doses).

That will take until February or so to complete.

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

#75
This could be the fastes approval in the whole drugs' history considering that

The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application.

This time is interrupted by one or two ‘clock-stops’ during which the applicant prepares the answers to any questions raised by the CHMP. The maximum duration of a clock-stop depend on how long the applicant thinks it will take to respond, but must be agreed by the CHMP. The first clock-stop usually lasts 3 to 6 months and the second one 1 to 3 months.

Overall, the assessment of a new medicine usually lasts around a year.

https://www.ema.europa.eu/en/human-regulatory/marketing-auth...

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

#76
post #64

Earlier quoted context omitted.

My 85 year old grandparents are excited, they get to hold their great grand children again. They’d be first in line if they could be.

Aside from hospital workers they're likely to be pretty high on the list, if my understanding is correct.

Heard it was something like this:

1. Long-term care residents/staff

2. Hospital workers

3. Anyone 85+ years old.

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

#77
post #70

Earlier quoted context omitted.

What makes you so confident? If someone gave you the source code to a major software project, even with a large team of highly qualified engineers working as fast as they could, how long would it take to read over the entire thing and be absolutely sure that there were no serious mistakes?

If a team from the UK had already done it, I would just go ahead and accept their analysis. The US should give emergency approval now, based on the UK approval.

That's a reasonable position, but if I were making a list of American government pandemic mistakes, this honestly wouldn't even crack the top hundred.

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

#78
post #9
post #5

How did they approve it that fast? Is the approval process so different and so much more efficient than the one in the EU or USA? Was it extremely rushed to make sure to get doses before they have to compete with other countries for limited supply? I'm pretty curious now. Let's hope for the best, i.e. a good vaccine, a good process and no trust problems, the latter because at least it feels rushed.

My understanding is that they've been carrying out a rolling evaluation that has been going on for the duration of the trials, which has helped accelerate the normal process. Having said that, I believe the EMA (EU) also carried out a rolling evaluation, so I'm not sure what the differences are there.

From what I remember from the news yesterday the EMA will be done with the evaluation (if they don't find anything that causes concern) by the end of the month, so they aren't that far off

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

#79

I had COVID-19 early in the year, and so did my Wife (not sure about my Daughter, harder to tell with kids). I would really like to know whether I should get the vaccine or not? All the info that's out there says that immunity to C19 is temporary, so a vaccine after having gone through it doesn't seem redundant. Does anyone know if there's been any research on effects of the vaccine on the people who got C19 and reco…

From what I have seen the data says immunity is at least six months, and potentially years as with the original SARS. For me it is easier, I had it only a month ago, so I am good at least till the summer.

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

#80

I had COVID-19 early in the year, and so did my Wife (not sure about my Daughter, harder to tell with kids). I would really like to know whether I should get the vaccine or not? All the info that's out there says that immunity to C19 is temporary, so a vaccine after having gone through it doesn't seem redundant. Does anyone know if there's been any research on effects of the vaccine on the people who got C19 and reco…

Having had Covid-19 should confer at least as much immunity as a vaccine does. It's possible that a vaccine could act as a "booster" to extend immunity, but I don't think there's any data on that.

Your fears about "cytokine storm possibility as a reaction to vaccine" are unfounded. These vaccines have been tested on tens of thousands of trial participants.

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