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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

#11

Post by nojito »

justforfunhere wrote: post #2

>> The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8oC) conditions. I read som…

In the US, they already have pre-purchased millions of dosages that are ready to go within 24 hours of FDA approval.

https://www.cbsnews.com/news/operation-warp-speed-covid-19-v...

It's quite remarkable in terms of logistics.

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

#12

Post by klmadfejno »

nojito wrote: post #8
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?

You can't rush Stage III of vaccine trials. 95% with a p of < .0001 is unheard of in Vaccines. This is an amazing feat for science.

> 95% with a p of That can't possibly be true.

Not to diminish the accomplishment though.

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

#13

Post by Irene »

Pfizer selected New Mexico, Rhode Island, Tennessee and Texas for their pilot delivery program "due to the states' immunization infrastructures, urban and rural variations, size and population diversity". First batches of vaccine will probably go to frontline medical workers first, followed by frail old people. a paper in Medrxiv favored "older first" model based on evolutionary game theory and mobility data, for largest decrease in mortality rates.

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

#14

Post by reverend_gonzo »

justforfunhere wrote: post #9
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?

I guess, from a business perspective, a vaccine manufacturer would seldom get a chance or a time like this. We are seeing history in making. Literally the whole world is holding its breath for a vaccine to arrive.

To be fair, every day is history in the making.

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

#15

Post by deugtniet »

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?

They do stagger the release, these people do not have a billion doses available right away. The next step is a limited global release. Stage 4 of the medication begins, and the safety is tracked in the global release. Later in the year, there will be more doses available, and everyone will be able to get vaccinated.

Furthermore, these are considered normal trial sizes it's been tested on tens of thousand of individuals. Every test subject remains tracked. Up to now, there are no permanent adverse effects found in the population that was tested.

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

#16

Post by qwerty456127 »

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?

Despite being extremely pro-vac I'm going to postpone getting vaccinated with this for as long as possible (at least a couple of years hopefully). Even if they would disallow me to travel abroad I would rather stay in my home country.

I've heard about a guy who volunteered to try the Russian vaccine - he got extremely sick and almost died from inflammatory cardiomyopathy as the result. So I want to see thousands of people who to get vaccinated and keep fine for some long time after that.

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

#17

Post by nojito »

klmadfejno wrote: post #12
nojito wrote: post #8

Earlier quoted context omitted.

You can't rush Stage III of vaccine trials. 95% with a p of < .0001 is unheard of in Vaccines. This is an amazing feat for science.

> 95% with a p of That can't possibly be true. Not to diminish the accomplishment though.

How is it not true?

Most are 85-90% but the jump from high 80s --> 95% is massive,

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

#18

Post by tuna-piano »

-Great great news. Can't wait to get the needle in the arm ASAP.

-Seems extremely effective at limiting covid disease.

-Very curious as to how long will the vaccine immunity will last?

-Seems with the second dose for 18-55 year olds, perhaps 75% will feel fatigue, 50% have chills and 20% will have a fever.[1] This hasn't been widely shared yet and I'm a bit concerned how the public will react.

-Safety: Given the huge trial size, we can be pretty confident that there aren't any significant negative short term effects. But yet the phase three trials will follow the participants for two years. Presumably, this is to find out about longer term safety+efficacy... but yet of course we will be vaccinating most of the world prior to the end of those two years.

How are we confident that these vaccines don't cause any long term safety concerns? Other vaccines have been pulled from the market for safety reasons - what happened in those cases that we're sure won't happen in this case?

I think given the fact that "anti-vaxxers" exist makes some people take the complete opposite position to distance themselves from the conspiracy theorists- "anything a doctor injects in your arm is safe". Of course the truth is that injecting stuff in people's arms is not always safe - which is why we have trials. Were these trials long enough to know with a high level of confidence if there are any long term effects of the vaccines?

[1] https://pubmed.ncbi.nlm.nih.gov/33053279/

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

#20

Post by icegreentea2 »

justforfunhere wrote: post #2

>> The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8oC) conditions. I read som…

Here are some larger on-market -80 class medical shippers: https://www.thermosafe.com/files/Product_Sheets/DurablesforH...

Guessing by eye, you can fit at least several hundred, up to low thousands of doses in each shipper. The inner volumes on these are pretty large, but a good chunk of it will be taken up by dry-ice.

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