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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

#61

Post by refurb »

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 has already hinted that their initial approval (EUA) may be restricted to certain populations where the risk-benefit is justified. In other words, they may not approve it for healthy, young adults where the risk of serious Covid complications is low. That "full" approval could come later after additional clinical experience is gained.

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

#62

Post by bzb6 »

grezql wrote: post #59
baybal2 wrote: post #27

Earlier quoted context omitted.

Because China already has a "national" vaccine, and they see no chance getting through Chinese bureaucracy for such a politicised deal?

"yes you can sell here, we only need to know the ingredients and know-how of this vaccine to approve its safety"

Isn’t it like that in the rest of the world?

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

#63

Post by rayiner »

mindcrime wrote: post #42
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 :)

Same. I'm not an anti-vaxxer or anything like that. But I think "don't use version 1.0" advice applies here just like it does for software. Especially given the possibility that things have been "hurried" in the name of expediency in terms of getting the vaccine(s) developed, tested, and approved. The good news, in a sort of perverse sense, is that some delay to see what happens with "early adopters" is kinda inevita…

> But I think "don't use version 1.0" advice applies here just like it does for software.

No it doesn’t, because vaccine development is more like bridge building than software development.

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

#64

Post by fy20 »

nojito wrote: post #34
tuna-piano wrote: post #18

-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…

>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.

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

#65

Post by dgacmu »

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?

A pandemic is a good time to do vaccine trials. They signed up 44,000 volunteers and got 170 cases unbelievably quickly. People were highly motivated to volunteer, making the enrollment faster, and the very high case rates in the US meant there for to their target very quickly.

Also, 170 cases is a _lot_ in terms of phase III studies.

Other than that, the vaccine is following basically the normal course. It won't get final approval until there is more time to monitor, but the EUA will be based upon saving lives now.

For more, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/

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

#66

Post by tuna-piano »

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…

I'm curious if anyone knows why Pfizer's mRNA vaccine still needs this while Moderna's mRNA vaccine does not?

Has Pfizer just not gone through the proper temperature testing or did they go through that testing and it showed that their vaccine needs to be stored so cold?

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

#67

Post by tzs »

richardARPANET wrote: post #19

Well done President Trump!

Wrong vaccine.

This one was developed in Germany with no money from "Warp Speed". There was a Warp Speed commitment to by 100m doses after it is approved which you might argue is some encouragement, but Japan did the same thing with 120m doses, and the EU did it for 300m and provided upfront money for R&D.

The US did also do the upfront money + commitment to purchase after approval for some vaccines, such as the Moderna one, so if you want to thank the US that is the one to do it for.

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

#68

Post by refurb »

superfx wrote: post #21

Anyone know why China is not on the list of countries in which Pfizer is seeking regulatory approval?

China has its' own regulatory requirements which typically (I don't know in this case if China is asking for it) requires a specific trial in an Asian population in order to get approval.

I'm assuming that China is probably not waiving that requirement since they have their own vaccines.

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

#69

Post by refurb »

tuna-piano wrote: post #66
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…

I'm curious if anyone knows why Pfizer's mRNA vaccine still needs this while Moderna's mRNA vaccine does not? Has Pfizer just not gone through the proper temperature testing or did they go through that testing and it showed that their vaccine needs to be stored so cold?

The second option. Stability testing is done quite early with any drug candidate and is a requirement for FDA approval. There is zero chance that Pfizer didn't test their vaccine at higher temperatures.

Although Moderna's and Pfzier's vaccines are both mRNA technologies, they aren't identical in either the mRNA itself or the lipid nanoparticle used to deliver the mRNA. That's why they have different stability profiles.

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