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Pfizer submits Covid vaccine to FDA for approval, to distribute in December
231–240 of 446 posts
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#232Earlier quoted context omitted.
I'm not anti vaxx. But I totally understand after institution after institution failed us all, that people will be skeptical about a miracle vaccine developed in mere months. I have faith in the scientists, but anyone can see the incentives are dodgy here.
Please cite the lengthy list of institutions that have failed us all.
Uhh, points at 2020
The CDC advising people to not buy masks in February because "they don't work" comes to mind. The US Gov in general completely letting businesses and individuals plunge into bankruptcy. I think a lot of people have been awakened to the fact that "the system" is pretty ambivalent to their personal well-being.
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#233>> 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.
You don't have to guess, this is published information. They have trays of 1000 doses, and up to 5 trays fit in a shipping box with the dry ice.
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#234Well 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 h…
> 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.
Note that the clinical trials for this vaccine 100% excluded pregnant women, and required males to agree to use two forms of contraception. IIUC they also excluded people with prior exposure to COVID-19.
I'd take it if I were 60, certainly 70 - an 80 year old with pre-existing conditions has a shockingly high 20% infection fatality rate(1). But at 35 and in decent health, with little exposure to at risk people around me? Better off to wait.
For healthy children and teens, it's going to take far more data to know if the vaccines are safer than COVID-19. For them it's about a 1 in 1 million fatality rate per infection(1). And we've screwed up before: one of the H1N1 vaccines turned out to occasionally cause narcolepsy, and that wasn't even novel vaccine technology.
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#235Earlier quoted context omitted.
> Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from. Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product.
>Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product. Interesting, I feel the exact opposite. I can't wait to take a mRNA vaccine, but the adenovirus ones seem sketchy given that Sinovac, J&J, and AstraZeneca have all seen serious adverse events in their trials, while Pfizer and Moderna have seen none, along with mu…
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Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#236Earlier quoted context omitted.
Most schools require vaccines which have been in circulation for a long long time and presumably whose long term risks are well understood. I think it would be pretty stupid to force mass vaccinate such a rushed vaccine, don't you think?
A lot less stupid than continuing with "distance learning".
You and I have very different definitions of stupid. Requiring an entire country to go whole hog on something with zero real understanding of long term effects is my definition of stupid. When is that ever the wise thing to do?
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#237One question I have about mRNA vaccines that I haven't been able to find the answer to through my own searching: how is the mRNA delivered to the cell? All the articles I read say that the mRNA is "taken up by the cell", but what is the mechanism? Do cells naturally just absorb free-floating mRNA? Or is a modified virus used to inject the mRNA?
In both the Moderna and Pfizer-BioNTech vaccines the RNA is encapsulated in “lipid nanoparticles”. These microscopic droplets of oily liquid — about 0.1 micron in diameter — enclose and protect the fragile genetic instructions as they are manufactured, transported and finally injected into people. https://archive.is/6dxTg
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#238Earlier quoted context omitted.
> Fortunately I don't need to though, because soon we'll probably have 2 great vaccines to choose from. Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product.
>Indeed! And I'll be going with the adenoviral route which has been used for more than fifty years, rather than the brand new, first time ever mRNA product. Interesting, I feel the exact opposite. I can't wait to take a mRNA vaccine, but the adenovirus ones seem sketchy given that Sinovac, J&J, and AstraZeneca have all seen serious adverse events in their trials, while Pfizer and Moderna have seen none, along with mu…
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Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#239One question I have about mRNA vaccines that I haven't been able to find the answer to through my own searching: how is the mRNA delivered to the cell? All the articles I read say that the mRNA is "taken up by the cell", but what is the mechanism? Do cells naturally just absorb free-floating mRNA? Or is a modified virus used to inject the mRNA?
It appears there are a few different approaches, described here:
https://en.wikipedia.org/wiki/RNA_vaccine#Delivery
Viral vectors were the ones I was familiar with. I am not sure which one the Pfizer vax uses, however.
Re: Pfizer submits Covid vaccine to FDA for approval, to distribute in December
#240One question I have about mRNA vaccines that I haven't been able to find the answer to through my own searching: how is the mRNA delivered to the cell? All the articles I read say that the mRNA is "taken up by the cell", but what is the mechanism? Do cells naturally just absorb free-floating mRNA? Or is a modified virus used to inject the mRNA?
Very very simplified: Basically, you have a blob of fat that the mRNA sits in. The fat sticks to the cell, merges with the cell membrane and the mRNA pokes into the cell. It's not a modified virus, it's a much simpler structure but it has a similar mechanism. It's much simpler in that it can't replicate itself or do much else. It's literally just the code for a protein that's found on the surface of the covid virus, in a blob of fat.
That's for the BioNTech/Pfizer vaccine. Other vaccines, such as the Oxford/AstraZeneca one do use a modified virus.