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FDA grants authorization to Moderna's Covid-19 vaccine

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Re: FDA grants authorization to Moderna's Covid-19 vaccine

#31

Post by bpodgursky »

lisper wrote: post #20
FreakyT wrote: post #7

Glad to hear it! One key advantage of the Moderna one versus the similar Pfizer/BioNTech vaccine is that it doesn't require deep freeze storage, only regular freezing temperatures. (-90º C for Pfizer/BioNTech vs -20º C for Moderna)

Does anyone here know the reason for the difference? They're both mRNA vaccines, right? So why does one need a deep freeze and the other one not?

The answer is "there is probably no difference, but Moderna has more experience with mRNA vaccines and felt good about the -20 requirement, but Pfizer is new to mRNA, and didn't":

https://www.npr.org/sections/health-shots/2020/11/17/9355633...

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#32

Post by throwaway201103 »

wycy wrote: post #29
FreakyT wrote: post #7

Glad to hear it! One key advantage of the Moderna one versus the similar Pfizer/BioNTech vaccine is that it doesn't require deep freeze storage, only regular freezing temperatures. (-90º C for Pfizer/BioNTech vs -20º C for Moderna)

Do both vaccines require 2 doses? Also, is the second dose different or just a duplicate of the first?

Both of the mRNA vaccines (Pfizer and Moderna) require two doses. Don't know if the 2nd dose is the same as the first.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#33

Post by systemvoltage »

handmodel wrote: post #25
systemvoltage wrote: post #24

Earlier quoted context omitted.

I think Gov should buy the vaccine and provide it for free. Private companies should rightfully charge a premium to the governments as they took: 1) Enormous risk 2) Expediency 3) Investment of talent 4) Demand is through the roof; all this even if the governments were involved in hedging the risk for spinning up manufacturing lines.

In the US that is what is happening - no one is paying for the vaccine. It is intellectually vapid to get worked about the fact companies are making a $15 marginal unit profit on a vaccine that has 10x the utility of the average annual physical but costs 1/10th as much.

I wasn't aware it is free in the US. That's great.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#34

Post by throwaway201103 »

m-ee wrote: post #23
throwaway201103 wrote: post #15

Earlier quoted context omitted.

Simply tell people, "if you've had COVID, don't get the vaccine" or maybe "go to the end of the line"

That’s terrible messaging given that reinfection is rare but possible and occasionally deadly. We want everyone to take it.

Hard to imagine that infection and recovery from the actual virus confers less immunity than the vaccine, but even without knowing that, it seems reasonable that people who have already recovered should be a lower priority for vaccination than more at-risk groups.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#35

Post by tertius »

blhack wrote: post #9
eganist wrote: post #5

Earlier quoted context omitted.

> and stopped vaccinating people who already had COVID How would you propose doing this without drawing blood from every single person getting a vaccine?

There are people I am personally acquainted with who have been PCR positive for COVID, who are now also receiving the vaccine.

If they haven't been proven to be infected why should it matter?

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#36

Post by refurb »

shoo wrote: post #14
maxerickson wrote: post #10

Earlier quoted context omitted.

It's $40, not super expensive. 600 million doses would cost $25 billion, a trifle compared to how much the pandemic is costing.

> Belgium’s budget state secretary, Eva De Bleeker, posted the price list on Twitter, with the amounts of each vaccine that her country intends to buy from the EU. The tweet was quickly deleted, but not soon enough to prevent interested parties taking screenshots, which have now made it public knowledge. This is the list of what the EU is paying: Oxford/AstraZeneca: €1.78 (£1.61) Johnson & Johnson: $8.50 (£6.30) Sano…

Well that's not good. Pharmaceutical companies are typically willing to negotiate on price if the agreed price is confidential.

(I have no idea if that was the case here or not)

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#37

Post by Exmoor »

throwaway201103 wrote: post #32
wycy wrote: post #29

Earlier quoted context omitted.

Do both vaccines require 2 doses? Also, is the second dose different or just a duplicate of the first?

Both of the mRNA vaccines (Pfizer and Moderna) require two doses. Don't know if the 2nd dose is the same as the first.

Both the first and second doses of the mRNA vaccines are identical.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#38

Post by refurb »

bpodgursky wrote: post #31
lisper wrote: post #20

Earlier quoted context omitted.

Does anyone here know the reason for the difference? They're both mRNA vaccines, right? So why does one need a deep freeze and the other one not?

The answer is "there is probably no difference, but Moderna has more experience with mRNA vaccines and felt good about the -20 requirement, but Pfizer is new to mRNA, and didn't": https://www.npr.org/sections/health-shots/2020/11/17/9355633...

As someone who has been involved in stability testing before, I doubt this is really the case.

In order to justify your stability, you need data to submit to the FDA (they don't take your word for it). When doing your initial stability studies, you try and collect data for the most ideal conditions - no refrigeration needed, stable for X years from room temperature to 30C (to account for conditions during shipment).

No doubt Pfizer lined up a number of early stability studies testing -80C, -50C, -20C, 0C, etc. They recognize that needing a -70C cold chain is a logistics hurdle. If they could avoid it at all, they would have pushed for it and had data to back it up.

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#39

Post by stjohnswarts »

mchusma wrote: post #2

If they stopped banning Astrazeneca too, and stopped vaccinating people who already had COVID, we could be done within 60 days. Astrazeneca is well above the FDAs original safety and efficacy guidance and something I'd be glad to take and give my family.

None of what you said is true...

Re: FDA grants authorization to Moderna's Covid-19 vaccine

#40

Post by seanwilson »

refurb wrote: post #38
bpodgursky wrote: post #31

Earlier quoted context omitted.

The answer is "there is probably no difference, but Moderna has more experience with mRNA vaccines and felt good about the -20 requirement, but Pfizer is new to mRNA, and didn't": https://www.npr.org/sections/health-shots/2020/11/17/9355633...

As someone who has been involved in stability testing before, I doubt this is really the case. In order to justify your stability, you need data to submit to the FDA (they don't take your word for it). When doing your initial stability studies, you try and collect data for the most ideal conditions - no refrigeration needed, stable for X years from room temperature to 30C (to account for conditions during shipment).…

> stable for X years from room temperature to 30C

How do you get this data for a large value of X without having to wait X years?

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