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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

#51

Post by tooltower »

seanwilson wrote: post #40
refurb wrote: post #38

Earlier quoted context omitted.

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?

Not OP, but this is the same way lightbulb or hard drive manufacturers can claim "greater than 50,000 hours of operation". Instead of testing for over a decade, they test many samples over a shorter time duration, and then they extrapolate. Like any other extrapolation, these estimates have their caveats. But for biological reagents, something like an exponential decay is often considered reasonable.

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

#52

Post by stu2b50 »

opendomain wrote: post #50

I am concerned that the Pfizer vaccine was put on hold [1]. I am also concerned that Moderna has never produced ANY drug beyond the third stage before. [2] How could we research if the approval was politically motivated? How can I know if this is actually safe? (1) https://www.vanityfair.com/news/2020/12/white-house-delays-p... (2) https://www.wsj.com/articles/modernas-covid-19-vaccine-is-cl...

It was not "put on hold", rather as many experts expected, especially with the state of the current administration, mass distribution and coordination is a clusterfuck. Which, to be fair, is a very challenging problem with a lot of minutia and moving parts. But "your amazon product will take another day to ship" is very different from "your amazon product is broken".

If you're worried that it was rushed by US politics: the "Pfizer" vaccine was made by Biontech, a German company, and has also been accepted (earlier, even) by regulators in Canada and the UK.

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

#53

Post by tathougies »

stjohnswarts wrote: post #41
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.

This is why I was so angry to find out that the Trump administration passed on 100 million doses. Are you kidding me? And they didn't have to pay for them if it wasn't proven to be effective. There was literally no downside! This has just been a terrible Presidency from all angles.

The US has 100 million doses of Pfizer and 50 million of Moderna, enough to cover a bit under half the country. Then, it has 500 million of the Oxford vaccine. Altogether, this is more than enough to cover the country. And then it has the option to purchase more..

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

#54

Post by maxerickson »

stjohnswarts wrote: post #41
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.

This is why I was so angry to find out that the Trump administration passed on 100 million doses. Are you kidding me? And they didn't have to pay for them if it wasn't proven to be effective. There was literally no downside! This has just been a terrible Presidency from all angles.

Their purchase targets across all the vaccine candidates should have been in the billions, with the idea of distributing any excess (FDA approved) vaccines around the world.

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

#55

Post by zaroth »

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.

The actual study results show the vaccine is highly effective within 10 days of the first dose.

Honestly a bit shocked based on the results and the number of lives that could be saved by effectively doubling the number of available doses that they didn’t try to get it modified to a single dose regimen.

Seems to me like just another way the FDA has screwed up this whole rollout.

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

#56

Post by coffeecat »

seanwilson wrote: post #40
refurb wrote: post #38

Earlier quoted context omitted.

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?

Assume that the reaction rate (shelf life) versus temperature relationship is described by the Arrhenius equation or some other model; perform experiments at elevated temperatures, and extrapolate to lower temperatures.

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

#58

Post by maxerickson »

Retric wrote: post #48
seanwilson wrote: post #40

Earlier quoted context omitted.

> 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?

The general rule is increasing temperature by 10C roughly doubles the rate of chemical reactions. https://www.ddltesting.com/package-testing/shelf-life-testin... Though in practice it’s more complicated. Basically, make predictions based on accelerated testing and then validate them in real time tests. So, if things hold up at 3 and 6 months real time you can probably trust them over longer timeframes.

In practice it seems the expiration dates on even boring drugs aren't real far into the future.

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

#60

Post by zaroth »

stjohnswarts wrote: post #41
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.

This is why I was so angry to find out that the Trump administration passed on 100 million doses. Are you kidding me? And they didn't have to pay for them if it wasn't proven to be effective. There was literally no downside! This has just been a terrible Presidency from all angles.

If Trump had stockpiled even more doses he would just be called a mass murderer for hoarding the initial supply. America has enough of the first round of production locked up.
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