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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

#61

Post by SAI_Peregrinus »

IfOnlyYouKnew wrote: post #12
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.

Nothing is "banned". AZ accidentally ran their first trial with only half the intended dose. For some reason, this turned out to work better than the intended regimen (90 % vs 60 % in the other trial). When they noticed the mistake, they pretended it had been their intention all along. That's one troubling error, one surprising result that doesn't fit expectations and could, therefore, indicate other, potentially dan…

> For some reason, this turned out to work better than the intended regimen (90 % vs 60 % in the other trial).

The difference isn't actually statistically significant. It's probably 60-70% effective overall.

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

#62

Post by cameldrv »

finolex1 wrote: post #59

Anyone knows why they insist on both doses given the limited supply of the vaccine and the marginal increase in effectiveness with the second dose? I would imagine every single day counts. https://www.lesswrong.com/posts/Rvzdi8RS9Bda5aLt2/covid-12-1...

If every single day counted, they would have done challenge trials. What counts is following the FDA's process, and the FDA's process says that you have to administer it in the same way as the trial. No one at the FDA is going to go out on a limb just to save a few thousand lives.

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

#63

Post by Retric »

maxerickson wrote: post #58
Retric wrote: post #48

Earlier quoted context omitted.

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.

Yea, prescription drug manufacturers have little incentives to seek multi year shelf lives. Combined with the slow approval process real time testing is likely considered sufficient.

https://www.pharmacytimes.com/news/some-medications-last-lon...

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

#64

Post by throwaway201103 »

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.

The vaccine itself is free. Insurance or patient or Medicaid will be billed for an office visit to administer the injection.

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

#65

Post by snowmaker »

finolex1 wrote: post #59

Anyone knows why they insist on both doses given the limited supply of the vaccine and the marginal increase in effectiveness with the second dose? I would imagine every single day counts. https://www.lesswrong.com/posts/Rvzdi8RS9Bda5aLt2/covid-12-1...

It's not an unreasonable suggestion (and a lot of people are making it now), but the risk with a single dose is low persistence. We know that the first dose has high effectiveness in the first month, but it may trail off sharply. Or it might not. Since we haven't tried a single dose, we don't know.

In animal studies, the second dose was required for a durable response, that's why Pfizer decided to go with it in their trial.

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

#66

Post by CyanLite4 »

cameldrv wrote: post #62
finolex1 wrote: post #59

Anyone knows why they insist on both doses given the limited supply of the vaccine and the marginal increase in effectiveness with the second dose? I would imagine every single day counts. https://www.lesswrong.com/posts/Rvzdi8RS9Bda5aLt2/covid-12-1...

If every single day counted, they would have done challenge trials. What counts is following the FDA's process, and the FDA's process says that you have to administer it in the same way as the trial. No one at the FDA is going to go out on a limb just to save a few thousand lives.

Challenge trials don’t work when 40% of infected are asymptomatic. And challenge trials especially don’t work when 15% of cases require hospitalization and ICU beds are already maxed out.

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

#67

Post by CydeWeys »

tathougies wrote: post #53
stjohnswarts wrote: post #41

Earlier quoted context omitted.

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..

It's two doses per person, so the first 150M only cover 75M people, not half of the country.

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

#68

Post by cameldrv »

CyanLite4 wrote: post #66
cameldrv wrote: post #62

Earlier quoted context omitted.

If every single day counted, they would have done challenge trials. What counts is following the FDA's process, and the FDA's process says that you have to administer it in the same way as the trial. No one at the FDA is going to go out on a limb just to save a few thousand lives.

Challenge trials don’t work when 40% of infected are asymptomatic. And challenge trials especially don’t work when 15% of cases require hospitalization and ICU beds are already maxed out.

I don't see how the asymptomatic fraction makes a normal trial superior to a challenge trial.

As for the hospitalization and ICU, those numbers are inflated, but regardless, in order to pass the trial, the same number of people need to be infected in the trial. The only difference is that while you're waiting for a few dozen people to be infected naturally because you gave them a placebo, millions are being infected and thousands are dying daily.

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

#69

Post by blibble »

stjohnswarts wrote: post #42
shoo wrote: post #14

Earlier quoted context omitted.

> 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…

I mean does anyone even care if it's under $100? Given what it has cost economies all over the world it is a drop in the ocean.

developing economies certainily do

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

#70

Post by waiseristy »

throwaway201103 wrote: post #64
handmodel wrote: post #25

Earlier quoted context omitted.

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.

The vaccine itself is free. Insurance or patient or Medicaid will be billed for an office visit to administer the injection.

Safeway and others have already been getting ready to administer the vaccine at no-cost to the patient. This isn't really an issue
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