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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

#101

Post by brobdingnagians »

dwaltrip wrote: post #81
tyre wrote: post #71

Earlier quoted context omitted.

From the linked article[0]: “Yes, Moderna’s vaccine prevents transmission. One dose is good for reducing infection by 63%, two by over 90%.” The number of people you need to vaccinate with a 63% effective vaccine versus a 90% effective vaccine is a huge gap. There are two issues with vaccines that staring at these numbers won’t tell you: 1. Not everyone is going to get vaccinated. 2. The number of people who will get…

The lesswrong quote seems to be misleading. It links to an article that says the vaccine may prevent / reduce transmission but that it hasn't been proven yet. Did I miss something?

The British Medical Journal has an article that makes the point, including quotes from Tal Zaks of Moderna, that the studies aren't designed to be statistically significant indicators of disrupting transmission, preventing hospitalisation, or even preventing death:

https://www.bmj.com/content/371/bmj.m4037

So, from what I can tell. It isn't proven to disrupt transmission or reduce hospitalisation/death. It would require much larger or longer studies, which they have opted not to do.

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

#102

Post by lultimouomo »

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...

One thing to consider is that vaccine production is going to scale up in time; since the second dose is a month after the first, giving two doses instead of one will not mean that half the number of people will be vaccinated. Assuming, for the sake of the argument, that vaccine production doubles every month, at any given point after the first month the amount of people that have received at least one does will be a bout 2/3rds of the single dose protocol.

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

#103

Post by m-ee »

avocad wrote: post #91

Does anyone know how they manage to produce complex microstructures like that, RNA inside a lipid capsule, on such a large scale? Does these vaccines need an adjuvant to work, or is the change to the affected cells large enough to trigger an immune reaction?

There’s no additional adjuvant. I have no idea how they’re produced, would love to learn more.

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

#104

Post by jrockway »

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...

> I am also concerned that Moderna has never produced ANY drug beyond the third stage before.

Have there been a lot of disease outbreaks preventable with an mRNA vaccine before? To make a product, you need customers. Whatever research we did to deal with SARS and MERS became moot when people stopped spreading the diseases; maybe Moderna could have delivered a vaccine, but there would have been no customers because other containment measures limited the spread.

My outsider impression of Moderna is that they had all the technology ready to deal with something like COVID-19, but there was no COVID-19 until now.

The fact that Pfizer/BioNTech independently produced a similar product on a similar timeframe is a pretty good indication that the technology was ready, and was just waiting for a market.

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

#105

Post by brobdingnagians »

IfOnlyYouKnew wrote: post #86
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...

They played it save when designing the protocol. Better to err on that side, than to risk failure because you chose a dose that's too low. Given that's what they trialled, there really isn't a mechanism that would allow either them or the FDA to change the protocol from what was tested. Yes, this is annoying. You can make that educated guess and not show up for your second shot and you'll probably help someone. But m…

"But medicine has a long history of people being rather convinced of theories that made an awful lot of sense and killed an awful lot of people."

That works for both sides, both the true believers and the skeptics. Both sides are absolutely convinced that they are right and the other side's belief will kill people. At least one side is wrong. Both have their reasons, both appeal to history, both appeal to science. It is a confusing time to live.

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

#106

Post by bzb6 »

blibble wrote: post #69
stjohnswarts wrote: post #42

Earlier quoted context omitted.

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

Developing economies are by definition irrelevant.

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

#107

Post by IncRnd »

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...

> but Moderna has more experience with mRNA vaccines

Let's keep things in perspective, please. This EUA is for Moderna's first product with any approval whatsover from the FDA. The lipid coating is a way for encasing the mrna vaccine in a kind of plastic for entering the cell.

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

#108

Post by reader_1000 »

Are mRNA vaccines safer than traditional ones? In the long run, which one will have less side effects? As far as I know, Both US and Europe are only going with mRNA vaccines for COVID. Is it intentional or just because there is no traditional vaccine that completed Phase III trials?

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

#109

Post by brobdingnagians »

gnicholas wrote: post #47
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?

According to NPR [1] > Moderna spokesperson Colleen Hussey explained to NPR in an email that its vaccine doesn't need to be kept so cold because of its particular "lipid nanoparticle properties and structure," and because the company has learned from experience — it's developed ten mRNA vaccine candidates already. "Now we don't need [ultra-cold conditions] as the quality of product has improved and [it] doesn't need…

Those LNPs have historically caused adverse reactions, per their 2018 SEC filing, hopefully their upgraded versions are improved and do not cause those reactions; I am hopeful.that they have, because of the reported results of their current clinical trials, but it is a data point:

https://www.sec.gov/Archives/edgar/data/1682852/000119312518...

"Most of our investigational medicines are formulated and administered in an LNP which may lead to systemic side effects related to the components of the LNP which may not have ever been tested in humans. While we have continued to optimize our LNPs, there can be no assurance that our LNPs will not have undesired effects. Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation reactions, antibody reactions including IgA, IgM, IgE or IgG or some combination thereof, or reactions to the PEG from some lipids or PEG otherwise associated with the LNP. Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events in one or more of our clinical trials. Many of these types of side effects have been seen for legacy LNPs. There may be resulting uncertainty as to the underlying cause of any such adverse event, which would make it difficult to accurately predict side effects in future clinical trials and would result in significant delays in our programs"

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

#110

Post by blackbear_ »

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...

> How could we research if the approval was politically motivated?

The analysis of the clinical trial was published in a very reputable and peer reviewed scientific journal [1,2].

> How can I know if this is actually safe?

In the reports [1,2].

If you believe that data is fake then I am afraid you just not want to be convinced.

[1] https://www.nature.com/articles/s41586-020-2622-0 [2] https://pubmed.ncbi.nlm.nih.gov/32991794/

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