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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

#161

Post by Siira »

kart23 wrote: post #99
gnicholas wrote: post #47

Earlier quoted context omitted.

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…

Read in between the lines for a moment. They're saying that the differences are secret, and they're not gonna release the specific structure of the LNPs and why the differences are there. The equivalent of having two proprietary binaries that both accomplish the same task, but have different code, and the reasons why are secret as well. And we're accepting this on the first mRNA vaccine ever to be used on a massive s…

> Yes they spent a lot of money and time creating the vaccine. Now open source it and let the rest of the world save their citizens.

And who’s going to pay for it? The whole PPE shortage was exactly because of this entitled attitude. If you artificially limit prices, you’ll only limit the supply (to possibly nothing, as vaccines have high upfront costs), and enable scalpers.

One obvious solution is to have a UN initiative that buys the IP and opensources it. I don’t know how hard this is. Generally, one big problem is the lack of gratitude on the part of freeriders. Otherwise, the goodwill it generated for the sponsors would probably be enough to make it happen.

PS: I live in Iran. I am not defending my privilege here.

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

#162

Post by Siira »

mensetmanusman wrote: post #155
kart23 wrote: post #99

Earlier quoted context omitted.

Read in between the lines for a moment. They're saying that the differences are secret, and they're not gonna release the specific structure of the LNPs and why the differences are there. The equivalent of having two proprietary binaries that both accomplish the same task, but have different code, and the reasons why are secret as well. And we're accepting this on the first mRNA vaccine ever to be used on a massive s…

Nation states have responded to this ambiguity by directing well financed hacker groups to steal this information. Their ethics say the ends justify the means.

I doubt they even think about the ethics. It’s not like they weren’t doing nefarious cyber activities before Covid-19.

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

#163

Post by Siira »

bsaul wrote: post #121
_Microft wrote: post #120

Earlier quoted context omitted.

It won't be taken by everyone in the world. There are countless vaccines being developed. The two mRNA based ones were the quickest to fulfil the criteria of their phase three trials. The AstraZeneca/Oxford vaccine and Sputnik V are based on more conventional methods (adenovirus vector) for example. Also: the implication of your statement about the "most fragile 1 percent" is that their lives are worth less than othe…

"inhumane attitude" could also be a good qualifier for using the population as lab rats. it's called a tradeof , and public policies is doing it all the time, including accepting people dying for the greater good of others. Otherwise we would have banned cars a long time ago.

No one is forcing you to take the vaccine. What’s wrong with you?

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

#164

Post by markus92 »

neuronic wrote: post #149
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)

Isn't the Pfizer/BioNTech one marked at this temp because they simply didn't have enough time to really figure out the safe temps? I recall reading an article that mentioned -90C as the "safe shot", meaning they can be 100% certain that the vaccine is stable at this temp but it might be stable at much lower temps. Also more BNT-XXX vaccines are in development.

Pfizer is spending a considerable amount of money on their cold chain, for example buying up pretty much all ultra-low temperature freezers they can find. I personally doubt they'd still be spending that money if they needed it, there's been plenty of time for a stability analysis by now.

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

#165

Post by loufe »

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)

If anyone is curious how this difference will make an impact in the big picture, I cannot recommend highly enough the Youtube video on Covid vaccine logistics by Wendover Productions (I can't search youtube at work to provide a direct link but it should be easily searchable).

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

#166

Post by maxerickson »

AndrewBissell wrote: post #136
reader_1000 wrote: post #125

Earlier quoted context omitted.

I looked the video and he says that based on vaccine literature, for the past any important vaccine safety signature was clear within two months meaning two months is enough to conclude whether a vaccine is safe or not. However, I think his answer seems a little bit superficial. Isn't the most part of the vaccine literature based on traditional vaccines? Yes I know that mRNA is not that much new but is literature on…

I have noticed this sleight of hand being used in a few different mRNA explainers. The two month window which has usually been sufficient to establish the safety of traditional vaccines isn't really applicable here, unless we have some reason to believe this new type of vaccine will present side effects and complications in the same way over the long term. But we don't have a good reason to believe anything about the…

The mechanism of action is actually a good reason to believe lots of things about them long term.

The mRNA is delivered, causes cells to express proteins and is naturally broken down (it's normal for the body to sweep up mRNAs over time).

Once the mRNA is gone, the long term effect is the immunity, which there's no reason to expect it to be different than immunity to similar antigens, which is something that is well studied.

So the immunity side of it is not a radical departure (antigens are presented to the body) and the delivery/mechanism is quite clear and has a natural brake (mRNA degradation).

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

#167

Post by ed25519FUUU »

rleigh wrote: post #129
zaroth wrote: post #55

Earlier quoted context omitted.

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.

Two doses is very common for vaccines because this is based upon how the immune system responds to real infections. The first dose will initiate a primary immune response. The second dose will act as a "challenge" to trigger a secondary immune response.

It sounds like one dose is enough to make you much less likely to develop serious symptoms or symptoms at all, and two doses gives you close to immunity.

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

#168

Post by rainbowzootsuit »

Retric wrote: post #63
maxerickson wrote: post #58

Earlier quoted context omitted.

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...

There's a US government program that tests drugs' efficacy beyond the manufacturer dating to extend the life of the stockpiles.

https://www.astho.org/Programs/Preparedness/Public-Health-Em...

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

#169

Post by ed25519FUUU »

neuronic wrote: post #152
BurningFrog wrote: post #142

Earlier quoted context omitted.

This argues against only giving one dose instead of two. But no one is proposing that. The argument is that while there is a vaccine shortage, it is better to give as many as possible one dose, instead of giving only half that many people two doses, leaving the rest unprotected. When available, everyone gets the second shot, which should work just as well 6 months later.

> which should work just as well 6 months later Do you have clinical evidence for that? I doubt it. OP still has a more valid point. Public trust in the vaccine and its apparent effectiveness ASAP after the vaccination campaign begins will be gigantic factors in its success. We all know that a hard lockdown brings down the new-infection numbers WEEKS after beginning the lockdown, yet there are still a lot of people o…

> We all know that a hard lockdown brings down the new-infection numbers WEEKS after beginning the lockdown, yet there are still a lot of people on Twitter, YT and at demonstrations (at least here in Germany) where folks are angry that the lockdown doesn't work 2 DAYS after its beginning.

In the spirit of understanding, in your words what are the biggest arguments against forcing a hard lock down?

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

#170

Post by rualca »

markus92 wrote: post #164
neuronic wrote: post #149

Earlier quoted context omitted.

Isn't the Pfizer/BioNTech one marked at this temp because they simply didn't have enough time to really figure out the safe temps? I recall reading an article that mentioned -90C as the "safe shot", meaning they can be 100% certain that the vaccine is stable at this temp but it might be stable at much lower temps. Also more BNT-XXX vaccines are in development.

Pfizer is spending a considerable amount of money on their cold chain, for example buying up pretty much all ultra-low temperature freezers they can find. I personally doubt they'd still be spending that money if they needed it, there's been plenty of time for a stability analysis by now.

> I personally doubt they'd still be spending that money if they needed it, there's been plenty of time for a stability analysis by now.

I don't believe your logic follows. There's a lot riding on this vaccine working as advertised, thus there is considerable pressure on Pfizer/BioNTech to deliver on that promise. If they know their vaccine is at peak effectiveness when transported at -90ºC and that the effectiveness drops if handled at lower temperatures, and if time is critical as it is, then they have all the reasons in the world to just play it safe by going with the costly but reliable option.

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