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?
> 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 to be highly frozen to avoid mRNA degradation," Hussey explained.
and
> It's possible that Pfizer's vaccine could eventually be shown to be stable in somewhat warmer conditions — or for longer times out of the freezer.
1: https://www.npr.org/sections/health-shots/2020/11/17/9355633...
The latter would require another phase2/phase3 trial I assume, and you'd think they would've tested the former by now thoroughly.
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 scale, all to protect their profits before the rest of the world can start producing vaccines. 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.
Their ethics say the ends justify the means.
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.
Sure, they could have shared all their secrets, and BioNTech theirs. Then, they would have come up with the same vaccine candidate and run two identical trials. Which would've been quite useless and far more risky.
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"
vs.
"may lead" / "may not have", "can be no assurance that [they] will not" / "could contribute" / etc.
This virus seems to have the unique ability to cause cognitive impairments at a distance.
It may very well be that later on they'll change the freezing requirement later.
https://www.npr.org/sections/health-shots/2020/11/17/9355633...
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.
How do you get this data for a large value of X without having to wait X years?
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.
https://www.pharmacytimes.com/news/some-medications-last-lon...
https://www.astho.org/Programs/Preparedness/Public-Health-Em...
If Pfizer has a short-list of candidates back in May, they could have had 6 months of stability data at approval.
They can keep those studies going and by next May have 12 months of data for the FDA to review and potentially update the transportation and storage requirements.
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.