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Pfizer vaccine doesn't need ultra-cold storage after all, company says:
In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.
The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.
If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.
"We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the US and around the world," Pfizer CEO Albert Bourla said in a statement. "If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply."
Also at www.pfizer.com
(Score: -1, Flamebait) by Anonymous Coward on Monday February 22 2021, @07:36PM (2 children)
Your logic on the lack of direct testing makes no sense. The mortality rates of COVID on healthy people below the age of 65 are just about 0. What is more unethical?
1) Refining a vaccine through repeated precisely targeted tests including exposure, ensuring optimal efficiency and safety relying on nothing but a small number of people who are both compensated fairly for the risk they take on and who offer their completely informed consent.
2) Developing a vaccine you think will work but with relatively little and potentially flawed (and easier to fabricate) data based entirely on indirect evidence, and then injecting tens of millions of people with it.
And on the testing issue - no. You are seemingly assuming that the physical integrity of the vaccine cannot be physically measured. This seems beyond improbable.
(Score: 3, Interesting) by Immerman on Monday February 22 2021, @08:18PM (1 child)
We're not talking about developing an effective vaccine - that part is done (hopefully)
We're talking about reducing the transportation and storage requirements on an approved vaccine.
While you're making sure the vaccine works, you're going to do everything not directly related to the vaccine itself by the books - which means store the you mRNA at cryogenic temperatures known to preserve RNA with minimal damage. DNA/RNA synthesis is old hat at this point, but it's typically for laboratories that want to receive the exact sequences they ordered, not something a bit degraded in shipping - any degradation will introduce undocumented confounding variables into their own experiments.
The question is not whether warmer temperatures cause damage to the vaccine mRNA - we know they do, that's why we've been storing them so cold. What we haven't known is if the increased degradation has a serious impact on the efficacy.
Vaccines maybe don't care about a little degradation - some of the damaged RNA will probably now code for slight variations on the original protein spikes. Some may be so badly degraded they won't work at all anymore. Or even do something wildly different. But you're injecting millions (billions? trillions? I don't know) of mRNA copies with every vaccine dose. Hopefully there's enough undamaged and "close enough" copies to still get the job done, but you have to test that independently from testing the pristine vaccine. And since testing requires resources that are already stretched thin by trying to rush a highly experimental new kind of vaccine into production, you're not going to do those tests until you no longer have need for those resources for testing the pristine vaccine.
As for intentionally infecting people who have received an known-degraded vaccine... it doesn't matter so much what makes sense - there's a library of laws regulating ethical human medical experimentation, and violating them can have serious legal and professional consequences. Human experimentation is heavily regulated, both legally and culturally, precisely because it's led to some very dark outcomes in the past.
And it's not like we can use small groups of low-risk populations for testing either. If all the test subjects were unlikely to get sick regardless, how could you possibly tell if your vaccine is doing anything? Vaccines aren't magic armor that stops you from getting infected, they just train your body to fight off the infection faster. Hopefully before you even know you were infected. And hopefully without you becoming contagious (though that can be a completely separate thing) But that means the only way to test them is to vaccinate enough people who *would* get severely ill without it, that the difference shows up clearly in statistical analysis.
Also - just because a vaccine works and is safe for 20-somethings, doesn't mean it will do the same for children and elderly - our bodies change over time, the only way to know for sure how safe and effective a vaccine will be within a demographic, is to test it within that demographic.
But
(Score: 0) by Anonymous Coward on Monday February 22 2021, @10:59PM
Oh man, that's a lot of words...
There's this thing, it's called an antibody test. The antibody test tells you if you've been exposed to the virus and your body is primed to fight it with antibodies. It's EXACTLY the kind of testing they do during the development of a vaccine to prove that the vaccine has triggered an immune response. You should learn how vaccines and testing work.
https://www.cdc.gov/coronavirus/2019-ncov/testing/serology-overview.html [cdc.gov]
The safe way to test a vaccine, on real live people, is to start by testing people for antibodies to begin with. A vaccine given to people who already have antibodies is a wasted vaccine. It can't be counted as 'effective' and it steals a dose away from someone who might actually need it.