margarita25
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FDA: Pfizer's Covid-19 vaccine safe and effective after one dose (nbcnews.com)
The new information comes ahead of a planned meeting at the FDA to consider emergency use of the vaccine.
Pfizer's Covid-19 vaccine candidate offers protection after the first dose, according to documents released Tuesday by the Food and Drug Administration.
The information was made public before a meeting Thursday of the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — an advisory group to the FDA that will vote on whether to advise the agency to grant emergency use authorization of the vaccine in the U.S. ...
ilovewings said:
Three indianapolis hospitals are supposed to receive the Pfizer vaccine within the week. My employer sent out emails to employees today stating they expect to begin vaccinations on December 14.
Quite sobering, really. Without an explanation of why they have their results, and an explanation for how they "mistakenly" gave a different dose than they thought they were giving, the whole thing looks gummed up.
Dr. Osterholm is optimistic about the vaccines, “we just need to make it to the vaccines”:
In Dr. Osterholm’s latest podcast, he gives a rather in-depth explanation and comparison of the vaccines. Good broadcast, as usual:
Hi, I realize I posted the link and forgot to read it lol. Thanks for reminding me.
Without reading the link yet, I assume you are referring to the dose error
(quick reference Oxford/AstraZeneca Covid vaccine 'dose error' explained
AstraZeneca Defends Dosing Error in Covid-19 Vaccine Trial )
Dr. O mentioned talked a little about this in a recent podcast, and said something about how this dosing error actually turned out to be good thing in hindsight/blessing in disguise bc it showed that the 50% dose reduction actually turned out to be more efficacious wrt it’s relationship to the boost and second shot (laywoman paraphrasing, IANAD, moo).
eta / qmfr: I think he talked about this in the second video, Ep 33
—
eta2:
New article from CIDRAP / U Minn / (Dr. O’s Organization) / marking:
Phase 3 trials show AstraZeneca COVID vaccine has up to 90% efficacy
It did turn out to be a good thing - although, it raises questions (I'm seeing it in the academic literature) about how this "mistake" happened. The vaccine is supposed to have a known amount of the active RNA in it. Not some other amount (in this case, a lesser amount). They do not test each vial, they test batches. So, apparently, they gave the dose not knowing that it was actual less and now we all want to know exactly how did that happen? Were the vials mismarked? Was it actually intentional (but not mentioned in the published data)? They keep making it sound like it was serendipity, but really, the people who got the half dose were originally slated to get the full dose - but didn't. That's not good technique.
Anyway, at some point (when?) they realized that about ⅓ of the people had better antibody responses and went back and figured out that they had had a different original dose (I'm sure they kept samples from all the batches and re-checked them).
But it is concerning if they actually shipped the vaccine thinking it was full dose...and it wasn't. They need to tell us how all of that happened!