Does the FDA think these data justify the first full approval of a covid-19 vaccine?

[Jim__]

7. Criticism of an earlier article by Peter Doshi on Covid vaccines.

Just to note: There are people who disagree with Peter Doshi.

source:

To be honest, I was hoping to avoid spending time on this. But claims by Peter Doshi in a January 4 BMJ op-ed headlined Pfizer and Moderna's "95% effective" vaccines seem to be embedding themselves into Covid vaccine skepticism lore. It's still topping BMJ Opinions "most read" list as I'm writing over 2 weeks later, and it's been reproduced in full on at least one of the major anti-vaccine websites (the one founded by Robert Kennedy Jr – but I don't want to link to it to show you). People keep asking me my opinion about it. So here it is. (Disclosure up front: Doshi and I were on opposite sides on the issue of evidence about HPV vaccines, too.)

...

The trial's primary estimate is based on 8 sick people in the vaccine group versus 162 getting an injection with placebo. To be counted, you had to have symptoms plus confirmation by a PCR test that you were infected with the virus. Doshi zeroes in on another group of people, labeled as having suspected Covid-19 without testing positive for the coronavirus.

That was 1,594 people in the vaccine group versus 1,816 with placebo. So he adds them to 8 versus 162 confirmed Covid illnesses, creating a category which he refers to as "a disease" called "covid-19 symptoms, with or without a positive PCR test result". That's the basis of his back-of-the-envelope calculations of alternative efficacy in the 19% to 29% range. Doshi argues it's valid to believe this means the vaccine's efficacy is so dramatically lower than 95% for 2 reasons:

If the PCR test results for "many or most" of these people were false-negatives, that would drag efficacy down; and
Cause doesn't matter, he says. If people with "suspected covid-19" had the same outcomes as those who also tested positive, then his category "may be a more clinically meaningful endpoint".

1. If the PCR test results for "many or most" of these people were false-negatives, that would drag efficacy down; and
   
2. Cause doesn't matter, he says. If people with "suspected covid-19" had the same outcomes as those who also tested positive, then his category "may be a more clinically meaningful endpoint".
   

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