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Sat Aug 28, 2021, 12:00 PM

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

OPINION: https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/

Peter Doshi, senior editor, The BMJ [British Medical Journal:https://www.bmj.com/]
August 23, 2021
Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

"The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

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Reply Does the FDA think these data justify the first full approval of a covid-19 vaccine? (Original post)
MisterNiceKitty Aug 2021 OP
FarPoint Aug 2021 #1
ProfessorGAC Aug 2021 #2
BootinUp Aug 2021 #3
Kali Aug 2021 #4
dawg Aug 2021 #5
Ohio Joe Aug 2021 #6
Jim__ Aug 2021 #7
Xoan Aug 2021 #8

Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:05 PM

1. What are you really trying to say?

Oh..you know, globally, 5 billon vaccinations have been administered...Great test poole...No deaths either...None from any of the vaccines

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:08 PM

2. Unrec

Pointless cherry picking of data while ignoring a sample set of a couple billion.

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:12 PM

3. Go fish. Nt

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:15 PM

4. why did you post this bullshit?

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:17 PM

5. Yes, they do.

And from a practical standpoint, the efficacy beyond 6 months is immaterial when there are no other approved alternatives. Six months duration is unquestionably better than nothing.

In time, more studies will be done and improved vaccines will be developed. But for the here and now, we're damned lucky to have the vaccines that are available.

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:22 PM

6. Peter Doshi... Discredited anti-vax nutter...

I don't expect bullshit like this will be bought here.

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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 12:24 PM

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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Response to MisterNiceKitty (Original post)

Sat Aug 28, 2021, 01:26 PM

8. A pandemic might be ...

a legitimate reason to hurry to grant a license to a coronavirus virus vaccine. People are dying, in droves, after all.

The author doesn't think so.

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