@bubu12
bubu12 : en fait moi je ne soutiens personne contrairement à tout les clowns de
ce site, je me base sur les résultats des essais cliniques.
Alors, que sont-ils devenus les 3.410 cas suspectés dans l’essai de Pfizer® ???
“Suspected
covid-19”
All
attention has focused on the dramatic efficacy results : Pfizer reported
170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo
groups.
But
these numbers were dwarfed by a category of disease called “suspected
covid-19”—those with symptomatic covid-19 that were not PCR confirmed.
According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of
suspected, but unconfirmed covid-19 in the overall study population, 1594
occurred in the vaccine group vs. 1816 in the placebo group.”
With 20 times more suspected than confirmed
cases, this category of disease cannot be ignored simply because there was no positive PCR test
result. Indeed this makes it all the more urgent to understand. A rough
estimate of vaccine efficacy against developing covid-19 symptoms, with or
without a positive PCR test result, would be a relative risk reduction of 19%
(see footnote)—far below the 50% effectiveness threshold for authorization set
by regulators. Even after removing cases occurring within 7 days of vaccination
(409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority
of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains
low : 29% (see footnote).
If many or
most of these suspected cases were in people who had a false negative PCR test
result, this would dramatically decrease vaccine efficacy. But considering that
influenza-like illnesses have always had myriad causes—rhinoviruses, influenza
viruses, other coronaviruses, adenoviruses, respiratory syncytial virus,
etc.—some or many of the suspected covid-19 cases may be due to a different
causative agent.
But why
should etiology matter ? If those experiencing “suspected covid-19” had
essentially the same clinical course as confirmed covid-19, then “suspected
plus confirmed covid-19” may be a more clinically meaningful endpoint than just
confirmed covid-19.
However, if confirmed covid-19 is on average
more severe than suspected covid-19, we must still keep in mind that at the end
of the day, it is not average clinical severity that matters, it’s the
incidence of severe disease that affects hospital admissions. With 20 times
more suspected covid-19 than confirmed covid-19, and trials not designed to
assess whether the vaccines can interrupt viral transmission, an analysis of
severe disease irrespective of etiologic agent—namely, rates of
hospitalizations, ICU cases, and deaths amongst trial participants—seems
warranted, and is the only way to assess the vaccines’ real ability to take the
edge off the pandemic.
There is a
clear need for data to answer these questions, but Pfizer’s 92-page report
didn’t mention the 3410 “suspected covid-19” cases. Nor did its publication in
the New England Journal of Medicine. Nor did any of the reports on Moderna’s
vaccine. The only source that appears to have reported it is FDA’s review of
Pfizer’s vaccine.