Vulpes vulpes

@bubu12
 

26 avril 21:27 No deaths were considered by the investigators to be related to the vaccine or placebo. No Covid-19–associated deaths were observed.

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

bubu12 26 avril 21:56

ca veut juste dire que les décès survenus dans l’étude ne sont pas lié à l’injection du vaccin ou du placebo, rien de plus, vous travestissez ce qui est écrit en plus

bubu12 30 avril 22:37

ah ben faut prendre des cours d’anglais mon petit pote

@Guepe maçonne
 

Guepe maçonne : J’avais déjà posté celle là ici par exemple : https://pubmed.ncbi.nlm.nih.gov/33301246/

The 371 individuals excluded from Pfizer vaccine efficacy analysis

Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine : 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals : 311 from the vaccine group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)

What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group ?  The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication.

@Guepe maçonne
 

Guepe maçonne : J’avais déjà posté celle là ici par exemple : https://pubmed.ncbi.nlm.nih.gov/33301246/

“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.

@micnet
 

De l’analyse de ces données publiques, il en ressort que :

• Ces vaccins ont reçu une Autorisation de Mise sur le Marché conditionnelle, valide un an au lieu des 5 ans pour les AMM standards. Les études en cours et planifiées doivent être finalisées pour l’obtention de l’AMM standard.
• Les essais cliniques, même s’ils ont été planifiés, ne sont pas terminés et certains n’ont pas encore commencé. Selon les vaccins, les échéances définitives sont prévues entre 2022 et 2025 (cf. tableau ci-dessus).
• Aucune donnée n’est disponible concernant l’interchangeabilité d’un vaccin COVID-19 d’un laboratoire avec les autres vaccins COVID-19 des autres laboratoires pour compléter le schéma de vaccination.

Conclusion

• En conclusion, l’AMM conditionnelle européenne obtenue dans 30 pays sur la base d’études incomplètes et/ou bibliographiques et d’études à venir, permet de comprendre en quoi l’administration du vaccin COVID-19 en 2021 est une procédure d’investigation à grande échelle. 
• Les personnes qui se font vacciner dans le cadre d’études encore en cours ou à venir (tels que les enfants, les femmes enceintes, et toutes les populations ciblées dans les tableaux présentés dans les EPAR) entrent donc dans des protocoles de recherche et d’expérimentation.
• Avant de se faire vacciner, chacun est en droit de demander toutes les informations utiles à son consentement éclairé, y compris la notice du médicament (cf. annexes de l’Autorisation de Mise sur le Marché, liens fournis en annexe 6 en fin de ce documents). De plus, un principe de précaution doit primer avant même l’obtention dudit consentement.

@Nigari
 
Merci pour votre article !