Vulpes vulpes

@PFIZE®bubu

Ma question, encore une fois est :

POURQUOI PFIZE® N’A PAS CONFIRMÉ / INFIRMÉ CES CAS SUSPECTÉS ?

bubu12 : si vous ne comprenez pas pourquoi ces données ne sont pas dans l’analyse je ne peux rien pour vous. C’est écrit dans le rapport. Mais vous ne comprenez peut être pas le principe de la vaccination et ce qui est testé ici ?

Vous n’avez pas compris ma question. Pourtant elle est bien simple.

Elle ne concerne pas la présence (ou absence) de ces données (quelles données ???) dans l’analyse, ni le principe de la vaccination et ce qui est testé ici  !

Je répète :

POURQUOI PFIZE® N’A PAS CONFIRMÉ / INFIRMÉ CES 3.410 CAS SUSPECTÉS PAR UN TEST PCR ?

@PFIZE®bubu

bubu12 : il suffit de lire le rapport, je sais c’est difficile ...

 Among 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. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.

Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020, FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine, p. 42

Dans le document il n’y a aucune mention sur la raison de cette non-confirmation des cas suspectés !

Dans l’article “Suspected covid-19” on explique pourquoi ces 3410 cas de covid-19 suspectés, mais non confirmés, posent des gros problèmes !

Ma question, encore une fois est :

POURQUOI PFIZE® N’A PAS CONFIRMÉ / INFIRMÉ CES CAS SUSPECTÉS ?

J’espère que vous comprenez mieux maintenant !!!

P. S. Pour les difficultés de lecture je vous suggère de vous adresser au siège. Ils feront le nécessaire.

@Tchakpoum
 

Vous n’êtes pas seul !

@PFIZE®bubu

bubu12 : vous n’êtes pas capable seul d’aller sur le site de la FDA ? et ben ... https://www.fda.gov/media/144245/download

Savez-vous ce qu’ils sont devenus les 3410 cas de covid-19 suspectés, mais non confirmés (1594 sont survenus dans le groupe vaccin contre 1816 dans le groupe placebo) dans l’étude ?

PFIZE® n’avait plus les moyens pour tester les participants à l’étude ???

Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020, FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine, p. 42

“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.

Merci pour la vidéo !

Comme on le précise bien, l’histoire est assez ancienne, mais ce qui change aujourd’hui est l’acceleration du déploiement et sa généralisation !

Nous sommes apparemment les derniers humains à connaître le sens des moments intimes et les zones blanches  !

« Heil Gates ! »