(merk: BNT162b2 var et tidligere navn på Comirnaty)
#1 Ingen av de over 20.000 placebo-individene døde av Covid-19
Noe helhetlig absurd med rapporten til FDA er at absolutt ingen i placebo-gruppen døde av Covid-19, midt under pandemien. (Derimot døde én person bare 3 dager etter første vaksine.) Det skulle stille spørsmål ved behovet for å krisegodkjenne en eksperimentell RNA-vaksine med ukjente langtidsvirkninger.
Fra 4.2.6. Safety - Overview of adverse events [side 32]
Serious adverse events [side 40]
A total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest [hjertestans] 62 days after vaccination #2 and died 3 days later, and the other participant had pre-existing atherosclerotic disease and baseline obesity [åreforkalkning og fedme] and died 3 days after vaccination #1 The placebo recipients died from myocardial infarction [hjerteattakk] (n=1), hemorrhagic stroke [hjerneslag] (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.
#2 Det var svært få i studien som hadde alvorlige tilfeller av Covid-19.
Det var flere tilfeller av Covid-19 i placebo-gruppen, men likevel få. Og sammenlagt hadde faktisk vaksinegruppen flere alvorlige reaksjoner/hendelser (SAE) enn placebogruppen (126 tilfeller mot 111 tilfeller).
Når BioNTech eller Pfizer - eller FDA for den saks skyld - forteller at vaksinen har 95% effekt, så gjenspeiler det tallet på positive PCR-tester i hver gruppe; det gjenspeiler altså ikke hvor mange i hver gruppe som opplevde alvorlige reaksjoner/hendelser.
Igjen spørsmål om hvordan FDA kunne mene at disse trasige dataene påkaller en krisegodkjenning.
Severe COVID-19 Cases [side 29]
In the final analysis of the evaluable efficacy population (7 days), four participants had severe
COVID-19 disease at least 7 days after Dose 2 (one subject who received BNT162b2 and three participants who received placebo). The vaccine recipient who had severe COVID-19 disease met the severe case definition because oxygen saturation at the COVID-19 illness visit was
93% on room air. The subject was not hospitalized, did not seek further medical care, and did
not have risk factors for severe disease. The three placebo recipients who had severe COVID19 disease met the severe case definition for the following reasons: one subject had an oxygen
saturation of 92% on room air without other severe disease criteria, one subject was hospitalized for noninvasive positive pressure ventilation with bilateral pneumonia, and one
subject had an oxygen saturation of 92% and ICU admission for heart block. One of these
placebo recipients with severe disease also had a body mass index > 30 kg/m2 as a risk factor,
while the other two participants did not have any risk factors for severe disease.
#3 BioNTech har planlagt å delvis ødelegge langtidsstudien.
BioNTech, sponsor av studien av sin egen vaksine, har planlagt å tilby vaksine til alle placebo-deltagerene i studien lenge før studien er over! Dette kan betydelig redusere sammenligningsgrunnlaget for langtidsbivirkninger.
5.1. Sponsor’s Plans for Continuing Blinded, Placebo-Controlled Follow-Up [s. 44]
The Sponsor plans to offer vaccination to participants ≥16 years of age who originally received
placebo and who become eligible for receipt of BNT162b2 according to local or national
recommendations. The Sponsor proposes that these participants will be unblinded upon request
and will have the opportunity to receive BNT162b2 as part of the study. The Sponsor also
proposes that all placebo recipients ≥16 years of age will be offered BNT162b2 after
completing 6 months of follow-up after Dose 2, if they did not request and receive vaccine
previously. The participants will provide consent to receive vaccination and to continue followup. For these participants, the Sponsor plans a total follow up period of 18 months, with one visit
1-month postvaccination and subsequent phone contacts at 1, 6, and 18 months
postvaccination. Safety and efficacy monitoring during this period will include collection of AEs,
SAEs, and screening and diagnosing COVID-19 cases.