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Emergency Use Authorization (EUA) for an Unapproved Product

Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum

 

Pfizer-BioNTech COVID-19 Vaccine study results of 44,000 participants ; 2 months after the second shot : 8 “cases” of Covid19 in the Vaccine group and 162 “cases” in the placebo group. It’s “95% effective".

What is the definition of a case ?

"the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period :

• Fever ;

• New or increased cough ;

• New or increased shortness of breath ;

• Chills ;

• New or increased muscle pain ;

• New loss of taste or smell ;

• Sore throat ;

• Diarrhea ;

• Vomiting

• Fatigue ;

• Headache ;

• Nasal congestion or runny nose ;

• Nausea..

 

NO ONE DIED in both groups from Covid19 !

The placebo was 100% effective at preventing death !...

 No data was provided about hospitalizations !

 Interestingly, 1 person died 3 days after injection ; but it’s “unclear” if the vaccine killed him ...

 

Here’s the text from the Emergency Use Authorization application Pfizer submitted to the FDA :

 “efficacy in preventing confirmed COVID-19 occurring at least 7 days after the second dose of vaccine was 95.0%, with 8 COVID-19 cases in the vaccine group and 162 COVID-19 cases in the placebo group....Secondary efficacy analyses suggested benefit of the vaccine in preventing severe COVID-19 and in preventing COVID-19 following the first dose, although available data for these outcomes did not allow for firm conclusions".

 "A 2-month median follow-up is the shortest follow-up period to achieve some confidence that any protection against COVID-19 is likely to be more than short-lived. “

 " However, risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure ".