Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months

“Procedures: The participants were randomly assigned in a 1:1 ratio to receive two 30-?g intramuscular injections, 21 days apart, of BNT162b2 (0.3 ml volume per dose) or saline placebo. Randomization was performed with an interactive Webbased system. Starting in December 2020, after BNT162b2 became available under emergency or conditional use authorizations, participants 16 years of age or older who became eligible for Covid-19 vaccination according to national or local recommendations were given the option to learn their trial assignment. Those who had been randomly assigned to receive placebo were offered BNT162b2. After unblinding of the group assignments, participants were followed in an open-label trial period…

Adverse Events: … During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the openlabel period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died.”

Notes: Therefore, over the six-month period documented by this report, the treatment group had a total of 20 fatalities [15 + 5] while the placebo group had 14.

According to Table S3 from the Supplementary Appendix:

• Over the six-month period documented by this report, the treatment group had 300% [(5,241 – 1,311) / 1,311] more 'Related Adverse Events' (RAE) than the placebo group. (An RAE is an event considered to be related to the injection by an investigator.)
  
  
• The treatment group also experienced 75% more 'Severe Adverse Events' than the placebo group.