Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92).
The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group. The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000. Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients.
“The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets.” THIS IS CALLING FOR PUBLIC RELEASE OF ALL TRIAL DATA so that INFORMED CONSENT can be given. This is huge.
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