Pfizer Vaccine’s Benefit-Risk Assessment In Older Male Adolescents A Close Call Due To Myocarditis
Executive Summary
For males 16-17 years old, excess cases of myocarditis/pericarditis from Comirnaty would exceed COVID-19 hospitalizations and deaths under ‘worst case’ scenario modeled by US FDA; agency nevertheless deemed approval warranted in this subpopulation, citing prevention of nonhospitalized COVID cases and public health benefits from vaccination.
You may also be interested in...
Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough
Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.
CDC Data More Positive on Myocarditis Benefit-Risk Than FDA’s Assessment of Pfizer’s Vaccine
Updated modeling on heart events in young adults presented to CDC’s vaccine advisors points towards much lower rates of the adverse event from mRNA vaccines than some of FDA’s modeling.
Full Approval Without Some Benefits: FDA Cautions Against Off-Label Use Of Pfizer’s COVID-19 Vaccine For Children, Boosters
Unique nature of COVID-19 vaccine distribution in the US rules out off-label prescribing for Pfizer and BioNTech’s fully approved shot, and FDA isn’t on board with it for children under 12 and boosters yet. The need to better understand dosing and myocarditis risk in young children appears to be a key motivating factor for discouraging unauthorized and unapproved use. FDA handed Pfizer six post-market requirements related to better characterizing the myocarditis risk with its vaccine and one post-market commitment.