Pfizer admits that it did not have time to assess the risks of myocarditis in children.
(Edited)
( Meeting Date: 26 October 2021 )
Pfizer admits that it did not have time to assess the risks of myocarditis in children.
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Overall Risk-Benefit ConclusionsCOVID-19 continues to be a serious and potentially fatal or life-threatening infection for children and there is a significant unmet medical need in the 5 to <12 years of age population.
Two primary doses of the 10 µg BNT162b2 vaccine given 3 weeks apart in 5 to <12 years of age have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern and high VE against symptomatic COVID-19 in a period where the delta variant was predominant.
The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis.
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