Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review
Executive Summary
Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.
You may also be interested in...
COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US
Five of the six modeling scenarios in the FDA’s quantitative benefit-risk assessment on myocarditis with Moderna’s vaccine assumed Omicron as the dominant circulating strain, with assumed average vaccine effectiveness of only 30% against COVID-19 cases and 72% against hospitalizations.
Moderna’s COVID Vaccine Sheds Negative Comparison On Myocarditis With BLA Approval
Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.
ACIP Upgrades Child Vaccine Booster Recommendation To ‘Should’
Not only should children age 12 to 15 get a booster, but 16- and 17-year-olds who previously 'may' get a booster, now also 'should' get one, the CDC advisory committee said.