Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion for Comirnaty to Treat COVID-19 in Children Aged 6 Months to ≤5 Years
Shots:
- The EMA’s CHMP has adopted the positive opinion recommending marketing authorization for a 3µg dose of Comirnaty in children aged 6mos. to ≤5yrs. The EC’s final decision is expected shortly
- The recommendation was based on the P-II/III trial evaluating Comirnaty in 4526 children aged 6mos. to ≤5yrs. The children received a third 3-µg dosage of the original COVID-19 vaccine at least 2mos., following 2nd dose
- The original COVID-19 vaccine was found to be 73.2% effective to prevent COVID-19 with a favorable safety profile similar to PBO. The US FDA granted EUA of the original COVID-19 Vaccine as a three 3-µg dose series in the same age group while submissions to other regulatory agencies are ongoing
Ref: Pfizer | Image: Pfizer
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