Shots:

• The CHMP opinion is based on the P-II/III trial to evaluate the safety, tolerability & immunogenicity of Comirnaty (10µg, given as 21 days apart) in ~4,500 children aged 5 to 12 yrs. with COVID-19
• The results showed that two-dose regimen of Comirnaty (10-µg doses) was 90.7% effective in patients without prior SARS-CoV-2 infection, measured from 7 days after 2nd dose compared to 30-µg dose in patients aged ≥12yrs, favorable safety profile & robust immune responses
• Additionally, initial data from an ongoing trial in patients aged 2 to <5yrs. is expected in late 2021 & patients aged 6mos. to <2yrs in Q1’22. If approved, Comirnaty will be 1st COVID-19 vaccine to be authorized in the EU

 Ref: Pfizer | Image: BioNTech