The EUA was based on the P-II/III trial evaluating the three 3-µg doses of COVID-19 vaccine vs PBO in 4526 children aged 6mos. through 4yrs. with COVID-19
The results showed that the vaccine elicited a strong immune response with a favorable safety profile at the third 3-µg dose after the second dose for 2mos. with no new safety signals, Ab responses were comparable to those aged 16 to 25yrs. immunized with two 30-µg doses
The frequency of adverse reactions in children was low than in children aged 5 through 11 yrs., 30.3% vs 27.3% reported AEs in patients aged 6 through 23mos. while 18.8% vs 18.9% in aged 2 through 4yr. The companies plan to submit the results to the EMA & other regulatory agencies globally for authorization in July
Ref: Bussinesswire | Image: Pfizer
