Pfizer and BioNTech Report EUA Expansion for Booster Dose of COVID-19 Vaccine in Children Aged 5 Through 11 Years
- The EUA was based on the P-II/III trial to evaluate the 10µg booster (third) dose of COVID-19 vaccine in children aged 5 to ≤12yrs. with COVID-19
- The results showed a strong immune response @5mos. after 2nd dose of the COVID-19 vaccine 10-µg two-dose primary series & generates neutralizing Abs against Omicron variant & wild-type SARS-CoV-2 virus with no new safety signals, was well tolerated with a safety profile similar
- The companies plan to file an application with other agencies globally. The companies also expected to share data from an ongoing P-I/II/III trial study of a 3-µg formulation of the COVID-19 vaccine on a three-dose schedule on children aged 6mos. to 4yrs. in the coming wks.
Ref: Businesswire | Image: Pfizer
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