Pfizer and BioNTech Seek the US FDA’s EUA for Booster Dose of their COVID-19 Vaccine in Children Aged 5 Through 11 Years
Shots:
- The companies have submitted an application to the US FDA for EUA of a 10-µg booster dose of the COVID-19 Vaccine for children aged 5 to 11yrs.
- The submission was based on the results from the P-II/III clinical trial which showed a strong immune response in children aged 5 to11yrs. who received a booster dose @ ~6mos. after the second dose of the COVID-19 vaccine 10-µg two-dose primary series & no new safety signals were observed
- The companies plan to submit the results to the EMA and other regulatory agencies globally for authorization in the coming wks. The companies also expected to share data from an ongoing study on children aged 6mos. to ≤5yrs. in Q2’22
Ref: Pfizer | Image: Pfizer
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