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Pfizer and BioNTech Seek the US FDA’s EUA for Booster Dose of their COVID-19 Vaccine in Children Aged 5 Through 11 Years

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Pfizer and BioNTech Seek the US FDA’s EUA for Booster Dose of their COVID-19 Vaccine in Children Aged 5 Through 11 Years

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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