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Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion for Comirnaty to Treat COVID-19 in Children Aged 6 Months to ≤5 Years

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Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion for Comirnaty to Treat COVID-19 in Children Aged 6 Months to ≤5 Years

Pfizer and BioNTech Receive the EMA’s CHMP Positive Opinion for Comirnaty to Treat COVID-19 in Children Aged 6 Months to ≤5 Years

Shots:

  • The EMA’s CHMP has adopted the positive opinion recommending marketing authorization for a 3µg dose of Comirnaty in children aged 6mos. to ≤5yrs. The EC’s final decision is expected shortly
  • The recommendation was based on the P-II/III trial evaluating Comirnaty in 4526 children aged 6mos. to ≤5yrs. The children received a third 3-µg dosage of the original COVID-19 vaccine at least 2mos., following 2nd dose
  • The original COVID-19 vaccine was found to be 73.2% effective to prevent COVID-19 with a favorable safety profile similar to PBO. The US FDA granted EUA of the original COVID-19 Vaccine as a three 3-µg dose series in the same age group while submissions to other regulatory agencies are ongoing

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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