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Pfizer-BioNTech’s COVID-19 Vaccine Receive the US FDA’s EUA for COVID-19 in Children Aged 6 Months through 4 Years of Age

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Pfizer-BioNTech’s COVID-19 Vaccine Receive the US FDA’s EUA for COVID-19 in Children Aged 6 Months through 4 Years of Age

Pfizer-BioNTech’s COVID-19 Vaccine Receive the US FDA’s EUA for COVID-19 in Children Aged 6 Months through 4 Years of Age

Shots:

  • 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

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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