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Pfizer and BioNTech Initiate Rolling Submission for EUA from the US FDA for COVID-19 Vaccine to Treat COVID-19

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Pfizer and BioNTech Initiate Rolling Submission for EUA from the US FDA for COVID-19 Vaccine to Treat COVID-19

Pfizer and BioNTech Initiate Rolling Submission for EUA from the US FDA for COVID-19 Vaccine to Treat COVID-19

Shots:

  • The companies have initiated a rolling submission for EUA of COVID-19 Vaccine in children aged 6mos. to <5yrs. The submission was based on the totality of data on the safety, tolerability, immunogenicity & efficacy of two 3 µg doses of COVID-19 vaccine & the submission is expected to be complete in the coming days
  • The companies are planning to share the data with the EMA & other regulatory agencies globally & will submit additional data on a third 3 µg dose in the coming mos., after completion of 2nd dose
  • If authorization is granted, it will be the 1st COVID-19 vaccine for pediatric populations under 5yrs. of age. The vaccine is already authorized for use in children aged ≥5yrs.

Ref: Businesswire | Image: Pfizer

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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