Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children

By Brian Buntz | July 11, 2022

Pfizer-BioNTechPfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old.

As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.

On June 17, FDA authorized the use of the Pfizer-BioNTech and Moderna vaccines in children as young as six months in the U.S. Before that, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in young children.

The EMA request included data from a Phase 2/3 randomized, controlled study based on data from 4,526 children 6 months to less than 5 years of age.

The study found that three doses of the vaccine resulted in a robust immune response with a safety profile similar to a placebo. In addition, the companies noted that adverse events were less common in young children than those between the ages of 5 and 12.

PFE shares were flat in mid-day trading, hovering around $53.15. BNTX shares were down 1.31% to $167.90.

Tell Us What You Think! Cancel reply

Related Articles Read More >

Pfizer logo
FDA allows pharmacists to prescribe Paxlovid 
vaccine
Will COVID-19 vaccines be updated by fall? 
COVID-19 vaccine
Young children in U.S. now eligible for COVID-19 vaccination
Florida
Florida chooses to not pre-order COVID-19 vaccines for young children

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards