Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Pfizer expands COVID-19 vaccine trial involving children under 12

By Brian Buntz | June 8, 2021

Pfizer-BioNTechPfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ: BNTX) will proceed with a COVID-19 vaccine trial involving as many as 4,500 children. The trial will significantly reduce the 30-mg dose that adults and adolescents receive. Investigators will administer a 10-µg dose to children aged 5 to 11 and give those aged six months to five years old a 3-µg dose.

The company anticipates data from 5- to 11-year-olds in September and plans on filing for emergency use authorization shortly after that.

The company anticipates that data for the 6-month to 2-year-old cohort will be available in October or November.

In related news, Pfizer and BioNTech must contend with concerns that their BNT162b2 could be linked to myocarditis in adolescents.

[Related: 50 of 2020’s best-selling pharmaceuticals]

A recently published preprint in the journal Pediatrics describes seven male adolescents who developed myocarditis after receiving the vaccine. All seven patients rapidly resolved after symptom onset. The researchers recommended further monitoring and reporting of such cases in adolescents.

In the positive column, a recently released CDC study reports that the Pfizer-BioNTech vaccine and the Moderna vaccine are jointly 91% effective at reducing the risk of COVID-19 infection in people who are fully vaccinated.


Filed Under: clinical trials, Drug Discovery, Infectious Disease, Uncategorized
Tagged With: BioNTech, clinical trials, coronavirus, covid-19, COVID-19 vaccine, COVID-19 vaccine trial, COVID-19 vaccines, FDA, Pfizer, Pfizer Inc.
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

lab microscope
Accelerating R&D with FAIR data
Amylyx
Amylyx notches first global approval for oral ALS therapy Albrioza
Novavax
FDA advisory panel backs Novavax COVID-19
Sage and Biogen
Zuranolone could offer rapid relief from postpartum depression 

Need Drug Discovery news in a minute?

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

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 Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50