Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA signals careful approach in mulling COVID-19 vaccine authorization in young children

By Brian Buntz | May 2, 2022

FDA logoFDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its protein-based vaccine could potentially offer immunogenicity advantages when used as a booster, although data to confirm that hypothesis are scant.

During the pandemic, the FDA has often announced regulatory decisions related to COVID-19 vaccines on the heels of VRBPAC meetings.

Approximately 18 million children between the ages of 6 months and 5 years old in the U.S. are currently ineligible for COVID-19 vaccination. The omicron wave complicated clinical trials focused on testing COVID-19 vaccines from Moderna and Pfizer in young children.

Finally, on June 28, the advisory committee is scheduled to meet to discuss the possibility of updating COVID-19 vaccines before the fall to improve efficacy. Both Moderna, Pfizer and BioNTech had begun work on an omicron-specific vaccine.

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, in a statement. “We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public. The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines. We intend to move quickly with any authorizations that are appropriate once our work is completed.”

After the agency has finalized the VRBPAC dates, it will make documents related to the forthcoming meetings publicly available.


Filed Under: Drug Discovery and Development
Tagged With: BioNTech, COVID-19 vaccines, FDA, Moderna, Novavax, NVX‑CoV2373, Pfizer, Vaccines and Related Biological Products Advisory Committee, VRBPAC
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Collage of close-up male and female eyes isolated on colored neon backgorund. Multicolored stripes. Concept of equality, unification of all nations, ages and interests. Diversity and human rights
How a ‘rising tide’ of inclusivity is transforming clinical trials
Mary Marcus appointed CEO of NewAge Industries
DNA double helix transforming into bar graphs, blue and gold, crisp focus on each strand, scientific finance theme --ar 5:4 --personalize 3kebfev --v 6.1 Job ID: f40101e1-2e2f-4f40-8d57-2144add82b53
Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
Data analytics tools help doctors analyze trends in patient outcomes and population health.
External comparator studies: What researchers need to know to minimize bias
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

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.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 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 and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE