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FDA hits pause on COVID-19 vaccine for children under 5

By Brian Buntz | February 11, 2022

FDA logoFDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years.

The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.

But FDA decided to postpone the meeting until further notice after Pfizer (NYSE:PFE) shared new data related to its emergency use authorization (EUA) request for an ongoing clinical trial testing the Pfizer-BioNTech vaccine in young children.

FDA indicated in a statement that it wants to review data related to a third dose of the vaccine to foster “a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

The agency noted that evaluating initial data from the clinical trial was “useful.” But FDA believes “additional information regarding the ongoing evaluation of a third dose should be considered,” explained Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Pfizer-BioNTech vaccine

Image courtesy of Wikimedia Commons.

The agency will confirm the timing for the next VRBPAC meeting after receiving more data from the ongoing clinical study.

Pfizer and BioNTech announced in a statement that they had decided to extend the rolling submission for an amended EUA for young children until more data are available.

The companies have committed to providing ongoing data from a clinical trial involving children aged 6 months to 4 years with the agency.

Before the announcement, CDC had instructed COVID-19 vaccine providers to prepare for vaccinating children under the age of 5 by Feb. 21.

The independent Data Monitoring Committee (DMC) monitoring the clinical trial for the COVID-19 vaccine favors continuing the trial, which could potentially support a three-dose schedule of the vaccine.


Filed Under: Infectious Disease
Tagged With: BioNTech, COVID-19 vaccine, FDA, 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.

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