FDA Panel to Discuss COVID-19 Vaccine Booster Doses, Variants

FDA Panel to Discuss COVID-19 Vaccine Booster Doses, Variants

The Food and Drug Administration (FDA) has scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss considerations for future COVID-19 vaccine booster doses. 

On April 6, the advisory committee intends to assist the Agency in developing a general framework that will inform its regulatory decision-making on updating the composition of COVID-19 vaccines to address variants, as well as the timing and populations for COVID-19 vaccine booster doses.

There will not be a vote at the meeting and there will not be any discussion of any product-specific applications.

“Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. 


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Pfizer and BioNTech have recently submitted a request to the FDA for Emergency Use Authorization (EUA) of an additional booster dose in adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

Moderna has also submitted an EUA request to the FDA for an additional booster dose of its COVID-19 vaccine in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

Reference

Coronavirus (COVID-19) Update: FDA to hold advisory committee meeting on COVID-19 vaccines to discuss future boosters. News release. March 21, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-hold-advisory-committee-meeting-covid-19-vaccines-discuss-future

Source: Medical Bag https://www.medicalbag.com/home/news/fda-panel-to-discuss-covid-19-vaccine-booster-doses-variants/

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