- For Immediate Release:
The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research
“Vaccines continue to be an important public health measure in fighting the COVID-19 pandemic. To date, the FDA has authorized three COVID-19 vaccines for emergency use that have met our rigorous standards for quality, safety, and effectiveness – two are authorized for individuals 18 and older, and one is authorized for individuals 16 and older.
We recognize that the next critical step is having vaccines available for use throughout the pediatric population.
As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range.”
- The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) will convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 10, 2021, via webcast.
- During the meeting the agency will provide a status update on our approach to emergency use authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age. The committee will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age. The committee will not discuss any specific products.
- The FDA intends to issue a Federal Register notice as soon as possible with details of the meeting, which will include information about the availability of a public docket for comments. At that time, public comments can be submitted for consideration by the committee and FDA.
- The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.
- In general, advisory committees include a Chair, members with scientific, medical and public health expertise, and a consumer and industry representative. Additional experts with specific expertise may be added for individual meetings as needed.
- The FDA intends to livestream the VRBPAC meeting on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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