- For immediate release:
The US Food and Drug Administration scheduled a meeting of its Vaccine and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021, to discuss Janssen’s application for emergency use authorization (USA) for a COVID-19 vaccine. Biotech Inc.
“A public discussion by members of the advisory committee on data presented in support of the safety and efficacy of the COVID-19 vaccine from Janssen Biotech Inc. will help ensure that the public has a clear understanding of the scientific data and information that the FDA will evaluate the in order to make a decision on whether to authorize this vaccine, “said FDA Acting Commissioner Janet Woodcock, MD.” The FDA remains committed to keeping the public informed about our assessment of data for COVID-19 vaccines so that the American public and medical community have confidence and safety in vaccines authorized by the FDA. “
The FDA intends to make supporting materials available to the public, including the meeting agenda and committee list, no later than two business days before the meeting. In general, advisory committees include a chairperson, members with scientific and public health experience and a representative from the consumer and industry. Additional members with specific experience can be added for individual meetings as needed.
VRBPAC members are independent, scientific and public health experts from across the country who advise the agency, which may include advice on safety and efficacy data presented in the EUA application. However, the final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
In terms of time to convene the VRBPAC meeting after the submission of the US application, this period of time will allow the FDA to fully assess the data and information presented in the US application prior to the meeting and be prepared for a robust public discussion with members of the advisory committee.
While the FDA cannot predict how long it will take for its ongoing assessment of data and manufacturing information after the VRBPAC meeting to make a decision on the US order, the agency will review the order as soon as possible, taking into account the discussion by the advisory committee, while doing so in a complete and scientifically based manner.
The FDA intends to issue a notice from the Federal Register as soon as possible with the details of the meeting, which will include information on a public protocol for comments. At that time, public comments can be sent. These comments will be reviewed by the FDA.
The FDA intends to broadcast the VRBPAC meeting live on the agency’s YouTube, Facebook and Twitter channels; the meeting will also be broadcast over the Web from the FDA website.
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security and protection of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.
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