- For immediate release:
On February 26, 2021, the US Food and Drug Administration scheduled a meeting of its Advisory Committee on Vaccines and Related Biological Products (VRBPAC) to approve the request for authorization for emergency use (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. discuss. .
” A public discussion by the advisory committee members on the information submitted in support of the safety and effectiveness of Janssen Biotech Inc. COVID-19 vaccine, will help ensure that the public has a clear understanding of the scientific data and information that the FDA will evaluate. in order to decide whether to authorize this vaccine, “said acting FDA commissioner Janet Woodcock, MD. The FDA remains committed to keeping the public informed of our evaluation of the data for COVID-19 vaccines, so that the US public and medical community have confidence in FDA-approved vaccines. ”
The FDA intends to make background material available to the public no later than two business days before the meeting, including the agenda of the meeting and the committee. In general, advisory committees consist of a chairperson, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be required for individual meetings.
The members of the VRBPAC are independent, scientific and public health experts from across the country who provide advice to the Agency, which may provide advice on the safety and efficacy data submitted in the EUA request. However, final decisions on the approval of the emergency vaccine are made by the FDA.
In terms of timing for convening the VRBPAC meeting after the submission of the EUA request, the FDA will allow this time to thoroughly evaluate the data and information submitted before the meeting in the EUA request and be prepared for a solid public discussion with the advisory committee members.
While the FDA cannot predict how long the ongoing evaluation of the data and manufacturing information will take after the VRBPAC meeting to make a decision on the request for an EUA, the agency will review the request as soon as possible, taking into account of the discussion by the advisory committee, while still being done on a thorough and scientific basis.
The FDA intends to issue a notice to the Federal Registry as soon as possible with details of the meeting, which will include information on a public dossier for comment. At that point, public comment can be made. These comments will be reviewed by the FDA.
The FDA plans to stream the VRBPAC meeting live on the agency’s YouTube, Facebook and Twitter channels; the meeting is also broadcast from the FDA website.
The FDA, an agency within the U.S. 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 safety and security of food supply, cosmetics, nutritional supplements, products that emit electronic radiation and for the regulation of tobacco products in our country.
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