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Coronavirus COVID 19 Update FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID 19 Vaccines

☷Coronavirus COVID 19 Update FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID 19 Vaccines

Food and Drug Administration
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   For Immediate Release: April 29 , 2022 Today , the U . S . Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee ( VRBPAC ) in anticipation of complete submissions of emergency use authorization ( EUA ) requests in the coming months that have been publicly announced by COVID - 19 vaccine manufacturers . It is important to note that the dates below are tentative as none of the submissions are complete . The agency understands the urgency to authorize a vaccine for age ......groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data . Should any of the submissions be completed in a timely manner and the data support a clear path forward following our evaluation , the FDA will act quickly and anticipates convening the following VRBPAC meetings: On June 7 , FDA intends to convene VRBPAC to discuss an EUA request for a COVID - 19 vaccine manufactured by Novavax to prevent COVID - 19 in individuals 18 years of age and older . On June 8 , 21 and 22 , the FDA has held dates for the VRBPAC to meet to discuss updates to the Moderna and Pfizer - BioNTech EUAs for their COVID - 19 vaccines to include younger populations . As the sponsors complete their submissions and the FDA reviews that data and information , it will provide additional details on scheduling of the VRBPAC meetings to discuss each EUA request . On June 28 , the FDA plans to convene the VRBPAC to discuss whether the SARS - CoV - 2 strain composition of COVID - 19 vaccines should be modified , and if so , which strain ( s ) should be selected for Fall 2022 . This meeting is a follow - up to the April 6 VRBPAC meeting that discussed general considerations for future COVID - 19 vaccine booster doses and the strain composition of COVID - 19 vaccines to further meet public health needs . “As we continue to address the ongoing COVID - 19 pandemic , there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members , ” said Peter Marks , M . D . , Ph . D . , director of the Center for Biologics Evaluation and Research . “We are providing a tentative schedule for discussion of these submissions , as these meetings will cover a number of topics that are of great interest to the general public . The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID - 19 vaccines . We intend to move quickly with any authorizations that are appropriate once our work is completed . ”Once the meeting dates are finalized , the FDA intends to make background materials available to the public , including the meeting agenda and committee roster , no later than two business days before each meeting . The agency is also prepared to schedule additional VRBPAC meetings as needed should additional complete EUA requests be submitted that warrant discussion with the FDA’s advisors . In general , advisory committees include a Chair , members with scientific , medical and public health expertise and a consumer and industry representative . The FDA intends to livestream the VRBPAC meetings on the agency’s YouTube channel; the meetings will also be webcast from the FDA website .


29 April 2022 ( April 29 2022 )



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Coronavirus COVID 19 Update FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID 19 Vaccines
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