Coronavirus Vaccine Safety To Be Discussed By FDA Advisory Committee In October

An FDA committee of independent expert advisors will meet late next month, to review and discuss scientific data about the best path forward in developing and releasing a safe and effective COVID-19 vaccine.

The U.S. Food and Drug Administration (FDA) announced the COVID-19 vaccine meeting in the Federal Register on August 27, indicating a public webcast will be held on October 22 to address the clinical development and data needed to pursue authorization and licensure of a vaccine for the novel coronavirus.

Officials from the U.S Department of Health and Human Services, along with medical experts from the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the Center for Biologics Evaluation and Research’s (CBER), will make presentations at the meeting.

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The meeting comes as some COVID-19 vaccines begin to move into Phase III clinical trials, but at least one drug maker had to pause a trial after an unexplained illness was reported. However, the committee will not be reviewing any specific vaccine application or product, according to the agency.

The FDA will post relevant meeting materials on the Vaccines and Related Biological Products Advisory Committee meetings main page, which will include audio and slide presentations for viewers to follow along.

Acting FDA Commissioner Stephen Hann, MD recently released a statement emphasizing that coronavirus vaccine and therapeutic decisions made by the agency will be based strictly on scientific driven data, as concerns mount that political pressure may be exerted on the agency to make a vaccine available before the U.S. elections this fall.

Currently, the COVID-19 outbreak has infected more than 6.3 million people in the U.S. in the United States resulting in more than 190,000 fatalities.


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