COVID-19 Vaccine Review Agenda Released
The draft agenda of the Advisory Committee on Immunization Practices (ACIP) initial meeting to review COVID-19 vaccine candidates was published on October 14, 2020.
The ACIP website states ‘The COVID-19 pandemic is changing rapidly and requires different strategies to maintain clinical preventive services, including immunization.’
The ACIP holds three meetings each year at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia to review scientific data and vote on vaccine recommendations.
This 3-day ACIP meeting has allocated Friday, October 30, 2020, for an all-day update from various groups, including the Vaccines and Related Biological Products Advisory Committee.
That morning session is scheduled to be followed by Post-licensure safety surveillance; End to end vaccine implementation; Modeling strategies for the initial allocation of SARS-CoV-2 vaccines; and Workgroup interpretation sessions.
Any interested person who wishes to make an oral public comment during an ACIP meeting should submit a request with the CDC before the meeting according to the instructions in the Federal Register Notice. Those who have not submitted a request before the meeting will only have an opportunity to speak as time permits or at the discretion of the Chair.
The ACIP Secretariat can be contacted at 1600 Clifton Road, N.E., Mailstop A27, Atlanta, GA 30329-4027 or [email protected].
Previously, the US Food and Drug Administration (FDA) issued new guidance on October 6, 2020, to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of a EUA for an investigational vaccine to prevent COVID-19.
And on August 28, 2020, FDA Commissioner Stephen M. Hahn, M.D., stated in a press release: “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible.”
“A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding the clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure.”
“It is critical for people to see the FDA’s expectations for data to support safety and effectiveness.”
“The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said Dr. Hahn.
PrecisionVaccinations publishes research-based vaccine development news.