Submit a Public Comment – By Jan 25, 2023 – Meeting of FDA Advisory Committee re Covid Vaccination
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⚠️CTA: Submit a public comment.⚠️ On Jan. 26, 2023, the FDA’s advisory committee on V—cine & Related Biological Products (VRBPAC) will meet to consider whether and how the composition for primary doses of the currently available C-19 v—cines should be modified and how and whether the composition and schedule for booster doses should be adjusted moving forward.
We encourage members of the public to submit a comment electronically or written to the VRBPAC. Comments must be submitted to the electronic filing system by 11:59 p.m. ET January 25, 2023.
SUBMIT PUBLIC COMMENT ELECTRONICALLY AT:
https://www.regulations.gov/commenton/FDA-2022-N-2810-0001
“At the upcoming January meeting, the agency is planning to examine the state of the pandemic, the evolution of variants and subvariants, and the available effectiveness, safety and immunogenicity data with the current monovalent and bivalent vaccines. The agency will also consider the potential composition of the current and next generation of COVID-19 vaccines for primary and booster immunization. There will also be presentations from manufacturers and the FDA summarizing the manufacturing considerations and timelines related to vaccine composition changes. Following the discussion and taking into account the advice provided by the VRBPAC at the meeting, the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.
FDA intends to make background material that includes the meeting agenda and committee roster, available to the public no later than 2 business days before the meeting.”
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