CDC’s Advisory Committee on Immunization Practices votes 13-1 that these two groups be first in line for vaccination once FDA authorizes a vaccine and ACIP recommends it. Goal of vote is to guide health departments in placing vaccine orders.
The US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices made its position on the initial allocation of a COVID-19 vaccine official, as members voted 13-1 to recommend that health care personnel and residents of long-term care facilities be the first to be vaccinated.
The committee held an emergency meeting 1 December to take a vote on prioritizing these two groups. ACIP had met...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
