New Filings At The EMA

The new Advisory Committee on Immunization Practices members endorsed Merck & Co.’s monoclonal antibody for RSV prevention, but some questioned its use in healthy babies and potential interactions with vaccines given at the same time.

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.

Sen. Bill Cassidy and HHS Secretary Robert F. Kennedy Jr. agree the disbanding of ACIP did not violate their agreement, but the perception that Kennedy is not following the spirit of the pledge could be more important long-term.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.