EMA Updates Flu Vaccination Recommendations
The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.
The European Medicines Agency announced on April 12, 2017 that it had issued an update on the recommendations for influenza flu strains that vaccine manufacturers should include in their vaccines for the autumn 2017 season. The updates were developed by the Ad hoc Influenza Working Group of the Biologics Working Party (BWP) and based on information provided by the World Health Organization.
A decision on a suitable A/Michigan/45/2015 (H1N1)pdm09-like virus strain for live, attenuated vaccines and the specific virus strains recommended are included in the recommendations. Marketing authorization holders should submit applications to change the composition of centrally authorized seasonal flu vaccines by June 12, 2017.
Source: EMA
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
