Essential Regulatory Laboratory Activities
CBER is an Essential Regulatory Laboratory (ERL) in WHO’s Global Influenza Surveillance and Response System (GISRS). In collaboration with regulatory authorities in the United Kingdom, Australia, and Japan, CBER experts contribute to the following activities each year for manufacture of influenza vaccines:
- Strain selection for seasonal influenza vaccine development and production
- Perform serological studies and share results to identify suitable influenza virus strains to include in seasonal influenza vaccines
- Analyze influenza virus isolates and prepare virus stocks of candidate strains for use by manufacturers for influenza vaccine production
- Contribute to the production and calibration of reagents needed for use in the SRID influenza vaccine potency assay
- Provide these reagents to vaccine manufacturers and the global community, as needed.
CBER fulfils these functions each year for seasonal influenza vaccines. CBER also made a commitment to serve as an ERL in WHO’s Pandemic Influenza Preparedness Framework, formalizing CBER’s role to carry out ERL functions in the case of a pandemic. CBER plays an essential role in ensuring availability of seasonal influenza vaccines, and national and global preparedness to respond in a timely manner to pandemic influenza threats.