During 2020 Influenza vaccines and the adjuvant MF59 were manufactured at this facility: three distinct products for the market, Agrippal®, Fluad® and Fluad QIV®, (seasonal influenza strain presentations, the latter two formulated with MF59 adjuvant).
Northern Hemisphere Influenza vaccine: Cultivation of egg adapted influenza viruses. Four strains are incorporated within the vaccine (Quadrivalent), trade name Fluad QIV®. Three strains are incorporated within the vaccine (Trivalent), trade name Agrippal® or Fluad®.
Southern Hemisphere Influenza vaccine: Cultivation of egg adapted influenza viruses. Four strains are incorporated within the vaccine (Quadrivalent), trade name Fluad QIV®.
Cultivation in eggs of attenuated influenza strains produced by either ‘Reverse Genetics’ or classical reassortant techniques. For seasonal strains, the work was undertaken at containment biosafety level 2 with classically reassorted strains or wild type B/Stains are typically utilised. Strains produced via reverse genetics can be utilised as seasonal component but this is not required routinely.
Attenuated influenza virus strains in reverse genetic form are designated as GMOs and an appropriate manufacturing licence (GM consent) has been granted from the UK Competent Authority. IAPO (Importation of Animal Pathogens Order 1980) does not apply to these strains due to attenuation at the genetic level. Vaccines candidate strains generated via reverse genetics are typically used for pre-pandemic, pandemic strain manufacture and are produced under biosafety level 2 enhanced controls.
Note: The manufacturing facility in Liverpool manufactures the bulk influenza vaccine in site 4 with eggs supplied from site 6. The formulation of the final bulk vaccine is also now carried out in site 4. The fill finish operations to manufacture individual influenza vaccine doses occurs at two contractor facilities, one based in Belgium and the other based in Spain as well as in the Seqirus facility in Holly Springs, North Carolina, US.