The influenza vaccine licensing process.
Influenza vaccines are unique because they require a licensing process which includes a procedure for rapid annual updates to vaccine strains. The licensing procedures in the European Union and the USA are described as examples. In the event of an influenza pandemic, vaccines will be required urgently and licensing process should reflect such needs.
Wood
J M
JM
National Institute for Biological Standards and Control, Blanche Lane, South Mimms, EN6 3QG, Hertfordshire, Potters Bar, UK. jwood@nibsc.ac.uk
Levandowski
R A
RA
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D007252:Influenza Vaccines; D014481:United States
D007252:Influenza Vaccines