The role of sodium bisulfite in the 1996-1997 USA influenza vaccine recall.
During the 1996-1997 influenza season, all the lots of influenza vaccine manufactured by Parke-Davis were recalled. This voluntary recall by the manufacturer was prompted by the finding of decreasing potency of the A/Nanchang/933/95 (H3N2) component of the vaccine. The primary cause of this lowered potency has been identified as primarily due to the presence of sodium bisulfite which was used to neutralize residual formaldehyde which in turn is used to inactivate the live influenza vaccine strains. This paper reviews these events and what we have learned.
Poland
G A
GA
Mayo Clinic and Foundation, Mayo Vaccine Research Group, Rochester, Minnesota 55905, USA. poland.gregory@mayo.edu
D004340:Drug Contamination; D006801:Humans; D007252:Influenza Vaccines / Q000592:standards*; D013447:Sulfites / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
D007252:Influenza Vaccines; D013447:Sulfites; C009279:sodium bisulfite