Suspension of supply of vaccines manufactured by BB-NCIPD, Bulgaria and distributed by Intervax
WHO was informed on 18 March 2011 of a quality complaint concerning lot no. D2076 of Td (tetanus-adult diphtheria vaccine) produced at BB-NCIPD, Ltd, Sofia, Bulgaria and distributed by Intervax. The complaint related to the presence of a foreign object (metal nut) in a vial of the batch supplied to Peru through the Revolving Fund of the Pan American Health Organization. No other complaints regarding this lot, other lots of Td, or other vaccines produced at the facility have been received.
WHO recommends that Td vaccine lot no. 2076 be recalled and destroyed by the manufacturer.
The quality problem is not considered to have affected immunogenicity of the Td vaccine. Therefore, there is no need for revaccination of persons who have already been administered this vaccine manufactured by BB-NCIPD.
WHO does not recommend recall of lots of Td other than no. 2076, or other WHO prequalified vaccines manufactured by BB-NCIPD [Tetatox (Tetanus vaccine (adsorbed); DIFTET -Adsobed Tetanus-Diphtheria vaccine (paediatric) and BCG vaccine]. This recommendation is based on an assessment of the nature of the complaint and the initial assessment of the probable impact on other lots of vaccines produced in the same facilities. Lots of the above-mentioned vaccines (other than Td lot 2076) already supplied are considered acceptable for use.
However, as a precautionary measure, WHO recommends the suspension of further supply through UN procurement agencies of all BB-NCIPD vaccines pending: 1) satisfactory completion of the complaint investigation by the manufacturer; and 2) implementation of actions to address: a) any deficiencies identified during the investigation; and b) the findings of the most recent audits of the manufacturing site by WHO and the Bulgarian Drug Agency.
The appropriate authorities of countries using vaccines produced by BB-NCIPD, Ltd which have not been supplied through UN agencies are encouraged to make their own benefit-risk evaluations when considering further supply of vaccines from BB-NCIPD, Ltd.