Panacea Biotec “Easyfive” pentavalent vaccine loses WHO prequalification

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De-listing by the World Health Organization prompts halt in procurement for GAVI-eligible countries but immediate supply disruption not expected

Geneva, 17 August 2011 – GAVI Alliance partners do not expect any major disruption in 2011 to supplies of pentavalent vaccines following today’s announcement  by the World Health Organization (WHO) that it has delisted “Easyfive,” a pentavalent vaccine produced by Panacea Biotec.

This means that UN agencies, including UNICEF which procures vaccines on behalf of the GAVI Alliance, will stop procurement of pentavalent vaccines produced by Panacea until the manufacturer has implemented appropriate corrective measures.

The delisting follows a routine audit by WHO in June of one of the company’s manufacturing sites which highlighted “serious inadequacies in quality assurance processes”.

These inadequacies included “inadequate design of the quality assurance system, including inadequate record-keeping and archiving of reference materials; testing deficiencies; and insufficient responsibility for quality assurance taken at various levels of the company”.

WHO-contracted laboratories have tested batches of the Panacea vaccines supplied through the UN system and found no quality or safety defects. WHO advises that if immunisation is withheld, however, there is a real risk of death or morbidity from the diseases against which the vaccines protect. Therefore, WHO recommends that batches of these vaccines already distributed to countries should not be recalled and should continue to be used.

Before the delisting, Panacea was one of four vaccine makers supplying GAVI-supported countries with the pentavalent vaccine, a life-saving vaccine that protects against five deadly diseases – diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (Hib).

GAVI Alliance partner UNICEF confirmed that it has secured sufficient availability from other suppliers to fill the immediate supply gap and is discussing strategies to ensure sufficient long-term supply.

All GAVI-supported vaccines purchased through the UN system must be pre-qualified by WHO as safe, effective, and relevant to the target population. Process for WHO pre-qualification includes a review of the general production process and quality control procedures, testing of the consistency of lots, and a site audit of manufacturing facilities.

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