The World Health Organization (WHO) has removed three combination vaccines of Panacea Biotech from its pre-qualification list.
It took the step after it found deficiencies in the quality management system followed in Panacea’s vaccine manufacturing facility in Punjab.
Shipments of these vaccines – combinations of diphtheria, pertussis, tetanus, Hepatitis B and Hib B vaccines – has been asked to be put on hold until a final decision on the acceptability for United Nations supply has been made by a WHO-convened ad hoc committee. This committee, once constituted, will review the present findings of the audit team. Panacea’s vaccine buyers — UNICEF and the Pan American Health Organization — supply such pre-qualified vaccines to the developing countries.
The company did not give an estimate of the revenue loss expected from the delay in supplies. Panacea’s Easyfive (DTwP-Hep B-Hib), Ecovac4 (DTwP-Hep B), and EnivacHB (Hepatitis B) are the vaccine brands that are under the WHO scanner.
The WHO site audit took place from June 27 - July 1.
In a similar situation a year ago, WHO had suspended pre-qualification granted to a pentavalent vaccine manufactured by Shanta Biotechnics. Despite corrective measures, the company is yet to be qualified for the supplies to international markets.
Panacea’s main revenue earner — oral polio vaccine (OPV) — will continue to be accepted by the WHO. The WHO committee has recommends the continued supply of the OPV vaccines supplied by the company, given that the formulation and filling of the OPV vaccines are carried out at a New Delhi site, where there is no evidence available to WHO of inadequate quality assurance.
An audit by a WHO team of the New Delhi site is scheduled for the coming weeks.
Since there is no evidence of quality or safety defects, batches of these vaccines already distributed to countries will not be recalled and will continue to be used.
In a statement, Panacea said the company has already initiated corrective measures and area confident of completing the process soon.
