Hyderabad: Vaccine manufacturers, representatives of World Health Organisation (WHO) and regulatory agencies from various countries on Wednesday began discussion to develop an international reference standard and reagents to evaluate Sabin Inactivated Polio Vaccine (sIPV).
The two-day first global workshop to discuss and finalise the candidate for international reference standard for sIPV is being organised here by Programme for Appropriate Technology in Health (PATH) with support from Gates Foundation.
Vaccine manufacturers from various countries, and 35 agencies including WHO, PATH, National Institute for Biological Standards and Control (NIBSC), Britain, US Food and Drug Administration (USFDA), Bill and Melinda Gates Foundation (BMGF) were attending the workshop.
Kutub Mahmood, Scientific Director, PATH told reporters that during the workshop, they hope to have a consensus on global standard for sIPV.
Fred Cassell from PATH, Martin Eisenhawer and Tiequn Zhou from WHO, Shanda Boyle from BMGF, Phil Minor from NIBSC and Harshavardhan from Bharat Biotech spoke about the roadmap for this global collaborative effort aimed at developing an affordable and efficacious polio vaccine.
While the experts mentioned that there 2 licensed products currently available from China and Japan, there is a need for additional manufacturers to meet the demand for sIPV to assist in the vaccine supplies for global eradication of Poliomyelitis.
With successful global polio eradication in near future, immunization with oral polio vaccine will be discontinued. The experts say sIPV will have higher efficacy than oral vaccine.
They said this help overcome problems in north Indian states like Uttar Pradesh where children are being given dozens of oral polio vaccines. They believe that 2-3 doses of sIPV will be sufficient.
It was indicated around 230 million doses of sIPV at affordable price would be required annually for global vaccination.
The experts also highlighted the need for GAP III containment facilities for the manufacturers of polio vaccines, including sIPV.
Kutub said 18 manufacturers around the world including two from India were engaged in development of sIPV. Panacea Biotech and Bharat Biotech of India are in various stages of development.
Martin Eisenhawer of WHO stated that they would engage with national regulatory authorities with reference to manufacture and control of sIPV.
The proceeding of the workshop will be submitted to the WHO – Expert Committee for Biological Standardization for further deliberations and endorsement of the international standard for sIPV.
Hyderabad-based Bharat Biotech played its part in bringing this workshop here. The city was chosen for being a prominent vaccine manufacturing hub in India and its contribution towards the eradication of polio and other vaccine supplies for India, other developing countries and international agencies.