Pharmabiz
 

PATH organises global workshop to develop International Reference Standard to evaluate sIPV

Our Bureau, BengaluruWednesday, July 11, 2018, 17:46 Hrs  [IST]

PATH, with a grant supported by Gates Foundation, organised the first global workshop to develop an International Reference Standard and Reagents to evaluate Sabin Inactivated Polio Vaccine (sIPV). The event is being held in Hyderabad on July 11 and 12, 2018.

The two day workshop is aimed to discuss and finalise the candidate for International Reference Standard for sIPV. It included participation from polio vaccine manufacturers from different countries including India, and WHO, PATH, NIBSC, US FDA, Bill and Melinda Gates Foundation and regulatory agencies from Japan, Korea and other countries.

Dr. Kutub Mahmood and Dr. Fred Cassell from PATH , Dr. Martin Eisenhawer, Tiequn Zhou of WHO, Shanda Boyle –BMGF, Phil Minor –NIBSC –England, Dr. Harshavardhan from Bharat Biotech spoke about the road map for establishing the International Reference Standard for sIPV.

While the experts mentioned that there 2 licensed products currently available from China and Japan, there is a need for additional manufacturers for IPV, with more than 12 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.

Further the experts also highlighted the need for GAP III containment facilities for the manufacturers of polio vaccines, including sIPV.

It was indicated around 230 million doses of sIPV at affordable price would be required annually for global vaccination. With regard to the development of sIPV in India, currently Panacea Biotech and Bharat Biotech are in various stages of development.

Dr. 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.

Bharat Biotech played its part to help bring this workshop to Hyderabad. The city was chosen for the global workshop for being a prominent vaccine manufacturing hub in India and its contribution towards the eradication of polio and vaccine supplies for India, emerging world and International Agencies.

PATH convened key global partners, including the polio vaccine manufacturers in India and abroad, NIBSC, US FDA, Gates Foundation, and the WHO to discuss findings from a recently completed global collaborative study on developing sIPV. The organisers said that meeting would lead to consensus around the IS, and lay forward the next steps towards determining country’s regulatory implications and licensure pathways for the Sabin IPV vaccine.

 
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