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More than 12 manufacturers needed to meet sIPV demand for global eradication of Poliomyelitis: Experts

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Hyderabad | Wednesday, Jul 11 2018 IST
The experts at the sidelines of the 2-day First Global Workshop to develop International Reference Standard for Sabin Inactivated Polio Vaccine (sIPV) being organised by PATH ( Program for Appropriate Technology in Health) with the support of Gates Foundation, which began here on Wednesday stressed the need of more than 12 manufacturers to meet the demand for sIPV to assist in the vaccine supplies for Global eradication of Poliomyelitis.

Addressing the media, Dr. Kutub Mahmood and Dr. Fred Cassell from PATH , Dr. Martin Eisenhawer, Tiequn Zhou of WHO, Shanda Boyle BMGF, Phil Minor NIBSC (National Institute for Biological Standards and Control) England, Dr. Harshavardhan from Bharat Biotech (Hyderabad) , spoke about the road map for establishing the International Reference Standard for sIPV.

There are 2 licensed products currently available from China and Japan, they mentioned and said that 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, the experts told reporters.

They also highlighted the need for GAP III (Global Polio Eradication) containment facilities for the manufacturers of polio vaccines, including sIPV.

They 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 from World Health Organisation (WHO) stated that they would engage with National Regulatory Authorities with reference to manufacture and control of sIPV.

Dr. Kutub Mahmood and Dr. Fred Cassel said the two-day Global Workshop to develop an International Reference Standard and Reagents to evaluate Sabin Inactivated Polio Vaccine (sIPV) .

It is aimed to discuss and finalise the candidate for International Reference Standard for sIPV, they said the workshop 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.

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., they informed and said Hyderabad-based 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, they said.

PATH convened key global partners, including the polio vaccine manufacturers in India and abroad, NIBSC, US FDA, Gates Foundation, and the World Health Organization (WHO) to discuss findings from a recently completed global collaborative study on developing an International Standard (IS) for the Sabin inactivated polio vaccine (sIPV) , a step forward toward securing global polio vaccine supplies during the current and post-polio eradication period.

This meeting will 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.

UNI KNR RJ 2246

-- (UNI) -- C-1-1-DL0098-1435182.Xml

 
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