Hyderabad: The world to a large extent has controlled the incidence of polio. While India has become a polio-free nation, countries such as Pakistan and Afghanistan are still struggling with about 12 cases reported this year. Nigeria which has been declared polio-free has seen resurfacing of polio cases.
Vaccination is moving from oral to Sabin Inactivated Polio Vaccine (sIPV), which is administered in the form of an injection. Around 230 million doses of sIPV would be required annually for global vaccination, as per industry estimates. Realising the need for adequate supply of vaccine, Hyderabad-based Bharat Biotech has begun its development of a vaccine.
Bahrat Biotech International Viral Vaccines and International Affairs director, Dr GVJA Harshavardhan, told Telangana Today, “We have started working on the type 1 and type 3 virus. We are developing a containment facility to deal with type II virus, which will be ready by the end of 2018. Then we will be carrying out different stages of clinical trials on the vaccine to tackle type 2 cases.”
Explaining the importance of sIPV, the vaccine lessened the severity of the viruses. To eradicate polio, the oral vaccine is not recommended now and the world is switching to inactivated vaccine. Bharat Biotech is looking at combination vaccines inclusive of the sIPV. If the regulatory system works on a fast track, the vaccine could be ready by 2023-24, he informed.
Several vaccine makers which are marking pentavalent vaccines are keen to include sIPV in their product portfolio. This is expected to bring down the price of vaccine significantly.
He added, “There are good volumes and India has a high birth cohort, which makes it viable for companies to develop new vaccines. As countries will look at stockpiling to be prepared for any endemic outbreak, companies like us will create capacities to meet such situation.”
In addition to Bharat Biotech, Indian Immunologicals and Panacea Biotech are also in various stages of vaccine development.
Industry to create standard for sIPV
The first Global Workshop to develop an International Reference Standard and Reagents to evaluate Sabin Inactivated Polio Vaccine (sIPV) is being held in Hyderabad on 11th and 12th July. The workshop is being organised by PATH with a grant supported by Gates Foundation.
The two-day global workshop is aimed to discuss and finalise the candidate for International Reference Standard for sIPV. 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.
Dr Kutub Mahmood and Dr Fred Cassell from PATH, Dr. Martin Eisenhawer, Tiequn Zhou of WHO, Shanda Boyle of BMGF, Phil Minor of 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 are two 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, immunisation with Oral Polio Vaccine will be discontinued.
They also highlighted the need for GAP III containment facilities for the manufacturers of polio vaccines, including sIPV. 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.
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.