Vaccine maker Panacea Biotec has entered into a collaboration with thr Serum Institute of India to take the former's fully liquid six-in-one vaccine onto a global stage, said Rajesh Jain, Panacea's Joint Managing Director.

Towards this plan, Panacea had signed two long-term agreements with Serum Institute and its wholly-owned subsidiary Bilthovan Biologicals BV. The alliance allows Serum to make and sell the fully liquid Whole cell Pertussis (wP) and Salk-based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DtwP-HepB-Hib-IPV) developed and commercialised by Panacea Biotec, touted to be the first of its kind, a joint note said.

Serum will ensure supply of the IPV bulk to Panacea, an important constituent for the Hexavalent vaccine, from BBIO, a bioengineering and pharmaceutical company registered in Netherlands. BBIO has the IPV technology, earlier possessed by only three other global vaccine manufacturers, including Sanofi and GlaxoSmithKline, Jain said.

Panacea's vaccine is one of its kind to include, Jain said, as it is easily administerable. IT contains six important antigens to protect against six diseases — Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenza type B and Polio. The two companies have an existing alliance for the local market and the product is available in India at ₹2,200 per pre-filled doze. The latest agreements focus on a global roll-out, Jain explained, since both companies complied with the World Health Organisation's Current Good Manufacturing Practice norms. Panacea stock price closed on Thursday at ₹264, up 3 per cent on the BSE.

Production challenges

Jain points out that millions of children in developing countries with an annual birth of about 121 million will get access to this vaccine. Being locally developed under the “Made in India” programme, it received regulatory support including fast-track approvals, Jain told BusinessLine .

Referring to the global supply constraints of IPV, he said, production challenges involved the breakdown of manufacturing plants and inability to scale up to meet the global demand. Only 52 per cent of the projected supply had been delivered to UN agencies as a result of which 18 countries could not introduce IPV in their immunisation and 15 had interruptions out of 70 IPV eligible countries approved for GAVI ( Global Alliance for Vaccines & Immunisation) support, the companies said.

Pricing, volumes

In two years, the two vaccine makers plan to get the product into the Centre's National Immunization Program. Other developing countries are also on the radar through stakeholders including governments, World Health Organization, GAVI, Bill and Melinda Gates Foundation (BMGF) and other United Nation Agencies, the companies said. Its pricing will be depend on bilateral discussions, volumes and so on, he said, adding they were flexible.

WHO prequalified IPV is essential to eradicating polio across the globe, and the effort has already cost $20 billion worldwide. There is a Global Polio Eradication Initiative (GPEI) in place and GAVI has been supporting the programme since 2013 having allocated $430 million till 2018 with an additional donor pledge of $23 million for 2019. At present, GAVI is evaluating IPV under Vaccine Investment Strategy for Global Public Good, the note said.

Global demand of IPV/ IPV containing vaccines is estimated to rise from about 100 million in 2020 when supply constraints remain, to 250-350 million doses every year starting 2022, depending upon a two or three dose schedule. The Strategic Advisory Group of Experts (SAGE) on Immunization in April 2017 had recommended at least two doses of IPV in the routine immunisation schedule of countries post withdrawal of the oral polio vaccine.

Adar C Poonawalla, Serum Chief Executive and Executive Director, said that the deal was “historic” since two Indian vaccine companies were collaborating to address unmet needs of both private and the public market globally. With the convenience of ‘Six in one’ it has potential of over 250 million doses in about four years with a market size of over $1.25 billion annually, he said.

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