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The move comes close on the heels of Pfizer Inc applying for a similar authorisation of its coronavirus vaccine in India on Saturday. The company has applied to the Drugs Controller General of India (DCGI), with Poonawalla saying the vaccine will “save countless lives” without giving details. The experimental vaccine can be stored at two to eight degrees Celsius and can be distributed more easily in India, which has the world’s second-highest number of infections at 9.6 million.
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“As promised, before the end of 2020, has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,” the company CEO Adar Poonawalla tweeted on Monday. The company’s policy is to file to register vaccines wherever there is market potential, whether that entails supplying vaccines directly to governments, private parties or through UN agencies.New Delhi, India – The Serum Institute of India, the world’s largest vaccine producer by volume, has sought government approval for emergency-use authorisation of the coronavirus vaccine that it has developed in partnership with the University of Oxford and British drugmaker AstraZeneca. Serum Institute of India has a large vaccine portfolio, so this is a relatively good performance.
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The company’s stance on price confidentiality provisions is confidential.Ībove-average performance in filing for registration. Serum Institute of India files to register the majority (>50%) of its relevant vaccines in 30-50% of LICs and some lower-middle income countries. Unlike its peers, however, it does not publish even a general pricing strategy for vaccines. Pricing strategy not published. Like its peers, Serum Institute of India does not systematically publish all prices for its vaccines in all countries in scope. While Serum Institute of India has received support from partners for both vaccines, the company is an integral contributor, ensuring the supply of these vaccines. Serum Institute of India intends to sell its pneumococcal vaccine for USD 2 per dose to Gavi countries, if and when it is approved. Its meningococcal A vaccine (MenAfriVac®), developed for African markets by the Meningitis Vaccine Project, is offered at USD 0.64 per dose. General pricing strategy. Serum Institute of India has a general policy of making vaccines available at affordable prices and has shown evidence of proactively taking steps to ensure affordable prices in LICs and MICs. This will help the long-term sustainability of its vaccine business. It can also specify its pricing policy for governments that self-procure, explicitly stating how it takes these countries’ ability to pay into account and what other factors it considers when pricing its vaccines.Ĭontinue to engage in strong, adaptive R&D. Serum Institute of India can continue to develop its strong and unique R&D model, which focuses on developing vaccines with characteristics aimed at improving access in LICs and MICs. Effective and transparent processes (including making information publicly available, where appropriate) will support stakeholders’ planning and contribute to the sustainability of the company’s business.ĭevelop and publish a pricing strategy for vaccines. Like peers, Serum Institute of India can publish what its pricing strategy is for Gavi and PAHO countries, as well as countries that procure through UNICEF. Strengthen its processes for aligning supply and demand. Serum Institute of India can develop – and share with stakeholders – clear and structured processes for aligning supply of their vaccines with global demand.