India on Monday approved Russia’s Sputnik V Covid vaccine for production and use in the country. It would be the third Covid-19 vaccine approved in India, after AsztraZeneca’s Covishield being produced at the Pune-based Serum Institute of India, and Hyderabad-based Bharat Biotech’s home-grown Covaxin developed in partnership with the Indian Council of Medical Research.
The approval by the government’s Subject Expert Committee (SEC) comes amid an acute shortage of vaccines worldwide and as India faces a surge in Covid-19 cases. India's drugs regulator will give the final go-ahead for the Sputnik V rollout but after the SEC clearance this is now a mere formality. It also follow a recent visit by Russian foreign minister Sergey Lavrov, where production of Sputnik V was discussed.
Dr Reddy's Laboratories had last week sought the government's approval for the vaccine to be used in India. The Russian Direct Investment Fund (RDIF) partnered with Dr Reddy's in September 2020 to conduct clinical trials of Sputnik V in India.
The Russian vaccine, developed by Moscow’s Gamaleya Institute has an efficacy of 91.6% based on the interim analysis of phase III clinical trials, which included data from 19,866 volunteers in Russia and also carried out Phase III clinical trials in the UAE, India, Venezuela and Belarus, according to the Sputnik-V website.
The Sputnik V vaccine has already been approved for use in more than 50 countries and as many as 3.5 million of its shots have been administered in Russia.
The issue of expediting approvals for the production and distribution of the Sputnik V vaccine had figured at the talks between India’s foreign minister S. Jaishankar and his Russian counterpart Sergey Lavrov in Delhi on April 6.
India to be major hub for Sputnik V
India is poised to become a major hub for producing the Sputnik V vaccine with five Indian companies having signed agreements for the production of the vaccine. The total capacity works out to around 950 million doses a year.
Panacea Biotec was the fifth Indian company in the run-up to the Russian foreign minister’s visit to sign an agreement for producing 100 million doses of the Sputnik V vaccine. Three other Indian companies have signed agreements in recent weeks to roll out the vaccine. These include Virchow Biotech and Stelis Biopharma for 200 million doses each and for Gland Pharma for the manufacture of 252 million shots annually.
Sputnik-V claims is an affordable vaccine and can be "stored at a temperature of +2 to +8°C " in its solid form. It says that these aspects of Sputnik-V allows for easy distribution of the vaccine in hard-to-reach regions across the globe.
More vaccines in pipeline
The other vaccines that are expected to be approved in the coming months are Johnson and Johnson, Novavax, Cadila Zydus and a nasal vaccine by Bharat Biotech. Cadila Zydus and Bharat Biotech are the two new indigenous vaccines in the pipeline while the other two are in partnership with US pharma giants.
Novavax and Johson & Johnson are two other vaccines that are on the fast track and have the backing of the Indo-Pacific Quad agreement for production in India. J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine while US pharma giant Novavax has an agreement with Serum Institute of India.
US pharma giant Johnson & Johnson is in talks with the Indian government to start clinical trials of its single-dose COVID-19 vaccine in the country, the company said on Friday.
The J&J vaccine has been approved for use in the United States, the European Union and other nations including Thailand and South Africa. The norms in India also require such companies to carry out local trials to prove their safety and efficacy of their vaccines before they can be approved for use.
