When a senior technical team from Russia’s health ministry descended on Hyderabad in November 2020, nobody knew that it was breaking an emerging oligopoly in the Indian market, quietly but decisively. The manufacturing of the Covid-19 vaccine wasn’t meant to be restricted to a few.

After auditing several facilities across the country, the Russian team chose three companies from Hyderabad, to undertake clinical trials for its Covid-19 vaccine, Sputnik V, in India and contract-manufacture the vaccine—Dr Reddy’s Laboratories (DRL), Hetero Biopharma, and Virchow Biotech.

The Russian Direct Investment Fund (RDIF), a sovereign wealth fund, which funded the vaccine development, hopes to source at least 300 million doses from India, the world’s largest vaccine producer. Sputnik V was developed by the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, with the backing of RDIF. Registered by the Russian Ministry of Health in August 2020, Sputnik V is the world’s first registered Covid-19 vaccine.

The Russian team audited several manufacturing facilities in the country, before signing up with the three Hyderabad-based companies.

An official close to the Sputnik V vaccine contract-manufacturing process in India says most of the vaccine Russia wants to source from India will be manufactured in Hyderabad. “Vaccines are already getting ready for export,” he says.

Along with Hyderabad-based Bharat Biotech International Ltd (BBIL), which has already rolled out the indigenously developed Covaxin, a clutch of pharma/vaccine companies are clearly making Hyderabad the vaccine capital of India.

“Hyderabad is a hub of pharmaceutical manufacturing. It has inherent installed capacity available in abundance. It is only extending the available platforms to manufacture the new vaccines,” says Dr Hemanth Nandigala, managing director of Virchow Biotech.

A Hyderabad-based industry official says Virchow has also signed a binding agreement to manufacture Sputnik V. It recently expanded the annual capacity to above 100 million doses.

Nandigala, however, refused to talk about Virchow’s plans for Sputnik V, citing a non-disclosure agreement.

“Sputnik V is a two-dose vaccine, with the second dose being a booster shot. After the third phase of clinical trials in Russia, the Russian government has approved the vaccine for use. They are claiming over 90% efficacy rate,” says the industry official.

According to the official, the Russian institute has signed agreements for technology transfer with all Indian companies that are manufacturing the vaccine for them. Hetero Biopharma has signed a deal to manufacture more than 100 million doses of Sputnik V.

On January 15, DRL received approval from the Drugs Controller General of India (DCGI) for phase 3 of clinical trials of Sputnik V. DRL is likely to start the third phase before the end of the month. Apart from the deal for undertaking trials in the country, DRL has also signed a contract with RDIF for distributing the first 100 million doses in India.

Along with Hyderabad-based Bharat Biotech International Ltd (BBIL), which has already rolled out the indigenously developed Covaxin, a clutch of pharma/vaccine companies are clearly making Hyderabad the vaccine capital of India.

G.V. Prasad, DRL’s co-chairman and MD, had earlier described the launch of the clinical trials as a significant step as they continued to collaborate with multiple entities along with government bodies to fast-track the process for launching the vaccine in India. “We are working towards making the vaccine available with a combination of import and indigenous production model,” he had said in a statement as the company commenced adaptive phase 2 and 3 clinical trials in early December.

Around a week before DRL started the clinical trials in December, RDIF had said in a statement that their second interim analysis of clinical trial data, in Russia, showed 91.4% efficacy for the vaccine on Day 28 after the first dose; and efficacy of more than 95%, 42 days from the first dose.

Apart from Russia and India, Sputnik is exploring other markets such as Bolivia, Venezuela, China, Brazil, Turkey, the U.A.E., and Pakistan, said the industry official from Hyderabad.

G.S. Reddy, a city-based vaccine expert, says Hyderabad is centrally located and several companies have established their production lines in the city. “These companies are now expanding their capacities at a furious pace. The Hyderabad-based Aurobindo Pharma bought a city-based vaccine startup, Tergene Biotech, and entered the vaccine space. Similarly, Gland Pharma is expanding its facilities as well,” he says.

Aldon Fernandes, vice president, R&D Biologicals, at the Navi Mumbai-based Bharat Serums and Vaccines Ltd (BSVL), agrees. “Vaccine manufacturers in and around Hyderabad have suddenly sprung into action with foreign tie-ups for contract manufacturing,” he says.

Apart from Covaxin, BBIL is developing three more vaccines.

The first one is an intranasal vaccine, CoroFlu, being developed jointly with the University of Wisconsin-Madison and FluGen, a vaccine manufacturer. BBIL will get an exclusive sale arrangement in India while FluGen will take care of the other markets, including the U.S.

BBIL’s second vaccine candidate is being developed in association with Thomas Jefferson University of Philadelphia. Under the licence agreement, BBIL gains exclusive rights to develop, market, and deliver Jefferson’s vaccine across the world, excluding countries such as the U.S. and Japan, and Europe, where Jefferson continues to seek partners.

The third vaccine is being developed under a licensing agreement with Washington University School of Medicine in St. Louis.

BBIL is keeping the status of the three vaccines under wraps. The first one among the three, CoroFlu, was supposed to start trials by December 2020, but has not received the regulator’s nod so far.

“Covaxin production is going on in full swing at Hyderabad’s Genome Valley facility. The production capacity for the vaccine is expected to reach 700 million doses annually by June-July, up from 200 million now. Three more BSL-3 (biosafety level 3) facilities are being readied, of which one 100-million facility is coming up near the existing facility,” says an official close to the company.

The company began dispatches of Covaxin on January 13 via Hyderabad’s Rajiv Gandhi International Airport.

Covaxin, which received emergency use authorisation (EUA) approval on January 3, is being distributed across the country. The vaccine maker worked in close association with the National Institute of Virology (NIV) under the aegis of Indian Council of Medical Research (ICMR), the state-run medical research organisation, for the development and roll-out of the vaccine.

Meanwhile, Virchow Biotech, operating from Medchal on the outskirts of Hyderabad, is also developing a vaccine indigenously. “It is at a pre-clinical trial stage. It is being developed in association with the Biotechnology Industry Research Assistance Council (BIRAC) under the World Bank-funded National Biopharma Mission (NBM). The target is to make it conducive to room temperature, but it may end up as a vaccine that requires a 2°C-8°C environment,” says the Hyderabad-based industry official.

While Nandigala declined to give details about the indigenous vaccine being developed by Virchow, it doesn’t change the fact that Hyderabad is front and centre of Covid-19 vaccine development and manufacturing in India. No wonder it has emerged as India’s new vaccine capital.

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