Home >News >India >Hetero to manufacture Sputnik V

Hetero Biopharma Ltd has agreed to contract manufacture more than 100 million doses every year of Russia’s Sputnik V vaccine against covid-19 in India.

Under an agreement with Russian Direct Investment Fund (RDIF), Hetero will start producing the vaccine from early next year, the sovereign wealth fund said in a statement on Friday.

This is the second partnership with an Indian company for RDIF, which has been backing and marketing the Sputnik V vaccine globally.

The fund has a pact with Dr Reddy’s Laboratories Ltd for sales and distribution of up to 100 million doses of the vaccine after successful completion of clinical trials and approval from the Drug Controller General of India.

“While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients," said B. Murali Krishna Reddy, director of international marketing at Hetero, according to the statement.

A spokesperson for Hetero said the vaccine will be produced at its biopharmaceutical facility in Hyderabad where it is based as the company currently does not have a dedicated vaccine manufacturing facility.

Hetero is likely to manufacture the vaccine primarily for the Indian market, but will not have distribution rights, the spokesperson said.

“The agreement is open-ended, and the issue of exports will be discussed at a later stage," the spokesperson said.

RDIF did not say whether the vaccines produced in India will be exported.

Dr Reddy’s will soon start phase 2 and 3 clinical trials of the vaccine with 100 participants for phase 2 and 1,400 for the last stage. The company expects to complete the trials earliest by March, with regulatory approvals and launch likely in the following month, subject to success in the trials.

With no domestic production of the vaccine, the company had procured the doses from RDIF earlier this month.

RDIF on Tuesday said its second interim results of the vaccine trial showed that Sputnik V is 91.4% effective in protecting people from covid-19. The second interim results, involving 18,794 participants from Russia, were revealed a week after they were administered the second dose.

The efficacy rate this time is marginally lower than the 92% calculated in the first interim analysis. The second dose of Sputnik V was administered 21 days after the first dose.

RDIF plans to price the Sputnik V vaccine for international markets at less than $10 per dose, or roughly 740. The price of the two-dose vaccine, co-developed with Gamaleya National Center of Epidemiology and Microbiology, will make the shots much cheaper than the messenger RNA vaccine candidates of American firms Pfizer and Moderna.

Meanwhile, Pune-based Serum Institute, the world’s largest vaccine maker by volume, may sell Covishield, the covid-19 vaccine being developed by the University of Oxford and AstraZeneca Plc, for around 500-600 per dose in the private market, more than twice the $3 (around 222) per shot it will cost the government, chief executive officer Adar Poonawalla had said on 19 November.

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