The Union health ministry on Thursday said the Covid-19 vaccine developed by Russia’s Gamaleya National Center will be available in Indian markets from next week.
Sputnik V is the third Covid-19 vaccine to receive emergency-use authorisation in India after the Serum Institute’s Covishield and Bharat Biotech’s Covaxin.
NITI Aayog member Dr VK Paul said the local production of Sputnik V will begin in July. Hyderabad-based Dr Reddy’s Laboratories will manufacture the vaccine in India. In September 2020, Dr Reddy’s and the Russian Direct Investment Fund entered into a partnership to conduct clinical trials of Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, and the rights for distribution of first 10 crore doses in India.
The Russian Direct Investment Fund also has contracts with other Indian firms, including Gland Pharma and Hetero Biopharma, to produce doses of the vaccine. The Russian Direct Investment Fund, Russia’s sovereign wealth fund, has said that more than 85 crore doses of the Sputnik V vaccine will be produced in India annually.
Sputnik V had shown a 91.6% efficacy in late-stage trials, according to results published in February. No serious adverse events were found to be linked with the vaccination. However, the trial did not include efficacy data of the vaccine for new variants of the coronavirus.
The vaccine is administered in two doses separated by 21 days and requires a minus 18-20 degree Celsius cold chain to remain stable. Efforts are underway to develop a freeze dried version of the shot, which will stay stable in the 2 to 8 degrees Celsius temperature range.
WHO-approved vaccine can come to India: Centre
The Centre on Thursday once again said that any vaccine approved by the United States’ Food and Drug Administration and the World Health Organization can come to India. Last month, the Centre had fast-tracked emergency approvals for foreign vaccines amid a surge in cases.
“Import license will be granted within 1-2 days,” said Paul. “No import license is pending,”
He added that the department of biotechnology and the Ministry of External Affairs were in touch with vaccine manufacturers like Pfizer, Moderna and Johnson & Johnson. “They were officially asked if they’d like to send doses to or manufacture in India,” said the NITI Aayog member. “The government told them that it will find partners and assist them. They said that they are working in their own way and they would talk of vaccine availability in Q3, in 2021.”
He said that 216 crore doses of vaccines will be manufactured in India between August and December. “There should be no doubt, vaccine will be available for all as we move forward,” said Paul. He added that India has so far administered 18 crore doses of Covid vaccine.
Paul also said that Bharat Biotech has welcomed the suggestion to share manufacturing licence with other companies, reported ANI. “Under this vaccine live virus is inactivated & this is done only in BSL3 labs,” he said. “Not every company has this. We give an open invitation to companies who want to do this. Companies that want to manufacture Covaxin, should do it together. The centre will assist so that capacity is increased.”
The Indian Council of Medical Research and the National Institute of Virology collaborated with Bharat Biotech to develop the Covaxin shot. Earlier this month, ICMR Director-General Balram Bhargava had said intellectual property rights for the use of Covaxin was shared between Bharat Biotech and the research body.
India is battling a severe second wave of the coronavirus. Hospitals across the country are struggling with acute shortages of oxygen and other medical supplies. Several states had to defer the third phase of vaccination, covering all above 18 years, due to a scarcity of doses.