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‘We expect to get the approval in the next few weeks,’ says Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy’s Laboratories (DRL).
India may soon have a third Covid-19 vaccine in the next few weeks with emergency use authorisation for the Russian jab Sputnik V.
“We expect to get the approval in the next few weeks,” said Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy’s Laboratories (DRL).
DRL had applied for restricted emergency use authorisation for Sputnik V in February. It has already lined up over 250 million doses of the vaccine for Indian citizens (from manufacturing partners) over the next 12 months.
The Russian Direct Investment Fund (RDIF) has formed manufacturing tie-ups with several partners in India to make around 752 million doses of Sputnik V, for both Indian (250 million) and global markets.
Telangana-based Virchow Biotech was the latest to sign an agreement with the RDIF to produce 200 million doses. Earlier, Hetero, Gland Pharma, and Stelis Biopharma (a Strides subsidiary) had entered into agreements with the RDIF to produce 552 million doses of Sputnik V in India, cumulatively.
The expert panel advising the Indian drug regulator, according to people in the know, had asked DRL to come back with more data on safety and immunogenicity from its phase 2 and 3 studies on the Russian vaccine. They said the expert panel deliberated on the application made by DRL in late February and felt that more data was required before a recommendation for approval.
The phase 3 study ended on February 21.
The firm has presented a safety profile from the phase 2 clinical study and interim data from the phase 3 study.
DRL partnered with the RDIF to conduct the clinical trials of Sputnik V and for its distribution rights in India. The vaccine underwent a bridge trial in Indian on 1,600 people.
Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included the data of 19,866 volunteers in Russia, who received both first and second doses of the vaccine. Sputnik V maintained an efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old, DRL claimed.
The human adenoviral vector (flu virus)-based vaccine candidate is developed by the Gamaleya National Research Institute of Epidemiology and Microbiology in Russia and was registered in that country in August last year.
DRL would market the vaccine in India. It said it hoped to supply to both government and private market.
On the pricing front, DRL has said it was discussing the Indian situation with the RDIF. In India, vaccine makers like Serum Institute of India have announced two separate prices -- one for the government and the other for the private market. RDIF had announced a global price of $10 per dose for Sputnik V earlier.
