A day after India granted emergency use authorization to Sputnik V, Russian COVID-19 vaccine marketing partner Dr Reddy’s Laboratories said the imported product would be available in the country from here this trimester.
It will start this quarter, via the imported route and availability will be increased next quarter once the Made in India Sputnik V goes into service. Discussions with the government and other stakeholders over pricing are underway, senior management at the Hyderabad-based pharmaceutical major said on Wednesday.
The contract with the Russian Direct Investment Fund (RDIF), which has partnered with Dr Reddy’s for clinical trials and distribution, is for 250 million units of vaccine (125 million person doses). This number is expandable, said API and Services Business CEO Deepak Sapra.
Separately, RDIF has made production pacts with six vaccine manufacturers in the country, he said. About 60-70% of the global volumes of Sputnik V will be manufactured in India. Most of them will be used in the country, he said, adding that Sputnik is made in Russia and a few other countries.
In a presentation during the interaction, which was attended by Chairman Satish Reddy and Co-Chairman and Managing Director GV Prasad, Mr. Sapra said the vaccine has a storage condition of minus 18-22 degrees C and a six month shelf life. Dr Reddy’s aligned the cold chain and made logistics arrangements to ensure last mile delivery across the country. It will also work with the government and leverage part of the immunization program infrastructure.
The vaccine will be imported in frozen form. Additional stability data is also generated over the temperature range 2-8 degrees Celsius. This will be available in a few months, after which the necessary modification request will be sent to the regulator, he said.
Based on the human adenovirus vector platform, Sputnik V is a two-dose intramuscular vaccine to be taken three weeks apart. Dr Reddy’s, who has undertaken the clinical trials in the country, is also responsible for harmonizing the quality produced in India. He will be in charge of the management of the manufacturing sites where production will begin soon. He will also be responsible for the regulatory, safety and pharmacovigilance aspects of the vaccine in India.