sputnik light: Russia seeks govt’s nod for export of Sputnik Light Covid vaccine manufactured in India by Hetero Biopharma | India News
In a communication to the Center, the Russian ambassador Nicholay Kudashev stated that Hetero Biopharma Limited has already manufactured one million doses of Component 1 of the Sputnik V and two million doses of Sputnik light But the six-month shelf life of the vaccine may expire before it is registered, resulting in wasted doses of the vaccine, the sources said.
The Sputnik-Light is the same as Component 1 of Sputnik V.
The issue, which was discussed at the Empowered 5 Group meeting recently, has been referred to the Subgroup of the National Group of Experts on Vaccine Administration for COVID-19 (NEGVAC) to consider vaccine export proposals, the sources said.
For the past few months, Russia’s Direct Investment Fund (RDIF) has been working closely with Indian pharmaceutical companies to increase production of the Sputnik vaccine in India that could be used in local and global markets, stated the ambassador. in your communication for the last time. month.
At this time, RDIF, together with Dr Reddy’s Laboratories, is working with the authorities interested in the registration of Sputnik Light in India.
“Hetero Biopharma Limited, one of the leading Indian pharmaceutical companies and RDIF’s partner in the production of Sputnik Light, has already manufactured one million doses of Component I of the Sputnik V vaccine and two million doses of Sputnik Light and intends to to continue its further production.
“However, the shelf life of the vaccine, that is, just 6 months, may expire before registration, resulting in the waste of several million doses of the vitally important Sputnik Light vaccine.
“We would like to point out that the Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the Sputnik Light vaccine produced in India and its export to other countries,” said the communication to VK Paul, President of the National Group of Experts on Vaccine Administration for COVID-19 (NEGVAC).
If a permanent or occasional permit could be granted to Hetero Biophar Limited to export the Sputnik Light vaccine produced by selling it to RDIF until its registration in India, this could encourage the company to increase vaccine production and provide the market. Indian with more supplies from the Sputnik Light at the time of its regulatory approval, he said.
Meanwhile, Sputnik Light has received permission from the Comptroller General of Drugs of India (DCGI) to conduct phase 3 bridge trials in India.
The permission of the DCGI was based on the recommendations of the Committee of Experts on the Matter on COVID-19 of the Central Organization for the Control of Medicines Standards (CDSCO), which held its meeting on August 5.
SEC recommendations indicated that the company submitted updated safety, immunogenicity and efficacy data from the phase 3 clinical trial of the SARS-CoV-2 virus vaccine (Sputnik Light), a single-dose vaccine conducted in Russia in conjunction with the proposal to carry out the phase 3 clinical trial.
The Committee noted that the company has presented the safety and immunogenicity together with the longevity of the antibodies, which gives a measure of the persistence of the antibodies in the participants.
After detailed deliberation, the committee recommended the granting of permission for the conduct of a phase 3 immuno-bridging clinical trial in the Indian population, subject to the condition that the primary endpoint must be assessed on days 42, 90 and 180 and an interim analysis can be performed. on day 42, as this data was not generated during the Sputnik V trial in India after the first dose, which was stated to be available only until day 21.
In July, the subject matter expert committee of the Central Medicines Standards Control Organization (CDSCO) had refused to grant an emergency use authorization for Sputnik Light.