The Russian ambassador has urged the Indian government to allow the export of single-dose Coronavirus vaccine Sputnik Light that is produced by Hetero, one of the RDIF’s partners in the production of the shot, to his country till emergency authorization is given to the vaccine from India’s drug regulator.
Russian Ambassador Nicholay Kudashev in a communication to the Centre, stated that Hetero Biopharma Limited already has manufactured one million doses of Component 1 of the Sputnik V and two million doses of the Sputnik Light but sources said that the six-month shelf life of the vaccine may expire before its registration which will result in the wastage of vaccine doses.
The Sputnik-Light is the same as component-1 of Sputnik V.
According to the sources, the problem which was discussed in the meeting of the Empowered Group 5 recently, has been stated to the Sub-Group of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) for considering Vaccine Export Proposals.
The ambassador stated in his communication last month, the Russian Direct Investment Fund (RDIF) over the last few months has been working closely with Indian pharmaceutical companies to increase the production of the Sputnik vaccine in India that could be used in the local and global markets.
Presently, RDIF together with Dr Reddy’s Laboratories is working with the authorities concerned on the registration of the Sputnik Light in India.
“Hetero Biopharma Limited, one of the leading Indian pharmaceutical companies and RDIF’s partner in the production of the Sputnik Light, has already manufactured one million doses of Component I of the Sputnik V vaccine and two million doses of the Sputnik Light and intends to continue its production further.”
“However, a shelf life tenure of the vaccine, i.e. 6 months only, may expire before its registration, which will result in the wastage of several million doses of the vitally important Sputnik Light vaccine.
The communication to V K Paul, chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) said, “We would like to note that Indian manufacturers of the Russian vaccine are discouraged by the current ban that prevents the use of the produced Sputnik Light vaccine in India and its export to other countries.”
If permanent or time-to-time permission might be granted to Hetero Biophar Limited to export the produced Sputnik Light vaccine by selling it to RDIF until its registration in India, this could encourage the corporate to proportion the assembly of the vaccine and supply the Indian market with more supplies of the Sputnik Light by the instant of its regulatory approval, it said.
Meanwhile, Sputnik Light has received the Drugs Controller General of India’s (DCGI) permission to conduct phase-3 bridging trials in India.
The DCGI’s permission has supported the recommendations by the topic Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation(CDSCO), which held its meeting on August 5.
The SEC recommendations stated that the firm presented updated safety, immunogenicity and efficacy data of Phase-3 clinical test of SARS-CoV-2 virus Vaccine – (Sputnik Light) – single-dose vaccine conducted in Russia along with the proposal to conduct phase 3 clinical trial.
The Committee noted that the firm has now presented the security and immunogenicity along side the longevity of the antibodies which provides a measure of the persistence of antibodies within the participants.
After detailed deliberation, the committee recommended for grant of permission for conduct of phase-3 immune-bridging clinical trial in the Indian population subject to the condition that the primary endpoint should be assessed at day 42, 90 and 180 and interim analyses are often conducted at day 42 as this data wasn’t generated during the Sputnik V trial in India after the first dose, which was stated to be available up to day 21 only.
In July, the topic expert committee of the Central Drugs Standard Control Organisation (CDSCO) had refused to grant emergency-use authorisation for Sputnik Light.
