NEW DELHI: The government is hoping for an early launch of the COVID-19 Sputnik Light single-dose vaccine in India and all stakeholders, including the Russian manufacturer and its Indian partners, have been urged to speed up application and regulatory approval procedures for the coup to boost the country’s vaccination campaign, sources said on Thursday.
An application for regulatory approval for Sputnik Light is expected to be filed in the coming weeks and it could become the first single-dose vaccine to be launched in India, sources said citing high-level discussions between senior government officials in the recent days to increase the national availability of COVID-19 vaccines.
At a meeting chaired by the Cabinet Secretary last week, it was suggested that a meeting be called immediately with all relevant stakeholders, including the Secretary of the Department of Biotechnology, the Comptroller General of Medicines of India. (DCGI), representatives of the Ministry of External Affairs, the Union Ministry of Health. officials, RDIF (Russian Direct Investment Fund) and domestic manufacturers to speed up regulatory approvals for Sputnik Light.
In addition, with the deployment of the one-dose Sputnik vaccine, the issue of the criticality of the recombinant component Adenovirus Type-5 (rAd-5), which is used in the second dose of the currently approved double-dose Sputnik V vaccine and for Production, which manufacturers are not very comfortable with, will also become redundant, sources familiar with the discussions said.
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About Sputnik Light, it was discussed at the meeting that Russia has already approved this vaccine, and trials are underway in other countries.
The Comptroller General of Medicines of India (DCGI) informed other participants that the application for regulatory approval of Sputnik Light is expected to be filed within the next 2-3 weeks.
It was also highlighted during the meeting that six double doses of Sputnik-V imported by Lakh will be available in May 2021, one crore of doses imported in June 2021 and 2.8 crore of doses (2.4 crore imported and 40 Lakh made in India) in July 2021, sources said.
From August 2021, the locally manufactured Sputnik V vaccine will be available in the domestic market and a technology transfer agreement for the manufacture of the Sputnik-V vaccine has been confirmed with six Indian manufacturers, sources added.
The Department of Biotechnology and the CDSCO (Central Drugs Standard Control Organization) are in contact with all these manufacturers to provide them with the necessary support in setting up their manufacturing facilities.
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It was also reported at a recent meeting that domestic manufacturers are not very comfortable with the production of the recombinant component of adenovirus type 5 (rAd-5), which is used in the second dose of vaccine, due to its low yield and inability. to fully absorb its production process.
Another round of meetings with manufacturers and RDIF is expected to take place shortly to resolve this issue.
At the same time, it was noted that the availability of single-dose Sputnik Light in the domestic market can significantly boost the country’s vaccination campaign.
In addition, the issue of the criticality of the rAd-5 component will also become redundant with its launch. It was therefore suggested that NITI Aayog immediately convene a meeting inviting all relevant stakeholders, including the secretary of DBT, DCGI, representative of MEA, representative of the Ministry of Health, RDIF and domestic manufacturers to expedite regulatory approvals. for Sputnik Light, ”another source said.
On April 12, the two-dose Sputnik V was approved by the Indian drug regulator for emergency use under certain conditions.
Dr Reddy’s labs import the vaccine for use in India.
Dr Reddy’s Laboratories Ltd had applied for permission to import and market the Gam-COVID-Vac combination vector vaccine, popularly known as Sputnik-V, developed by the Gamaleya Institute, in Russia for emergency use authorization .
The combined vector vaccine Gam-COVID-Vac (Component I and Component II) was developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and is approved in 30 countries across the world.
DRL worked with the Russian developer to obtain regulatory approval for importation for marketing in India.
Interim results of immunogenicity and safety efficacy from the Russian phase 3 clinical trial have been published in the journal Lancet.
As many states report vaccine shortages, the government is trying to obtain imported vaccines, including Sputnik vaccines from Russia, while talks are also underway for COVID-19 vaccines developed by US majors Pfizer and Moderna.
In addition, the government is also seeking to step up domestic manufacture of vaccines, including those manufactured by Serum Institute and Bharat Biotech, among other Indian manufacturers currently at various stages of their vaccine production.