The Drugs Controller General of India (DCGI) granted approval to the single-shot Sputnik Light vaccine for restricted use in emergency situations in India, Dr Reddy's Laboratories Ltd. announced on Monday.
Sputnik Light is a one-dose vaccine and the same as the first component — recombinant human adenovirus serotype number 26 (rAd26) — of the two-dose Sputnik V vaccine. Following its Phase III clinical trial of the single-shot Sputnik Light vaccine in India, Dr. Reddy’s had submitted its application for approval to the DCGI in December 2021, in addition to data from clinical trial in Russia, the company said in a statement.
The standalone Sputnik Light vaccine is the latest vaccine to be approved by the DCGI as part of India’s national inoculation effort against COVID-19. Sputnik Light is the 9th COVID-19 vaccine in the country to be approved by the drug regulator for use among public. The one-shot vaccine is the second COVID-19 vaccine to be made available in India by Dr Reddy’s.
“DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India. This is the 9th #COVID19 vaccine in the country. This will further strengthen the nation's collective fight against the pandemic,” Union Health Minister Mansukh Mandaviya said in a tweet.
Sputnik Light has been approved in over 30 countries around the world including Argentina, UAE, Philippines and Russia. Earlier this year, an independent comparative study conducted by the Spallanzani Institute in Italy showed that Sputnik V demonstrates strong protection against the Omicron variant, with over two times higher virus neutralising activity compared to the Pfizer vaccine.
A preliminary study of the Gamaleya Center which has developed the vaccine has found that Sputnik Light as a booster significantly increases virus-neutralising activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection.
A unique comparative study conducted at Lazzaro Spallanzani National Institute for Infectious Diseases in Italy by a team of 12 Italian and 9 Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute and Alexander Gintsburg, Director of the Gamaleya Center has shown that Sputnik V vaccine demonstrates more than 2 times higher titers of virus neutralizing antibodies to Omicron (B.1.1.529) variant than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).
The study was conducted in the equal laboratory conditions on comparable sera samples from individuals vaccinated with Sputnik V and Pfizer with a similar level of IgG antibodies and virus neutralising activity against Wuhan variant. Sputnik V showed significantly smaller (2.6 times) reduction of virus neutralising activity against Omicron as compared to reference Wuhan variant than Pfizer vaccine (8.1-fold reduction for Sputnik V in contrast to 21.4-fold reduction for Pfizer vaccine).
According to the Russian Direct Investment Fund (RDIF), based on the data collected by the Spallanzani Institute and results of previous studies, heterologous (“mix & match”) boosting with Sputnik Light is a solution to increase other vaccines’ efficacy and extend the booster protection period as optimal adenoviral platform configuration provides better protection against Omicron and other mutations.
In September 2020, Dr Reddy’s partnered with the RDIF to conduct clinical trials of Sputnik V and distribute the vaccine in India. In April 2021, the DCGI granted approval to the two-dose Sputnik V vaccine for restricted use in emergency situations in India.
India has at least eight more vaccines approved under its national COVID-19 immunisation program. There are Oxford-AstraZeneca developed Covishield being manufactured by Pune based Serum Institute of India, Bharat Biotech’s Covaxin, Russia’s Sputnik V imported by Dr Reddy’s, Zydus Cadila’s ZyCoV-D, Johnson and Johnson by USA based Janssen Pharmaceutical Companies, m RNA vaccine from Moderna Moderna, Inc an American pharmaceutical and biotechnology. While India is still waiting for Johnson and Johnson and Moderna vaccines, Zydus Cadila last week said that it has started supplying doses to the government of India.
The government in December 2021 also approved Covovax which is a protein subunit COVID-19 vaccine developed by Novavax Inc, an American biotechnology company based in Gaithersburg, to be manufactured and marketed in India by Serum Institute of India (SII) as Covovax. Corbevax is another protein subunit vaccine recently approved by India. It has been developed by Texas Children's Hospital at the Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.
With the administration of more than 14.70 lakh Doses (14,70,053) vaccine doses in the last 24 hours, India’s COVID-19 vaccination coverage has exceeded 169.63 Cr (1,69,63,80,755) as per provisional reports till 7 am on Monday. India’s COVID-19 total tally continues to swell gradually. At least 83,876 new cases were reported in the last 24 hours. India’s Active Caseload is presently at 11,08,938. Active cases constitute 2.62 per cent of the country's total positive cases.
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