Dr Reddy's Denied Nod for Phase 3 Trials of Sputnik Light Vaccine
Here is everything you need to know about the single dose Sputnik Light COVID-19 vaccine.
India's drug regulator has denied Dr Reddy's Laboratories permission to conduct Phase 3 trials of the single dose Sputnik Light COVID-19 vaccine, in India, according to reports.
The subject expert committee (SEC) did not find any "scientific rationale" to conduct Phase 3 trials and hence did not consider the application to carry out trials in India, The Economic Times reported quoting sources.
The application is said to have been taken up for discussion on Wednesday, 30 June.
COVID-19: What Is Sputnik Light?
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – this means it is the first dose of the Sputnik V vaccine.
Sputnik Light was also developed by the Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF).
The single dose vaccine was approved for emergency use in Russia in May.
The single-dose also costs $10.
What Is Sputnik Light's Efficacy?
The single dose Sputnik Light vaccine demonstrated 79.4 percent efficacy, according to a statement released by the RDIF.
The efficacy rate is based on data from 28 days after the injection was administered as part of Russia’s mass vaccination program between 5 December 2020 and 15 April 2021.
"An efficacy level of almost 80% is higher than that of many two-dose vaccines," the RDIF claimed.
It was also demonstrated during laboratory tests that Sputnik Light had proven effective against all new strains of the coronavirus, the statement said.
“The single-dose regimen solves the challenge of immunizing large groups in a shorter time, which is especially important during the acute phase of the spread of coronavirus, achieving herd immunity faster,” RDIF Head Kirill Dmitriev said.
How Is It Different From Sputnik V?
Sputnik V was the world’s first registered vaccine against coronavirus.
It is a two-dose vaccine which is based on the established human adenoviral vector platform.
It is made from two components - recombinant adenovirus 26 or Ad26 and adenovirus 5 or Ad5. The first dose (Ad26) is the main vaccine, and the second (Ad5) is a booster shot.
The RDIF on Tuesday, said in a statement that Sputnik V has confirmed 97.8 percent efficacy among more than 81,000 people in the United Arab Emirates UAE.
The vaccine is fully effective against severe infections and there were no instances of adverse aftermath after vaccination, it further said.
India approved emergency use of Sputnik V in April this year.
The vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which allows for easy distribution worldwide, including hard-to-reach regions.
The maximum retail price of the imported vaccine is Rs 995.40 per dose.
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