Sputnik Light COVID Vaccine: DGCI denies permission for Stage 3 Trials, Russian Safety Data to be considered for Approval
Sputnik Light comprises the first dose component of the Russian vaccine, Sputnik V. Russia had launched the single-dose vaccine in May. The vaccine uses a recombinant human adenovirus like the Johnson & Johnson vaccine.
The central government's Subject Expert Committee (SEC) on July 1, 2021 denied permission to Dr. Reddy's Laboratories to carry out the Phase-III trials of ‘Sputnik Light’ in India. Sputnik Light is a new version of the Russian COVID-19 vaccine, Sputnik V.
Sputnik Light is a one-dose vaccine like the Johnson & Johnson COVID vaccine. It was approved in Russia on June 2nd.
Russian Safety Data to be considered for Approval?
Dr Reddy's Laboratories stated that the Subject Expert Committee (SEC) that advises the Drugs Controller General of India (DCGI) has asked the company to submit safety, immunogenicity and efficacy data from Sputnik V's Phase-III trials in Russia to consider Sputnik Light for emergency use in the country.
The company said in a statement that the SEC was of the view that, " As the safety and immunogenicity data of component-1 in the Indian population has already been generated in the country in another trial, there seems to be inadequate data and justification in conducting a separate trial."
Sputnik Light can submit Russian safety data in India: Dr Reddy's pic.twitter.com/0RxLSukA0p— ANI (@ANI) July 1, 2021
• The SEC on June 30, 2021 deliberated on Dr Reddy’s submission for Marketing Authorisation of Sputnik Light in India.
• The company had presented to the SEC, the interim safety and efficacy data from the Phase I / II clinical trial of Sputnik Light in Russia. It had also submitted the clinical trial protocol for a Phase III trial of Sputnik Light in India.
What is Sputnik Light?
• Sputnik Light comprises the first dose component of the Russian vaccine, Sputnik V. Russia had launched the single-dose vaccine in May. The vaccine uses a recombinant human adenovirus like the Johnson & Johnson vaccine.
• Sputnik Light has also been developed by the Gamaleya National Research Centre of Epidemiology and Microbiology in coordination with the Russian Ministry of Health and the Russian Direct Investment Fund (RDIF).
How safe is Sputnik Light?
• According to RDIF's statement earlier, the Sputnik Light COVID-19 vaccine demonstrates 78.6 percent to 83.7 percent efficacy among the elderly. This is as per the real-world data collected by the Ministry of Health of the Buenos Aires province (Argentina).
• As per the data, among more than 40,000 of whom received a shot of Sputnik Light as a part of the mass-scale civil vaccination program, the infection rate between the 21st and 40th day from the date of receiving the first dose was only 0.446 percent.
• On the other hand, the infection rate among the non-vaccinated adult population was 2.74 percent for a comparable period.
• The Phase-III trials were carried out in Russia, UAE and Ghana also showed the vaccine’s efficacy to be 79.4 percent.
India has already granted Emergency Use Authorisation (EAU) to Russia's Sputnik V, Serum Insititute’s Covishield, Bharat Biotech’s Covaxin and Moderna's vaccine, all of which are two-dose vaccines.
Dr. Reddy's Laboratories has the sole distribution rights for the first 250 million doses of the Sputnik V vaccine in India as per its agreement with Russian sovereign fund RDIF.