As COVID-19 vaccine advancements continue, the Drugs Controller General of India (DCGI) has approved the conducting of Phase III bridging trials for the Sputnik Light vaccine. While the Subject Expert Committee (SEC) had previously refused to allow Phase III trials of the Russsian vaccine as well as granting emergency-use authorisation, recent data appears to have led to a change of heart.
On July 1, the government's Subject Expert Committee had dismissed an application by Dr Reddy's. Reportedly they had not found any rationale behind conducting a fresh trial because the single dose jab is purportedly the same as a single dose of Sputnik V vaccine. At the time, an Economic Times report had quoted a source to say that the immunogenicity of a single dose of the vaccine had previously been tested and the results had been sub-par. "Hence the SEC did not find any rationale to conduct the trial again," the article quoted the source as saying.
Several studies however have suggested that a a single dose of the Sputnik V vaccine may be enough to elicit strong antibody response against SARS-CoV-2. According to a study published recently by The Lancet, the real world effectiveness of Sputnik Light is believed to be more than many two-dose vaccines. The study said that a single dose of the jab prevented 78.6% of laboratory-confirmed SARS-CoV-2 infections, 87.6% of hospitalisations and 84.8% of deaths from COVID-19.
"With respect to Sputnik V, data provided by a phase III study showed efficacy of 91.6% for prevention of symptomatic infection in a 2-dose schedule, and of 87.4% at 14 days post vaccination with one dose. From 15 to 21 days after the first dose, efficacy against moderate/severe COVID-19 was 73.6%. Remarkably, in participants older than 60 years, vaccine efficacy was 91.8%," the study added.
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