Sputnik Light phase 3 trial denied in India; why Dr Reddy's didn't get approval for Russia's single shot vaccine

On one hand, as Covishield received the Green Pass for EU, on the other Sputnik Light was shown the red signal in India. On Wednesday, the Subject Expert Committee (SEC) set up by the government, denied permission to Dr. Reddy's Laboratories for conducting Phase 3 trials of Sputnik Light in India. Sputnik Light is a single-dose vaccine introduced in May, by the makers of Sputnik V, the Covid-19 vaccine developed in Russia.

As per the sources widely quoted, the expert committee did not find any scientific basis to conduct Phase 3 trials and therefore, did not consider Dr Reddy's application seeking to conduct the final trials of the Covid vaccine.

"The SEC has denied permission to Dr Reddy's to conduct Phase 3 trials on the Russian vaccine Sputnik Light in India," ANI quoted sources as saying.

The rationale behind the refusal  

Sputnik V is a two-dose vaccine, with the second dose being a booster shot. The Sputnik Light vaccine does away with the booster shot and is made of the first component, which is also the first component of Sputnik V.

Dr. Reddy's Laboratories wanted to test the immunogenicity of the vaccine. The results of the earlier trials of Sputnik V were relied upon. The immunogenicity data from the trials on both doses were noted. Since the immunogenicity data related to the single-dose vaccine was not so great, therefore the expert committee did not see the need to conduct the trial again.

About Sputnik Light

Like Sputnik V, Sputnik Light has also been developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF).

RDIF CEO Kirill Dmitriev had said soon after the launch of Sputnik Light that Russia is expected to introduce the one-dose vaccine in India soon. The RDIF had also said Sputnik Light vaccine demonstrates 78.6 per cent to 83.7 per cent efficacy among the elderly. The efficacy quoted is based on the data collected by the Ministry of Health of the Buenos Aires province (Argentina). The infection rate between 21^st and 40^th day from the date of receiving the vaccine was 0.446 percent. This data was collected from over 186,000 elderly people, of which 40,000 received a shot of Sputnik Light.

However, this infection rate among the non-vaccinated population was 2.74 per cent in the same period. So far, Phase 3 trials of Sputnik Light have been conducted in Russia, Ghana and UAE.

Meanwhile, Sputnik V has been the third vaccine to get approval from the Indian drug regulator and is being administered in a few private hospitals since it was approved in April. Dr Reddy's Laboratories is importing the vaccine for use in India.