Pharma major Dr Reddy’s Laboratories and the Russian Direct Investment Fund on Saturday announced that have received approval from the Drugs Controller General of India to conduct an adaptive Phase II and III human clinical trials in the country to evaluate the Sputnik-V coronavirus vaccine, PTI reported.
On October, Indian regulators declined a proposal from Dr Reddy’s Laboratories to conduct a large study on the Russian vaccine. An expert panel of the Central Drugs Standard Control Organisation stated that there was not enough data available on the safety and immunogenicity of the vaccine from early-stage trials abroad, with no inputs on Indian participants.
In a statement on Saturday, Dr Reddy’s said the late-stage clinical trials will be a multi-centre and randomised controlled study, including safety and immunogenicity study. “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic,” Dr Reddy’s co-chairperson and Managing Director GV Prasad said.
Russia’s sovereign wealth fund, the Russian Direct Investment Fund or RDIF, and Dr Reddy’s had agreed to collaborate on the clinical trials and distribution of the Sputnik V vaccine in India in September. Under the partnership, Dr Reddy’s will conduct the clinical trials, and subject to regulatory approval, distribute the finished vaccine in India. RDIF, which is marketing the Sputnik V, will supply 100 million doses to Dr Reddy’s.
“We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial,” said Kirill Dmitriev, chief executive officer of the Russian Direct Investment Fund after the renewed approval.
On September 10, Russia had started inoculating volunteers with the Sputnik V vaccine against the coronavirus in Moscow. The country had rolled out the first batch of the vaccines for public use on September 8. The vaccine was found to produce an antibody response in all participants in early-stage trials, according to results published in the medical journal The Lancet.
Russia had announced in August that it has developed the world’s first coronavirus vaccine, but was criticised by scientists and experts for not conducting Phase III trials to determine its safety. A vaccine is deemed safe to be commercially available only after Phase III – a much larger efficacy trial involving thousands of participants.
The advanced trial for the vaccine began on August 26. The Phase III trials of Sputnik V is currently underway in Belarus, Venezuela and the United Arab Emirates.
More than 100 coronavirus vaccines are being developed around the world. Globally, the coronavirus has infected more than 3.92 crore people and killed 11,03,352, according to Johns Hopkins University. The worldwide recoveries have crossed 2.7 crore.