More data sought on Sputnik V Covid-19 vaccine

Hyderabad-based Dr Reddy’s applied for emergency use authorization (EUA) to the Central Drugs Standard Control Organisation (CDSCO) on February 19 for the human adenoviral vector-based vaccine candidate.

 It will be some time before Sputnik V, the Russia-developed vaccine against the Coronavirus disease (Covid-19), is approval for use in India. The subject expert committee (SEC) of the national drug regulator asked Dr. Reddy’s Laboratories, which is conducting clinical trials on it locally, to come back with more data.

In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V and for its distribution rights in India. (Reuters Photo)

Hyderabad-based Dr Reddy’s applied for emergency use authorization (EUA) to the Central Drugs Standard Control Organisation (CDSCO) on February 19 for the human adenoviral vector-based vaccine candidate.

The subject expert committee took up the application on Wednesday, but did not recommend that the vaccine be approved for use in India with the current data set that was produced before its members.

“The subject expert committee has sought more data such as the immunogenicity data from the company. The application has not been rejected, they will be given a chance to present their case once again after they have all the relevant documents,” said a senior government official with knowledge of the matter, requesting not to be identified. The company had presented the safety profile of Phase 2 clinical trials, and interim data from Phase 3 trials.

The vaccine is currently undergoing Phase 3 clinical trials in India. Sputnik V has demonstrated an efficacy rate of 91.6% in the interim analysis of the Phase 3 clinical trials, which included data on 19,866 volunteers in Russia, who received both the first and second dose of the vaccine.