At a time when India has already started vaccination drive for children in the age group of 15-18 years, Dr Reddy’s Laboratories is in talks with the Indian drug regulator and trying to bring Sputnik M vaccine to India. Russia’s COVID-19 vaccine is for the 12 to 18-year-old category.
According to a senior executive of the Dr Reddy’s, Phase 3 clinical trial data of single dose vaccine Sputnik Light has already been submitted to the regulator and is awaiting approval.
“Sputnik M is a sputnik for adolescents. In Russia, Sputnik M has been given the approval by the regulator for children in the 12 to 18 years old group. The same data has been made available here. We are in the process of translating the data and we will be having a conversation with the regulator on this data within the next few months,” said Deepak Sapra CEO – API and Services Dr. Reddy’s.
He also said the company may probably conduct another round of clinical trials in India if the Indian regulator says so.
Sapra added the company is fully geared to make Molnupiravir, a COVID-19 drug both API and Formulations, at its facilities, even as it approached World Health Organization (WHO) for the prequalification of the drug.
Sapra said the clinical trials for the Sputnik Light are over in India and the data has been submitted to the Drug Controller General of India.
“It has demonstrated efficacy which is consistent and in line with the result that we have seen in the global trials which we have conducted in Russia. What we conducted in India is safety and immunogenicity studies,” Sapra said.