New Delhi: India's regulating body on Wednesday declined a proposal from Dr Reddy's Laboratories to conduct a large study on the effectiveness of the Russian-made 'Sputnik V' vaccine against the novel coronavirus.
According to reports, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) stated that there was not enough data available on the safety and immunogenicity of the vaccine from early-stage trials abroad. Therefore, Dr. Reddy's Laboratories has been asked to first conduct a smaller trial of the vaccine.
The expert committee looking into Dr. Reddy's Laboratories' proposal had held a meeting on October 5 where it was recommended that the firm should follow the regulatory requirements and conduct phase 2/3 trial in the country with "proper monitoring for humoral and cell-mediated immune response."
Although the Russian coronavirus vaccine candidate was declared as the first vaccine that can defeat the virus, it has caused much controversy. Several international bodies, including the World Health Organization (WHO) have questioned the efficacy of the vaccine.
The Indian government too is yet to commit to incorporate the Russian vaccine candidate in its COVID-19 fight. Recently, Union Health Minister Harsh Vardhan had also said that no definitive decision had been made on the Russian vaccine. A call in this regard, Vardhan said, will be taken by Prime Minister Narendra Modi.
The Indian Government remains optimistic about rolling out a COVID-19 vaccine by early 2021. At the same time, the World Health Organization (WHO) has said that with many vaccine candidates under development across the world in various phases, there is a possibility of a potential vaccine surfacing by the end of the year.
It is pertinent to mention here that Russia's sovereign wealth fund, the Russian Direct Investment Fund or RDIF, and global pharmaceutical company Dr Reddy's Laboratories had agreed to collaborate on the clinical trials of the Russian vaccine candidate in the country.