New Delhi: A subject expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Wednesday deferred its decision on the emergency licensure for Sputnik V vaccine and sought additional data on immunogenicity of the vaccine from the applicant Dr Reddy’s Laboratories, a senior government official said.
Dr Reddy’s on Friday had applied to the Drugs Controller General of India (DCGI) V.G. Somani, who heads CDSCO, for an emergency licence for the Russian Sputnik V vaccine.
“They had submitted safety and interim immunogenicity data from their bridging study. The SEC asked them to submit the final data on immunogenicity,” the source said.
A spokesperson for Dr Reddy’s declined to comment on the SEC meeting today.
Bharat Biotech International Ltd, which had also sought an application for conducting efficacy trials for Covaxin in children, was asked by the SEC to first submit the data on efficacy on adults from their phase 3 efficacy study, the source said. On Monday, Bharat Biotech chairman and managing director Krishna Ella had said that the efficacy data for Covaxin would be available in two weeks. The vaccine was given an emergency licensure by Somani in January despite not having efficacy data.
Dr Reddy’s is currently conducting a phase 2 and 3 bridging study aimed at proving that the vaccine produces an immune response, or immunogenicity, against covid-19 in the Indian people just like it does in Russians, for which original developers Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology have announced efficacy data.
If an emergency licence is awarded, Sputnik V will provide India with one of the most efficacious vaccines available against covid.
A phase 3 study in Russia, published in The Lancet last month, showed the vaccine had an efficacy of 91.6%. This is lower than the vaccines of Pfizer and Moderna but significantly higher than that of the jab developed by the University of Oxford and AstraZeneca. The Oxford vaccine is manufactured in India by Serum Institute of India under the Covishield brand. It received an emergency licence in January and is currently being administered to healthcare and other frontline workers.
Sputnik V is being commercialized globally by Russian Direct Investment Fund (RDIF). RDIF had in September signed a pact with Dr Reddy’s, wherein the Indian drugmaker would conduct the bridging study and distribute doses to 100 million people if it were granted a licence. This was later increased to 125 million.
India’s Hetero Biopharma is also contracted to manufacture the vaccine—with a capacity of 100 million doses per annum through another pact with RDIF. The Russian sovereign fund is also in advanced talks with Panacea Biotec for manufacturing the vaccine. RDIF plans to manufacture 300 million doses of the vaccine in India.
