India could begin phase-III clinical trials of the Russian-developed Sputnik V vaccine for COVID-19 within a few weeks, according to Dr Reddy’s Laboratories Ltd. CEO for API and pharmaceutical services Deepak Sapra.
Speaking to Reuters, Sapra said that they hoped to get approval from Indian regulators within the next few weeks in order to commence clinical trials. These trials will enrol 1,000-2,000 participants and will be conducted at multiple governments and private hospitals across India.
Dr Reddy’s has a deal with the Russian Direct Investment Fund (RDIF) to conduct Phase III trials, get local regulatory approval and distribute the final vaccine in India, with RDIF to supply 100 million doses to Dr Reddy’s.
In addition, RDIF has deals with other Indian manufacturers to produce 300 million doses of the vaccine in shot in India.
"Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India,” G. V. Prasad, CEO Dr Reddy's, had told the Economic Times after the announcement of a tie-up with RDIF.
With India steadily maintaining the highest number of new daily cases of COVID-19 in the world, the need for an effective vaccine is urgent. However, RDIF has said that vaccine deliveries to India could begin only by late 2020, while Sapra says it could take even longer.
On August 11, Russia became the first country to grant regulatory approval to a COVID-19 vaccine, prompting concerns from Western scientists over the speed with which it received this.
A study published in the medical journal Lancet in early September stated that the vaccine successfully produced an immune response in COVID-19 patients. Several scientists from the US, Italy and other countries then published an open letter calling for the study’s authors to respond to concerns they had raised about the vaccine study. The Russian scientists in turn announced their readiness to provide required explanations to the Lancet.
The Russian vaccine was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Health Ministry, which completed Phase I and Phase II trials in July.
Russia’s health minister recently stated that one in seven people who received the vaccine would experience side effects such as muscle pain and weakness for about 24 hours alongside an occasional increase in body temperature.
As per the draft guidelines for the development of a COVID-19 vaccine, released by the Central Drugs Standard Control Organization, vaccines developed outside of India will receive authorisation on the basis of clinical trial data after passing safety and effectiveness evaluations, while Indian-developed vaccines will need to prove effectiveness and generate antibodies in 50 per cent of those administered with it.
“In case, a vaccine has been developed and has undergone clinical trial development outside India and marketing authorization application for the same have been submitted to CDSCO, the clinical data generated will be considered for evaluation of overall safety and effectiveness of the vaccine. However, additional clinical trial may be required in local population to confirm the safety and effectiveness in Indian population. The extent of local clinical trial requirements will be decided on case by case basis considering the urgency, unmet need of the vaccine in the country,” reads the CDSCO draft guidelines.
