The Russia Direct Investment Fund (RDIF) and Hyderabad’s Dr. Reddy’s Laboratories are set to supply 100 million doses of the Russian COVID-19 vaccine, Sputnik V. Named after the first artificial Earth satellite launched by the Soviet Union, Sputnik V is the first COVID-19 vaccine approved by any government for use among the general public.
The Sputnik V Vaccine
Sputnik V was developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology in collaboration with Russia’s defence ministry. It’s based on the DNA of a SARS-CoV-2 type adenovirus, a common cold virus. The vaccine uses a weakened virus to deliver small parts of a pathogen, stimulating an immune response. Administered in two doses, it consists of two types of a human adenovirus. Promising results have been shown in Phase 1 and 2 trials, with no serious adverse effects reported and a stable immune response observed in all participants.
Phase 3 Trials in India
Phase 3 trials of Sputnik V will be conducted in India as part of regulatory requirements. These trials will provide essential data on the vaccine’s efficacy in the Indian population. In addition to the Sputnik V partnership, India is also collaborating with the USA on COVID-19 vaccine development.
Regulatory Requirements in India
In India, approval for a vaccine is granted by the Central Drugs Standard Control Organization (CDSCO). Vaccines developed outside India must undergo late-phase human trials, typically both phase 2 and 3, in an Indian population. However, given the extraordinary circumstances, CDSCO can also give emergency authorisation without late-phase trials.
Concerns over the Vaccine
Despite promising initial results, there are concerns regarding the safety and efficacy of Sputnik V due to its rapid production and lack of accessible data. The results for phase 1 and 2 trials, though reportedly successful, were the only ones made public by Russia. The importance of late-phase human trials has been underscored, as a vaccine’s efficacy can differ across different population groups.
Vaccine Manufacturing in India
Manufacturing the vaccine in India presents additional challenges. Despite being home to the Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, there is currently no agreement for the production of Sputnik V in India.
India as a Vaccine Powerhouse
India is a global player in vaccine production. In FY20, vaccine exports represented 4.27% of total pharma exports. Approximately 70% of WHO vaccines and 90% of measles shots are sourced from India, showcasing its manufacturing prowess.
About the Adenovirus Vector Vaccine
Adenoviruses (ADVs) are DNA viruses that induce many illnesses, including colds and respiratory infections. In vaccines, adenovirus is used as a tool to deliver genes or vaccine antigens to the target host tissue. While there are drawbacks to using adenovirus vector vaccines, they are preferred due to their genetic stability.
About the Central Drugs Standard Control Organisation
CDSCO, under Directorate General of Health Services, Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India. The organization, under the Drugs and Cosmetics Act, 1940, is responsible for the approval of drugs, conduct of clinical trials, setting standards for drugs, overseeing the quality of imported drugs, and coordinating the activities of State Drug Control Organizations.
