Russia’s SPUTNIK V finds an Indian partner- Dr Reddy’s Laboratory

 

Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia has allied Dr Reddy’s Laboratories (DRL), the Hyderabad-based drug manufacturer to cooperate on clinical trials and distribution of Sputnik V vaccine in India. This arrangement claims to deliver the vaccine for general use probably beginning late 2020.

After obtaining regulatory approvals from DCGI (Drug Controller General of India) for conducting trials in India, DRL will receive 100 million doses of the Covid19 vaccine — developed by the Gemaleya National Center of Epidemiology and Microbiology (Moscow, Russia). The results of the early phases (Phase 1 and 2) of trials with the vaccine were recently published in Lancet in September 2020, while both India and Russia were laying the groundwork to pursue further trials and production of the vaccine in India. The Indian Council of Medical Research (ICMR) expresses that Russia has a good track record in development of vaccines.

Sputnik V is based on proven vaccine against adenovirus – the common cold. The vaccine is expected to provide immunity from SARS-CoV-2 (agent responsible for Covid19), for up to two years, according to the Russian health ministry. Findings of phase I/II trial of this vaccine, involving 76 healthy volunteers (aged 18-60 years), which used recombinant adenovirus type 26 and type 5 vector (rAd26-S and rAd5-S), suggests that 85% of participants had detectable antibodies at 14 days after first dose, leaping up to 100% by day 21, after the boosting dose. The findings are published in The Lancet, a renowned peer-reviewed journal in the field of medicine.

Competitors in the field

Meanwhile, AstraZeneca or Oxford vaccine (AZD1222) is also in Phase-3 trials which has partnered India’s Serum Institute to produce it and has secured its position among the leaders in race for public use, even after recent unfortunate pause in its trials due to alleged side effects. DCGI has now revoked its earlier suspension on Oxford Covid-19 vaccine, allowing to continue phase two and three trial and put certain conditions like extra care during screening, close monitoring for adverse events during follow-up.

There are two other Indian vaccines that are being developed and are in Phase I and II stage trials and have shown no significant side-effects yet.

Zydus Cadila is working on ZyCoV-D, has completed phase I and II clinical trials. ZyCoV-D utilises technology based on Plasmid DNA translating into viral protein. Bharat Biotech Limited has developed COVAXIN, in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is an inactivated vaccine with alum as adjuvant.

Globally around 321 vaccine candidates are in development as either confirmed projects in clinical trials or in early-stage "exploratory" or "preclinical" development, as of September 2020. Out of these only seven vaccines are in phase III clinical trial. The WHO also implemented an access to COVID‑19 Tools Accelerator for coordinating global vaccine development, a program called "COVAX" in collaboration with Global Alliance for Vaccines and Immunisation (GAVI) and the Coalition for Epidemic Preparedness Innovations (CEPI). COVAX has the goal to accelerate the development and manufacturing of COVID-19 vaccines, and to assure that access to licensed vaccines is equitably provided to all countries.

Its very comforting to see that multinational companies are doing their utmost to find the answer to this pandemic, but it will be crucial to maintain patient safety. The last thing we need after a pandemic is a global havoc due to adverse events arising from the very cure we are trying to find.