India will produce more than 100 million doses a year of the vaccine against Russia’s coronavirus disease (Covid-19) Sputnik V starting in 2021 following an agreement between Russia’s Direct Investment Fund (RDIF) and Hetero Biopharma, with headquarters in Hyderabad.
Sputnik V is based on a well-studied platform of human adenoviral vectors and has demonstrated an efficacy rate of 91.4%, based on the second interim data analysis of the largest double-blind, randomized, placebo-controlled phase III clinical trial in the history of Russia involving 40,000 volunteers. The results were announced by Gamaleya Center and RDIF on November 24.
Phase 3 clinical trials of the vaccine are approved and ongoing in Belarus, the United Arab Emirates, Venezuela and other countries, and phase 2/3 has been approved in India. India, along with Brazil, China, South Korea and others, will provide the vaccine to at least 50 countries that have requested more than 1.2 billion doses.
Read also | AstraZeneca plans new vaccine trial as efficacy is questioned
“RDIF has submitted an application to the World Health Organization (WHO) for expedited registration (Emergency Use List, EUL) and prequalification of Sputnik V,” said Alexander Gintsburg, Director General of the Gamaleya Research Institute, Moscow , in an email. interview. The WHO EUL procedure streamlines approvals for global use of new or unlicensed products during public health emergencies.
“There is now real hope that vaccines, in combination with other tried and tested public health measures, will help end the pandemic. The urgency with which vaccines have been developed must be matched by the same urgency to distribute them fairly. As we work to implement a safe and effective vaccine, we must continue essential public health actions to suppress transmission and reduce mortality, ”said DR Poonam Khetrapal Singh, WHO Regional Director for Southeast Asia.
The EUL procedure for the Oxford-AstraZeneca vaccine has begun. “The WHO has had several discussions with AstraZeneca following the expression of interest that the WHO issued for the emergency use list and prequalification of vaccines. We will receive more clinical data in the coming weeks. There are eight sites, some are manufacturing sites, and we will analyze the data carefully. We hope to finalize the evaluations early next year, ”said Dr. Khetrapal Singh.
Sputnik V is a human adenovirus-based vaccine candidate and the only late-stage adenovirus-based Covid-19 vaccine candidate that uses two different vectors for different injections, human adenovirus types Ad5 and Ad26. In vaccines that use the same vector for both injections, the immune system can launch defense mechanisms against the second, making the vaccine less effective.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has been shown to be safe and effective without long-term side effects in more than 250 global clinical trials over the past two decades. It uses two different human adenoviral vectors that have been genetically modified so as not to cause the infection to trigger a stronger and longer-term immune response compared to vaccines that use one or the same vector for two doses.
“While we look forward to the results of clinical trials in India, we believe that manufacturing the product locally is crucial to allow rapid access to patients. This collaboration is a further step towards our commitment in the battle against Covid-19 and the realization of the objective of the ‘Make-in-India’ campaign as envisioned by our honorable Prime Minister of India, ”said B. Murali Krishna Reddy , director, international marketing, Hetero Labs Limited, in a statement.
“The results follow the encouraging results of the two previous candidate vaccines from Pfizer and Moderna. Both are mRNA vaccines, while the AstraZeneca vaccine is a viral vector vaccine. We may have several different candidate vaccines that can be used to fight this disease. This is a good development, as we would like to provide access to as many effective and safe vaccines as possible so that we can cover the population, billions of people, around the world, ”said Dr. Khetrapal Singh.
“While there are many challenges to ending Covid-19 beyond the introduction of the vaccine, vaccination is the best opportunity we have to stop Covid-19 transmission and minimize its associated morbidity and mortality. Based on currently available evidence, Sputnik V may play a role in the global fight against Covid-19, ”Dr. Gintsburg said, in an email.
.
