CEO Erez Israeli said the company would begin phase II trials in the next few days
Dr Reddy’s Laboratories on October 28 said it plans to complete phase III clinical trials of its Sputnik V COVID-19 vaccine as early as March and will seek approval from the Drug Controller General of India (DCGI).
CEO Erez Israeli said the company would begin phase II trials in the next few days.
Dr Reddy's recently received permission from DCGI to conduct phase II and III trials of the Russian vaccine. In phase II, it will be enrolling 100 participants. If it receives an approval to continue, it will recruit 1,400 subjects for phase III, Israeli said. Phase III will follow after the completion of phase II trials.
“I hope we will finish phase II by December, which means not just the enrolment and the trial but also compilations of results," Israeli said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
If everything goes smoothly, the trial is expected to be completed by March-end, but if there any delays in compilation and submission, it could take up to mid-May, he explained. "Data from India will be complemented by the global clinical trial data of the vaccine."
In September, Dr Reddy’s and Russia’s sovereign wealth -- the Russian Direct Investment Fund (RDIF) -- entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of deal, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
Israeli said the vaccine will be produced in India, at a third party site in Baddi, but declined to offer details on the vaccine pricing.
Sputnik V, the COVID-19 vaccine developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the sovereign Russian Direct Investment Fund, became the first vaccine to be cleared for public use. The results of Sputnik V of phase I/II clinical trials on 76 people were published in medical journal The Lancet in early September, showing that the vaccine candidate triggered a strong immune response. Russia is enrolling 40,000 volunteers as part of phase III trails, starting September, and will take six months to complete.Sputnik V vaccine is based on a modified human adenovirus as vector, which carries the protein of the SARS-CoV-2 virus.