Dr Reddy's gets the nod to conduct human trials for the vaccine while Mankind Pharma signs an agreement with RIDF that will make 300 million doses of Sputnik V available in India.
The nod came after the Hyderabad-based company submitted a reworked application to the Drugs Controller General of India (DCGI) on October 13 with more information on phase 2 and 3 trials.
Developed by Moscow’s Gamaleya Institute, the Russian Defence Ministry and the Russian Direct Investment Fund (RIDF), Sputnik V is based on a modified human adenovirus as the vector which carries the SARS-CoV-2 virus protein.
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.
Dr Reddy’s trials will be a multi-centre and randomised controlled study on 1,500 volunteers and will include safety and immunogenicity study.
The same day, it was reported that Delhi-based Mankind Pharma had signed an agreement with the Russian Direct Investment Fund (RIDF) for the distribution and sale of Sputnik V in India.
The companies are yet to officially confirm the development that will make 300 million doses of Sputnik V available for distribution in India.Track this LIVE blog for all the latest updates on coronavirus pandemic
In September, Dr Reddy’s and RDIF, which is marketing the vaccine overseas, entered into a partnership to conduct trials for Sputnik V and its distribution in India. RDIF will supply 100 million doses to Dr Reddy’s after getting regulatory approval in India.
In addition to Indian clinical trial data, the Russians will provide safety and immunogenicity study from the Russian phase 3 clinical trial as well.
Sputnik V is undergoing trials in Moscow with 40,000 participants. Last week, Phase 3 trials commenced in the UAE as well. The trial will take six months to complete.
Media reports say the two-dose vaccine is available for the public in Russia but may not be available in other countries at least till the first half of 2021.
On September 16, RDIF reached an agreement with Dr Reddy’s to conduct clinical trials and distribute 100 million doses of vaccine in India.
The results of Sputnik’s Phase 1 and 2 trials were published in The Lancet in early September and showed that the vaccine triggered a strong immune response.
The results of the two trials, conducted in June-July this year and involving 76 participants, showed 100 percent of participants developing antibodies to the new coronavirus with no serious side effects, news agency Reuters reported Lancet as saying.Russia became the first country to give approval to the vaccine but came in for criticism for going ahead with Sputnik V without a large-scale trial.