In the revised protocol, Dr Reddy's said the phase 2 trial of the Russian COVID-19 vaccine Sputnik V would include 100 subjects while phase 3 would involve 1,400 volunteers.
An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Dr Reddy's Laboratories for phase 2 clinical trials of the Russian COVID-19 vaccine Sputnik V in India.
The panel had earlier asked Dr Reddy's to resubmit the protocol with some additional information for conducting phase 2 and 3 trials. Subsequently, the Hyderabad-based pharmaceutical firm had on October 13 submitted a reworked application to the Drugs Controller General of India (DCGI).
The subject expert committee (SEC) asked the firm to re-apply, saying it would have to conduct both phase 2 and 3 trials and couldn't directly go on to phase-3 trial for the vaccine in India.
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.
In its revised protocol, Dr Reddy's said the phase 2 trial would include 100 subjects, while phase 3 would involve 1,400 volunteers, news agency PTI cited sources as saying.
SEC on COVID-19 deliberated on the application on October 16.
"Following deliberation, the SEC has recommended the grant of permission for the phase 2 clinical trial of the potential vaccine first. After they submit the safety and immunogenicity data of the first phase, they then would be allowed to proceed for phase 3 of the trials," the source told PTI.
The Indian pharma giant has collaborated with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
Upon regulatory approval in India, RDIF will supply to drug maker Dr Reddy's 100 million doses of the vaccine, the firm said in September.
The phase-3 trial of Sputnik V is currently underway in Russia since September 1 on around 40,000 subjects. Sputnik V has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and the RDIF.
Russia will also begin phase 3 trials of a second potential vaccine against COVID-19, developed by Siberia's Vector Institute, in November-December.Click here for Moneycontrol's full coverage of the COVID-19 vaccine