Phase 3 clinical trial of Bharat Biotech's indigenously-developed COVID-19 vaccine - Covaxin - began at AIIMS Delhi on November 26. Three volunteers and Dr MV Padma Srivastava, the chief of Neurosciences Centre at AIIMS Delhi received the first dose of vaccine.
Covaxin, being developed jointly by Bharat Biotech and Indian Council of Medical Research (ICMR), will be administered to around 15,000 volunteers at the AIIMS over the next few days.
"The first dose of 0.5 ml intramuscular injection was given to four volunteers. They were under observation for two hours and will be monitored for the next few days," a source told PTI.
Dr Srivastava said, "Covaxin is the first indigenously-developed anti-coronavirus vaccine and on top of that, my institute is participating in the trial. I am honoured to be the first volunteer to receive the shot. I am happy to be a part of such a great cause. I am perfectly fine and I'm working."
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.
Covaxin phase 3 trial also began at Sola Civil Hospital in Gujarat's Ahmedabad on November 26. On the first day, five healthy volunteers were given the first dose of the vaccine. The second dose will be given after 28 days, said Principal Investigator, Sola Civil, Dr Parul Bhatt.
Meanwhile, Sir JJ Hospital in Mumbai is also likely to commence the phase 3 trial soon. The ICMR completed paperwork on November 25 and enrolment of suitable volunteers, following the norms, is likely to begin from November 27.
COVID-19 Vaccine Watch: What you need to know about manufacturing and pricing
According to the dean of Sir JJ Hospital, Dr Ranjit Mankeshwar, it is expected to enrol at least 1,000 people for the trial of the coronavirus vaccine candidate.
The phase-three randomised double-blind placebo-controlled multi-centre trial would cover around 28,500 subjects aged 18 years and above. It would be conducted in around 25 sites across 10 states.
Besides Covaxin, four other vaccines are under different phases of clinical trial in India with the Serum Institute of India conducting the phase-three trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Zydus Cadila has completed the phase-two clinical trial.
Dr Reddy's Laboratories will soon start combined phase 2 and 3 clinical trials of the Russian COVID-19 vaccine Sputnik V in India.Click here for Moneycontrol's full coverage of the COVID-19 outbreak