SUMIT SAXENA
New Delhi, Sep 8 (IANS) Covid-19 is raging like a wild fire across the country, making India the second worst hit country after the US.
But there is a bright spot amid this mayhem — India’s first indigenous Covid-19 vaccine, Covaxin developed by Bharat Biotech, may be launched in early 2021.
Covaxin has successfully completed Phase 1 trials and the Centre has given its approval for Phase 2 of clinical trials from September 7.
Speaking to IANS, Sanjay Rai, Professor, Community Medicine, and Principal Investigator for Covid-19 vaccine trial at AIIMS, said: “Phase 1 trial has been successfully completed. Phase 2 trial is most likely to get completed sometime in October. After this, the Phase 3 trial will begin. Covaxin may be launched in early 2021 (after completion of all trial stages).”
In the first phase of the Covaxin trial, around 375 participants were studied across 12 locations. From July 20 onwards, AIIMS began human trials of Covaxin on 100 healthy volunteers aged between 18 and 55 years. In Phase 1, the blood samples collected from the volunteers were monitored for side effects.
Covaxin is an “inactivated” vaccine, which injects doses of the virus that have been killed, aiming to prompt the body to build antibodies, and in this process the virus does not pose a threat.
On a comparison of Covaxin with Russia’s Covid-19 vaccine, Rai insisted that Covaxin is better placed than the Russian vaccine.
He added that Covaxin and the Oxford University-AstraZeneca vaccine candidate in India are technically at the same level in the clinical trials stage, though the Oxford vaccine has reached Phase 3 clinical trials in Britain, Brazil and South Africa.
India on Tuesday reported 75,809 new Covid-19 cases recorded in the last 24 hours, while the death toll mounted to 1,133, the highest single-day spike in fatalities so far.
India is now the the second worst hit country by Covid-19 after the US with 42,80,442 coronavirus cases since the first was reported on January 30. The US has recorded 63,00,431 cases and 1,89,206 deaths so far.
Queried on the level of satisfaction with the vaccine trials in progress, Rai said he is content with the progress made so far, but declined to share the content of the report on Phase 2 trials so far.
Rai added that all rules and regulations are being followed while conducting Covaxin clinical trials, and nothing is being done in rush.
On when would the mass production of Covid-19 vaccine begin, Rai said: “The companies involved in vaccine production see the beginning of Phase 3 trials as a positive sign in the development of the vaccine, to take a risk and begin production.”
In Phase 1, the age group profiling is done (wherein vaccine study is done on people in different age groups). In Phase 2, nearly 600 to 700 people are vaccinated, and if the vaccine performs successfully in this phase, then it progresses to Phase 3, which is called the efficacy study (in this phase, thousands of people are enrolled).
(Sumit saxena can be contacted at sumit.s@ians.in)
