Saswati Sarkar
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Written By: Saswati Sarkar | Updated : August 18, 2020 9:24 AM IST
Bharat Biotech's Covaxin uses an inactivated strain of the novel coronavirus.
As the COVID-19 pandemic keeps ravaging the world, affecting above 21 million people and taking as many as 7 lakh lives, scientists are leaving no stones unturned in their quest for a vaccine. There have a been quite a few updates recently on the vaccine front, the most important being the launch of Russia's Sputnik V, the first COVID-19 vaccine of the world to be approved for public use. Coming back to India, the country's first homegrown vaccine to tackle the pandemic, Covaxin, is also showing promise in the preliminary findings of its phase I clinical trial.
According to media reports, initial findings from this trial suggest that this vaccine is safe. Developed by Hyderabad-based pharma company Bharat Biotech, Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, Covaxin started its phase I human trial in 12 medical institutes of the country. AIIMS Delhi, Patna, Post-Graduate Institute (PGI) of Medical Sciences in Rohtak and Gillurkar Hospital and Research Institute in Nagpur are among a few among them. Dr Savita Verma, one of the principal investigators of this vaccine, has recently been quoted saying, "The vaccine is safe. We have not observed any adverse events in any of the volunteers at our site."
After this vaccine was found safe on animals in its preclinical trial, Covaxin entered the phase I clinical trial in July. It is supposed to conclude by the end of August. India's first indigenous COVID-19 vaccine is being tried on 375 volunteers currently. They are in the age bracket of 18-55 years with no comorbidity. Pregnant women and those with comorbidities have been kept out of the trial. Also, all the volunteers were screened for diabetes, hypertension, kidney function and immunity. Those who cleared the screening were only allowed to participate.
This phase is slated to begin in September. The trial will be conducted with 750 volunteers and they will be in the age bracket of 12-65. While the first phase focussed on the safety of Covaxin, phase II will gather information on its efficacy. It will also aim to find out if the vaccine has any side effect. Covaxin will move to Phase III clinical trial if the prior trials indicate that it is safe and effective. The Gauhati Medical College and Hospital (GMCH) may be included as one of the centres for Phase-II trial of the vaccine.
Covaxin has been developed with an inactivated strain of the novel coronavirus. The inactivated strain used in this vaccine doesn't multiply inside human cells. It simply primes the immune system and stimulates its antibody response towards the virus. This is a tried and tested technology used in several vaccines including seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis.
The inactivated strain of Covaxin was isolated by NIV in its high-containment facility at the Genome Valley in Hyderabad and collected by ICMR. After receiving the isolated strain, Bharat Biotech developed the first set of vaccines within 40 days. The preclinical trials started after this.
