COVAXIN: Light at the end of the tunnel?

Dr. Dimpee Lahkar

(The writer is a faculty member, Tezpur Medical College. She can be reached at daina59@rediffmail.com)

We, Indians are reeling under a lot of pressure following the outbreak of corona pandemic. But there seems to be light at the end of the tunnel. India is very soon going to start vaccination of its masses as it has succeeded in developing our very own indigenous vaccine- COVAXIN. Bharat Biotech is planning to launch its vaccine for COVID-19 in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities.

COVAXINTM, India's indigenous COVID-19 vaccine is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV) and Bharat Biotech. This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.

The vaccine received approval from Drug Controller We, Indians are reeling under a lot of pressure following the outbreak of corona pandemic. But there seems to be light at the end of the tunnel. India is very soon going to start vaccination of its masses as it has succeeded in developing our very own indigenous vaccine- COVAXIN. Bharat Biotech is planning to launch its vaccine for COVID-19 ineneral of India (DCGI) for Phase I & II Human Clinical Trials and an Adaptive, Seamless Phase I, followed by Phase II Randomized, Double blind, Multicentre Study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152).

The All India Institute of Medical Sciences (AIIMS) in New Delhi has submitted a proposal to the Institute of Ethics Committee to start Phase 3 clinical trials of Bharat Biotech's COVID-19 vaccine candidate Covaxin. Bharat Biotech has received an approval from drugs controller general of India to begin Phase 3 trials of its coronavirus vaccine candidate Covaxin in India. AIIMS Delhi is one of the hospitals selected for the final-stage trials to be conducted across the country. AIIMS ethics committee, which consists of 15 members, is likely to take around 10 to 14 days to grant the necessary ethical approval.

Covaxin phase 1 and 2 clinical trials

AIIMS Delhi plans to recruit between 2,000 and 5,000 participants for the phase 3 trial. According to reports, Bharat Biotech had submitted the Phase 3 trial application for India to the national drugs controller on 2 October, and received its approval on 22 October, suggesting minor procedural changes to the trial plan. The firm aims to enrol 26,000 participants for the Phase 3 clinical trials at 25 to 30 hospital sites across 13 to 14 states. For Phase 1 trials, Bharat Biotech had recruited 375 subjects, and as part of the Phase 2 trials, the vaccine candidate was administered to 400 participants. According to the former head, pulmonary medicine department, AIIMS, Phase 3 trial results will eventually decide which vaccine would work and which wouldn't. India's first indigenously developed coronavirus vaccine, Covaxin will commence its Phase III clinical trials at a private hospital in Bhubaneswar amid the race to develop a 'potential' vaccine against the COVID-19 pandemic.

Bhubaneswar's IMS and SUM Hospital is among the 21 medical institutes selected across 13-14 states for the phase-III trial and will provide two doses each for the vaccine and placebo recipients. About 2,000 subjects could be enrolled per hospital. During the phase II trial of Covaxin, the vaccine has been tested in 12 hospitals across the country and volunteers between the ages of 18 and 55 with no co-morbidity conditions took part in the trial. The vaccine trial took place in Hyderabad, Kancheepuram, Patna, Rohtak, Delhi, Goa, Bhubaneswar and Lucknow, among other places. It is also worth mentioning that drug maker, Dr. Reddy's laboratories had also recently got DCGI approval to conduct clinical trials of RUSSIA'S SPUTNIK-V vaccine.

COVAXIN status in Assam:

Around 2,000 people in Guwahati are likely to be administered doses of Covaxin, as part of the Phase III clinical trial of India's first COVID-19 vaccine candidate. Though the date for commencement of human trials in Guwahati is yet to be finalized, it is likely to begin by the end of this month or early next month in various medical colleges, viz, GMCH. Report suggests that the trial would take about a month's time, or may be even more. It may be mentioned that Guwahati initially was picked as a centre for the Phase II trials, but later it was decided that it will be one of the centres in the Phase III trials.

According to various reliable sources, COVAXIN has shown very good efficacy and it is heartening to see that India will soon start vaccination of its people by next year. We can only be positive about it and hope the end to this pandemic comes soon.