Safety primary criteria in vaccine development: Covaxin maker Bharat Biotech after Anil Vij contracts Covid-19

Covaxin, the vaccine indigenously developed by the Hyderabad-based Bharat Biotech International Limited, is currently the most promising among the candidates in the country. Bharat Biotech recently announced the beginning of Phase 3 trials of Covaxin among 26,000 volunteers across 25 sites in partnership with the Indian Council of Medical Research (ICMR). It is the largest clinical trial conducted for a Covid-19 vaccine in India.

“Safety is our primary criteria in vaccine development. Inactivated vaccines technology has delivered the safest form of vaccines for the past several decades, as apposed other new and unproven technologies. The vero cell manufacturing platform used for COVAXIN has delivered more than 300 million doses till date, with an excellent safety track record,” the company said in a statement on Saturday.

The statement came after Haryana health minister Anil Vij tested positive for the coronavirus disease (Covid-19) and was admitted to a hospital. Vij, a Bharatiya Janata Party (BJP) leader, volunteered to be a part of the third phase trial of Covaxin, which started in Haryana on November 20. He was administered a trial dose but it’s not immediately clear whether he was given the vaccine candidate during the trial or a placebo.

Here’s everything you need to know about Covaxin and its trial phases:

1. The Phase 3 trials of Covaxin is the only efficacy trial being conducted in India for Covid-19 vaccines, to determine its suitability to the diverse Indian population.

2. Trial volunteers will receive two intramuscular injections approximately 28 days apart. The vaccine efficacy will be determined 14 days after the second dose. The trial is double-blinded and randomised — the investigators, participants and the company will not be aware of who is assigned to which group — where 50% of subjects will receive the vaccine and 50% of subjects will receive a placebo.

3. Covaxin has been evaluated in approximately 1,000 subjects in Phase 1 and Phase 2 clinical trials, with promising safety and immunogenicity data. Volunteers who wish to participate in this trial should be over 18 years of age.

4. In case of any adverse event, the reporting process is as per CDSCO-DCGI guidelines according to which volunteers can contact the principal investigator at the site or during active follow up. The principal investigator determines the severity of the adverse event after which reports are submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and Sponsor.

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5. Bharat Biotech, the company which is developing Covaxin, has in two decades conducted more than 80 clinical trials, across 18 countries, in 600,000 subjects and has supplied more than 4 billion doses, to more than 80 countries. Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom. The company is also conducting other clinical trials in the US and the UK.

6. In India, the Phase 3 trials of India’s first Covid-19 vaccine have begun in Haryana, Delhi, West Bengal, Gujarat, Odisha and Madhya Pradesh

Besides the Hyderabad-based firm’s Covaxin in the country, four other potential vaccines are under various phases of the human clinical trial. Serum Institute of India is conducting Phase 3 trial of the Oxford-Astrazeneca Covid-19 vaccine and the indigenously developed vaccine by Zydus Cadila has completed Phase 2 trial.