The world is racing against time to develop a vaccine for COVID 19, and India is not far behind. Bharat Biotech India (BBIL)’s COVAXIN has been given an affirmative nod by the Central Drugs Standard Control Organization (CDSCO) to conduct human clinical trials for the vaccine.

Developed in collaboration with the National Institute of Virology, the trails are scheduled to start in July. The COVAXIN vaccine started development in early May. NIV provided an isolated strain of the novel coronavirus from an asymptomatic patient to BBIL. The firm used it to work on the work on developing an “inactivated” vaccine as its high containment facility in Hyderabad.

CDSCO has provided BBIL approvals for phase I and II clinical trials. This will bring India one step closer to developing COVID 19 vaccine domestically. The first phase is usually conducted on a tiny group to find out what dosage of the vaccine is safe for use, whether it has any particular side effects and whether it helps in developing immunity in the patient.

The second phase will be conducted one a group of more than 100 people who fit the description of those for whom the vaccine is intended. This will be based on characteristics like age and sex. This particular stage will identify how effective the vaccine will be on the general population.

Like most of the new drugs, vaccines also follow a testing process of four stages, starting with pre-clinical trials to phase II studies, which is conducted on thousands of patients. It is after the regulatory checks and monitoring that the firm submits the post-marketing surveillance details.  BBIL currently plans to start the Phase I and Phase II trials in July but is still unsure of the overall timeline for testing and the final regulatory approval.

Few other Indian pharma, including Zydus Cadila, Serum Institute of India, and Panacea Biotec, are also working to create a vaccine as well. Still, none have received approval to conduct the clinical trials yet.

BBIL is developing two other vaccines in association with Thomas Jefferson University and others with the University of Wisconsin – Madison and FluGen. Both vaccines are currently in the pre-clinical stage. However, AstraZeneca, which has developed ChAdOx1-S in association with the University of Oxford, is already at phase III trials. The vaccine has been agreed to be manufactured by Serum Institute.