Bharat Biotech on Monday said that it has begun phase III trials of its COVID-19 vaccine ‘Covaxin’. Krishna Ella, Chairman and Managing Director, said that the firm is also attempting to make the vaccine in the form of a nasal spray. The CEO had raised concerns over the prospect of distributing vaccines to 1.3 billion people. As the vaccine under development by the company is a two-dose injectable vaccine, over 2.6 billion doses will have to be developed.
Ella said the company is also trying to develop a single dose vaccine to work around the logistical difficulty of distributing two doses to 1.3 billion people. The single-dose vaccine will be in the form of a nasal drop. While the vaccine will require two drops, it will work as a single dose when developed. Ella was speaking at an event held by the Indian School of Business, reported The New Indian Express.
The Phase III trials will involve 26,000 volunteers across India and is conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is India’s first phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in the country. The trial has been registered at www.ctri.nic.in (CTRI/2020/11/028976) and approved by the Drugs Controller General of India. The Subject Expert Committee (SEC) of the DGCI recommended granting permission to carry out Phase III clinical trials for the vaccine last week.
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to receive Covaxin or a placebo. The trial is double-blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group, Bharat Biotech said in a press statement.
Covaxin has been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity data. Volunteers participating in this trial will be adults over 18 years of age.
Bharat Biotech developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility.