Covaxin enters phase-3 trials

Bharat Biotech’s Covaxin enters phase-3 trials

Bharat Biotech’s Covaxin enters into phase-3 trials. Covaxin is a Coronavirus vaccine jointly developed by the Bharat Biotech, ICMR (Indian Council of Medical Research), and the National Institute of Virology.

In phase-3 clinical trials, around 26,000 volunteers will participate across 25 centers in India. They will take two shots of Covaxin in 28-days apart. All volunteers will be of 18-years of age. It will be a double-blind placebo-controlled multicentre trial. It means the company, participants, investigators will not aware of which volunteer is assigned to which group. During the phase-1 and phase-2 trials, the company conducted tests on around 1,000 volunteers. The vaccine maker got the approval on October 2 from the Drug Controller General of India’s (DCGI) to conduct phase 3.

Among 25 centers, 8 have received approval from the ethics committee to conduct trials. The ethics committee observes whether trials are meeting their study protocols. All centers have their own ethics committee.

Krishna Ella, Chairman and Managing Director, Bharat Biotech, at a virtual program organized by Indian School of Business, said, “it [Covaxin] entered the phase 3 trials.” She further added, the company is also “working on another vaccine through nasal drops my feeling is by next year it will reach the population.”

The company is planning to launch by February next year (2021). It is planning to manufacture 500 million doses of Covaxin in the first phase. The company already started manufacturing some doses in its Hyderabad plant at its own risk. The Hyderabad plant can manufacture about 150 million doses in a year. It is also setting up one more plant that will be operational by December 2020.

How Covaxin will work

Covaxin uses non-infectious or dead Coronavirus that no longer cause infection but help to develop antibodies to fight Coronavirus. Hepatitis A and polio vaccines are developed by the same mechanism using dead pathogens. The advantage of using dead pathogens to develop vaccines is that they can’t replicate in the human body. So they are safer than the vaccines which are developed by live but weak pathogens.

AstraZeneca and the University of Oxford are developing the vaccine by using weak but live Coronavirus. During the process, the company extracted the SARS-CoV-2 spike protein and insert it into an adenovirus (the virus that causes the common cold). Inside the human body, it will mimic the Coronavirus and will trigger the immune system. This way the immune system will train itself to fight against the Coronavirus.