COVAXIN : India’s preparation for massive vaccination drive.

-Chitra Roy, University of Calcutta

Covaxin, India’s indigenous COVID-19 vaccine, has been a subject of criticism due to its approval for restricted emergency use despite hot having published any phase 3 efficacy data. However, until recently, Bharat Biotech, the manufacturer of Covaxin claimed that its vaccine potentially generated safety data with the robust immune response against several viral proteins.

Covaxin is a 2 dose Covid-19 vaccine, which is highly purified and an inactivated vaccine, to be given 28 days apart, and it is the only vaccine allowed for a test on children of 12 years and above. It is manufactured in Bharat Biotech’s Biosafety Level 3 biocontainment facility, which is one of its kind in the world. It was in June that it announced the development of Covaxin in collaboration with ICMR and NIV. Phase 1 trials started in July and Phase 2 in September. It was found that Covaxin was safe with no adverse health effects in those two phases as stated by Sai Prasad, the executive director of Bharat Biotech. It was also stated that a well-designed vaccine development protocol was followed with a primary goal of attaining a strong immune response. Several conditions like attack rates, disease type, the ability of disease detection, and recruitment timelines have all been taken into consideration during the trial design.

In Phase 1 and Phase 2 of the Covaxin clinical trial, approximately 1000 subjects were evaluated. And what is important to note, is that, the results were promising in terms of safety and immunogenicity with its acceptance in the international peer-reviewed scientific journals. Initiation of Phase 3 efficacy trial started in mid-November and till-date approximately 22,500 volunteers have been vaccinated in 25 centres across India and is safe as per present data available.

These factors have contributed to the recommendation from the Subject Expert Committee (SEC) for granting its permission to use Covaxin in restricted emergencies while the clinical trial is still ongoing in the background.

Dry runs of Covid-19 are being conducted in many districts of the states and union territories. These dry runs of vaccinations are dummy runs to provide further information and insights into gaps and bottlenecks before the actual drive commences.

Considering the promising results of the vaccine in clinical trials, the company already seemed to have envisioned the success of Covaxin, and thereby has built a capacity for manufacturing 200 million doses and further plans to expand it and set the grounds for 500 million doses. An investment of around Rs. 350-400 crore has already been done for the vaccine development, new and updated manufacturing facilities are established, and also includes the investment for conducting Phase 3 clinical trial.

Reference: http://www.daijiworld.com/news/newsDisplay.aspx?newsID=787763