Apart from Oxford/Astrazeneca vaccine, the other vaccine candidate that is all set to get restricted emergency-use approval in the coming days is Bharat Biotech’s Covaxin. The subject expert panel of India’s drug regulator on Saturday has recommended it for emergency use. While the final nod rests with the Drug Controller General of India (DCGI), Covaxin moving a step closer to getting approval carries major significance for India in the global scenario as 10 countries have already shown interest in India’s first home-grown vaccine. 10 million doses of the vaccine have already been produced for the Indian market.
Here is all you need to know about this vaccine:
Made-in-India vaccine: This is the first made-in-India vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.
An inactivated vaccine is one which is developed by inactivating (killing) the live microorganisims that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. There are many inactivated vaccines against Hepatitis A, Influenza, Polio, Rabies, which offer “excellent protection”, Bharat Biotech has said.
Covaxin’s efficacy as proved in animal studies
Bharat Biotech in its report published after animal studies said that its vaccine candidate showed protective efficacy. The vaccine candidate was administered in 20 rhesus macaques, divided in four groups. One group was administered with placebo, while three other groups were immunised with three different vaccine candidates. “To summarize, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus,” it said.
Covaxin’s human clinical trial outcomes
The third phase of trial is still going on, while the company has already published the findings of the first two rounds. It followed a double-bind, randomised, multi-centre phase two clinical trial which included children as well.
Efficacy to be determined only after two shots
After Haryana minister Anil Vij tested positive after receiving one dose of the vaccine during the trial, the company clarified that the efficacy is to be determined only after 14 days post the second dose. Also, as its trial was random in which some received the vaccine and some received placebo, there was no way to know whether the minister received a vaccine shot or a placebo shot.
Union health minister Dr Harsh Vardhan has on Saturday clarified that the first phase of vaccination which will include frontline workers will be free. There has been no talk on the price of Covaxin though Dr Krishna Ella, the MD of Bharat Biotech, earlier said that the vaccine will be cheap, cheaper than a water bottle, he had said in a conference, pointing to a water bottle. Since his comment, it has been estimated that it will come at a cost lower than Rs 100.
According to reports, Bharat Biotech’s total investment is about Rs 350-400 crore for the development of the vaccine, including new manufacturing facilities, investment for trials etc.
Covaxin in other countries
Bharat Biotech has already signed a letter of intent with US firm Ocugen to co-develop Covaxin for the US market. The company was also in talks with 10 countries in South America, Asia and Central Asia, and Eastern Europe.