Aside from the Oxford / Astrazeneca vaccine, the other candidate vaccine that is set to gain restricted approval for emergency use in the coming days is Covaxin from Bharat Biotech. The Indian drug regulator’s panel of subject matter experts on Saturday recommended it for emergency use. While final nod goes to the Controller General of Drugs of India (DCGI), the fact that Covaxin comes one step closer to gaining approval is of great significance for India on the global stage as 10 countries already have shown interest in India’s first homegrown vaccine. 10 million doses of the vaccine have already been produced for the Indian market.
This is everything you need to know about this vaccine:
Vaccine made in India: This is the first vaccine manufactured in India developed by Bharat Biotech in collaboration with the Indian Council for Medical Research and the National Institute of Virology.
Inactivated vaccine
An inactivated vaccine is one that is developed by inactivating (killing) the live microorganisms that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognize it and produce an immune response. There are many inactivated vaccines against hepatitis A, influenza, polio and rabies, which offer “excellent protection”, said Bharat Biotech.
Expert panel recommends Covaxin from Bharat Biotech for restricted emergency use
Covaxin efficacy proven in animal studies
Bharat Biotech in their report published after animal studies said that their vaccine candidate showed protective efficacy. The candidate vaccine was administered to 20 rhesus macaques, divided into four groups. One group was given a placebo, while three other groups were immunized with three different candidate vaccines. “In summary, the candidate vaccine was found to generate strong immune responses. Therefore, infection and disease in primates is prevented after extensive exposure to the live SARS-CoV-2 virus, ”he said.
Covaxin Human Clinical Trial Results
The third phase of the test is still ongoing, while the company has already published the results of the first two rounds. It followed a double-linked, randomized, multicenter phase two clinical trial that also included children.
The effectiveness will 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 efficacy will be determined only after 14 days after the second dose. Also, as their trial was randomized in which some received the vaccine and others received placebo, there was no way to know whether the minister received a vaccine injection or a placebo injection.
Price
The union’s health minister, Dr. Harsh Vardhan, clarified on Saturday that the first phase of vaccination, which will include frontline workers, will be free. The price of Covaxin has not been discussed, although Dr. Krishna Ella, MD of Bharat Biotech, previously said that the vaccine will be cheap, cheaper than a bottle of water, he said at a conference, pointing to a bottle of water. Since your comment, it has been estimated that it will cost less than Rs 100.
Investment
Bharat Biotech’s total investment is reported to be around Rs 350-400 million for vaccine development, including new manufacturing facilities, investments for trials, etc.
Covaxin in other countries
Bharat Biotech has already signed a letter of intent with the US firm Ocugen to jointly 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.
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