Under normal circumstances, researchers and scientists take years to formulate and launch a vaccine; However, the global impact of COVID on humanity has pushed a ‘go’ button on all vaccines, where it is safe to expect a vaccine in the next 4-5 months (in a span of 12-18 months).
Covaxin, the candidate vaccine developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) is in a phase 2 clinical trial in the country. And now manufacturers have sought approval from drug regulators to begin the third phase of the clinical trial. The Comptroller General of Drugs of India (DGCI) has reportedly asked Bharat Biotech to submit “full safety and immunogenicity data from the phase II trial” and some clarification before moving on to the next stage.
The results of the animal-based vaccine trial were found to be favorable. “The candidate vaccine was found to elicit strong immune responses. Therefore, it prevents infection and disease in primates after large amounts of exposure to the live SARS-CoV-2 virus.”
The candidate vaccine has been tested in 12 hospitals in India, involving volunteers between the ages of 18 and 55. These volunteers had no comorbidities. The locations where the trial was held include Hyderabad, Delhi, Goa, Rohtak, Patna, Kancheepuram, and Bhubaneswar, among other places.
The science behind the vaccine
Covaxin falls into the category of inactivated vaccines. For the unverified, this means that the pathogenic virus is ‘inactivated’ to prevent it from causing infection, however, some parts of the virus can be identified by the immune system, causing an immune reaction.
Bharat Biotech took a strain of coronavirus isolated from the National Institute of Virology in Pune to develop the inactivated vaccine at its Hyderabad, Genome Valley facility.
The previous week, the firm shared that Covaxin will use ViroVax’s Alhydroxiquim-II adjuvant to stimulate the immune response in the body and provide longer-lasting immunity. “There is a critical need for the development and availability of adjuvants that clarify the mechanisms of action that induce increased antibody responses to vaccine antigens, resulting in long-term protection against pathogens. Adjuvants also improve sustainability. of the global vaccine supply due to its moderate antigen effect, “shared Krishna Ella, President and Managing Director of Bharat Biotech.
According to the official statement from Bharat Biotech, once the vaccine is injected into a human, it has no potential to infect or replicate as it is a killed virus. It simply serves the immune system like a killed virus and generates an antibody response to the virus.
Phase 3 for Covaxin
To launch the phase 3 trial, Bharat Biotech will enroll 28,500 volunteers who will be 18 years or older. The trial will take place in 10 states of India, including Mumbai, Delhi, Patna and Lucknow.
According to PTI reports, a dose of 0.5 ml on days 0 and 28 will be the dose administered for volunteers.
What to expect
Once the tests are done, Bharat Biotech will be targeting a manufacturing capacity of 300 million doses.
India is the largest vaccine producing country in the world and if India can produce indigenous vaccine, it will help combat capacity and manage delivery capacity.
ICMR has said that the candidate vaccine will follow all global standards to produce the most effective vaccine, which may take some time.
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