As India ramps up its vaccine production, Bharat Biotech chairperson Dr. Krishna Ella on Friday, explained how COVAXIN was formed while conversing with Republic Media Network Editor-in-chief Arnab Goswami. Talking on the 'Nation wants to Know', Dr. Ella explained how a COVID-19 virus strain was chemically inactivated to form COVAXIN's antivirus and added to an adjuvant to get the necessary response from the body. Bharat Biotech has teamed up with govt's ICMR to produce India's first indigenous COVID vaccine.
When asked how CAVAXIN was produced, Dr. Ella said, "For me, it is another virus. We have a history of understanding the problem and solving it be it the Rotavirus or typhoid. We wrote to ICMR to get the virus strain and they responded immediately. So, then it was just another vaccine production for us.
He elaborated, "When we get the strain, we multiply the virus and fill them in small tubes, making the master virus bank. From that we make the working virus bank - this is the one used for production, while the master virus bank is stored for the next 40 years. The virus is added to the cells stored in the fermentor, infecting them and then downstream them making a pure virus. This virus is then inactivated chemically to knock off the RNA in the virus. So now, it looks like the virus, but cannot replicate".
"When you inject this, the body thinks that a virus has come and starts producing an immune response to that. But this virus cannot replicate. And we need a TTT response and not the immune response for this virus. We licensed one company in the US - Virovax to manufacture the adjuvant and combined it with this virus to develop the TTT and not the immune response. We finished vial stage production in 2 months," he added.
In March, Bharat Biotech said that its COVID-19 vaccine - Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - has shown an interim clinical efficacy of 81% in its Phase 3 trials. The phase 3 trials involved 25,800 subjects and is the largest ever trial conducted in India. COVAXIN has been granted permission for restricted use in an emergency situation by the DGCI in January 3. Union Health Minister Dr. Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and the recent double mutation (Indian variant). The participants enrolled were between the age of 18-98 years old including 2,433 over the age of 60 and 4,500 with comorbidities.
After Subject Expert Committee (SEC)'s nod to COVAXIN several politicians had questioned why Phase 3 trials protocol have been modified for the Bharat Biotech vaccine candidate, urging Health Minister Harshvardhan to clarify on the same. Meanwhile, Tharoor stated that the DCGI 'approval was premature and could be dangerous', opining that its use should be avoided till full trials are over. Several others have questioned the vaccines due to 'lack of trust' on Modi govt.
Centre has approved Rs 1567.50 crores to ramp up its COVAXIN production apart from the grant of Rs 65 crores to enhance their production capacity at their new Bengaluru plant- touching 6-7 crore vaccine doses/month by July. Apart from Bharat Biotech, three public sector companies - Haffkine Biopharmaceutical Corporation Ltd , Mumbai, Indian Immunologicals Limited, Hyderabad and Bharat Immunologicals & Biologicals Limited, Bulandshahr too have been given grants to enhance their production capacity. While Haffkine will produce 20 million doses per month within six months, the other two will produce 10-15 million doses per month by Aug-Sep 2021.