JOIN USCovid-19 crisis: Here's all you need to know about India’s new vaccine by Biological E
India is all set to welcome its second indigenous Covid-19 vaccine. Hyderabad-based pharmaceutical company, Biological E, has got approval from the Central Drugs Standard Control Organisation (CDSCO) to start phase three trials of their vaccine.
The company expects to start producing 75-80 million doses every month from August 2021. The vaccines will be made available at a very affordable price.
What is this new vaccine?
Biological E is collaborating with Baylor College of Medicine, Texas, in making this vaccine. This vaccine uses recombinant-protein technology, in which a harmless agent is sent to the human body to stimulate an immune response in cells. It is a two-dose vaccine that has to be taken 28 days apart.
What were Phase 1 and Phase 2 trial results?
Phase one and two trials were conducted on 360 healthy individuals between 18 and 65 years of age. The trials helped in evaluating the safety and immunogenicity of the vaccine.
Mahima Datla, Managing Director, Biological E, told News18, “We are delighted with the success of Phase 1 and 2 clinical trials of our COVID-19 vaccine candidate. The results of these clinical trials are very positive and promising. We believe that our vaccine candidate will become another effective global COVID-19 vaccine as we move forward into Phase III clinical trials."
The company is receiving support from The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) in all three trials of this vaccine.
When will the vaccine be ready?
Currently, the company is preparing for the phase three trial of this vaccine. They are set to test it on 1,268 healthy candidates within the age group of 18-80 years in 15 different centres across the country. It will help in understanding the efficacy rate of the vaccine.
The company is expecting to finish the phase three trial and launch the vaccine in August 2021. “It’s (75-80 million doses per month) a significant capacity and we have already scaled up. We have confidence in our manufacturing capabilities to be able to deliver that number August onwards,” said Datla in an interview with The Times Of India.
Datla has also mentioned that they would like to apply for emergency use authorisation (EUA) for the drug based on government advice.
How is this vaccine priced?
Dr Maria Elena Bottazi, associate dean, National School of Tropical Medicine (NSTM) at Texas-based Baylor College of Medicine, which is collaborating with Biological E on this vaccine, said this vaccine has a hepatitis B vaccine-like model and uses traditional technology for production. She also said it is cheap to produce at only about $1.5 (Rs 110 approx) per dose.
Datla also reiterated that this vaccine is going to be affordable.
India has been rolling out Covaxin and Covishield vaccines at Rs 1,200-Rs 1500 and Rs 700-Rs 900, respectively. However, with the country facing a massive vaccine crunch, the central government has given emergency approval to Russia’s Sputnik V, priced at $10 per shot globally.