<p>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.</p>.<p>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.</p>.<p><strong>What is this new vaccine?</strong></p>.<p>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.</p>.<p><a href="https://www.deccanherald.com/national/4000-single-day-covid-deaths-for-third-day-in-a-row-343-lakh-new-infections-985709.html" target="_blank"><strong>Read | 4,000 single-day Covid deaths for third day in a row; 3.43 lakh new infections</strong></a></p>.<p><strong>What were Phase 1 and Phase 2 trial results?</strong></p>.<p>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.</p>.<p>Mahima Datla, Managing Director, Biological E, <a href="https://www.news18.com/news/india/biological-e-vaccine-phase-iii-trial-rollout-price-all-you-need-to-know-3735116.html" target="_blank">told News18</a>, “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."</p>.<p>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.</p>.<p><a href="https://www.deccanherald.com/international/india-s-wider-gap-for-covishield-doses-a-reasonable-approach-says-fauci-985714.html" target="_blank"><strong>Also Read | India’s wider gap for Covishield doses a reasonable approach, says Fauci</strong></a></p>.<p><strong>When will the vaccine be ready?</strong></p>.<p>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.</p>.<p>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 <a href="https://timesofindia.indiatimes.com/business/india-business/biological-e-set-for-covid-vaccine-rollout-by-august/articleshow/82445644.cms" target="_blank">an interview</a> with The Times Of India.</p>.<p>Datla has also mentioned that they would like to apply for emergency use authorisation (EUA) for the drug based on government advice.</p>.<p><a href="https://www.deccanherald.com/state/top-karnataka-stories/false-negatives-compound-covid-19-ordeal-for-many-in-bengaluru-985661.html" target="_blank"><strong>Also Read | False-negatives compound Covid-19 ordeal for many in Bengaluru</strong></a></p>.<p><strong>How is this vaccine priced?</strong></p>.<p>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.</p>.<p>Datla also reiterated that this vaccine is going to be affordable.</p>.<p>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.</p>
<p>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.</p>.<p>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.</p>.<p><strong>What is this new vaccine?</strong></p>.<p>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.</p>.<p><a href="https://www.deccanherald.com/national/4000-single-day-covid-deaths-for-third-day-in-a-row-343-lakh-new-infections-985709.html" target="_blank"><strong>Read | 4,000 single-day Covid deaths for third day in a row; 3.43 lakh new infections</strong></a></p>.<p><strong>What were Phase 1 and Phase 2 trial results?</strong></p>.<p>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.</p>.<p>Mahima Datla, Managing Director, Biological E, <a href="https://www.news18.com/news/india/biological-e-vaccine-phase-iii-trial-rollout-price-all-you-need-to-know-3735116.html" target="_blank">told News18</a>, “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."</p>.<p>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.</p>.<p><a href="https://www.deccanherald.com/international/india-s-wider-gap-for-covishield-doses-a-reasonable-approach-says-fauci-985714.html" target="_blank"><strong>Also Read | India’s wider gap for Covishield doses a reasonable approach, says Fauci</strong></a></p>.<p><strong>When will the vaccine be ready?</strong></p>.<p>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.</p>.<p>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 <a href="https://timesofindia.indiatimes.com/business/india-business/biological-e-set-for-covid-vaccine-rollout-by-august/articleshow/82445644.cms" target="_blank">an interview</a> with The Times Of India.</p>.<p>Datla has also mentioned that they would like to apply for emergency use authorisation (EUA) for the drug based on government advice.</p>.<p><a href="https://www.deccanherald.com/state/top-karnataka-stories/false-negatives-compound-covid-19-ordeal-for-many-in-bengaluru-985661.html" target="_blank"><strong>Also Read | False-negatives compound Covid-19 ordeal for many in Bengaluru</strong></a></p>.<p><strong>How is this vaccine priced?</strong></p>.<p>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.</p>.<p>Datla also reiterated that this vaccine is going to be affordable.</p>.<p>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.</p>