Written By: Longjam Dineshwori | Updated : August 3, 2020 10:55 AM IST
Serum Institute CEO Adar Poonawalla said they hope to launch Oxford-AstraZeneca coronavirus vaccine by the end of 2020.
As COVID-19 continues to spread around the world, countries are racing to find a vaccine for the disease. Russia is likely to start a mass vaccination campaign against the novel coronavirus in October, Russian media reported quoting health minister Mikhail Murashko. As per media reports, a COVID-19 vaccine developed by Russia's Gamaleya Institute has successfully completed clinical trials and is expected to be approved by regulators this month. Three more COVID-19 vaccine candidates have completed early clinical trials and found to be safe and to induce an immune response in healthy volunteers. These are the vaccines developed by Oxford University with support from AstraZeneca, China's CanSino Biologics and another by U.S. pharmaceutical company Pfizer and German biotechnology company BioNTech. Particularly, the Oxford vaccine is drawing the attention of experts from across the globe.
The Serum Institute of India (SII) is one of the partners of AstraZeneca for manufacturing the Oxford vaccine candidate. SII is preparing to manufacture 20 crore 200 million doses of Oxford-AstraZeneca coronavirus vaccine, which will be called Covishield in India. The institute has also been granted permission by the Drugs Controller of General of India (DCGI) to conduct Phase 2, 3 human trials of the vaccine in the country.
The DCGI nod late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee on COVID-19, government officials told PTI.
"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the news agency quoted an official as saying.
Currently, clinical trials of the Oxford vaccine candidate are being conducted in the United Kingdom, Brazil and South Africa.
The SII had submitted a revised proposal for phase 2 and 3 clinical trials on Wednesday and included additional information sought by the expert panel.
According to the revised proposal, the trials will be conducted across 17 selected sites and enroll 1,600 people aged above 18 years. The trial sites include AIIMS Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
The observer-blind, randomized controlled study aims to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults.
The SII had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine.
Serum Institute CEO Adar Poonawalla said they hope to launch Oxford-AstraZeneca coronavirus vaccine under the brand name Covishield by the end of 2020. He is also hopeful that it will be an efficacious, immunogenic vaccine, viable for mass use.
According to Poonawalla, the institute is also aiming to announce the availability of its own COVID-19 vaccines by the end of 2021. He informed media persons that they are working on five coronavirus vaccine candidates including 2 of their own. The two vaccine candidates of SII are Codagenix, which is in pre-clinical trials, and the second one is Novavax, which is just a month or two behind the Oxford-AstraZeneca vaccine Poonawalla said.
