The Drug Controller General of India on Monday announced that it has given approval to Serum Institute of India, Pune, to conduct Phase 2 and 3 clinical trials of the Oxford University's Astra Zeneca Covid-19 vaccine (COVISHIELD) in India.
In London, the UK government said that its manufacturing pact with Mumbai-based global pharmaceutical and biotechnology company Wockhardt will guarantee the supply of millions of doses of COVID-19 vaccine, whenever it is ready.
The Department for Business, Energy and Industrial Strategy in UK confirmed it has entered into an 18-month agreement with the company to carry out the crucial "fill and finish" stage of the manufacturing process, which involves dispensing the manufactured vaccine substance into vials ready for it to be distributed. In the UK, Wockhardt is one of the largest suppliers of the National Health Service for over 20 years.
Also, the Department of Biotechnology, under the Union Science and Technology Ministry, has identified 11 centres where several thousands of healthy volunteers will be tested in large-scale trials of two Indian vaccines.
The first set of selected institutions includes King Edward Memorial Medical College, Pune, Inclen Trust, Palwal (Haryana), National Institute of Epidemiology, Tirunelveli (Tamil Nadu), Christian Medical College, Vellore, and Society for Health and Allied Research, Hyderabad.They are to begin within weeks preparatory activities such as surveillance studies to decide the local population's exposure to infections.The second set of institutions includes two in Delhi and one each in Visakhapatnam, Bhubaneswar, Puducherry and Shillong.These two are home-grown vaccines, one developed by Bharat Biotech, Hyderabad, and another by Zydus Cdila, Ahmedabad. Tests to determine the safety and efficacy of these vaccines began early last month at multiple sites across the country.The trials will determine safety of the vaccines and their capacity to generate an immune response. If the trials are encouraging, the vaccines will be then assessed for their capacity to protect people from infection through the large-scale Phase 3 trials.
On Sunday, Russia announced that it plans to start a nationwide inoculation campaign in October with a vaccine that is yet to complete clinical trials, the latest evidence of the global potential for cutting corners.
In US, despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.
The Food and Drug Administration’s approval of a new vaccine is typically an exhaustive process, where agency employees meticulously go through data from clinical trials to review whether the vaccine is both safe and effective, reports New York Times. The threshold for approving vaccines is typically higher than it is for therapeutic drugs because they will be used in millions of otherwise healthy people, meaning that even rare side effects could affect many more people than a drug that treats a specific illness, the newspaper adds.
