Covid-19 vaccine may need ‘emergency authorisation’
Indian authorities told lawmakers on Wednesday that they are keeping open the option of an “emergency authorization” of vaccines that are undergoing clinical trials for use.
At a marathon meeting of the parliament’s home affairs panel, top officials from the Indian Council of Medical Research (ICMR) also informed MPs that phase 3 trials of the Oxford-AstraZeneca vaccine—widely considered as the global front runner—will start from this weekend with about 1,700 volunteers across 17 locations in India.
Director General of ICMR, Dr Balaram Bhargava, told the panel that phase 3 trials normally require at least 6 to 9 months. “But looking at the immediacy, the government can always go for emergency authorisation,” an official aware of the discussions quoted Bhargava as saying. Earlier, the Serum Institute of India -- which has partnered with AstraZeneca for production and trials, hinted about a shorter timeline and seeking emergency use authorisation.
The panel also discussed the psychological stress arising out of the long-drawn battle against Covid, especially among children. AIIMS director Dr Randeep Guleria told the panel that the institute will soon come up with a protocol for hospitals and other institutions on the issue.
The Union government has formed a high-level expert panel to oversee acquisition and distribution of a Covid-19 vaccine with Niti Aayog member Dr VK Paul as its head and Union health secretary Rajesh Bhushan as its co-chair. While informal discussions on the vaccine administration started last month, the panel first met on Monday to discuss a procurement deal for a Covid-19 vaccine, asking officials of five pharma firms, including three that have candidates in clinical trials, to present a road map within three days of how soon they can produce large quantities and what pricing they expect if their shot is approved.
Indian authorities are waiting for disclosure of health and efficacy data of the Russian vaccine, which became the first to be approved anywhere in the world, although scientists have flagged concerns over the lack of scientific data. For now, officials are looking at the AstraZeneca candidate as well as the one by United States’s Moderna, which at present have the largest number of people in clinical trials.
Officials involved in the planning also stated that state governments, which have been told to focus on the Test-Trace-Treat strategy, have been told not to contact or go into direct agreements with vaccine producers since all vaccines would be centrally procured to maintain a smooth distribution chain and better management.
India is also closely following nine vaccine development programmes including the ones in Germany and Israel.