New Delhi, January 12
The central government has procured 1.1 crore doses of Covishield vaccine from the Serum Institute of India, the health ministry said in its briefing on Tuesday.
The central government said it cost Rs 200 per dose, excluding taxes. Covaxin, the other vaccine that has been approved for use in India, has cost the government Rs 206 a dose to procure.
VK Paul, member (health) of Niti Aayog, said at the briefing that both vaccines were safe for use, despite the controversy surrounding the lack of data on Covaxin, a vaccine that is still in phase 3 of its trials.
This will be used in the central government’s first phase of inoculation that will begin on January 16. The central government aims at vaccinating three crore frontline workers, including health workers, in the first phase. The Centre will bear the cost of that phase.
Drug Controller General of India, the country’s federal drug regulator, has so far approved two vaccinations—Covishield, a vaccine jointly developed by Oxford and British-Swedish multinational pharmaceutical Astrazenenca that Pune’s Serum Institute of India will manufacture for the country, and ‘Covaxin’, an indigenously developed vaccination by Bharat Biotech in collaboration with the Indian Council for Medical Research—for restricted emergency use. Covishield has already completed trials and has shown an average of 70 per cent efficacy in two doses.
The drug regulator’s approval of a vaccination that is still in Phase 3 of its trials has been controversial, with experts calling the approval premature. ICMR, one of India’s apex body overseeing biomedical research in the country, has since clarified that the approval was in “clinical trial mode”—a term that many experts say they have never heard before.
A vaccine typically goes through four stages of trial. In Phase 1, investigators spend months testing a vaccination on a small group of people with no underlying health conditions. This is mainly aimed at understanding the side-effects of the medicine and the dosage that is be required to be given. Phase 2 is administered to a larger group of people. Investigators usually administer the same dosage found safe in the previous stage, and monitor this group for several months to monitor side effects. The two stages are meant to check the immune system’s response to the vaccine.
The third stage involves a larger group of people to monitor toxicity and immunogenicity—the immune system’s response—on a much larger scale. Efficacy results of this stage are used to get approval for the vaccine.
Phase 4 usually involves monitoring the vaccination and its adverse effects continuously even after the vaccination has been released.