New Delhi: The Drugs Controller General of India (DGCI) has
given approval to the Pune-based Serum Institute of India (SII) to conduct
Phase 2 and 3 human clinical trials of the Covid-19 vaccine candidate developed
by the Oxford University.
“Each subject will be administered two doses four weeks
apart, following which the safety and immunogenicity will be assessed at
predefined intervals… SII has to submit the safety data to the Central Drugs
Standard Control Organisation (CDSCO) at each stage before proceeding to the
next,” a senior official was quoted as saying.
As many as 1600 people over 18 years of age will be
administered with ‘COVISHIELD’ as part of the trials being conducted at 17
selected institutes, including AIIMS, Delhi, in the country.
SII, the world’s largest vaccine maker, has entered into a
pact with Swedish-British pharma giant AstraZeneca which developed the vaccine
candidate along with the University of Oxford, UK. It aims to manufacture a
billion doses for low and middle-income countries by 2021.
Initial trials on 1,077 adults in UK revealed that the
vaccine provoked a T cell response within 14 days of vaccination (white blood
cells that can attack cells infected with the SARS-CoV-2 virus), and an
antibody response within 28 days (antibodies are able to neutralise the virus
so that it cannot infect cells when initially contracted). Also, there were no
serious adverse health events during trials so far.
Currently, phase 2 and 3 clinical trials of the Oxford
vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in
Brazil and phase 1 and 2 clinical trials in South Africa.