SII produces 1.5 billion annual dosages for polio, diphtheria, tetanus, BCG among other vaccines.
Pune's Serum Institute of India
(SII) is all set to start phase-2 clinical trials of the Oxford University
prime vaccine candidate (AZD-1222) developed in collaboration with British-Swedish pharma giant AstraZeneca.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
"This is because large-scale trials on over 10,000 healthy volunteers is being conducted by Oxford University
in the UK and the primary data would be made available to the Indian regulator for review," said someone close to the development. By November, one can expect some conclusive data to be out, the person said.
vaccine candidate is a front runner in the vaccine development race globally and in India, SII has partnered with AstraZeneca
to make and supply the vaccine in India and other low and medium income countries (LMIC). Meanwhile, SII has started producing Covishield at Pune.
SII is conducting phase-2 and 3 trials in the country India to access data on the Indian demographics. The Drug Controller General of India (DCGI) gave its nod to SII to conduct the trials here in the first week of August. The subject expert committee (SEC) on Covid-19 evaluated SII's proposal and approved it for an observer-blind, randomised controlled study to determine the safety as well as immunogenicity (the ability of the vaccine to evoke an immune response) of the Oxford-AstraZeneca vaccine candidate.
Dubbed Covishield, the vaccine is also under trials in Brazil and South Africa apart from the UK. "It is important to conduct the trials on Indian volunteers as there are not many Asian volunteers in the UK trials," said a government official.
In India, each subject will be given two doses of the vaccine four weeks apart, after which safety and immunogenicity will be assessed at pre-set intervals. Trials will happen across 17 sites on 1,600 healthy volunteers aged above 18 years.
Some of the sites chosen for trial include AIIMS, Delhi, AIIMS, Jodhpur, Nehru Hospital in Gorakhpur, BJ Medical College in Pune, Andhra Medical College in Vishakhapatnam, KEM Hospital and Nair Hospital in Mumbai. SII did not verify the names of the sites.
Around 160 people are likely to be a part of the KEM Hospital group. The proposal is under review of the ethics committee. The Indian Council of Medical Research (ICMR) wrote to the hospital in the first week of August regarding this trial. "Screening of people for Covid19 antibodies will begin and we wont recruit very young or very old people," said Hemant Deshmukh, dean of KEM Hospital
After phase-2 of the trial, SII will submit safety data, evaluated by the Data Safety Monitoring Board, to the Central Drugs Standard Control Organisation (CDSCO). Once it gets a nod, it can proceed to phase 3. As such data published in peer reviewed medical journal The Lancet in July showed that the vaccine candidate induced a strong immune response and nor major safety concerns in the early stages of the study in UK.
SII has also secured $150 mn risk funding from the Bill and Melinda Gates Foundation to supply 100 mn doses to Gavi, the Vaccine Alliance at Rs 250 per dose. The firm has noted that it will keep the prices below Rs 1,000 per dose in India. India is also a part of the countries where Gavi will supply the vaccine to ensure equitable distribution of Covid vaccines across the globe.