Serum Institute gets nod for Oxford vaccine trials
NEW DELHI: India’s drug controller on Monday gave approval to Pune-based vaccine manufacturer Serum Institute of India (SII) for conducting phase II and III clinical trials on the vaccine against the coronavirus disease (Covid-19) developed by Oxford University and Astrazeneca, according to the Union health ministry.
The trials are expected to begin within the week, according to people aware of the matter.
This would make the Oxford a st raze ne ca vaccine—called Covishield — the first one to enter phase II and III trials in India. Phase I human trials have started on two indigenously developed vaccines — Bharat Biotech International Ltd’s Covaxin and Zydus Cadila’s ZYCOV-D — to assess their safety.
The company has already bet big on the vaccine working — investing up to $450 million in mass-producing the vaccine.
Serum Institute of India declined to comment on
the regulatory approval for it to conduct the trials.
Four other vaccine candidates being supported by the Department of Biotechnology (DBT) under the science ministry are in advanced stages of pre-clinical trials and are likely to enter human trials in another four to six weeks.
Confirming the development, a senior official in the Central Drugs Standard Control Organisation (CDSCO) said: “The subject expert committee that went through the data and protocol
submitted for the trial was satisfied with the results, and based on their opinion the drugs controller permitted its trial in India.”
It was always understood that India’s drug regulator would approve the clinical trials once on July 20, Oxford University published research that showed that the initial trial results of the vaccine candidate were promising.
CHANDIGARH : The Postgraduate Institute of Medical Education and Research (PGIMER) is among 17 institutes across the country chosen for trials of the Oxford University-astra Zeneca – Covid-19 vaccine (Covishield), which it’s likely to start by the end of August.
The institute has been selected for the trials after the Drugs Controller General of India granted approvals to the Serum Institute of India in Pune for conducting phase 2 and 3 of the Covishield trials.
Dr Madhu Gupta, Principal Investigator of the trials and professor, Community Medicine and School of Public Health, PGIMER, says the protocol has just been finalised and clearance for trials will be sought by the ethics committee of the institute.
“Things are going at a really fast pace. The ethics committee will now review the protocol because the patient’s safety is the utmost priority. They will see the harms and the benefits and once they approve it, we will look for a site, recruit staff and start the trial. I think by the end of this month we will be able to start the recruitment of individuals for six-month long trials,” Dr Gupta said.
The institute will advertise for participants who are above 18-years of age, healthy, have not contracted the infection and are not in contact with any Covid-19 positive patient.
“Around 2,000 people will be examined and about 1,600 persons will be selected. Out of them we have committed around 250 people from PGIMER. Recruitment will be done in the first month and it will be a competitive process among the sites. We will see whether participants develop protection against the virus,” Dr Gupta said.
Prof Jagat Ram, director, PGIMER, said, “The results of the trials will have far-reaching impact. We will strengthen our capacities, wherever required, to come out with tangible outcomes. A core group will be constituted to work out the modalities and comprehensive plan with timelines to meet the desired expectations of the Drugs Controller General of India and contribute towards containing the pandemic to the best of our abilities.”
Around 2,000 people will be examined and 1,600 will be selected. Of them, we have committed around 250 from PGIMER. DR MADHU GUPTA, principal investigator for the trials.