Clinical trial to evaluate if Covishield vaccine can prevent symptomatic Coronavirus Disease 2019 (COVID-19)
Mysore/Mysuru: Mysuru’s JSS Hospital and Medical College has been shortlisted by Indian Council of Medical Research (ICMR) for Serum Institute of India’s COVID-19 vaccine candidate — Covishield — trial. The clinical trial is designed to evaluate if an investigational vaccine can prevent symptomatic Coronavirus Disease 2019 (COVID-19) in adults.
The institution has also been shortlisted for oral medicine trial of a private pharmaceutical company. JSS, with its advanced facilities and an exclusive COVID-19 Testing Laboratory, is the second hospital in Karnataka that has been shortlisted to take up the COVID-19 vaccine trials. The other institute is Jeevan Rekha Hospital, Belagavi which has been chosen for human trials of Covaxin, another vaccine candidate.
In a latest development this morning, the Drugs Controller General of India (DCGI) has given approval to Serum Institute of India for conducting phase II and III clinical trials of Oxford University-AstraZeneca vaccine against Coronavirus disease in the country, the Union Ministry of Health & Family Welfare (MoH&FW) said.
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 DCGI permitted its trial in India.”
On July 20, the initial trial results for the vaccine candidate, Covishield, which were made public by Oxford University, had shown promising results. The preliminary trial results published in the medical journal ‘The Lancet’ said that the vaccine candidate was safe and induced immune reaction against SARS-CoV-2, which causes Covid-19, and protect healthy people from infection.
Speaking to Star of Mysore this morning, Dr. H. Basavana Gowdappa, Principal of JSS Medical College said that the ICMR had examined the records and facilities of the JSS Hospital and had shortlisted the institute for trials. “We cannot divulge any details now as things are not finalised. The trials will be to prevent symptomatic Coronavirus Disease. That’s what we know as of now and we received the shortlisted news a few days back,” he said.
Hospital sources said that the ICMR evaluated the facilities of the hospital and most likely, the institute will make the cut in Karnataka. “Samples will be sent to JSS Hospital once the preliminary process is completed at the Serum Institute. This apart, the IMCR has selected the hospital for the trials of an oral drug for COVID-19 too.
Now that the Drugs Controller General of India has approved the clinical trials, the Serum Institute of India will be able to kick-off the trials, effectively putting it ahead in India’s own race for a COVID-19 vaccine.
Serum Institute of India has a tie-up with Swedish-British firm AstraZeneca, which developed the vaccine along with The University of Oxford, to manufacture this vaccine for low-and middle-income countries. The firm plans to conduct its phase II/III trials on around 1,600 participants. The vaccine is made from a weakened version of a common cold adenovirus taken from Chimpanzee and genetically modified to make it impossible for it to infect humans.