Serum Institute begins clinical trial of Oxford Covid-19 vaccine in India
Oxford Covid-19 vaccine: The Oxford-AstraZeneca COVID-19 vaccine candidate has been in the news for being one of the most promising and potential vaccines against novel coronavirus, the deadly virus that causes COVID-19 disease. Serum Institute of India, who are the official partners for the distribution and marketing of the vaccine in India and many other countries, on Tuesday, began clinical trials of the vaccine candidate.
SII’s trials for the Oxford-AstraZeneca vaccine, Covishield, started on Tuesday with the first batch of volunteers being screened by the Bharati Vidyapeeth Deemed University (BVDU) Medical College and Hospital in Pune.
On Tuesday, as part of the process, the three men and women each were screened. They will be administered the vaccine if their RT-PCR and antibody test reports are clear.
“We are enrolling six persons for the trial, and the screening process is underway. Their RT-PCR and antibody tests are being conducted. If the reports are favorable, the vaccine doses will be administered,” Dr. Sanjay Lalwani, medical director of Bharati Vidyapeeth’s medical college and hospital, confirmed.
“Today, we have screened some patients. Tomorrow, we will get their COVID antibody test reports, and if they come negative, we will inoculate with the ‘Covishield’ vaccine,” Sanjay Lalwani, principal investigator for the hospital said. He added that the hospital aims to have about 300-350 participants as part of the trial.
The Indian Council of Medical Research director-general, Balram Bhargava also confirmed that the trials for Covishield have begun in the country. ICMR apart from being the apex medical research institute in the country is also the secondary sponsor to phase 2 and 3 trials of Covishield, to be conducted on around 1,600 participants. Another vaccine undertrials in the country, Covaxin, has been developed by Bharat Biotech in collaboration with ICMR.
The vaccine candidate, developed by Jenner Institute of Oxford University, will be launched under the brand name “Covishield” in India. The Serum Institute has tied up with British-Swedish pharmaceutical firm AstraZeneca to produce 1 billion doses of the vaccine in the country.
The vaccine is made from a weakened version of a common cold, adenovirus, taken from chimpanzees, and genetically modified. The vaccine candidate – ChadOx1NcOV – has shown encouraging results in early human trials, according to experts. Results of the Phase 1/2 trial, published in ‘The Lancet’ medical journal, shows that the vaccine had induced strong immune response.
Screening and enrollment of participants for such clinical trials is a long process, undertaken only after getting approval from the ethics committee of the hospital. While the trials are planned to be conducted at 17 sites in the country, only seven have so far received such approvals, and BVDU is one of them. Others include Jehangir Clinical Development Center and KEM Hospital in Pune, King George Hospital at Visakhapatnam, Rajendra Memorial Research Institute of Medical Sciences at Patna. All these hospitals are likely to begin screening of participants later this week. In about 1-2 days of receiving the approval, the hospitals will start administering the vaccine to the participants in the trials, sources have said.
Oxford-AstraZeneca vaccine in India was reported to be ready in 73 days, on Sunday. However, SII later refuted such claims and said that the vaccine will only be commercialized after proper trials are conducted. Two more vaccines – Bharat Biotech’s Covaxin, and Zydus Caldia’s Zy-CoV-D are also undertrials in the country.