TrialSite has chronicled the onset of the AstraZeneca Phase 3 trial, investigating what was purportedly one of the frontrunning COVID-19 vaccine candidates known as the “Oxford” vaccine or AZD1222. In India, the commercial sponsor AstraZeneca has partnered with an elite company known as Serum Institute of India, the world’s busiest vaccine manufacturer owned by a billionaire family. With the study placed on hold in the United States by the US Food and Drug Administration (FDA) due to a couple of safety events in the United Kingdom (UK), the trial resumed in the UK, Brazil, and India. Although a participant died in the Brazil trial recently, it was identified in the local media that the individual didn’t receive the study vaccine, but rather the placebo; hence the study continued. Now Brihanmumbai Municipal Corporation (BMC) in Mumbai, which has been conducting a Phase 2 clinical trial investigating AZD1222 on as many as 163 healthy volunteers at both BMC run King Edward Memorial (KEM) Hospital and BYL Nair Hospital, reports that the vaccine elicits a strong immune response and adverse events.
They May Have Sufficient Data
According to a recent local news report from Hindustan Times, Suresh Kakani, municipal commissioner for BMC, reports, “We are planning to include 50 more volunteers, 25 of each from the two hospitals, for the trial. We are expecting to run the trial on 200 volunteers. But if experts believe 13 candidates are enough for the conclusion of the second phase, we may stop selecting more candidates.”
Indian Clinical Trials Insurance Coverage Indicates All OK Thus Far
According to this Indian media, Mr. Kakani commented that the Indian Council of Medical Research (ICMR), the national Indian research agency, insures every trial participant for death and/or adverse events. Kakani emphasized that thus far, there has been no need for insurance payments—e.g., no adverse effects of any kind, which is promising given the incident that occurred in the UK. However, it should be noted that this has only been a Phase 2 trial with 163 participants, while the Phase 3 study involves up to 40,000.
Call to Action: This news is promising, given it would appear that this Phase 2 study is getting close to wrapping up, and at least thus far, there are no reported adverse events involving the Oxford vaccine (AZD1222). Of course, as we have all learned with COVID-19 and vaccine and therapy trials, things are subject to change. TrialSite tracks these COVID-19 vaccine trials closely.