AstraZeneca Oxford University COVID-19 vaccine trials resumed!
Galatta | Sep 13, 2020, 02:53 pm
The world is racing to find a cure or vaccine for the COVID-19 Novel Corona Virus Pandemic that has been rapidly spreading across all the countries! There are very few vaccine candidates which are in the advanced level of phase 3 clinical trials. One such vaccine is the AZD1222, being jointly developed by AstraZeneca and the Oxford University. The Phase 3 trials were put on hold, after 1 of the volunteers developed some unknown complications. The case was investigated and it came to be known that the volunteer had neurological symptoms. An independent Committee was formed to look into the complications and review safety, as part of a routine step as mentioned by the company as well as the World Health Organisation (WHO).
AstraZeneca has now stated that the Committee, "has concluded its investigations and recommended to the MHRA that the trials in the UK are safe to resume!" Following this recommendation, the Phase 3 clinical trials have resumed in the UK. After the trials were paused in the UK, the Drug Controler General of India (DGCI) had sent a showcause notice to Serum Institute of India, demanding why they had not been informed of the complications in the trial. Serum Institute of India, which is handling the trials for AZD1222 in India, also paused the trials following the complications. However, despite the trials resuming in the UK, the Indian trials would only resume after approval from the DGCI!
Talking about this, Adar Poonawalla - the CEO of Serum Institute of India said, "We should not jump to conclusions until the trials are fully concluded." He also added, "The recent chain of events are a clear example why we should not bias the process and should respect the process till the end." Talking about this hiccup in the trials, the WHO Chief Scientist Soumya Swaminathan said, "This is a wake-up call to recognise that there are ups and downs in clinical development and that we have to be prepared." The AZD1222 is one of the nine COVID vaccines which are in the late Phase 3 trials, around the world. The statement from AstraZeneca continued, "AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials."