Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod
After pharma company AstraZeneca announced the resumption of its Covid-19 vaccine trial in the UK, its India partner Serum Institute said it will also restart the trials once the Drug Controller General of India (DGCI) gives the nod.
DGCI has earlier sent a show-cause notice to the Pune-based firm, questioning why it has not stopped trials while trials have been stopped in four other countries after a UK volunteer reportedly showed symptoms of neurological disorder which affects the spinal cord. Following this, Serum Institute of India paused the phase 3 trial in India, which was scheduled to begin next week.
“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” AstraZeneca said in a statement on Saturday.
“As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford,” Serum Institute of India’s CEO Adar Poonawalla tweeted after AstraZeneca announced it is resuming the trials.
The World Health Organization’s (WHO) chief scientist on Thursday said AstraZeneca’s pause of an experimental vaccine for the coronavirus after the illness of a participant is a “wake-up call”. “This is a wake-up call to recognise that there are ups and downs in clinical development and that we have to be prepared,” Soumya Swaminathan said.
HT
