Serum Institute to resume COVID-19 vaccine trials in India after DCGI nod
Sep 12, 2020
New Delhi [India], September 12 : Hours after clinical trials for AstraZeneca and Oxford University coronavirus vaccine resumed on Saturday in the UK, pharma major Serum Institute of India (SII) said it will resume the trials in India once Drugs Controller General of India (DCGI) gives it requisite permission.
AstraZeneca PLC had on September 6 paused the trial of coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was also reported that the clinical trials had been put on hold in other countries including USA, UK, Brazil and South Africa.
Following the developments, India's top drugs regulator had asked SII to suspend any new recruitment in phase two and three clinical trials for COVID-9 vaccine till further orders.
The DCGI directed the pharma company to increase safety monitoring of the subjects already vaccinated with the candidate vaccine and submit its plan and report.
SII now has to submit clearance from Data and Safety Monitoring Board (DSMB), UK and DSMB India to obtain clearance from DCGI's office before it can resume trials, officials said.
"Once DCGI will give us the permission to restart the trials in India, we will resume the trials," Serum Institute of India said in its statement.
According to the reports on Saturday, clinical trials for 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.
Adar Poonawalla, CEO and Owner, Serum Institute of India, said no conclusions should be drawn till the trials are completed.
"As I'd mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chains of events are a clear example why we should not bias the process and should respect the process till the end. Good news, UniofOxford," he said in a tweet.
India's top drugs regulator granted permission to SII on August 2 to conduct phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.
The vaccine will be manufactured by Serum Institute in India under technical collaboration with Oxford University and AstraZeneca which have developed the candidate vaccine.
