Suspended Vaccines trials restarted in India
The Serum Institute of India which had paused the trials of Oxford-AstraZeneca vaccine has been allowed to restart them.
The Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to continue testing the Oxford-AstraZeneca vaccine after it had been suspended on September 11, following an unexplained neurological illness in one of the trial participants. The clinical trials will go as per schedule with the earlier order to suspend any recruitment for the phase two and three trials being revoked.
AstraZeneca has resumed trials in the UK where the anomaly was reported. This happened just two days after trial was suspended after Medicines Health Regulatory Authority confirmed that the process was safe. Trials have also been resumed in Brazil and South Africa. However, trials remain suspended in the USA with the Food and Drugs Administration still not having given the go ahead. This candidate is among the most promising ones under trial across the world.
On Tuesday, the Data and Safety Monitoring Board (DSMB) of India and UK submitted recommendations and requested restarted of trials. In India, the DCGI’s green light comes with certain conditions like taking additional care during screening, ensuring better informed consent and close monitoring of side effects during follow up. The SII has also been asked to keep the DCGI updated on the details of medications used for the treatment of adverse events.
Recommendations from the DSMB include recommencing immunisation trials and enrolling remaining participants subject to conditions. This involves submitting revised participant information sheet, consent form and additional safety monitoring plan, all of which SII has complied with. The firm has also submitted a summary of safety follow up seven days after vaccination which stated there were no serious effects and reported side effects were mild and resolved themselves in the following days.
Hiccups like these are exactly the reason why we should respect the process and not jump to conclusions, according to SII’s CEO Adar Poonawalla. SII has promised to produce one billion doses and no single manufacturer has yet matched these numbers, he said. But even at this rate, it would be at least 2024 before everyone in the world is immunised, he said, assuming it would be a double dose vaccine.