A research scientist works inside a laboratory at the Serum Institute in India, the world’s largest vaccine manufacturer, working on vaccines against the coronavirus disease (COVID-19) in Pune. (Image used for representation: Reuters)
The Pune-based company halted trials on Thursday, saying it would review the situation and wait for pharmaceutical giant AstraZeneca to restart its trials in the UK.
- News18.com New Delhi
- Last update: September 12, 2020 11:19 PM IST
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The Serum Institute of India (SII) said on Saturday that the phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate will resume after receiving the green signal from the Controller General of Medicines of India (DCGI). The development came shortly after pharmaceutical giant AstraZeneca said it had resumed clinical trials after getting the go-ahead from British regulators.
“Once DCGI (Comptroller General of Drugs of India) gives us permission to restart the trials in India, we will resume them,” said SII Executive Director Adar Poonawalla. In a tweet, he urged people not to “jump to conclusions until the trials are fully concluded.”
As I mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example of why we must not skew the process and we must respect the process to the end. Good news, @UniofOxford. https://t.co/ThIU2ELkO3
– Adar Poonawalla (@adarpoonawalla) September 12, 2020
The statement came in response to AstraZeneca’s announcement that vaccine trials have resumed in the UK. “Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have been resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” the company said in a statement. release.
The Comptroller General of Drugs of India, Dr. VG Somani, had directed the SII to increase the safety control of the already vaccinated subjects as part of the trial and to present the plan and report. This was days after AstraZeneca said it had stopped trials due to “unexplained illness” in a study participant.
The central drug regulatory authority had issued a show of cause notice to IBS on September 9 for failing to inform it that AstraZeneca has paused clinical trials of the candidate vaccine in other countries and also for failing to submit victim analyzes of “serious adverse events informed “.
The Pune-based firm had said Thursday that it was pausing the trials and reviewing the situation until AstraZeneca restarts them.
AstraZeneca’s candidate vaccine is one of nine worldwide currently in late-stage phase 3 human trials.
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