Serum Institute to resume Covid-19 vaccine trial after DGCI gives its go-ahead


After pharmaceutical company AstraZeneca announced the resumption of its Covid-19 vaccine trial in the UK, its partner at India Serum Institute said it will also restart trials once the General Medicines Controller of India (DGCI) gives its okay.

The DGCI previously sent a show of 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 show symptoms of a neurological disorder affecting the spinal cord. After this, the Serum Institute of India stopped the phase 3 trial in India, which was scheduled to start next week.

Read also | AstraZeneca trial of Oxford coronavirus vaccine resumes after UK green light

“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,” AstraZeneca said in a communicated on Saturday.

“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, ”Serum Institute of India CEO Adar Poonawalla tweeted after AstraZeneca announced it will resume testing.

The World Health Organization (WHO) chief scientist said Thursday that AstraZeneca’s pause from an experimental vaccine for coronavirus after a participant’s illness is a “wake-up call.” “This is a wake-up call to recognize that there are ups and downs in clinical development and that we have to be prepared,” said Soumya Swaminathan.

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