Serum Institute of India officially halts the trial of Astrazeneca-Oxford vaccine in India

Serum Institute of India (SII) on Thursday said that it was halting the trial of the Astrazeneca-Oxford University Covid vaccine in India, a move that comes after it received a show cause notice from the Drug Controller's General of India (DCGI) that had pulled up the company for not informing it about the adverse event that was reported in the global trial. Serum on Wednesday morning had said that it was going ahead with the trial of the vaccine in India despite Astrazeneca's decision to halt it.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials", said Adar Poonawala, CEO of Serum Institute of India in a statement. Poonawala added that the company is following the DCGI’s instructions. ET had reported on Wednesday that the Principal Investigators working on this vaccine have halted recruitment of participants for the trial as the Data Safety Monitoring Board had not given their nod to start the trial.


The DCGI asked the company to explain why its trials should not be suspended as it has not informed the central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of Phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns. V G Soman, the Drug Controller General of India also threatened “action deemed fit” in the absence of a quick response from SII.

AstraZeneca and Oxford University this week announced that trials of the vaccine were being put on hold in countries such as the US, UK, Brazil and South Africa.

“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered, and we voluntarily paused vaccination to allow review of safety data by an independent committee,” AstraZeneca said in a release.

SII, which has tied up with AstraZeneca to manufacture the University of Oxford’s vaccine candidate for Covid-19, was to have begun Phase 2 trials last week with the recruitment of 1,600 participants across the country.

SII, the world’s largest vaccine manufacturer by volume, had said it would supply 400 million doses by December. ET reported last month that SII had set a price of $3 for each Covid-19 vaccine dose for low- and middle-income countries as part of a partnership with Gavi, The Vaccine Alliance and the Bill & Melinda Gates Foundation. It is to manufacture and deliver up to 100 million doses of the AstraZeneca-Oxford and Novavax Covid-19 vaccines for India and 92 other low- and middle-income countries that can be available as early as the first half of 2021, SII said in a statement.