Serum has partnered with AstraZeneca to carry out trials and manufacture the Oxford University's Covid-19 vaccine doses in India at its Pune facility.
Pune-based vaccine maker Serum Institute of India on Thursday halted the ongoing clinical trials of the Covid-19 vaccine in the country. “We are reviewing the situation and pausing India trials till AstraZeneca restarts trials,” a statement issued by the institute said. It further said the company was following the Drugs Controller General of India’s (DCGI) instructions and would not be able to comment further on trials.
The company did not comment on the impact of this decision on its vaccine manufacturing plans in India. Serum has partnered with AstraZeneca to carry out trials and manufacture the Oxford University’s Covid-19 vaccine doses in India at its Pune facility.
The decision to halt the trials was made after the company was pulled up by Dr VG Somani, the Drugs Controller General of India, for failing to inform about AstraZeneca pausing the clinical trials of the Oxford Covid-19 vaccine in other countries and not submitting the casualty analysis of the reported serious adverse event.
The DCGI sought an explanation from Serum as to why the permission granted on August 2 for Phase 2 and 3 clinical trials of the vaccine candidate should not be suspended. A Serum team was in Delhi to meet the officials and subsequently announced that they were halting the trials.
Serum was in the process of recruiting 1,600 participants for the India trial and had started administering the shots across the 17 trial sites across the country. It had started manufacturing the Covid-19 vaccines at its Pune facility and was looking at making 60-70 million doses per month.
AstraZeneca has voluntarily paused vaccination for reviewing of safety data by an independent committee. They called it a routine action and expect to resume trials after the review.
AstraZeneca and Oxford had started Phase 3 trials for the Covid-19 vaccine in August with trials in the US, the UK, Brazil, South Africa and India and cover 30,000 participants across 100 sites to assess safety, efficacy and immunogenicity of the vaccine.