Serum Institute to resume vaccine trials after DCGI nod

MUMBAI: A day after Oxford University-AstraZeneca announced that trials of its proposed Coronavirus vaccine candidate have resumed, Serum Institute said it is awaiting further direction from India's drug regulator. Clinical trials for the AstraZeneca-Oxford coronavirus vaccine resumed in the UK following a confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the company said on September 12.
While international trials were paused earlier on September 8, Serum Institute halted India trials days later on September 10, following a show-cause notice issued by the country's drug regulator. International trials were suspended by UK drug company AstraZeneca due to a serious side-effect reported in a UK-based participant.
On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators, a statement by AstraZeneca says. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume, it added.
Drugs Controller General VG Somani sought to know in the notice to Serum why permission granted for Phase 2 and 3 trials shouldn’t be suspended till patient safety is established. The regulator also asked the company to suspend new recruitment of subjects in phase 2 and 3 clinical trials till further orders. The Pune-based firm had failed to inform the regulator about the adverse event reported in the global trial, and had said on September 10, it was continuing with trials since it had faced no issues.
In June, UK firm AstraZeneca had signed a pact with Serum for manufacturing a billion doses of the vaccine at its Pune facility. Earlier, the company had announced Phase 2 and 3 trials of 1,600 patients across 17 sites in India after the regulator’s go ahead in August.
The outcome of these trials is being watched closely in India and globally as the AstraZeneca vaccine candidate is a strong contender and could be the first one to be rolled out being in an advanced stage. The company hopes that a vaccine would be ready by year-end or early 2021.
AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information, the statement adds. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.