MUMBAI: A day after Oxford University-AstraZeneca announced that trials of its proposed Coronavirus vaccine candidate have resumed, the Serum Institute said it is awaiting further instructions from the Indian drug regulator. Clinical trials for the AstraZeneca-Oxford coronavirus vaccine resumed in the UK after the Medicines Health Regulatory Authority (MHRA) confirmed it was safe to do so, the company said on Sept. 12.
While the international trials were halted on September 8, the Serum Institute halted the trials in India days later, on September 10, following a show of cause notice issued by the country’s drug regulator. The international trials were suspended by the British pharmaceutical company AstraZeneca due to a serious side effect reported in a participant from the United Kingdom.
On September 6, the standard review process triggered a voluntary pause in vaccination in all global trials to allow review of safety data by independent committees and international regulators, according to a statement from AstraZeneca. The UK committee has concluded its investigations and recommended to the MHRA that it is safe to resume trials in the UK, he added.
Drug Comptroller General VG Somani sought to know in the notice to Serum why the permission granted for Phase 2 and 3 trials should not be suspended until patient safety is established. The regulator also asked the company to suspend new recruitment of subjects in phase 2 and 3 clinical trials until new orders are submitted. The Pune-based firm had not informed the regulator about the adverse event reported in the global lawsuit, saying on September 10 that it was continuing with the lawsuits as it had faced no problems.
In June, the British company AstraZeneca signed a pact with Serum to manufacture one billion doses of the vaccine at its Pune facility. Previously, the company had announced phase 2 and 3 trials of 1,600 patients at 17 sites in India after the regulator approved in August.
The outcome of these trials is being closely monitored in India and around the world, as the AstraZeneca candidate vaccine is a strong competitor and could be the first to be implemented at an advanced stage. The company expects a vaccine to be ready by the end of the year or early 2021.
AstraZeneca and the University of Oxford, as sponsors of the trial, cannot release further medical information, the statement added. All investigators and trial participants will be updated with relevant information and this will be disclosed in global clinical registries, in accordance with clinical trial and regulatory standards.
.
