Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine for COVID-19, on Thursday issued a statement announcing that it will be pausing the vaccine trials in India till AstraZeneca restarts them. The pharma giant AstraZeneca had announced a pause on human trials of the COVID-19 vaccine after one of the volunteers developed an illness.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front,” the Serum Institute said in a statement.
We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.#SII #Latestnews #Covid_19 pic.twitter.com/CUeFY5oLus
— SerumInstituteIndia (@SerumInstIndia) September 10, 2020
In a statement issued on Tuesday evening, AstraZeneca had said that late-stage studies of AstraZeneca's COVID-19 vaccine candidate are on temporary hold and said its "standard review process triggered a pause to vaccination to allow review of safety data.”
Earlier, the Drugs Controller General of India had issued a show-cause notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate. DGCI's Dr VG Somani, in his show-cause notice, had asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
The SII had said that it is continuing with the trials in India and will follow the protocol.
During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety. The trials also assess effectiveness by tracking who gets sick and who doesn't between patients getting the vaccine and those receiving a dummy shot.
Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.
Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany's BioNTech. Those two vaccines work differently than AstraZeneca's, and and the studies already have recruited about two-thirds of the needed volunteers.
(With PTI inputs)