Serum Institute gets approval to resume Indian trial of AstraZeneca COVID vaccine: source
An employee is seen at the Reference Center for Special Immunobiologicals (CRIE) of the Federal University of Sao Paulo (Unifesp) where the trials of the Oxford/AstraZeneca coronavirus vaccine are conducted, in Sao Paulo, Brazil, June 24, 2020. PHOTO: REUTERS
Serum Institute of India has received Indian regulatory approval to resume local clinical trials of AstraZeneca’s potential COVID-19 vaccine, a source familiar with the matter said on Wednesday.
The approval came from the Drugs Controller General of India, the source said.
AstraZeneca has resumed British clinical trials of the vaccine - one of the most advanced in development for COVID-19 - after they were paused earlier this month following a serious side effect in a trial participant.
Trials have also resumed in Brazil and South Africa.
The trial remains on hold in the United States, the U.S. Food and Drug Administration’s top official confirmed on Tuesday.
Serum, the world’s biggest vaccine manufacturer, did not immediately respond to Reuters’ requests for comment. The DCGI did not return an email seeking comment.