AstraZeneca Gets India Go-Ahead To Resume COVID-19 Vaccine Trials, US Nod Awaited

AstraZeneca plc AZN COVID-19 vaccine clinical trial is set to resume in India after local partner Serum Institute of India received the go-ahead from Indian regulators, Reuters reported Wednesday.

What Happened: The Drugs Controller General of India has approved the trial of the British drugmaker’s COVID-19 vaccine, a person familiar with the matter told Reuters. Trials have reportedly also restarted in Brazil and South Africa.

AstraZeneca has yet to get clearance from the Food and Drug Administration to resume trials in the United States, Bloomberg reported.

FDA Commissioner Stephen Hahn said during an online event, as per Bloomberg, that the regulator is “going to do very significant work with the company to figure out if there’s a significant safety issue or not.”

Why It Matters: The Cambridge, United Kingdom-based drugmaker resumed its vaccine trails in the United Kingdom last week after a temporary suspension due to a volunteer developing symptoms of a neurological disorder.

On Tuesday, Pfizer Inc PFE said its vaccine candidate caused no major side effects in trial volunteers participating in a late-stage study.

The Centers for Disease Control and Prevention asked states earlier in September to be ready to distribute two vaccine candidates, most likely ones being developed by Moderna Inc MRNA and Pfizer, according to the New York Times.