Skip to content

Serum Institute approved to resume India trial of AstraZeneca COVID vaccine

September 16, 2020

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 (DCGI), according to the source.

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, but remain on hold in the United States.

Indian regulators had allowed Serum’s trials of the AstraZeneca vaccine to resume under certain conditions, including increased safety monitoring and informing volunteers about new findings, a DCGI source said.

“We allowed them (to resume trials) after a detailed discussion with authorities in the UK and the company itself,” the source added.

https://www.reuters.com/article/us-health-coronavirus-serum-institute/serum-institute-gets-approval-to-resume-india-trial-of-astrazeneca-covid-vaccine-source-idUSKBN2670PP

From → Uncategorized

Leave a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

%d bloggers like this: