India seeks vaccine data

INDIA’S drugs regulator said last Wednesday (9) that it had sought more data to make a decision on emergency authorisation for AstraZeneca’s Covid-19 vaccine candidate and one developed locally by Bharat Biotech and the government.

India, which is the world’s biggest vaccine-maker, has said it may authorise some shots in the coming weeks, and experts at the country’s Central Drugs Standard Control Organization (CDSCO) met under an “accelerated approval process” to discuss the applications that were made only last week.

The regulator said it asked the Serum Institute of India, which is the local manufacturer of the AstraZeneca vaccine, to present updated safety data from its ongoing third-stage trial in the country.

It has also asked for immunogenicity data from clinical trials in the UK and India, and for the British authorities’ assessment of its emergency-use request there.

Bharat Biotech will also have to provide safety and efficacy data from its vaccine candidate’s ongoing Phase III clinical trials in India for further consideration. The company had only presented data from the initial trials.

The Serum Institute did not respond to requests for comment. Bharat Biotech declined to comment.