India seeks more data for emergency AstraZeneca shot approval

By Nivedita Bhattacharjee BENGALURU (Reuters) - India's drugs regulator said https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MTI3NQ== on Wednesday 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 this week. The regulator said it had 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.

Reuters December 10, 2020 00:06:24 IST
India seeks more data for emergency AstraZeneca shot approval

India seeks more data for emergency AstraZeneca shot approval

By Nivedita Bhattacharjee

BENGALURU (Reuters) - India's drugs regulator said https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MTI3NQ== on Wednesday 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 this week.

The regulator said it had 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.

The CDSCO said Pfizer Inc, which was the first company to seek emergency use authorisation in India through an application on Saturday, had sought more time to make a presentation before it.

The regulator also recommended Phase I/II trials for a vaccine candidate developed by Gennova Biopharmaceuticals Ltd, based in the western Indian city of Pune. It will be the ninth vaccine candidate that the country could manufacture.

A source with direct knowledge of the matter told Reuters that a decision on emergency use would be taken "in toto" and it was too early to say whether the vaccines being considered would be rejected or accepted.

India has reported nearly 10 million COVID-19 infections, putting it behind the United States globally in overall cases.

(Reporting by Nivedita Bhattacharjee, Krishna N. Das, Chandini Monappa and Abhirup Roy; Editing by Andrew Heavens and Alexander Smith)

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