Coronavirus: Sinopharm vaccine undergoing regulatory review, report says

Centre for Drug Evaluation reviewing company’s application to release one of its two candidates to market, Chinese news website says

Products have been undergoing testing in 10 countries in South America and the Middle East

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The results of final-stage tests of one of Sinopharm’s two Covid-19 vaccine candidates are being reviewed by the regulator. Photo: AFP

Published: 9:30pm, 24 Dec 2020Updated: 2:13am, 25 Dec 2020

China’s drug regulator has begun reviewing an application by state-owned company Sinopharm to take one of its two Covid-19 vaccines to market, according to local media.

The report, on news website Jiemian and citing information from the Centre for Drug Evaluation, did not specify which of the two candidates developed by the company, formally known as China National Pharmaceutical Group, was being reviewed.

The two products, developed by different institutes under Sinopharm, have been undergoing testing for safety and efficacy in 10 countries across South America and the Middle East. In early December, the United Arab Emirates approved one of them for use, saying it was 86 per cent effective.

Sinopharm filed for approval to launch its product on November 25, before the UAE data had been published. The drug evaluation centre said on Wednesday it had agreed to review the application, the news report said.

Sinopharm did not immediately respond to requests for comment on Thursday.

Shanghai-based vaccine expert Tao Lina said it was possible the Sinopharm product might be granted conditional approval in the coming weeks.

“The conditions for Covid-19 vaccine approval might include requirements for further studies on safety and efficacy for groups like children and the elderly,” he said.

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