Release coronavirus vaccine efficacy data, ex-China drug watchdog chief urges country’s pharma firms

[Hamartia Antidote]

China must release Covid-19 vaccine efficacy data, former food and drug chief says

Bi Jingquan urges Chinese pharmaceutical firms to be more transparent to build public trust in their products.

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• Bi Jingquan urges Chinese pharmaceutical firms to be more transparent to build public trust in their products
• Shots by Sinovac, Sinopharm and CanSino Biologics have been approved for use in some countries without publishing comprehensive phase 3 clinical trial results

The former chief of China’s food and drug regulator has urged the country’s
coronavirus vaccine makers to give more details about clinical trial data.

On the sidelines of the first day of the annual session of China’s top advisory body, Bi Jingquan said pharmaceutical firms should release efficacy information to build public trust.

“The companies should themselves know that, with data, the more transparency, the better,” Bi, the director of the China Food and Drug Administration between 2015 and 2018, said on Thursday.

“Publish all your data; it’s good for strengthening everybody’s trust.”

A number of domestically developed vaccines, including shots by Sinovac Biotech and state-owned Sinopharm, have been given qualified approval for public use in China and other countries, but the lack of publicly available data and transparency has raised concerns about their effectiveness.

Sinovac published combined phase 1 and 2 results for its CoronaVac vaccine in The Lancet medical journal in November but so far the company has not released efficacy data for the phase 3 trials through a peer-reviewed journal. Instead, governments in each of the countries where the trials took place have released their own data.

“China’s vaccines are not bad. The Centre for Drug Evaluation will in time release its evaluation report to the public,” said Bi, deputy director of the economic affairs committee of the Chinese People’s Political Consultative Conference.

Bi assumed the post in August 2020, two years after he was forced to resign as Communist Party secretary of the then CFDA in the aftermath of a scandal in which a Chinese vaccine maker was found to have systematically
forged production data for about 113,000 rabies vaccines
.
The Butantan Institute in Brazil, one of the CoronaVac’s phase 3 test sites, said in December that Sinovac had demanded it withhold the full result of the vaccine’s efficacy.

In January the institute said the vaccine was 78 per cent effective, adding later that the figure only applied to patients with symptoms and who required treatment. When trial participants who did not need treatment were factored in, the efficacy rate
was 50.4 per cent.

Sinopharm and private firm CanSino Biologics have also yet to release detailed results from phase 3 trials of their vaccines, despite being approved for use in China and other countries.