Coronavirus: China approves clinical trial for German vaccine candidate

Simone McCarthy
·5-min read

China’s regulator has given the go-ahead for a clinical trial of a German Covid-19 vaccine, moving the experimental candidate – among the most advanced in the global race – one step closer to potential approval and use in the country.

The candidate was found to be more than 90 per cent effective in preventing infections of the coronavirus, according to preliminary data.

The experimental vaccine, built by German firm BioNTech SE, is being developed in partnership with Shanghai Fosun Pharmaceutical (Group) Co., Ltd for the China market and American company Pfizer Inc. globally.

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The Chinese firm, known as Fosun Pharma, received approval from China’s National Medical Products Administration to start an in-country trial of the candidate, according to a company statement on Friday.

The step comes after BioNTech and Pfizer offered the world a dose of optimism last week, announcing that the experimental vaccine, known as BNT162b2, appeared to be more than 90 per cent effective in preventing Covid-19 infection as compared with a placebo, based on an interim assessment of data from their global clinical trial.

The preliminary finding far exceeded efficacy parameters set out by regulators, such as those in US, China and with the World Health Organization (WHO), which all called for Covid-19 vaccines to be at least 50 per cent effective.

The efficacy finding could change as the trial continued to its final assessment point, experts said, but it was hailed as good news at a time when new global Covid-19 cases for the week reached a record 3.6 million, according to the latest WHO tally.

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The approved clinical trial would allow Fosun Pharma to generate local safety and efficacy data from a smaller-scale trial to then pair with data from Pfizer’s global phase 3 trial, which includes 44,000 participants, as it seeks approval for use in China.

BioNTech chief executive Ugur Sahin called the start of the trial an “important step forward”.

“Time is of the essence in this effort and we greatly appreciate the support by Chinese regulators and the collaboration with our Chinese partner Fosun Pharma. We will continue to collaborate closely to advance clinical development in China towards market approval,” he said.

Wu Yifang, chairman and chief executive of Fosun Pharma, said the alliance was working to make the vaccine available for supply in China.

The approval of the phase 2 trial puts the vaccine in a position to be among the first foreign-made vaccines approved for use in China, pending subsequent regulatory action and successful trial results.

Other Chinese firms have also entered into agreements with foreign vaccine makers, including Shenzhen Kangtai Biological Products, which is expected to begin trials in China this year of the candidate in development by British-Swedish company AstraZeneca Plc, Reuters reported this month.

China has several home-grown vaccines that are well into phase 3 trials worldwide. Among those, candidates by China National Biotec Group and Sinovac Biotech Ltd have already been approved for use in China under an emergency use programme.

In March, Fosun Pharma entered into a US$135 million deal with BioNTech to develop and commercialise Covid-19 vaccine products using the firm’s mRNA technology for mainland China, Hong Kong, Macau and Taiwan.

A deal for a potential 10 million-dose supply to Hong Kong and Macau has already been signed.

But it remains unclear how many doses in total would be earmarked for the China market. BioNTech and Pfizer have projected their European production capacity to be up to 1.3 billion doses in 2021. Fosun Pharma has also signalled an interest in building facilities to produce the vaccine locally.

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Earlier this month, Guo Guangchang, chairman of Fosun Pharma’s parent company Fosun International, said he was hopeful the candidate would become available in China at the same it was available in the US and Europe.

“Or, at least, the timing of its launch in China will be just a little bit behind them,” Guo told the South China Morning Post.

Pfizer said it would have met the requirements to file for emergency use authorisation of the vaccine in the US by the third week of November.

Immunologist Ashley St John, an associate professor at Duke-NUS Medical School in Singapore, said that based on the company’s report of the interim data there was “reason to be optimistic”, not only that this vaccine might work, but that those employing the same strategy of using mRNA technology, which was not yet approved on the market, might also work.

“[One] caveat is that this is an interim analysis and the full trial results are not ready yet, so we can expect that 90 per cent efficacy value to potentially change a bit as more data is available,” she said, noting that complete data, even from the interim report, had yet to be released.

“Most importantly … this result does not give us any information on how long the vaccine will protect.”

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