Coronavirus: BioNTech may become first foreign vaccine approved for use in mainland China

The panel advising the country’s regulator gave the green light to the jab, which will be the first using cutting-edge mRNA technology on offer on the mainland
China looks set to use the drug as a booster for those who have received two shots of home-made vaccines

Coronavirus pandemic

Josephine Ma

Published: 4:43pm, 15 Jul 2021

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A Chinese advisory panel has given the green light to the Covid-19 vaccine developed by BioNTech, meaning it will become the first vaccine developed overseas to be used on the mainland once it receives approval from the drug regulator.

If the National Medical Products Administration acts on the panel’s advice, the jabs – made under the brand name Comirnaty – will also become the first vaccine using cutting-edge mRNA technology to be made available in the mainland.

Wu Yifang, chief executive of Fosun Pharma, which has exclusive rights to distribute the vaccine in Greater China, told a shareholder meeting that the review process has been smooth, according to Caixin magazine.

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“Our communication with the National Medical Products Administration has been smooth, and the authorities are racing against time on the review,” Wu said.

The BioNTech vaccine is already available in Hong Kong, where it accounts for more than half the 4.58 million doses administered.

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Fosun has started preparing a Shanghai plant to start providing vaccines for the mainland, the report continued.

The report quoted a source as saying the vaccine would be used as a booster for those who have already received Chinese-made vaccines and the government would provide the jabs for free.

It remains unknown if the regulator will allow people to receive BioNTech as their initial vaccine.

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Fosun and BioNTech have yet to respond to requests for comments.

Both the government and Fosun have previously been tight lipped about the timetable for approvals. In April, BioNTech chief executive Ugur Sahin said he expected the Chinese authorities to give it the green light “by June at the latest”.

China has previously approved a number of domestically developed vaccines, including products by Sinopharm, Sinovac, Zhifei, as well as a single dose vaccine by CanSino. It has also given emergency use approval for vaccines by the Institute of Medical Biology of the Chinese Academy of Medical Science and Kangtai Biologicals.

BioNTech chief executive Ugur Sahin had expected China to approve the vaccine by the end of June. Photo: Reuters

China achieved a target of vaccinating 40 per cent of the population – or 630 million people – last month and is on track to meet its goal of inoculating 70 per cent by the end of the year.

But as the Delta variant becomes a dominant strain in many parts of the world, many countries are mulling boosters. Countries using Chinese jabs such as Turkey, the United Arab Emirates and Bahrain, have been giving third shots of mRNA vaccines to those who have received two doses of Sinovac or Sinopharm.

Chinese officials have also indicated they were considering mixing vaccines to improve the effectiveness of the jabs.

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Fosun formed a US$200 million 50:50 joint venture with BioNTech in May to build a plant capable of supplying up to 1 billion doses of coronavirus vaccine a year.

A subsidiary of Fosun will contribute up to US$100 million of assets including cash and a manufacturing facility, while BioNTech will provide the licence and manufacturing know-how.

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Fosun also told the shareholder meeting that its plans remain on schedule and is expecting to reach the annual capacity of 1 billion doses by the end of the year, according to Caixin.

Fosun has been selling Comirnaty to Hong Kong and Macau. In Hong Kong it is now available to people aged 12 or over, while the alternative choice, from Sinovac, is only available to over-18s.

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After months of limbo, Taiwan’s Foxconn and Taiwan Semiconductor Manufacturing Company said earlier this week that they have struck a deal to buy 10 million doses of BioNTech’s vaccine for the island for US$350 million and import them straight from Germany.

The vaccines will be donated to Taiwan’s government which tried in vain to buy the shots directly from BioNTech and blamed Beijing for blocking the deal for political reasons.

Additional reporting by Elizabeth Cheung

This article appeared in the South China Morning Post print edition as: Mainland panel approves first foreign-made jab