BioNTech May Become 1st Foreign Vaccine Approved in Mainland
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• Although China has administered more than 1.4 billion doses of COVID-19 vaccines, Chinese drug regulators completed an expert panel review of a Covid-19 mRNA vaccine co-developed by Fosun Pharma with Germany’s BioNTech SE, and now the shot is in the administration review stage, according to Fosun.
• Chinese authorities plan to use the vaccine, with the brand name Comirnaty, as a booster shot for people who have received inactivated-virus forms of vaccines, people close to regulators told Caixin News. The booster shot is likely offered free, the person said.
Comirnaty: The 1st vaccine developed overseas
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 (same jab as Pfizer-BioNTech's) – will also become the first vaccine using cutting-edge mRNA technology to be made available in the mainland. The Pfizer or Comirnaty vaccine will have an adjusted label of Pfizer-BioNTech/Comirnaty.
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. “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 HK, where it accounts for more than half the 4.58 million doses administered.
Booster shot
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 will be for free.
It remains unknown if the regulator will allow people to receive BioNTech as their initial vaccine. Fosun and BioNTech have yet to respond to requests for comments. 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.
Mixing vaccines to improve the effectiveness?
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.
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.
Despite the high number of injections, China maintains a strict outbreak control policy, including quarantine of at-risk areas and control of travel.
Sources: Caixin News. SCMP, by Josephine Ma.
https://www.scmp.com/news/china/science/article/3141228/biontech-track-become-first-foreign-covid-19-vaccine-approved
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