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Photographer: Victoria Jones / PA Wire
Photographer: Victoria Jones / PA Wire
The Chinese company with the right to trade Pfizer Inc.-The BioNTech SE coronavirus vaccine in Hong Kong is preparing to seek vaccine approval shortly after the US clears it up, according to people familiar with the matter.
Shanghai Fosun Pharmaceutical Group Co. is preparing to submit the documentation to the Hong Kong drug regulator for review next week, said the people, who asked not to be identified because the discussions remain private.
The development comes as Hong Kong announced on Friday that it has reached agreements for 15 million doses of injections from Pfizer-BioNTech and Chinese developer Sinovac Biotech Ltd., with the first vaccines due next month.
Authorization for the injection of Pfizer-BioNTech in the Asian financial center would be among a wave of rubber stamp approvals expected around the world, as many endorsements depend on the US Food and Drug Administration. Approve the vaccine, which could arrive as soon as this weekend. Countries that lack the capacity to independently validate experimental therapies often rely on rigorous reviews from world-leading pharmaceutical authorities such as the FDA.
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While Hong Kong could approve the vaccine’s emergency use authorization shortly after Fosun submits the required documentation, there is no guarantee. The review process could be complicated by the fact that Hong Kong does not have a precedent for granting emergency use of the vaccines, one of the people said.
Hong Kong has a history of licensing drugs once they have been reviewed by major regulators. It granted conditional approval of Gilead Sciences Inc.’s antiviral drug remdesivir to treat Covid-19 in mid-July, following a similar decision by the European Union.
Spokesmen for Fosun and the Hong Kong Food and Health Bureau did not immediately respond to a request for comment.
Other countries, including Canada and the United Kingdom, have already given the green light to the vaccine, the data of which shows it has a 95% protection rate against Covid-19. The EU is also reviewing the Pfizer-BioNTech injection and is expected to authorize it soon.
Hong Kong eagerly anticipates a green-light vaccine. While its coronavirus outbreak is not as alarming as many global hot spots, the city of 7.5 million people has been plagued by repeated resurgence since the summer.
The government has stepped up social distancing measures that include closing restaurants and asking people to work from home to prevent the spread of Covid. The revival delayed a key travel bubble with Singapore and reduced the competitiveness of Hong Kong’s financial industry.
Fosun obtained the rights from Germany-based BioNTech in March to develop and commercialize mRNA injection in mainland China, Hong Kong, Macao and Taiwan. The Chinese company said in August that it intends to supply 10 million doses to Hong Kong and Macao, distributing them through Hong Kong’s Jacobson Pharma Corp.
While Pfizer applied for emergency use authorization from the UK and the US, the right to approve the vaccine with regulators in Hong Kong rests with Fosun, under an agreement with BioNTech in which the Chinese drugmaker invested $ 50 million in the German company for a 0.7% stake.
Fosun has not yet applied for authorization to use the Pfizer-BioNTech vaccine in mainland China. The company is currently conducting a trial testing the injection’s safety and ability to elicit an immune response. It will submit data from that, as well as a Phase III trial conducted overseas, to the China National Medical Products Administration for approval for general use.
– With the help of John Liu, Dong Lyu and Jinshan Hong
(Add Hong Kong vaccine offers in the third paragraph)
