Hong Kong Buys 15 Million Vaccine Doses From Pfizer, Sinovac
Pfizer Vaccine Clearance to be sought in Hong Kong after FDA nod
(Bloomberg) -- The Chinese company with the rights to market the Pfizer Inc.-BioNTech SE coronavirus vaccine in Hong Kong is preparing to seek approval of the shot soon after the U.S. clears it, according to people familiar with the matter.
Shanghai Fosun Pharmaceutical Group Co. is getting ready to submit paperwork to the drug regulator in Hong Kong for review as soon as next week, said the people, who asked not to be identified because the discussions remain private.
The development comes as Hong Kong on Friday announced it has struck deals for 15 million doses of shots from Pfizer-BioNTech and Chinese developer Sinovac Biotech Ltd., with the first vaccines to be received next month.
Authorization for the Pfizer-BioNTech shot in the Asian financial hub would be among a wave of rubber-stamp approvals expected around the world, as many endorsements are contingent on the U.S. Food and Drug Administration approving the vaccine, which could come as soon as this weekend. Countries lacking the capacity to independently validate experimental therapies often rely on rigorous reviews by world-leading drug authorities like the FDA.
While Hong Kong could sign off on the vaccine’s emergency-use authorization soon after the required paperwork is submitted by Fosun, there’s no guarantee. The review process could be complicated by the fact Hong Kong doesn’t have a precedent for granting emergency use for vaccines, one of the people said.
Hong Kong has a history of authorizing medications once they have been reviewed by leading regulators. It granted conditional approval of Gilead Sciences Inc.’s antiviral drug remdesivir to treat Covid-19 in mid-July, following a similar decision from the European Union.
Spokespeople for Fosun and Hong Kong’s Food and Health Bureau didn’t immediately respond to a request for comment.
Other countries including Canada and the U.K. have already given a green light to the vaccine, which data shows has a 95% protection rate against Covid-19. The EU is also reviewing the Pfizer-BioNTech shot and is expected to authorize it soon.
Hong Kong is anxiously anticipating a green-lit vaccine. While its coronavirus outbreak isn’t as alarming as those in many global hot spots, the city of 7.5 million people has been plagued by repeated resurgences since summer.
The government has ramped up social-distancing measures that include closing restaurants and asking people to work from home to prevent Covid’s spread. The resurgence delayed a key travel bubble with Singapore and dented the competitiveness of Hong Kong’s financial industry.
Fosun secured rights from Germany-based BioNTech in March to develop and market the mRNA shot across mainland China, Hong Kong, Macau and Taiwan. The Chinese company said in August it intends to supply 10 million doses for Hong Kong and Macau, distributing them through Hong Kong’s Jacobson Pharma Corp.
While Pfizer sought emergency use authorization from the U.K. and U.S., the right to clear the vaccine with regulators in Hong Kong falls with Fosun, under a deal with BioNTech that saw the Chinese drugmaker investing $50 million in the German firm for a 0.7% stake.
Fosun has yet to apply for authorization for the Pfizer-BioNTech vaccine’s use in mainland China. The company is currently running a trial testing the shot’s safety and ability to generate immune response. It will submit data from that, as well as from a Phase III trial conducted overseas, to China’s National Medical Products Administration for approve for general use.
©2020 Bloomberg L.P.
With assistance from Bloomberg