HONG KONG – Shortly after Australia’s recent provisional approval for the mRNA-based COVID-19 vaccine Comirnaty (tozinameran), originally developed by Pfizer Inc. and Biontech SE, Hong Kong has approved it, too, for emergency use ahead of rivals developed in mainland China. It is the first vaccine to be approved in the Chinese territory, made possible through a collaboration between Biontech and Shanghai Fosun Pharmaceutical Group Co. Ltd. A spokesperson for Hong Kong’s Food and Health Bureau told BioWorld that the approval Jan. 25 followed a recommendation from an advisory panel on COVID-19 vaccines after Fosun submitted “hundreds of pages” of documents for the application.

Biontech and Fosun Pharma initially agreed to develop and commercialize of the vaccine in greater China early last year.

The approval is important because Hong Kong has been struggling to contain outbreaks of COVID-19. On Jan. 26, it reported 64 new cases of COVID-19, bringing the total number of cases to date to 10,223, with 172 deaths. Although the number of cases is comparatively low given Hong Kong’s high population density with 7.5 million people, the city has imposed tight restrictions on residents and businesses in some areas. And, over the past week, authorities have enforced two strict lockdowns in different neighborhoods, preventing people from leaving the areas. Over the weekend, authorities set up a cordon around some 150 buildings in the densely populated area of Jordan and tested more than 7,000 residents before lifting the localized lockdown around midnight on Monday. Of the tests, 13 came back positive.

Prior to the Hong Kong green light, Comirnaty has been authorized for use by health regulators in over 50 countries and regions, including the UK, U.S., Canada and the European Union.

The vaccine will be produced in Biontech's manufacturing facilities in Germany and supplied to Hong Kong for use under a COVID-19 vaccination program slated to start in February, after the Chinese New Year holidays. Meanwhile, Fosun still has to provide updates on the vaccine’s safety and quality certificates for each batch manufactured.

Other vaccines on the way?

Other candidates that were supposed to be in Hong Kong’s vaccination program, such as Sinovac Biotech Ltd.’s Coronavac and the viral vector vaccine COVID-19 Vaccine Astrazeneca, developed by Astrazeneca plc and Oxford University, have not been approved yet. As of Jan. 13, authorities in Hong Kong had only received the application for Comirnaty from Fosun but no submissions yet for the other two vaccines. Nor had they received applications for other vaccines developed in mainland China.

Wallace Lau, convenor of Hong Kong’s advisory panel on COVID-19 vaccines, said during a press conference that the panel would need more information from Sinovac Biotech before deciding next steps.

While the the Food and Health Bureau had noted Sinovac Biotech’s lower than previously reported efficacy rate in Brazil trials, Lau said the panel was still awaiting the complete clinical trial data. He mentioned the need for an expert review on any side effects, evidence of approval by drug regulatory bodies outside Hong Kong and other data supporting the safety and efficacy of the vaccine.

David Hui, a member on the advisory panel, said it was “very likely” the approval process for a vaccine could be completed within a month if data submitted by manufacturers was complete and up to local regulatory standards.

A dynamic situation

Initially, Sinovac’s Coronavac was supposed to arrive in Hong Kong this month. Then Biontech was expected to follow within the first quarter with Astrazeneca's vaccine to come midyear. The spokesperson for the Food and Health Bureau declined to provide any estimates on when the next approval may happen.

This has not stopped Hong Kong Chief Executive Carrie Lam from seeking supplies from a fourth supplier, state-owned China National Pharmaceutical Group Co. Ltd. also known as Sinopharm.

“We have been very concerned about the supply of vaccines for Hong Kong people, because this is really sort of the light at the end of a tunnel. Over many months, we have worked out advance purchase agreements with three manufacturers. Actually, we are still discussing a fourth in order to have at least one vaccine per technology,” said Lam during a press conference held Jan. 25.

Though Sinopharm had conditional approval in mainland China in Dec 2020, Hui from the advisory panel said Sinopharm had yet to publish results from its phase III trials in medical journals.

Hong Kong, technically a Special Administrative Region of China, is nominally independent and has its own drug regulator although there are some projects underway that would lead to closer integration. There are plans to unite the two under the Greater Bay Area (GBA) project, which ties Hong Kong, Macau and nine mainland Chinese cities into a competitive megalopolis.  

Under the GBA, some healthcare institutions operating in nine mainland cities would be allowed to use Hong Kong-registered drugs with urgent clinical use and medical devices used in Hong Kong public hospitals with urgent clinical use and advanced clinical applications, subject to the approval of Guangdong Province.

“The National Medical Products Administration (NMPA) also entrusted the Guangdong Provincial Medical Products Administration to commence the relevant work in relation to simplifying the registration process for importing proprietary Chinese medicines for external use registered in Hong Kong,” said Sophia Chan, Hong Kong’s Secretary for Food and Health. 

“Hong Kong has a sound drug registration system and the Department of Health has implemented administrative control system for medical devices. I believe the above measure will not only help attract local and multinational pharmaceutical, biomedical and health technology companies to apply for registration of new pharmaceutical products in Hong Kong, but also improve the level of healthcare services in the GBA,” she said.

For now, Hong Kong will continue picking and approving its own COVID-19 vaccines regardless of what mainland China does.

“To enhance the public's confidence in vaccines, the government's work in vaccine administration will be based on scientific evidence and adhere to the principles of openness and transparency," a Hong Kong government spokesman said.  “We will provide members of the public with the latest information on the relevant vaccines through different channels in a timely manner and make public the views of experts on the vaccines, so that the public can grasp correct and comprehensive information on them,” he added.