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BioNTech and Fosun Pharma Receive Authorization for Emergency Use in Hong Kong for COVID-19 Vaccine

Wednesday, January 27, 2021

BioNTech SE and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that according to the Food and Health Bureau of the Hong Kong Special Administrative Region of the PRC ("Hong Kong"), the COVID-19 vaccine COMIRNATY® (also known as BNT162b2, Chinese product name: 復必泰TM) based on BioNTech's proprietary mRNA technology has received authorization for emergency use in Hong Kong. The vaccine will be produced in BioNTech's manufacturing facilities in Germany, and supplied to Hong Kong for administration under the Hong Kong SAR Government's COVID-19 Vaccination Program.

"We are excited and encouraged that COMIRNATY® has been authorized to emergency use in Hong Kong. This is an important milestone in the joint efforts of BioNTech and Fosun Pharma to achieve vaccine accessibility globally. We will continue working closely with BioNTech to complete the ongoing clinical trial and marketing registration in Greater China," Wu Yifang, Chairman and CEO of Fosun Pharma said. "We will also cooperate closely with HKSAR regarding vaccination deployment plan to ensure that Hong Kong citizens can receive a well-tolerated and effective mRNA COVID-19 vaccine as soon as possible in order to protect the health of millions of households."

On 16 March 2020, BioNTech and Fosun Pharma announced a strategic collaboration to work jointly on the development and commercialization of COVID-19 vaccine products in Greater China based on BioNTech's proprietary mRNA technology platform.

Ugur Sahin, M.D., CEO and Co-founder of BioNTech commented, "The authorization for emergency use in Hong Kong is another step forward in bringing our vaccine to people worldwide. This Authorization is also a testament to the successful collaboration with our partner, Fosun Pharma, as we work together to help address the pandemic. Moving forward, we hope to rapidly rollout the vaccine across Asia and will continue to evaluate the vaccine for use against additional mutations that might occur."

According to the data from the global Phase 3 Clinical trial, BioNTech's mRNA-based COVID-19 vaccine met all primary efficacy endpoints, demonstrating effectiveness of 95% in preventing COVID-19 in adults and 94% in adults over 65 years of age. Efficacy in the trial was consistent across age, gender, race and ethnicity. This mRNA-based COVID-19 vaccine has been granted EUA in Hong Kong and has been authorized for use by the health regulatory authorities of over 50 countries and regions, including the United Kingdom, the United States, Canada, and the European Union.

COMIRNATY® is a COVID-19 vaccine which is based on messenger RNA, a natural molecule that acts like a blueprint providing instructions for human cells to make a target protein, or antigen, which activates the body's immune response against the respective virus. mRNA vaccines utilize the genetic sequencing of the virus but not the virus itself. Therefore, mRNA vaccine has no viral component and no risk of infection. Also, mRNA vaccine has advantages such as short development cycle, enabling rapid development of novel vaccine candidates to meet viral mutations; the dual mechanism of humoral and T-cell immunity is immunogenic and does not require adjuvants; it is easy to mass-produce and supports the goal of global supply. The goal of all vaccines, mRNA and conventional vaccines is to stimulate the immune system to generate protective, long-lasting antibody and T cell responses against SARS-CoV-2 and prevent subsequent infection upon exposure to the virus.

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