The Advisory Panel on COVID-19 Vaccines (Advisory Panel) convened a meeting today (November 7) on the application for emergency use of Comirnaty bivalent vaccine by Fosun Pharma. The meeting was chaired by convenor Professor Wallace Lau Chak-sing.

     In accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K) (the Regulation), Fosun Pharma submitted to the Secretary for Health an application earlier for the authorisation of Comirnaty Original/Omicron BA.4-5 bivalent vaccine by Fosun Pharma/BioNTech for emergency use. At the same time, it also submitted the overseas authorisation obtained, and information related to the safety, efficacy and quality of the vaccine. The Advisory Panel convened a meeting today to examine the information and reports submitted by Fosun Pharma.

     The Advisory Panel considered that, under the current epidemic situation, the benefits of authorising the use of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine as booster for protecting against COVID-19 outweigh the risks. To ensure that the relevant vaccine continues to fulfil the requirements of safety, efficacy and quality, the Advisory Panel suggested adding conditions to require the applicant to continue providing the latest clinical data, safety update reports, and quality certification documents by the drug manufacturer for each batch of vaccines, etc. The Advisory Panel will compile its views and submit the above advice to the Secretary for Health for consideration.

     The Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases under the Centre for Health Protection of the Department of Health, joined by the Chief Executive's expert advisory panel, had earlier recommended that the Comirnaty Omicron BA.4-5 bivalent vaccine can be used as an alternative to the fourth dose of the current ancestral strain vaccines for eligible persons aged 12 years or above following the current vaccination schedule (the ancestral strain vaccine can also be used as the fourth dose).

     A Government spokesman said, "The Government welcomes the submission of recommendation by the Advisory Panel on the authorisation application for the vaccine. The Secretary for Health will consider the relevant recommendation and come to a decision on the authorisation of the vaccine for emergency use as soon as possible. Vaccination is highly effective in preventing severe cases or deaths from COVID-19. We strongly appeal to members of the public who have not been vaccinated, especially senior citizens, chronic patients and other immunocompromised persons who face a much higher fatality risk after COVID-19 infection, to get vaccinated with no delay for the sake of their health. Members of the public who are currently eligible for a third or fourth dose should also get the dose as soon as possible."

     According to the Regulation, the Secretary for Health may, under the state of public health emergency, authorise the use of COVID-19 vaccines which fulfil the criteria of safety, efficacy and quality for the purpose of the COVID-19 Vaccination Programme led by the Government. The Regulation also specifies the conditions and procedures which the vaccine manufacturer or its representative, importer, or wholesale dealer must follow when submitting application for seeking authorisation for emergency use. The Advisory Panel will examine the information of relevant vaccine and provide a clear recommendation to the Government. The Secretary for Health will consider the advice of the Advisory Panel before authorising a vaccine for emergency use.

Ends/Monday, November 7, 2022
Issued at HKT 22:46

NNNN