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Secretary for Health authorises Comirnaty bivalent vaccine for emergency use in Hong Kong
     The Government announced today (November 18) that the Secretary for Health has authorised the Comirnaty Original/Omicron BA.4-5 bivalent vaccine (i.e. Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose Dispersion for Injection COVID-19 mRNA Vaccine (nucleoside modified)) by Fosun Pharma/BioNTech for emergency use in Hong Kong in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K).
     According to the Regulation, the Secretary for Health may, with reference to the advice of the Advisory Panel on COVID-19 Vaccines, authorise the use of COVID-19 vaccines which fulfil the criteria of safety, efficacy and quality for specified use in Hong Kong under emergency situation, which is basically for COVID-19 vaccination programmes led by the Government. The Advisory Panel has submitted its recommendations to the Secretary for Health. It considers that, under the current epidemic situation, the benefits of authorising the use of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine as a booster for protecting against COVID-19 outweigh the risks.
     Having regard to the advice of the Advisory Panel and having considered the threat to public health posed by COVID-19, the Secretary for Health considers that the authorisation is necessary and is in the public interest. The Secretary for Health has exercised the powers conferred upon him under section 3 of the Regulation to authorise the use of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine in Hong Kong for a specified purpose. To ensure that the relevant vaccine continues to fulfil the requirements of safety, efficacy and quality, the Secretary for Health has attached conditions to the aforesaid authorisation, including requiring the applicant to continue providing the latest clinical data on the vaccine, safety update reports, and quality certification documents by the drug manufacturer for each batch of vaccines.
     According to the information provided by the drug manufacturer, the first batch of the Comirnaty Original/Omicron BA.4-5 bivalent vaccine to be supplied to Hong Kong is expected to arrive Hong Kong from Germany at the end of this month. After receiving shipment of the relevant vaccine and completing the necessary quality assurance procedures, the Government will provide the relevant vaccines to the public as soon as possible. Details will be announced later.
     Following the earlier advice of 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, the Government will arrange for the Comirnaty Original/Omicron BA.4-5 bivalent vaccine to be used as an alternative to the fourth dose in accordance with the current vaccination schedule. Both types of vaccines currently provided (Sinovac and Comirnaty vaccines) can continue to be used as the fourth dose.
     The Government spokesman said, "In addition to people aged 50 or above who should receive the fourth dose, people aged 18 to 49 may also choose to receive the fourth dose after considering the individual risk and benefit (e.g. at a higher risk of COVID-19 exposure or with personal needs). Vaccination is highly effective for preventing severe cases and deaths after COVID-19 infection. We strongly call upon members of the public to receive vaccines following the vaccination schedule, especially senior citizens, chronic patients, and other immunocompromised persons who face a higher chance of death after COVID-19 infection."
Ends/Friday, November 18, 2022
Issued at HKT 13:26
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