About the Vaccines
Benefits & Protection
Allowing members of the public to be administered with safe and effective COVID-19 vaccines is crucial to the resumption of the normal ways of life in Hong Kong.
According to currently available information, the vaccines the Government plans to purchase are effective in providing protection against COVID-19. The Government will continuously monitor the updated information related to the effectiveness of the vaccines.
For individuals with chronic diseases, can I have COVID-19 vaccination?
A concise guide:
Types of Vaccines
The Government provides the public with the following COVID-19 vaccines:
- Inactivated virus technology platform - by Sinovac Biotech (Hong Kong) Limited
- mRNA technology platform - by Fosun Pharma in collaboration with the German drug manufacturer BioNTech (BNT162b2 mRNA vaccine)
- Vaccination Fact Sheet for Comirnaty
- Supplementary notes on use of Comirnaty Bivalent Vaccine
- Supplementary notes on use of Comirnaty vaccine for children aged 5 to 11 years
- Supplementary notes on use of Comirnaty vaccine for toddler aged 6 months to less than 5 years old
- COVID-19 vaccination for those aged 12 or above
- Vaccination Fact Sheet Video
- Note: Both Fosun-BioNTech and Pfizer-BioNTech produce mRNA vaccines using the technology of BioNTech. The Comirnaty vaccines supplied to Hong Kong are manufactured by BioNTech in Germany.
The Government will continue sourcing safe and effective vaccines from other vaccine manufacturers or drug companies.
Dosages
For the current arrangements of additional dose(s) of COVID-19 vaccination, please click here.
Regulatory Framework
1. Authorization under the Prevention and Control of Disease (Use of Vaccines) Regulation
Summary
The Government published the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K) (the Regulation)in the Gazette on 23 December 2020, which provides the legal framework under the present state of public health emergency to bring in COVID-19 vaccines which satisfy the criteria of safety, efficacy and quality for emergency use. The Regulation will remain in effect until 23 December 2023.
The Regulation empowers the Secretary for Health to, based on the objective clinical data of a COVID-19 vaccine (including third phase clinical research data), with reference to the expert advice of an independent advisory panel and having regard to the approval given by a regulatory authority in a place outside Hong Kong that performs the function of approving pharmaceutical products (including emergency use), after being assessed as safe and effective based on science, and with evidence supporting its quality, authorize and allow the specified use of the relevant COVID-19 vaccine in Hong Kong under the emergency situation.
The Government has set up the Advisory Panel on COVID-19 Vaccines, with members appointed by the Chief Executive. The Advisory Panel provides expert advice on recommendation of authorization of the vaccines to the Government, which is made available for public information.
The Advisory Panel has promulgated a guidance to specify the information required for application for authorization under the Regulation which has been uploaded to the website of the Health Bureau.
COVID-19 Vaccine Authorized Under the Regulation
On 25 January and 18 February 2021 respectively, the then Secretary for Food and Health authorized the COVID-19 vaccine by Fosun Pharma/BioNTech (Comirnaty) and that by Sinovac Biotech (Hong Kong) Limited (CoronaVac) for emergency use in Hong Kong in accordance with the Regulation. With a view to strengthening the transparency of information regarding vaccines, the expert advice on vaccines given by the Advisory Panel has been uploaded to the website of the Health Bureau.
2. Registration under the Pharmacy & Poisons Regulations
Summary
With the large-scale use of COVID-19 vaccines worldwide, more and more scientific and clinical data are reinforcing the safety and efficacy of the vaccines. The Government published the Prevention & Control of Disease (Use of Vaccines) (Amendment) Regulation 2022 in the Gazette on 9 September 2022 to introduce a transitional arrangement for vaccines authorized under the Regulation such that the relevant drug manufacturers may, subject to the availability of sufficient scientific data and clinical information, apply to have the relevant vaccines included in the registration regime under the Pharmacy and Poisons Regulations (Cap. 138A)
According to Cap. 138A, pharmaceutical products (including vaccines) must satisfy the criteria of safety, efficacy and quality for registration with the Pharmacy and Poisons Board of Hong Kong (the Board) before they can be sold or supplied in Hong Kong. Applicant of registration of pharmaceutical products is required to submit sufficient information to the Board to substantiate the safety, efficacy and quality of the pharmaceutical product. Upon submission of application and the relevant documentation required from applicants of registration, the Board will evaluate the registration application in accordance with established procedures and requirements.
COVID-19 Vaccine Registered Under Cap. 138A
On 16 December 2022, the Comirnaty ancestral strain vaccine (30 micrograms/dose) and Comirnaty bivalent vaccine (registered by Fosun Industrial Co., Limited), as well as CoronaVac vaccine (registered by Sinovac Biotech (Hong Kong ) Ltd.), have satisfied the criteria of safety, efficacy and quality, and are registered as pharmaceutical products in Hong Kong in accordance with Cap. 138A. List of registered COVID-19 vaccines has been uploaded to website of the Board.
Possible Side Effects
In general, the majority of vaccines are safe. Common side effects are usually mild and temporary e.g. mild fever, soreness, redness, or swelling at the injection site. Some may experience more severe, but in general rare, adverse effects.
It is a matter of fact that the research and development period of COVID-19 vaccines is greatly compressed as compared to other regular vaccines. Hence, the occurrence of rare or unpredictable severe adverse event after widespread vaccination on the population cannot be completely ruled out. The Government will monitor any adverse event that occurs to the recipient associated with the administration of the relevant vaccine.
Reporting of adverse events after immunization
The Department of Health (DH) has an adverse drug reaction (ADR) reporting system which receives adverse events following immunization (AEFIs) reports to monitor the safety of COVID-19 vaccines. If you have any suspected adverse event occurred after immunization, please alert healthcare professionals (e.g. doctors, dentists, pharmacists, nurses and Chinese medicine practitioners), when seeking their advice, to report the AEFIs to the DH if they considered that the AEFIs may be associated with the vaccination.
The main purpose of the pharmacovigilance system is to detect potential signals of possible side effects of the vaccines. According to the World Health Organization (WHO), an AEFI is any medical occurrence that follows immunisation and that does not necessarily have a causal relationship with the usage of the vaccine.
To tie in with the vaccination programme as well as to monitor any adverse event that occurs to the recipient associated with the administration of the relevant vaccine, the Government has set up the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (“Expert Committee”). The Expert Committee will perform continuous monitoring of the possible adverse event following administration of COVID-19 vaccines, and provide professional views and suggestions on safety monitoring of the authorised vaccines. The Expert Committee will conduct causality assessment of clinical events based on the WHO algorithm for suspected serious adverse events.
As endorsed by the Expert Committee, when there are obvious medical causes (including clinical diagnosis and pathology reports) for certain clinical events including death cases, the healthcare professionals may consider the event not fulfilling the criteria for reporting as AEFIs. On the other hand, under the CARE Programme, the DH and the Hospital Authority (HA) have set up mechanism to refer death cases not fulfilling reporting criteria of AEFIs to HKU for surveillance and analysis. The HKU would provide regular reports to the Expert Committee; if unusual pattern is detected, the DH will be notified and the information will be referred to the Expert Committee for assessment as soon as possible.
Click here to read the relevant presentation slides.
Click here to read more about the safety monitoring of COVID-19 vaccines.
Click here to access the Dedicated COVID-19 Vaccine Adverse Event Online Reporting System.
Report on the Safety Monitoring of COVID-19 Vaccines in Hong Kong
According to the risk communication plan endorsed by the Expert Committee, figures and summary of clinical events received will be released and updated periodically (latest Report at below).
Click here for the latest Report on the Safety Monitoring of COVID-19 Vaccines in Hong Kong.
