Go to main content
Government amends regulations under Prevention and Control of Disease Ordinance
     The Government published in the Gazette today (September 9) the Prevention and Control of Disease (Use of Vaccines) (Amendment) Regulation 2022 (Amendment Regulation) to introduce a transitional arrangement for handling the registration of COVID-19 vaccines. At the same time, the Government has also amended eight public health emergency regulations under the Prevention and Control of Disease Ordinance (Cap. 599) to maintain the legal framework for relevant anti-epidemic measures undertaken by the Government.

Prevention and Control of Disease (Use of Vaccines) (Amendment) Regulation 2022

     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. Based on scientific evidence and real-world experience gained from the vaccination of hundreds of millions of people overseas and locally, the CoronaVac and Comirnaty vaccines currently provided in Hong Kong are able to reduce the risks of severe illness and death arising from COVID-19 infection in a safe and efficacious manner. The latest research data from the University of Hong Kong also shows that receiving three doses of either the CoronaVac or Comirnaty vaccine is highly effective in preventing severe cases and deaths with an efficacy of over 90 per cent.

     As at September 4, around 18.78 million doses of CoronaVac and Comirnaty vaccines had been administered for Hong Kong citizens. The Department of Health received 7 883 reports of adverse events, which is 0.04 per cent of the total vaccine doses administered. According to the latest clinical and safety data, the safety profiles of the CoronaVac and Comirnaty vaccines are similar to that of their use in places outside Hong Kong, and also on par with other vaccines provided under general vaccination programmes, such as seasonal influenza vaccines and vaccines provided to infants and young children.

     On a global level, the drug regulatory authorities of a number of countries (such as the United States, Canada and Singapore, etc) have started to gradually regularise the regulation and use of COVID-19 vaccines. With respect to Hong Kong, COVID-19 vaccines (include the CoronaVac and Comirnaty vaccines) are currently authorised for emergency use under the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K). The Government needs to introduce a transitional arrangement for these authorised vaccines, 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).

     As such, the Government set up the Amendment Regulation to provide a legal framework during the transition period, in order to extend the statutory civil immunity currently applicable to persons involved in the prescription, dispensing and administration of authorised vaccines and members of specified Government-appointed committees and panels to cover COVID-19 vaccines to be registered under Cap. 138A and administered under a Government vaccination programme in future. The Amendment Regulation also extends the validity of Cap. 599K for one year, i.e. from midnight on December 23, 2022, to midnight on December 23, 2023, with a view to providing sufficient time for the authorised vaccines under Cap. 599K to migrate to registration under Cap. 138A.

     Furthermore, the Amendment Regulation also imposes requirements necessitating doctors who administer COVID-19 vaccines registered under Cap. 138A to collect specified personal information of the relevant vaccine recipients and report to the Director of Health, with a view to assisting the Government to collect comprehensive and accurate COVID-19 vaccination records so as to effectively monitor the use of the vaccines.

Extending expiry dates of emergency regulations

     As the local and global COVID-19 epidemic situation remains severe, there is a need for the Government to extend the expiry dates of various public health emergency regulations under Cap. 599 to maintain the legal framework for implementation of relevant anti-epidemic measures, in a bid to allow the Government to continue to take appropriate measures in a timely manner to combat the current epidemic and safeguard public health.

     The Government has gazetted the amendments to the following regulations today to extend their expiry dates from September 30, 2022, to March 31, 2023.
(1) Compulsory Quarantine of Certain Persons Arriving at Hong Kong Regulation (Cap. 599C)
(2) Prevention and Control of Disease (Disclosure of Information) Regulation (Cap. 599D)
(3) Compulsory Quarantine of Persons Arriving at Hong Kong from Foreign Places Regulation (Cap. 599E)
(4) Prevention and Control of Disease (Requirements and Directions) (Business and Premises) Regulation (Cap. 599F)
(5) Prevention and Control of Disease (Prohibition on Gathering) Regulation (Cap. 599G)
(6) Prevention and Control of Disease (Regulation of Cross-boundary Conveyances and Travellers) Regulation (Cap. 599H)
(7) Prevention and Control of Disease (Wearing of Mask) Regulation (Cap. 599I)
(8) Prevention and Control of Disease (Compulsory Testing for Certain Persons) Regulation (Cap. 599J)

     Extending the expiry dates of the relevant regulations seeks to maintain the legal framework for the implementation of the relevant anti-epidemic measures. It does not imply that the restrictions currently imposed under those regulations will be maintained until the corresponding expiry dates. The relevant statutory framework has provisions in place to allow flexibility such that the Government may tighten, relax or even suspend specific requirements and conditions subject to development of the epidemic situation.

     A Government spokesman said, "Vaccination has always been a key pillar of the Government's anti-epidemic work. We will continue to proactively implement the vaccination programme and press ahead and encourage high-risk groups, in particular elderly people and young children, to get vaccinated, in order to protect them from severe illness and even death after infection, and at the same time build a protective barrier in Hong Kong. Members of the public should also receive the primary doses and booster dose according to the recommended time and dosage with no delay."

     The Government will closely monitor the development of the epidemic situation and review the various measures in place from time to time, thus making suitable adjustments taking into account all relevant factors.
Ends/Friday, September 9, 2022
Issued at HKT 15:58
Today's Press Releases