Following is a question by the Hon Holden Chow and a written reply by the Secretary for Food and Health, Professor Sophia Chan, in the Legislative Council today (April 21):
 
Question:
 
     There have been, from time to time, serious adverse events in which members of the public felt unwell or even died after receiving the coronavirus disease 2019 (COVID-19) vaccines since the COVID-19 Vaccination Programme commenced on February 26 this year. There are views that although the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation has, after making assessment, considered that there was no causal relationship between such events and the administration of the vaccines, such events have undoubtedly discouraged some members of the public from getting vaccinated. In this connection, will the Government inform this Council:
 
(1) of the up-to-date number of reports on serious adverse events following COVID-19 vaccination received and, among such reports, the respective numbers on (i) deaths and (ii) other cases; whether it knows the causes for the illness or deaths of the persons concerned; if it knows, set out such information in a table;
 
(2) of the measures put in place to boost public confidence in the safety of the COVID-19 vaccines; whether such measures include disseminating information on the safety of the vaccines through the private doctors and clinics participating in the vaccination programme, so as to allay public concerns; and
 
(3) whether it has discussed with the Mainland authorities allowing Hong Kong residents who hold COVID-19 electronic vaccination records downloaded via the "iAM Smart" mobile application to enter the Mainland without being subject to quarantine; if so, of the progress of such discussion; if not, the reasons for that?
 
Reply:
 
President,
 
     Vaccination is the current focus of the global anti-epidemic work. The Government has implemented the COVID-19 Vaccination Programme since February 26, 2021. So far, about 1.12 million doses of COVID-19 vaccines (including 610 000 doses of the Sinovac vaccine and 510 000 doses of the BioNTech vaccine) have been administered to members of the public. Both vaccines meet the criteria of safety, efficacy and quality. The Government will adopt the concept of "vaccine bubble" as announced earlier as the new direction in fighting the epidemic, with an aim to restoring the normal operations of society in a gradual and orderly manner. However, the premise is that the public needs to work together and get vaccinated proactively in order to help Hong Kong beat the epidemic as soon as possible.
 
     In consultation with the Constitutional and Mainland Affairs Bureau, Innovation and Technology Bureau and Information Services Department, my consolidated reply to the various parts of the question raised by the Hon Holden CHOW is as follows:
 
(1) The Sinovac vaccine and BioNTech vaccine authorised by the Government for emergency use in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K) are safe, efficacious and of good quality. The two vaccines have been administered on over tens of millions and even over a hundred million people around the globe. Their safety and efficacy are beyond doubt.
 
     According to the World Health Organization (WHO), Adverse Events Following Immunisation (AEFI) refers to any untoward medical occurrence which follows immunisation and does not necessarily have a causal relationship with the usage of the vaccine. All along, the Department of Health (DH) has been cooperating with local experts to closely monitor the safety of the relevant vaccines, including enhancing the existing surveillance system and carrying out active surveillance with reference to the guidelines of the WHO. The purpose is early identification of rare or delayed serious adverse events following large-scale immunisation. In addition to encouraging healthcare providers and the pharmaceutical industry to report AEFIs through the enhanced existing surveillance system, DH also partners with the University of Hong Kong to conduct the "COVID-19 Vaccines Adverse Events Response and Evaluation Programme (CARE Programme)" to actively monitor Adverse Events of Special Interest related to COVID-19 vaccines.
 
     As at April 4, there were about 556 100 doses of COVID-19 vaccines administered in Hong Kong. During the same period, DH received a total of 1 357 AEFI reports (about 0.24 per cent of all doses administered). Among the AEFI reports, there are 754 hospitalisation cases reported by the Hospital Authority (HA). The symptoms of the cases mainly included chest discomfort, chest pain, dizziness, fever, headache, hypertension, numbness, palpitation, etc. As regards the four cases reported by private hospitals, the symptoms mainly included blurred vision, chest pain, headache and increased blood pressure. Apart from the abovementioned AEFI reports, during the same period, DH also received 584 other AEFI reports with milder conditions which did not require hospitalisation, such as dizziness, headache, chest discomfort, rash, palpitation, etc.
 
     The remaining 15 cases are death case reports by HA with history of COVID-19 immunisation. Existing information indicates that most of these cases died of cardiovascular diseases. The Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (Expert Committee) has already concluded three of these reports that there was no causal relationship between the deceased's outcome and COVID-19 vaccination. The medical history and preliminary autopsy findings of the remaining cases showed that the outcomes of the deceased persons were not directly associated with COVID-19 vaccination. Their assessment will be concluded by the Expert Committee when necessary further information is available.
 
     According to the mortality data in Hong Kong, during the same period in 2019 (i.e. February 26 to April 4), among people aged 55 or above, there were 17.2 deaths per 100 000 population due to ischaemic heart diseases and 28.1 deaths per 100 000 population due to heart disease. The Expert Committee has basically concluded that the reported death cases were not related to vaccination. The above figures also indicate that the rate of occurrence of deaths from cardiovascular diseases among all people who have been vaccinated (3.1 deaths per 100 000 population) is in fact lower than that of the general population.  Statistically, there is no sign that the relevant death cases are caused by vaccination. The Expert Committee has reviewed these data and considered that so far there is no unusual pattern identified after administration of vaccines. The Expert Committee will continue to closely monitor the situation.
 
     The Government will regularly publish the summary report on safety monitoring of COVID-19 vaccines in Hong Kong on the thematic website for the COVID-19 Vaccination Programme. The latest report is available at www.drugoffice.gov.hk/eps/do/en/doc/Safety_Monitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf.
 
(2) Since the implementation of the vaccination programme, the Government has disseminated to members of the public information on the benefits of vaccination and correct messages, the views of experts and details of the vaccination programme, etc. via different channels, in adherence to the principles of openness and transparency and based on scientific evidence. Government officials have also explained the progress of the vaccination programme and information on the vaccines at different occasions through the media. We have also set up a thematic website for the COVID-19 Vaccination Programme to enable members of the public to obtain the latest information and accurate messages through an official channel, including how the vaccines work, their protection and vaccination fact sheets, etc. We have also stepped up monitoring of false information on vaccines within the community and made clarifications as necessary.
 
     On the other hand, DH has issued guidelines (www.covidvaccine.gov.hk/pdf/VSS_DoctorsGuide.pdf) to private doctors participating in the vaccination programme and conducted seminars to explain the content of the relevant programme and the arrangements for vaccination, etc. DH has also reminded the private doctors that they should provide to the vaccine recipient the pamphlets with vaccination fact sheets, explain the content of the pamphlets, respond to the recipient's questions, assess whether the recipient's health situation is suitable for vaccination and if there are any contraindications or precautions and handle enquiries, etc.
 
     Furthermore, together with various healthcare professional groups, DH has developed and promulgated the "Interim Guidance Notes On Common Medical Diseases and COVID-19 Vaccination In Primary Care Settings" (www.covidvaccine.gov.hk/pdf/Guidance_Notes.pdf) to provide medical workers with health guidance on handling different target groups and administration of vaccines. DH has also invited doctors to assist in the production of short clips and messages for dissemination on social media and other media platforms, with a view to enhancing the vaccination rate of COVID-19 vaccines. Details can be found under the section "Education & Media Resources" of the thematic website for the COVID-19 Vaccination Programme.
 
(3) Since the implementation of the COVID-19 Vaccination Programme, members of the public will be provided with a hard copy of vaccination records after vaccination. They can also download their electronic vaccination records using the "iAM Smart" mobile app. Both paper and electronic vaccination record bear a verifiable QR code which adopts digital signing technology to ensure that the data it contains is tamper-proof. Related technology also supports the verification and collection of vaccination records through scanning of the QR codes. To facilitate the gradual resumption of cross-boundary people flow between the two places, we have already commenced technical discussion on the interfacing of vaccination records and technology platform with the Guangdong Provincial Government to enhance the interconnectivity of relevant digital records and technology platform.
 
     On the other hand, the Hong Kong Special Administrative Region (HKSAR) Government has been communicating and liaising closely with the relevant authorities in the Mainland and Macao Special Administrative Region (SAR) Government on disease prevention and control measures, as well as on arrangements for cross-boundary travel for residents of the three places.  We are actively exploring the resumption of normal cross-boundary activities amongst residents of the three places in a gradual and orderly manner when the epidemic situation in the three places is under control and without increasing public health risks.
 
     As a first step to gradually resume the cross-boundary flow of people amongst Hong Kong, Guangdong and Macao in an orderly manner, the HKSAR Government introduced the Return2hk Scheme on November 23, 2020 to facilitate Hong Kong residents who are currently in Guangdong Province or Macao to return to Hong Kong. The Scheme has been operating smoothly. As at April 18, 2021, more than 130 000 return journeys have been made by Hong Kong residents upon fulfilment of specified conditions under the Scheme without being subject to compulsory quarantine. The HKSAR Government is planning to extend the scope of the Return2hk Scheme for Hong Kong residents returning to Hong Kong from other places in the Mainland by the end of April. Meanwhile, we are planning to launch the Come2hk Scheme in mid-May for non-Hong Kong residents in Guangdong and Macao to enter Hong Kong without being subject to compulsory quarantine, upon fulfilment of specified conditions under the Scheme. 
 
     The HKSAR Government will maintain close communication with the relevant authorities in the Mainland and Macao SAR Government to discuss the resumption of cross-boundary people flow amongst the three places in a gradual and orderly manner having regard to the latest epidemic situation.

Ends/Wednesday, April 21, 2021
Issued at HKT 16:16

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