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LCQ8: Related matters of seasonal influenza vaccination
     Following is a question by Professor the Hon Joseph Lee and a written reply by the Secretary for Food and Health, Professor Sophia Chan, in the Legislative Council today (November 18):
     Amid the haze of the Coronavirus Disease 2019 (COVID-19) epidemic, quite a number of members of the public are worried about the serious conditions arising from dual infections with influenza and COVID-19. They have therefore received influenza vaccination earlier than last year, resulting in a tight supply of influenza vaccines. Earlier on, the Department of Health (DH) indicated that it had procured a total of 878 000 doses of influenza vaccine for the 2020-2021 vaccination programmes, including 628 000 doses for the Government Vaccination Programme (GVP) and 250 000 doses for the Seasonal Influenza Vaccination School Outreach (Free of Charge - Primary School) (SIV). Besides, DH would provide free vaccination to the eligible people of high-risk groups in phases. In this connection, will the Government inform this Council:
(1) of the respective quantities of vaccines procured in each of the past three years under (i) GVP and (ii) SIV and the respective expenditures involved;
(2) of the number of persons who received influenza vaccination under the Vaccination Subsidy Scheme (VSS) in each of the past three years and the amount of expenditure involved, with a breakdown by target group (i.e. (i) children between six months and under six years old, (ii) children aged between six and under 12, (iii) persons aged between 50 and 64, (iv) persons aged 65 or above, and (v) others);
(3) whether it knows the number of persons who received, other than under VSS, in the past three years influenza vaccination at private (i) hospitals and (ii) clinics (with a breakdown by the groups mentioned in (2));
(4) given that members of the public have a strong demand for influenza vaccination and some private doctors have indicated that they fail to obtain sufficient quantity of vaccines, whether the authorities will regularly review the supply of vaccines to Hong Kong, the demands of the public and private healthcare systems for vaccines as well as the vaccine stock of the Government and, when necessary, procure additional doses of vaccines and carry out coordination work, including providing the private medical sector with additional vaccines again on the condition that private doctors undertake to abide by specified requirements (which include not charging additional fees and giving high-risk persons priority to receive vaccination); if so, of the details and the resources involved; if not, the reasons for that; and
(5) given that there have been recent cases in South Korea and Taiwan in which some residents had adverse reactions or even died soon after receiving influenza vaccination, and that it is learnt that one of the pharmaceutical companies involved is a major vaccine supplier in Hong Kong, whether the authorities have formulated measures to tackle the occurrence of similar cases in Hong Kong; if so, of the details; if not, the reasons for that?
     Influenza can cause serious illnesses in high-risk individuals and even healthy persons. Given that influenza vaccines are safe and effective, all persons aged six months or above except those with known contraindications are recommended to receive influenza vaccines to safeguard their health. In consultation with Department of Health (DH), our reply to various parts of Professor the Hon Joseph Lee's question is as follows:
(1) and (2) The number of persons from the eligible groups receiving seasonal influenza vaccination (SIV) under various government vaccination programmes and the amount of subsidies involved in the past three years are detailed in Annex. Since some members from the eligible groups might have received SIV by arrangement other than government vaccination programmes, the figures related to these persons are not reflected in Annex. In addition, other expenditure such as manpower, publicity and other administrative expenses are also involved in the implementation of the above programmes. Resources for the above activities are absorbed by DH's overall provision for disease prevention which is not separately accounted for.

     The quantities of influenza vaccines under various government vaccination programmes procured by DH in the past three years and the contract amount are set out below -
Season Quantities of influenza vaccines procured
($ million)
2018/19 (Actual) 654 000 30.1
2019/20 (Actual) 815 000* 40.8*
2020/21 (Estimate) 878 000 83.0
* Including a total of 1 700 nasal influenza vaccine doses actually procured in 2019/20 season, involving an expenditure of $340,000.
(3) The DH does not maintain information about number of persons who have received seasonal influenza vaccines in private hospitals and/or clinics outside the Vaccination Subsidy Scheme (VSS).
(4) The Government keeps closely in view of the supply of influenza vaccines for vaccination programmes and private healthcare sector and maintains close liaison with vaccine suppliers in order to make adjustments to the relevant arrangements when necessary. In view of the keen demand for seasonal influenza vaccines by members of the public recently and its tight supply around the world, the Government announced on October 22 that it would procure additional vaccines, as well as provide an additional 100 000 doses of vaccines in phases to Public-Private-Partnership Team which provides vaccination for schoolchildren and doctors enrolled in the VSS which require the vaccines. This facilitates high risk groups to receive vaccination early and helps relieve the tight supply in the private healthcare sector.
     The DH has earlier contacted more than 1 600 doctors who have enrolled in the "2020/21 SIV School Outreach (Free of Charge)" and the VSS on their demand for seasonal influenza vaccines and informed them of the relevant arrangements.  Separately, the Home Affairs Department will allocate additional inactivated influenza vaccine and live attenuated influenza vaccine to non-governmental organisations and the district organisations partnering with healthcare facilities/doctors/clinics enrolled in the VSS across the 18 districts to provide influenza vaccination for the public. The allocation exercise is currently under way and is expected to be completed in December 2020.
     Regarding the supply of vaccines in the local private healthcare sector, the DH has been closely in touch with the vaccine suppliers and noted the arrival of a new batch of influenza vaccines of around 85 000 doses in mid to late November 2020 for supply to local private healthcare sector. The Government will continue to closely liaise with the vaccine suppliers and make further adjustments when necessary.
(5) In relation to the earlier reports from certain overseas places of adverse reactions and deaths following influenza vaccination, DH has liaised with the World Health Organization (WHO), the health authorities concerned at relevant places and the vaccine supplier, and noted that relevant health authorities considered that there was no evidence on safety concerns of relevant influenza vaccines. Health authorities at Korea and Taiwan had also announced investigation results of relevant incidents. The DH also confirmed with the vaccine supplier that the influenza vaccine supplied to Hong Kong was of a different batch.

     In fact, any products (including vaccines for human use) fall within the definition of "pharmaceutical product" under the Pharmacy and Poisons Ordinance (Cap. 138) (the Ordinance) must satisfy the criteria of safety, efficacy and quality for registration with the Pharmacy and Poisons Board of Hong Kong before they could be sold or distributed in Hong Kong.
     For manufacturers of pharmaceutical products, the most important and effective way to ensuring the quality and safety of their products is to strictly comply with the Good Manufacturing Practices (GMP) for medicines. Manufacturers of locally manufactured and imported pharmaceutical products have to comply with the requirements of GMP under the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
     The Ordinance also stipulates that only licensed manufacturers or wholesale dealers could carry on business as an importer/exporter of pharmaceutical products. Licensed manufacturer could only import pharmaceutical products for its own manufacturing or export its own manufactured products.  Import and export of pharmaceutical products are subjected to the control under the Import and Export Ordinance (Cap. 60). Licensed wholesale dealers are required to apply for Import/Export Licence for each import/export shipment of pharmaceutical products (including vaccines) from the DH.

     According to the WHO guidelines on regulatory preparedness for provision of marketing authorisation of human pandemic influenza vaccines in non-vaccine-producing countries, the procured vaccines should be produced in compliance with GMP, tested for quality and safety by the vaccine manufacturer, and went through the procedures for quality control testing and released by the responsible national control laboratory in accordance with "WHO's guidelines for independent lot release of vaccines by regulatory authorities".

     The DH normally does not conduct sampling checks on pharmaceutical products (including vaccines) at the time of import to avoid delaying their import to and supply in the local market. On the other hand, the DH has put in place a regular market surveillance mechanism based on risk assessment to collect samples of both locally manufactured and imported pharmaceutical products (including vaccines) from suppliers and the market for analysis. The sampling arrangement for pharmaceutical products from the market is based on the risk assessment with the information collected from overseas drug regulatory authorities, rapid alert mechanism of the PIC/S, complaints or enquiries made by local suppliers or healthcare professionals.
     In addition, the Drug Office (DO) of the DH has adverse drug reaction (ADR) reporting system to collect ADRs (including Adverse Event Following Immunization) reported from the pharmaceutical trade and healthcare professionals, and conducts assessment on the causality between the drug and the adverse event. The DO will assist in the formulation of the necessary risk assessment strategy which include issuing safety alert through press releases, advising healthcare professionals on the safety information, instructing the pharmaceutical trade to conduct drug recall, deregistrating pharmaceutical products, etc., in order to keep the safety of drugs under review.
Ends/Wednesday, November 18, 2020
Issued at HKT 19:20
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