Update on monitoring COVID-19 vaccination

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     In the preceding three months till 11.59pm on June 28, the Department of Health (DH) received 10 reports (Note 1) of adverse events following COVID-19 immunisation. No death cases were reported by the Hospital Authority (HA) involving individuals who had received vaccines within 14 days before they passed away and had potential association with vaccination.

     As at 8pm on June 28, around 20.82 million doses of COVID-19 vaccines had been administered for members of the public. Around 6.92 million people had received at least one dose of vaccine, including 95.3 per cent of the population aged 3 or above. The DH received 8 126 reports of adverse events (0.04 per cent of the total vaccine doses administered). Among the death cases concerning persons who had been vaccinated, including 120 cases (Note 2) with vaccination within 14 days before they passed away (0.0006 per cent of the total vaccine doses administered), none of the death cases were associated with vaccination.

     As of today, the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation had concluded that 118 death cases had no causal relationship with vaccination, while for two cases the causal relationship with vaccination could not be established. The Expert Committee considered that there is no unusual pattern identified so far, and will continue to closely monitor the relevant situation and collect data for assessment.

     According to information from the HA, during the three-month period from March 29 to June 28, 2023, the overall ratio of death cases was 172 cases for every 100 000 people, whereas the average ratio of death cases for the same period in 2018 to 2020 was 144 cases for every 100 000 people. Among these death cases, the ratio of death cases with acute stroke or acute myocardial infarction was 8.6 cases for every 100 000 people, whereas the average ratio of death cases under the same category for the same period in 2018 to 2020 was 9.2 cases for every 100 000 people. Furthermore, the ratio of miscarriage cases was 47.8 cases for every 100 000 people, whereas the average ratio of miscarriage cases for the same period in 2018 to 2020 was 72 cases for every 100 000 people. Based on the statistical analysis of the above figures, there is no evidence that vaccination increases the risk of death or miscarriage for recipients.

     The majority cases of adverse events received so far are relatively minor cases. The relevant details can be found in the "Report on the Safety Monitoring of COVID-19 Vaccines in Hong Kong" (www.drugoffice.gov.hk/eps/do/en/doc/Safety_Monitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf).

     Furthermore, the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K) will expire at midnight on December 23 this year. The Government plans to cease the Indemnity Fund for Adverse Events Following Immunization with COVID-19 Vaccines (AEFI Fund) alongside the cancellation of the emergency use regime. The Government is closely monitoring the progress of the registration of COVID-19 vaccines under the Pharmacy and Poisons Regulations (Cap. 138A) and the available data on the safety of the COVID-19 vaccines to determine the timetable for ending the AEFI Fund.

     A Government spokesman said, "In spite of the full resumption of normalcy in society, COVID-19 infection still poses certain health risks. COVID-19 vaccination is highly effective in preventing severe cases and deaths from COVID-19. We appeal to members of the public, in particular high-risk individuals such as the elderly and children, to receive the first three doses of COVID-19 vaccine and get an additional vaccine booster in a timely manner in accordance with the latest recommendation made by the experts."
 
     The spokesman added that, to tie in with the new phase of resumption of normalcy, the Government has established a system of the new normal to manage COVID-19 as an upper respiratory tract illness. The Government will continue to keep a close watch on the situation of COVID-19 variants and assess the risks, as well as keeping track of the World Health Organization's latest assessment of the epidemic situation, with a view to making further adjustments to the vaccination arrangements as necessary.

     Separately, such updates on vaccination monitoring will no longer be released through press releases. The Government will continue to publish relevant information on COVID-19 vaccination on the thematic website for the COVID-19 Vaccination Programme (www.covidvaccine.gov.hk/en).

Note 1: Provisional figures. In the preceding three months till 11.59pm on June 28, the DH did not receive any reports of suspected myocarditis or pericarditis involving adolescents in the age group of 3 to 15, and did not receive any reports of serious or unexpected adverse events following COVID-19 immunisation for children aged under 3.

Note 2: In the preceding three months till 11.59pm on June 28, the DH did not receive any death reports involving individuals who had received COVID-19 vaccination within 14 days before passing away.

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