The Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation, set up under the Department of Health (DH) to provide independent assessment on the potential causal link between Adverse Events Following Immunisation (AEFIs) and COVID-19 vaccination, convened a meeting today (August 4) to assess serious adverse events relating to COVID-19 vaccination.

     According to the World Health Organization, an AEFI is any medical occurrence that follows immunisation and that does not necessarily have a causal relationship with the usage of the vaccine. The DH has put in place a pharmacovigilance system for COVID-19 immunisation, and is partnering with the University of Hong Kong to conduct an active surveillance programme for Adverse Events of Special Interest under the COVID-19 Vaccines Adverse Events Response and Evaluation Programme. The main purpose of the pharmacovigilance system is to detect potential signals of possible side effects of the vaccines.

     As of July 31, a total of 11 984 persons had been infected with COVID-19 in Hong Kong, of which 212 had died of the disease. Separately, about 5.66 million doses of COVID-19 vaccines had been administered for members of the public in Hong Kong. Around 3.23 million people had received at least one vaccine dose. In the same period, the DH received 4 719 reports of adverse events (0.08 per cent of total vaccine doses administered), including 27 death cases with vaccination within 14 days before they passed away (0.0005 per cent of total vaccine doses administered).

     So far, the Expert Committee had assessed the 27 death cases and concluded that 18 death cases had no causal relationship with vaccination, and preliminarily considered that nine cases were not associated with vaccination. The Expert Committee considered there is no unusual pattern identified so far, and it will continue to closely monitor the situation and collect data for assessment.

     According to the local mortality data, in the period between February 26 and July 31 of 2019 (Note), among people aged 30 or above, there were 1 552 deaths (i.e. 28.5 per 100 000 population) and 2 592 deaths (i.e. 47.6 per 100 000 population) due to ischaemic heart diseases and heart disease respectively. In addition, according to information by the Hospital Authority, during the period from July 5 to August 1 of 2021, the ratio of death cases out of those without a vaccination record was 78.1 cases for every 100 000 people, whereas the ratio of death cases for those with a vaccination record was 2.6 cases for every 100 000 people. The overall death rate during this period of time is similar to that recorded in the past three years. Based on the above figures, there is no evidence that vaccination increases the risk of death for recipients.

     For the serious or unexpected AEFI cases (e.g. myocarditis), the Expert Committee has reviewed available clinical data and information for conducting causality assessment. The results will be included in the updated safety monitoring report (as at July 31) to be published at the Government's designated website on August 6. In addition, information related to AEFIs of COVID-19 vaccines and relevant statistics will also be released in the weekly "Update on monitoring COVID-19 vaccination" press release and the Government's designated website regularly.

Note: The COVID-19 Vaccination Programme was officially launched on February 26, 2021.

Ends/Wednesday, August 4, 2021
Issued at HKT 19:45

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