Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation assesses 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 (HKU) to conduct an active surveillance programme for Adverse Events of Special Interest (AESI) under the COVID-19 Vaccines Adverse Events Response and Evaluation Programme (CARE Programme). The main purpose of the pharmacovigilance system is to detect potential signals of possible side effects of the vaccines.
As of May 31, a total of 762 339 cases had tested positive for SARS-CoV-2 virus by nucleic acid tests and 450 865 positive cases through rapid antigen tests in Hong Kong, of which 9 379 died. Separately, about 17.08 million doses of COVID-19 vaccines had been administered for members of the public in Hong Kong. Around 6.7 million people had received at least one vaccine dose. In the same period, the DH received 7 571 reports of adverse events (0.04 per cent of total vaccine doses administered), including 108 death cases with vaccination within 14 days before they passed away (0.0006 per cent of total vaccine doses administered).
So far, the Expert Committee had assessed these 108 death cases and concluded that 72 death cases had no causal relationship with vaccination, one case of which causal relationship with vaccination could not be established (Note), preliminarily considered that 11 cases were not associated with vaccination, and 24 cases pending further information for assessment. 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, among people aged 30 or above, there were 3 856 deaths (i.e. 70.5 per 100 000 population) and 6 546 deaths (i.e. 119.6 per 100 000 population) due to ischaemic heart diseases and heart disease respectively in 2020. In addition, according to information by the Hospital Authority, during the period from May 2 to May 29 of 2022, the overall ratio of death cases was 46.8 cases for every 100 000 people, whereas the average ratio of death cases for the same period in 2018 to 2020 was 43.9 cases for every 100 000 people. Based on the above figures, there is no evidence that vaccination increases the risk of death for recipients.
The Expert Committee has also reviewed available clinical data and information for conducting causality assessment of other serious or unexpected AEFIs and AESIs. The results will be included in the updated safety monitoring report (as at May 31) to be published at the Government's designated website on June 10. 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: A death case involved a 74-year-old male who passed away on the same day after receiving the first dose of Comirnaty vaccine in November 2021. Preliminary autopsy revealed coronary artery disease. In the final autopsy report, the cause of death as shown by the autopsy appears to be anaphylaxis and ischaemic heart disease. However, according to available information, the deceased did not experience discomfort during the observation period after vaccination and there was no sign of anaphylaxis attack during resuscitation. In addition, the condition of ischaemic heart disease of the deceased was very severe, which was considered as a significant condition contributing to the death. On the basis of the above, the Expert Committee considered that a causal relationship between the death and vaccination could not be established.
Ends/Tuesday, June 7, 2022
Issued at HKT 19:00
Issued at HKT 19:00