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 to conduct an active surveillance programme for Adverse Events of Special Interest (AESI) 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 January 31, a total of 14 197 cases had tested positive for the SARS-CoV-2 virus in Hong Kong, of which 213 died. Separately, about 11.13 million doses of COVID-19 vaccines had been administered for members of the public in Hong Kong. Around 5.36 million people had received at least one vaccine dose. In the same period, the DH received 6 894 reports of adverse events (0.06 per cent of the total vaccine doses administered), including 64 death cases with vaccination within 14 days before they passed away (0.0006 per cent of the total vaccine doses administered).
So far, the Expert Committee has assessed the 64 death cases and concluded that 48 death cases had no causal relationship with vaccination, and preliminarily considered that 14 cases were not associated with vaccination. Two cases are still 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 (Note). In addition, according to information by the Hospital Authority, during the period from January 3 to January 30 of 2022, the ratio of death cases out of those without a vaccination record was 166 cases for every 100 000 people, whereas the ratio of death cases for those with a vaccination record was 10.3 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.
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 January 31) to be published at the Government's designated website on February 11. 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 (figures rectification): In the period between February 26 and November 30 of 2020, among people aged 30 or above, there were 2 978 deaths (i.e. 54.4 per 100 000 population) and 5 071 deaths (i.e. 92.7 per 100 000 population) due to ischaemic heart diseases and heart disease respectively; in the period between February 26 and December 31 of 2020, among people aged 30 or above, there were 3 292 deaths (i.e. 60.2 per 100 000 population) and 5 573 deaths (i.e. 101.8 per 100 000 population) due to ischaemic heart diseases and heart disease respectively.
Ends/Wednesday, February 9, 2022
Issued at HKT 19:14
Issued at HKT 19:14