Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation assesses serious adverse events relating to COVID-19 vaccination
******************************************************************************************
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 in Hong Kong, convened a meeting today (February 27) 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 (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 February 26, about 20.7 million doses of COVID-19 vaccines had been administered for members of the public in Hong Kong. Around 6.9 million people had received at least one vaccine dose. In the same period, the DH received 8 102 reports of adverse events (0.04 per cent of total vaccine doses administered), including 120 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 120 death cases and concluded that 117 death cases had no causal relationship with vaccination, two cases of which causal relationship with vaccination could not be established (Note), and preliminarily considered that one case was 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.
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 February 28) to be published at the Government’s designated website on March 3. In addition, information related to AEFIs of COVID-19 vaccines and relevant statistics will also be released in the “Update on monitoring COVID-19 vaccination” press release and the Government’s designated website regularly.
Note: A death case involved an 83-year-old man who passed away five days after receiving the first dose of CoronaVac vaccine in May 2022. Preliminary autopsy revealed ischaemic heart disease. In the final autopsy report, the cause of death as shown by the autopsy appears to be acute myocarditis. Investigations could not identify the cause of acute myocarditis. From literatures and overseas data so far, there is no evidence indicating that the vaccination could cause acute myocarditis. Moreover, studies conducted by HKU under the CARE Programme also did not find any association between CoronaVac vaccination and myocarditis. Nevertheless, based on the available information, the Expert Committee considered that a causal relationship between the death and vaccination could not be established. Another case was reported in the press release on June 7, 2022 (www.info.gov.hk/gia/general/202206/07/P2022060700613.htm).