DH’s response to media enquiries on suspected adverse events following immunisation with COVID-19 vaccine

     In response to media enquiries, the Department of Health (DH) said that it had received updates from the Hospital Authority (HA) today (April 27) about two hospitalisation cases with a history of COVID-19 vaccination first reported on April 5 and April 19, 2021, respectively. Both patients had chronic illnesses and the updated reports did not have clinical evidence to support that the events were caused by the vaccines.
 
     The first case involved a 76-year-old man with a history of hypertension, diabetes and hyperlipidemia. He complained of right-sided weakness and was admitted to Tseung Kwan O Hospital on April 5. He was diagnosed with hypertensive intracranial haemorrhage. Today, the HA provided updated information that the patient passed away on April 26 due to pneumonia. According to information, he received the second dose of CoronaVac COVID-19 vaccination at a private clinic 26 days (i.e. March 31) prior to his death. There was no record that the man complained of feeling unwell during observation at the clinic.
 
     The second case involved a 74-year-old woman with a history of pulmonary fibrosis, osteoporosis and gastritis. She complained of shortness of breath and cough, and was admitted to Pamela Youde Nethersole Eastern Hospital on April 19. Today, the HA provided updated information that the patient was diagnosed with pneumonia and passed away on April 25. According to information, she received the second dose of Comirnaty COVID-19 vaccination at a community vaccination centre 18 days (i.e. April 7) prior to her death. There was no record that the woman complained of feeling unwell during observation at the vaccination centre.
 
     The DH contacted the HA upon the initial report of the cases for information to facilitate causality assessment. After receiving updates from the HA today, the DH immediately contacted the HA to obtain further information and will pass the cases based on the established mechanism to the Expert Committee on Clinical Events Assessment Following COVID-19 Immunisation (Expert Committee) for conducting causality assessment. So far, there is no clinical evidence to indicate that the events were caused by the vaccines.
 
     According to the World Health Organization (WHO), an Adverse Event Following Immunisation (AEFI) is any medical occurrence that follows immunisation and that does not necessarily have a causal relationship with the usage of the vaccine. The Expert Committee conducts causality assessments based on the WHO algorithm for suspected serious adverse events.
 
     Up to and including April 25, 2021, there were about 1 275 300 doses of COVID-19 vaccines administered in Hong Kong. During the same period, the DH had received a total of 2 131 AEFI reports (0.17 per cent of all doses administered), including 15 reports of death with vaccination history within 14 days (0.001 per cent of all doses administered). Among these 15 cases, the Expert Committee has concluded no causal relationship with COVID-19 vaccination for three cases, preliminarily considered no association with vaccination for eight cases, and will conduct causality assessments for the remaining four cases when necessary information is available.
 
     According to the risk communication plan endorsed by the Expert Committee, figures and summaries of clinical events received will be released and updated through the designated website biweekly. When a suspected adverse event fulfilling the reporting criteria of AEFIs involving a death case within 14 days of vaccination is received, it will be announced via a press release as soon as possible.