1. Government announces initial investigation results regarding packaging defects of BioNTech vaccine

The Department of Health (DH) had earlier noticed that there was an accumulated number of cases of packaging defects (including loose vial caps, leakages from the vials, etc.) regarding the BioNTech vaccines (batch no. 210102). The DH immediately notified the vaccine supplier (Fosun Industrial Co., Limited (Fosun) and German drug manufacturer BioNTech) and requested for prompt follow-up. At the same time, in view that the supplier has launched an urgent and comprehensive investigation on the packaging defects, the Government agreed to the supplier’s recommendation and suspended vaccination of batch 210102 and 210104 of the BioNTech vaccines in Hong Kong for the sake of prudence and as a precautionary measure.

According to the initial investigation results, Fosun and German drug manufacturer BioNTech considered that there is no evidence indicating any safety risks of the BioNTech vaccines delivered to Hong Kong (batch no. 210102 and 210104). Members of the public who have received the BioNTech vaccines do not need to worry. The subsequent investigation work will mainly target on ascertaining the integrity of the intrinsic properties of the relevant batches of vaccine, and that the batches are safe for use.

Premised on the condition of safety, the Government will strive to resume the administration of the BioNTech vaccine for members of the public as soon as possible, so as to protect public health and the health of citizens.

For details, please refer to the press release:

https://www.info.gov.hk/gia/general/202103/27/P2021032700785.htm

2. Safety monitoring of COVID-19 vaccines

DH has put in place a pharmacovigilance system for COVID-19 immunization, including receiving reports of Adverse Events Following Immunization (“AEFIs”) related to the COVID-19 vaccines used in Hong Kong from healthcare professionals and pharmaceutical industries.

Pursuant to the requirements of the Prevention and Control of Disease (Use of Vaccines) Regulation, Cap. 599K to monitor any adverse event that occurs to the recipient associated with the administration of the relevant vaccine, the Director of Health appointed the Expert Committee on Clinical Events Assessment Following COVID-19 Immunization (“Expert Committee”) to provide independent assessment of potential causal link between AEFIs and COVID-19 vaccines used in Hong Kong and to provide expert advice to the Government on safety-related matters. The Department of Health also partners with the University of Hong Kong to conduct an active surveillance programme for Adverse Events of Special Interest (“AESIs”) related to COVID-19 vaccines.

Thematic webpage:

https://www.covidvaccine.gov.hk/en/vaccine

Report on the Safety Monitoring of COVID-19 Vaccines in Hong Kong (updated regularly):

https://www.drugoffice.gov.hk/eps/do/en/doc/Safety_Monitoring_of_COVID-19_Vaccines_in_Hong_Kong.pdf

3. Multilingual information

To facilitate more ethnic minorities to receive the Government’s latest information, various materials on COVID-19 vaccine safety monitoring and fact sheets etc. have been translated into multiple languages. For details, please refer to the attachment.

PDF version: </inc/uploads/2021/06/Selected_EM_HEM_Videos_CHP_20210329.pdf”>Click here