The Government today said it will ensure that clinical research data of relevant COVID-19 vaccines fulfil the safety and efficacy requirements scientifically after having been assessed by experts.

It made the remarks in response to media enquiries on the regulation and monitoring of COVID-19 vaccines.

The Government also emphasised that the quality assurance of the vaccines must be well supported in order for the vaccine to be approved for emergency use in Hong Kong.

It noted that emergency legislative work for introducing COVID-19 vaccines proven to be safe and effective into Hong Kong is now being conducted.

The proposed legislative framework will empower the Secretary for Food & Health, on the premise that the relevant vaccine has received a drug regulatory authority's endorsement, in accordance with objective medical data of the individual vaccine including making reference to the expert views of an independent expert advisory panel, to allow the relevant vaccine to be put to designated use in Hong Kong.

With an established mechanism to closely follow up on every report of adverse drug reaction received, the Department of Health conducts causality assessment on reports of Adverse Event Following Immunisation, in particular serious adverse events, submitted by drug registration certificate holders and healthcare professionals to ascertain whether they are associated with the vaccination.

The department also monitors the latest safety and efficacy assessment issued by drug regulatory authorities of advanced countries and jurisdictions and the references promulgated by the World Health Organization.

If the benefits of the vaccine are considered to be outweighed by the risks, the department will take appropriate actions including referral of the relevant information to the Pharmacy & Poisons Board of Hong Kong for review and consideration on the necessity to suspend or revoke the vaccine’s drug registration.

Regarding the possible adverse effect following COVID-19 vaccine immunisation, the department will conduct monitoring based on the relevant requirements under the proposed emergency legislation for use of COVID-19 vaccines and make reference to the prevailing mechanism, while maintaining the same level of vigilance for control.

For the issue on legal liability for the emergency use of COVID-19 vaccines, the Government said it is reviewing international practices in the use of vaccines which are recently developed under the public health emergency situation to formulate an appropriate arrangement.

It also pointed out that defining and clarifying the legal responsibility for the emergency use of COVID-19 vaccines will help Hong Kong obtain the vaccines which fulfil the requirements of safety and efficacy as soon as possible. But this does not mean that the drug manufacturer is immune from all relevant responsibilities with regards to the vaccine, including quality assurance.

The Government said it will strive for the early supply of the vaccines to Hong Kong and ensure that they must first satisfy relevant requirements and procedures, including completion of phase 3 clinical trials and obtaining emergency use approval by the local jurisdiction's drug regulatory authority and Hong Kong pursuant to the emergency legislation which is under preparation to ensure the vaccines' safety, efficacy and quality.