Vaccines advisory panel meets

February 10, 2021

The Advisory Panel on COVID-19 Vaccines today held a meeting on the application for emergency use of COVID-19 vaccine by Sinovac Biotech (Hong Kong).

 

Sinovac submitted to the Secretary for Food & Health an application for the authorisation of its COVID-19 vaccine for emergency use, together with the vaccine's Phase 1 and 2 clinical data that it had submitted to the World Health Organization and National Medical Products Administration (NMPA).

 

It also provided the Phase 3 clinical information of its trials conducted in Brazil that it had submitted to the NMPA, as well as those conducted in Turkey and Indonesia.

 

The advisory panel noted the Department of Health has followed relevant guidelines to request Sinovac to have relevant research data published in medical journals.

 

As Sinovac indicated that it has considerable difficulties in compiling the relevant information for publication in medical journals within a short period of time, having regard to the urgency for vaccination, the advisory panel has assessed and examined the aforesaid information on safety, efficacy and quality submitted by Sinovac.

 

The advisory panel considered the relevant clinical research data provided by Sinovac to be positive, but it requested Sinovac to provide additional data and information to establish that the benefits of using its COVID-19 vaccine for protection against the virus outweigh the risks.

 

It will convene a meeting after receiving the relevant information.

 

After the advisory panel provided a recommendation on the application for authorisation of the vaccine, the Secretary for Food & Health will come to a decision on the authorisation of the vaccine for emergency use as soon as possible.

 

The Government reiterated it will ensure that vaccines satisfy the criteria of safety, efficacy and quality, and obtain emergency use approval in accordance with the relevant requirements as well as stringent approval procedures under the Prevention & Control of Disease (Use of Vaccines) Regulation, before arranging for the public to receive the vaccines.

 

Its work in vaccine administration will continue to be based on scientific evidence and adhere to the principles of openness and transparency to enhance the public's confidence in vaccines.

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