The Department of Health has been actively following up with Sinovac Biotech (Hong Kong) with a view to obtaining as soon as possible the Phase 3 clinical data of its COVID-19 vaccine for emergency use, the Government said today.
According to the latest reply from Sinovac, the company is preparing the relevant information and will submit it to the department as soon as possible.
According to the Prevention & Control of Disease (Use of Vaccines) Regulation, the Secretary for Food & Health may, under the state of public health emergency, authorise the use of COVID-19 vaccines which fulfil the criteria of safety, efficacy and quality for the purpose of vaccination programmes conducted by the Government.
The regulation also specifies the conditions and procedures which the vaccine manufacturer or its representative, importer, or wholesale dealer must follow when submitting an application for seeking authorisation for emergency use.
To complete the authorisation process in a timely and smooth manner, the department has been processing part of the information provided by Sinovac and has also requested the company to provide as soon as possible the Phase 3 clinical data it has submitted to the World Health Organization.
After receiving the necessary information and relevant clinical data, the Advisory Panel on COVID-19 Vaccines appointed by the Chief Executive will review them and make a recommendation in accordance with the regulation to ensure the relevant vaccine fulfils the criteria of safety, efficacy and quality.
The Government said it will ensure the authorised vaccines satisfy the aforesaid criteria before providing vaccination for members of the public, adding that it will adhere to the principles of openness and transparency so that the public can obtain the latest information on vaccines.
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