The Department of Health has been actively following up with Sinovac Biotech (Hong Kong) to obtain relevant information of its vaccine to commence approval procedures as soon as possible.

The Government made the statement in response to media reports on the submission of phase 3 clinical data of Sinovac’s vaccine to the Department of Health.

In accordance with the guidance of the Advisory Panel on COVID-19 Vaccines, the Department of Health had previously requested Sinovac to have the relevant clinical data published in medical journals.

However, Sinovac indicated that it has considerable difficulties compiling the relevant information for publication in a short period. Having regard to the urgency for vaccination, the department has requested Sinovac to provide its phase 3 clinical data submitted to the World Health Organization (WHO) for assessment.

The Government stressed it did not set today as the deadline as reported in media reports.

Up till now, Sinovac has provided the Department of Health with its phase 1 and phase 2 clinical data submitted to the WHO and drug regulatory authorities of other jurisdictions, among other information.

Sinovac has also provided to the department a set of its phase 3 clinical data of trials conducted in Brazil that it had submitted to drug regulatory authorities of other jurisdictions.

Furthermore, Sinovac indicated that it could provide to the department as early as this week the phase 3 clinical information of its trials conducted in Brazil and Turkey, etc that it submitted to the WHO.

After compilation of all the information, the Department of Health will submit the documents to the advisory panel next week for review and arrange a meeting for the panel to assess and put up a recommendation as soon as possible to make sure the relevant vaccine satisfies the criteria of safety, efficacy and quality.

The Government added it will continue to adhere to the principles of openness and transparency so that the public can obtain the latest information on vaccines.