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SFH authorises COVID-19 vaccine by Sinovac for emergency use in Hong Kong
     The Secretary for Food and Health (SFH) authorised today (February 18) the COVID-19 vaccine by Sinovac Biotech (Hong Kong) Limited (Sinovac) (i.e. CoronaVac COVID-19 Vaccine (Vero Cell), Inactivated) for emergency use in Hong Kong in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K).
     According to the Regulation, the SFH may, with reference to the advice of the Advisory Panel on COVID-19 Vaccines, authorise the use of COVID-19 vaccines which fulfil the criteria of safety, efficacy and quality for specified use in Hong Kong under an emergency situation, which is basically for vaccination programmes led by the Government. The Advisory Panel has submitted its recommendations to the SFH. It considers that, under the current epidemic situation, the benefits of authorising the use of the COVID-19 vaccine by Sinovac for protecting against COVID-19 outweigh the risks.
     Having regard to the advice of the Advisory Panel and having considered the threat to public health posed by COVID-19, the SFH considers that the authorisation is necessary and is in the public interest. The SFH has exercised the powers conferred upon her under section 3 of the Regulation to authorise the use of the COVID-19 vaccine by Sinovac in Hong Kong for a specified purpose. The relevant authorisation will take effect on February 18, 2021. To ensure that the relevant vaccine continues to fulfil the criteria of safety, efficacy and quality, the SFH has attached conditions to the aforesaid authorisation, including requiring the applicant to execute a relevant risk management programme, and continue to provide the latest clinical data and laboratory analysis certificates for each batch of vaccines, as well as timely updates of quality reports. With a view to strengthening the transparency of information regarding vaccines, the expert advice on vaccines given by the Advisory Panel has been uploaded to the website of the Food and Health Bureau (www.fhb.gov.hk/en/our_work/health/rr3.html).
     According to the information provided by the vaccine supplier, the first batch of around 1 million doses of the Sinovac vaccine will be delivered to Hong Kong shortly. The territory-wide vaccination programme led by the Government will be launched as soon as possible after receiving the shipment of the vaccine and completing all necessary quality assurance procedures. The Government will continue to actively follow up on the emergency use authorisation and supply schedule of the remaining vaccines already purchased and make preparations for the arrangements for administration of the relevant vaccines. The Government will also continue to adhere to the vaccine procurement strategy and make advance purchases of vaccines which fulfil the criteria of safety, efficacy and quality, including vaccines which are still in the development stage, with a view to ensuring availability of different types of vaccines and sufficient supplies for the whole of Hong Kong.
     The Government spokesman said, "The Government 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 Regulation, before arranging for members of the public to receive the vaccines. To enhance the public's confidence in vaccines, the Government's work in vaccine administration will continue to be based on scientific evidence and adhere to the principles of openness and transparency. At the same time, we will continue to monitor the use of the vaccines. The Government will provide members of the public with the latest information on the relevant vaccines through different channels in a timely manner, and make public the views of experts on the vaccines, so that the public can grasp correct and comprehensive information on them."
Ends/Thursday, February 18, 2021
Issued at HKT 16:33
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