Use of vaccine approved

January 25, 2021

The Secretary for Food & Health (SFH) authorised the COVID-19 vaccine by Fosun Pharma/BioNTech for emergency use in Hong Kong in accordance with the Prevention & Control of Disease (Use of Vaccines) Regulation, the Government announced today.

 

The Advisory Panel on COVID-19 Vaccines submitted its recommendations to the SFH earlier, which considered that, under the current epidemic situation, the benefits of authorising the use of the COVID-19 vaccine by Fosun Pharma/BioNTech for protecting against COVID-19 outweigh the risks.

 

Taking into account the advisory panel's advice and the threat to public health posed by COVID-19, the SFH considered that the authorisation is necessary and is in the public interest. She has exercised the powers conferred upon her under section 3 of the regulation to authorise the use of the COVID-19 vaccine by Fosun Pharma/BioNTech in the city for a specified purpose.

 

To ensure that the relevant vaccine continues to fulfil the requirements of safety, efficacy and quality, the SFH has attached conditions to the authorisation, including requiring the applicant to continue providing the latest clinical data on the vaccine, safety update reports, and quality certification documents by the drug manufacturer for each batch of vaccines.

 

The advisory panel also noted reports of suspected adverse events in some overseas countries after administration of the Fosun Pharma/BioNTech vaccine. According to the information released by the relevant authorities, some common side effects, such as fever or nausea, may affect individuals who already have serious illnesses and are particularly weak.

 

The Department of Health has requested the vaccine supplier to provide relevant information in response to the advisory panel's recommendations.

 

Meanwhile, the Joint Scientific Committees under the Centre for Health Protection will review relevant information to assist with determining the precautions for use by priority groups for receiving the relevant vaccine.

 

The expert advice on vaccines given by the advisory panel has been uploaded to the Food & Health Bureau's website to strengthen the transparency of information on vaccines, the Government added.

 

According to the information provided by the vaccine supplier, the first batch of one million doses of the Fosun Pharma/BioNTech vaccine to be supplied to Hong Kong have completed production and are undergoing safety and quality testing.

 

Subject to the completion and passing of the relevant tests, the vaccines are expected to arrive in Hong Kong from Germany in late February.

 

The citywide vaccination programme led by the Government will be launched as soon as possible after completing all necessary quality assurance procedures.

 

The Government said it will continue to adhere to the vaccine procurement strategy and make advance purchases of vaccines which fulfil the criteria of safety, efficacy and quality, including those that are still in the development stage, to ensure the availability of different types of vaccines and sufficient supplies for the whole city.

 

It also noted that its work in vaccine administration will 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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