Advisory Panel on COVID-19 Vaccines convenes meeting to conduct continuous benefit-risk analysis of authorised COVID-19 vaccines
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The meeting today was chaired by convenor Professor Wallace Lau Chak-sing. At the meeting, on the application made by Sinovac on lowering the age limit for receiving the Sinovac vaccine to age three, the Advisory Panel reviewed the relevant information submitted by Sinovac, including the phase 1 and phase 2 clinical trial data published in peer reviewed medical journals, real-world safety data collected in Mainland China, the preliminary data from the phase 3 clinical trials conducted in countries such as South Africa and Chile, and other relevant clinical trial data. The relevant information indicated that the Sinovac vaccine had good safety when administered on children aged three to 17 of different ethnicities. Also, compared with adults aged 18 or above, children aged three to 17 developed better immunogenicity response. After considering the relevant information and weighing the risks posed by the COVID-19 epidemic to the local community, the Advisory Panel recommended to extend the eligibility of the Sinovac vaccine to cover children aged three to 17. The Advisory Panel also recommended to provide the relevant information to the Joint Scientific Committees (Scientific Committee on Vaccine Preventable Diseases and Scientific Committee on Emerging and Zoonotic Diseases) under the Department of Health for examination, in order to facilitate with determining the priority groups for receiving the relevant vaccine. The Advisory Panel will submit the above recommendation to the Secretary for Food and Health (SFH) for consideration.
Regarding the administration of the Comirnaty vaccine on children aged five to 11, the Advisory Panel noted the relevant clinical data published and the situation regarding overseas emergency use authorisation. The Advisory Panel recommended the Government to follow up with Fosun Pharma on the issue of lowering the age limit and to request Fosun Pharma to provide the relevant information.
A Government spokesman said, "The Government welcomes the recommendation by the Advisory Panel on lowering the age indication of the Sinovac vaccine. After examination by the Joint Scientific Committees, the SFH will consider the relevant recommendation and come to a decision as soon as possible. The Government will also follow up with Fosun Pharma on the matters related to lowering the age limit of the Comirnaty vaccine to cover children aged five to 11. The Government will continue to ensure that the authorised vaccines satisfy the criteria of safety, efficacy and quality, and will continue to disseminate the latest safety and scientific information on the relevant vaccines to the public and relevant stakeholders in a timely manner."
The SFH authorised two COVID-19 vaccines, namely the Comirnaty vaccine and the Sinovac vaccine, in accordance with the Prevention and Control of Disease (Use of Vaccines) Regulation (Cap. 599K) on January 25 and February 18 respectively. To comply with the conditions of authorisation, the authorisation applicants are required to submit the latest clinical data on the vaccines, safety update reports and quality certification documents, etc. for continuous review and monitoring.
Ends/Monday, November 15, 2021
Issued at HKT 23:00
Issued at HKT 23:00
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