Subject:

The validity of requiring stringent regulatory authority in vaccine policy by HK Gov't.

Introduction:

The requirement of stringent regulatory authority (SRA) as a criterion for recognised vaccination records during the COVID-19 pandemic as enforced in the HKSAR vaccine-related policy (Government of HKSAR, 2021) is debatable.

Concern:

The HKSAR Government is incorrectly applying SRA as one of the criteria to determine whether the COVID-19 vaccine administrated overseas is acceptable, which is effectively barring qualified Hong Kong residents to return home and others to visit.

Primary Facts:

1. “The concept of a SRA was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria to guide medicine procurement decisions …“ (WHO, 2021). Note: bolded by the petition author.
2. ”The current definition of SRA has been adopted by the Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP), whose scope is pharmaceuticals and not vaccines. The WHO Expert Committee on Biological Standardization (ECBS), under whose scope vaccines fall, has not defined SRA and has not used the term with respect to vaccines” (WHO, 2020). Note: bolded by the petition author.

Summary:

The requirement of SRA as one of the criteria for recognised vaccine records does not align with the concept, current definition, and scope of an SRA which was developed to guide medicine procurement decisions. Second, the current definition of SRA whose scope is pharmaceuticals and not vaccines. Third, the WHO ECBS, under whose scope vaccines fall, has not defined SRA and has not used the term with respect to vaccines.

Recommendation:

According to the available data, there is no evidence that the use of the SRA is related to any vaccines. The petition author strongly urges the HKSAR Government to review the evidence of the proper usage of SRA in vaccine-related public health policy and update the relevant policy accordingly.

Declaration:

The petition author is not associated with and does not have any conflict of interest with any organisations, products, and services cited in this report. This report intends to provide public health services.

Reference URL Links:

1. https://www.coronavirus.gov.hk/eng/inbound-travel.html#quarantinemeasures2
2. https://www.who.int/initiatives/who-listed-authority-reg-authorities/SRAs
3. https://extranet.who.int/pqweb/sites/default/files/documents/Product-Eligibility_COVAX-Facility_Dec2020_0.pdf