The procedures for the Advisory Panel on COVID-19 Vaccines to examine the information and data and the Government to approve the authorisation of the Sinovac vaccine are stringent and comprehensive.
The Government issued the statement today in response to a media report that casts doubt on the approval procedures for authorising the vaccine by Sinovac and leading people to falsely believe that the Government has lowered the standards for authorising the Sinovac vaccine.
It pointed out on February 18 that the relevant report is not truthful and provided a response.
The Government explained that its approval procedures met all the relevant requirements under the Prevention & Control of Disease (Use of Vaccines) Regulation and were no different from those adopted for approving the Fosun Pharma/BioNTech vaccine for emergency use in Hong Kong.
Sinovac Biotech (Hong Kong) submitted an application on January 25 to the Secretary for Food & Health for authorisation of its COVID-19 vaccine for emergency use in accordance with the regulation. It also provided supporting documents and information.
The advisory panel convened on February 10 and February 16 for the relevant application and reached a consensus for submitting a recommendation to the Secretary for Food & Health to approve the vaccine.
With respect to the requirement that the information submitted needs to be published in medical journals, Sinovac has indicated it has considerable difficulties in compiling the relevant information for publication in a short period of time.
Sinovac has provided to the Department of Health the Phase 1 and 2 clinical data that it had submitted to the World Health Organization (WHO) and National Medical Products Administration (NMPA).
It has also provided to the department the Phase 3 clinical information of trials conducted in Brazil, as well as the Phase 3 clinical information of trials conducted in Turkey and Indonesia.
The relevant data has been examined by the advisory panel’s 12 experts who have all participated in peer reviews in their respective academic fields. With reference to the relevant requirements of WHO guidelines, the statement pointed out that the panel conducted the assessment in a thorough, objective and holistic manner.
The relevant procedures are on par with the peer reviews normally conducted for academic journals, the statement noted, adding that the assessment procedures for the relevant information are not different even though the relevant information has not yet been published in medical journals.
According to the regulation, the Secretary for Food & Health can authorise a vaccine provided that a regulatory authority in a place outside Hong Kong that performs the function of approving pharmaceutical products has approved the vaccine for administration to people, including for emergency use.
Such authorisation may also proceed if the vaccine is listed in accordance with the emergency use listing procedure by the WHO or is in the list of prequalified vaccines published by the WHO.
In other words, under the framework of the regulation, approval by the WHO is not an essential requirement for authorising a vaccine for emergency use in Hong Kong, the statement stressed, noting that a number of overseas regulatory authorities have approved vaccines for emergency use before the individual vaccines were listed for emergency use or prequalified by the WHO.
Currently, the Sinovac vaccine has been approved for use by the regulatory authorities of Brazil, Turkey, Indonesia, Chile and Mexico, and the NMPA.
Casting doubt on the authorisation procedures for emergency use due to authorisation from the WHO yet to be obtained stems from misunderstanding of the mechanism for authorising vaccines for emergency use in the international arena, the statement added.
The Government emphasised that it will ensure that COVID-19 vaccines satisfy the criteria of safety, efficacy and quality before arranging the public to receive the vaccines.
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