The government has decided to exempt mainland drugmaker Sinovac from having to publish data from late-stage clinical trials in a medical journal, before a panel of experts decides whether to recommend its coronavirus vaccine for use here, after the firm said it was facing difficulties collating such information for publication.
Sinovac was supposed to have already delivered a million doses of coronavirus vaccines to Hong Kong by the end of January, but authorities have been unable to approve the jabs because the firm had not supplied the necessary data.
It was originally supposed to be the first vaccine to arrive for the government’s planned universal vaccine programme.
A statement issued by the Food and Health Bureau on Friday said given the urgency of the situation, it has agreed that Sinovac will instead send data from its Phase III clinical trials in Brazil that it has already submitted to the World Health Organisation (WHO), to the expert panel here.
This bypasses the requirement for the information to be published in a medical journal, which a spokesman said would have guaranteed a higher level of recognition.
It is not clear whether the information to be provided is any different to that which would have been published in reputable journals.
The spokesman said Sinovac could provide such data by the end of the week, and authorities can collate the information and forward it to the panel for consideration next week.
He stressed that the government will ensure that any vaccine approved for use would meet safety, efficacy and quality requirements before they are given to the public.
So far, authorities have only approved a German vaccine produced by BioNTech. The first shipments are due to arrive by late February.
Govt waives publication requirement for Sinovac
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