The Government received written notification from Fosun Industrial Co., Limited this morning (March 24) that as notifications of observed deviations in the vial seal of Comirnaty vaccine (BioNTech) product (batch 210102 (Expiry 06/2021)) were received, BioNTech and Fosun Pharma have initiated an investigation to identify the root cause of these packaging issues. For the sake of prudence, the concerned vaccination should be suspended immediately for the time being while investigation is ongoing.
So far, BioNTech and Fosun Pharma have no reason to believe that there is a risk to product safety. However, for the sake of prudence, vaccination of the batch 210102 should be suspended until the investigation is completed. Meanwhile, batch 210104, another batch of BioNTech vaccines procured by Hong Kong, should also be put on hold and not be administered. This is a precautionary measure to continuously ensure vaccine safety.
As BioNTech vaccines procured by Hong Kong belong to the above batches, all Community Vaccination Centres (CVCs) stopped vaccinating BioNTech vaccine with immediate effect today until further notice. Those who have made appointments to receive BioNTech vaccination from today onwards need not go to CVC for vaccination.
The Department of Health will hold an urgent meeting with Fosun Industrial Co., Limited today to obtain further details of the incident and discuss on the follow up measures.
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