Fosun BioNTech Batch No 210102

Covid19 Mask

The Governments of HKSAR and Macao SAR have temporarily suspended Covid-19 vaccinations using Comirnaty.

A press release issued by the Hong Kong Government at 10am 24 March, read below or here, said that it had received notice from the manufacturer that there may be a packaging defect with the closure of the medicine bottle.

For the sake of caution, the government has decided to suspend all vaccinations using this type of vaccine during the investigation period.

BionTech and Fosun Pharma have not found any reasons to believe safety has been compromised. The Department of Health will be having an emergency meeting with the distributors to understand the incident.

Hong Kong currently has two batches of vaccine including Batch Number 210102 (expires 21 June) and 210104. Batch number 210104 will remain sealed and unused until an investigation has been carried out.

For those already vaccinated, which includes bc magazine staff, there has been no notification from the manufacturer that the improper closure is harmful. It may though affect the efficacy of the vaccine.

Suspension of BioNTech vaccination
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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.

This post will be updated as more information is available:
Edited 13:42 added English press release and link

For more information on Covid-19 in Hong Kong see the government website www.coronavirus.gov.hk

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