Fosun BioNTech Batch No 210102 – Update

At today’s daily press conference the Secretary for Civil Service Patrick Nip said the Hong Kong Government had received notice from Fosun Pharma/BionTech that there may be a problem with the packaging with Comirnaty batch number 210102.

BioNTech requested that vaccinations stop during the investigation period, while stressing that this is just a precaution. The Department of Health (DoH) and the CHP have decided that all local vaccinations in Hong Kong using Fosun BioNTech vaccine known as Comirnaty will stop until further notice. 

Director of Health Dr. Constance Chan said the DoH has stringent protocols to monitor the distribution of medications locally.

Hong Kong has imported two batches of BioNTech vaccine:
585,000 doses on 28 February 2021 – Batch Number 210102.
758,000 doses on 7 March 2021 – Batch Number 210104.
150,000 doses from batch number 210102 have been used as of 23 March.

Dr. Chan said since these vaccinations have begun health staff have filed the following reports:
8 incidents when staff found cracks in the container.

22 incidents of leakage due to overpressure in the vile.

16 incidents of loose caps or caps that were not straight were found.

8 incidents where marks or dirt were found on the bottle

To be extra cautious whenever staff found abnormalities, they did not use these viles and threw them away.

Dr. Chan commented that those who have been vaccinated should not worry as there are very strict protocols for the staff to follow. This was echoed by Secretary for Food and Health Professor Sophia Chan who wanted to remind people that there is no evidence of any problems with the doses already administered to people in Hong Kong.

Thru their distributor Fosun Hong Kong, the Government submitted feedback to the manufacturer BioNTech. The manufacturer recommended Hong Kong suspend use of Batch Number 210102 temporarily. Batch Number 210104 is still in the warehouse and Fosun recommended that this batch not be used for the moment too. Dr. Constance Chan said that they will await the report from BioNTech as to whether batch 210104 can be used. If not, this batch will be returned, and HKGOV will request a new batch from BioNTech.


This morning an investigation was launched by the DoH. Fosun will request BioNTech to review the procedures inside their manufacturing plant. While locally Fosun will review the arrival procedures to see if their handling in Hong Kong had anything to do with these events.

Beyond those waiting for their first dose are those waiting for the second dose. The first group of which are scheduled for this Saturday, 27 March. The DoH is pressuring BioNTech for a prompt response and report.  Currently, the DoH procedure is to administer the 2nd doses on day 21. Although there are studies and recommendations that suggest the second dose be effective up to Day 42. Dr. Chan said the DoH preference is to continue with day 21 but this all depends on what the manufacturer says.

Statement from Fosun Pharma

Fosun received written notice from BioNTech on the evening of 23 March 2021 informing them that there may be a “small number of defects related to the cap of the vial” in batch number 210102.

Fosun added that “As, at the date of this announcement, there is no evidence to suggest that the safety of the relevant batches of product may be at risk.”

Fosun BioNTech Batch No 210102

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