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.”