Vaccine packaging being followed up

March 24, 2021

(To watch the full media session with sign language interpretation, click here.)


The Government today said there is no reason to believe a packaging issue affecting a batch of the BioNTech vaccine poses a safety risk and it is following up with the Hong Kong agent and the manufacturer.


Director of Health Dr Constance Chan told the media this afternoon that the Government suspended administering the BioNTech vaccine as a precaution.


“As far as this case is concerned, we have received information related to, for example, cracks in the container - there were eight such cases.


“There were reports of leakage due to overpressure inside the vial and leakage of normal saline upon dilution - there were 22 such reports.


“There were 16 reports related to loose caps and there were 11 reports related to stains or marks on the outside of the bottles.


“We have taken all these referrals very seriously and under the established mechanism, we will ask the agent in Hong Kong - that is Fosun Industrial Co in this case - and they will in turn inform the manufacturer BioNTech whose manufacturing plant is located in Germany.


“So upon receipt of the written notification from BioNTech this morning, they advised us that at present there is no evidence which leads to any risks related to the vaccine’s safety.


“However, as a precautionary measure, BioNTech requested us to suspend the use of batch 210102 until the investigation is complete.


“At the same time, the other batch, that is 210104, is currently in the warehouse and not yet used. As a precautionary measure BioNTech also requested Hong Kong to put on hold the use of the second batch.”


Dr Chan added that an investigation will be carried out in Hong Kong as well as at the manufacturing plant in Germany.


“We arranged an urgent meeting with Fosun Industrial Co this morning, and according to their risk management plan, they will conduct an investigation in Hong Kong, mainly focused on the logistics chain, the transport, the handling and the delivery to these community vaccination centres to see if there are any issues.


“At the same time, they will also liaise with BioNTech to conduct inspections at the manufacturing plant in Germany to ascertain whether or not there are any issues there.


“So until the investigation is completed, we shall put on hold the vaccination service of the BioNTech vaccine.”


Secretary for Food & Health Prof Sophia Chan reiterated at the same media session that Hong Kong has a sound drugs monitoring system which includes vaccines.


“The system is in place and it is robust. There will be continuous drugs monitoring. And finally, I think with the existing mechanism that we have, all the vaccines that we have authorised for emergency use are safe, efficacious and also of required quality.


“This time, it is the packaging issue that, as requested by the manufacturer, has suspended the vaccination.”


Regarding the interval between the BioNTech vaccine's two doses, the Department of Health said currently there is limited information on the safety, immunogenicity and efficacy of receiving the vaccine if more than 21 days have elapsed since the first dose.


The department said analysis of the BioNTech vaccine's phase III efficacy showed that it was feasible to administer the second dose from 19 to 42 days.


The World Health Organization, according to the current available clinical data, also recommends that the interval between doses could be extended to 42 days.


If more than 21 days have elapsed since the first dose, the United States Centers for Disease Control & Prevention and Health Canada both recommend the second dose to be given at the earliest opportunity without repeating the series.

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