Initial vaccine probe completed

March 27, 2021

An initial investigation found that there is no evidence indicating any safety risks concerning the two batches of BioNTech vaccines delivered to Hong Kong and the people who have received the BioNTech vaccines do not need to worry.

 

The Government made the announcement today after it received the initial investigation results from the supplier of the vaccine.

 

It said the Department of Health earlier noticed that there were an accumulated number of cases of packaging defects, including loose vial caps and leakage, regarding batch 210102 of the BioNTech vaccine.

 

The Government agreed to the supplier’s recommendation and suspended vaccination of batch 210102 and 210104 for the sake of prudence and as a precautionary measure.

 

It explained that Fosun Industrial Co and BioNTech have launched a comprehensive investigation covering all aspects of the supply chain to find out the potential causes that may have led to the packaging defects of one of the batches.

 

According to the investigations completed so far, there is no indication of any obvious systemic factors during the processes from filling and packaging to administration that could have led to the relevant packaging defects.

 

However, the investigation results do not rule out the relevant situation may have been caused by environmental conditions during the long-haul transport process.

 

That said, having regard to consolidated figures from the investigation, it is believed that the relevant situation is not related to cold-chain and logistical management.

 

As regards the other vaccine doses which had been delivered to Hong Kong, random sample testing of vaccine vials which are intact did not uncover any issue of vaccine leakage.

 

The Government emphasised that the subsequent investigation will mainly ascertain the integrity of the intrinsic properties of the relevant batches of vaccine and that it is actively following up with Fosun and BioNTech to strive to complete the investigation procedures within a week.

 

It added that it will closely liaise with the supplier on the supply of the remaining doses of the vaccine to ensure that implementation of the city’s vaccination programme can be continued.

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