Two batches of Comirnaty COVID-19 vaccine with packaging defects to be returned to manufacturer in Germany

     A Government spokesman announced today (April 29) that two batches of the Comirnaty COVID-19 vaccine, put on hold earlier due to packaging defects, will be returned to the manufacturer, BioNTech, in Germany for disposal.

     On March 24, the Government suspended the use of two batches of the vaccine (Batch Nos. 210102 and 210104) for the sake of prudence and as a precautionary measure after being notified of packaging defects including loose vial caps and leakage from the vials. The Government received the latest notification from BioNTech that the two batches concerned should be returned to the manufacturer in Germany.

     BioNTech has also finished the investigation on the cause of the packaging defects and confirmed that the root cause of the incident was the imperfect crimping process at one packaging plant in Germany, and that there is no safety issue related to the defects.

     The spokesman said that Fosun has arranged for the affected batches to be replaced by new batches that were packaged in another packaging plant (Baxter) in Germany. Since the resumption of the vaccination service of the BioNTech vaccine in Hong Kong, similar complaints related to crimping defects have not been received.

Ends/Thursday, April 29, 2021
Issued at HKT 20:00