Hong Kong Suspends Fosun-BioNTech Vaccine After Packaging Defects Reported

The Hong Kong government has temporarily stopped administering the Fosun-BioNTech vaccine for COVID-19, following reports from the manufacturer of packaging defects in the vaccine’s vial seal. Until further notice, the Community Vaccination Centres will not administer the vaccines from Fosun-BioNTech to the public. Instead, only vaccines manufactured by SinoVac will be provided.

The government received a notification from Fosun on March 24 that there are packaging defects in the vaccine batch numbered 210102, and vaccine centres that use the Fosun-BioNTech vaccine were closed around 8 am that day. In a government press conference, Constance Chan, the Director of Health, said there were eight cases of cracks in the container and 22 reports of leakage of saline due to overpressure in the bottle during dilution. The government also received 27 reports related to loose caps and stains outside the container. The Department of Health said it had disposed all the problematic vials.

BioNTech and Forsun Pharma say they are now conducting an investigation into the cause of packaging issues. Another batch of Fosun-BioNTech vaccines numbered 210104, has also been put on hold and will not be used. At this stage, the manufacturers believe that the packaging defects pose no risk to product safety.

Hong Kong citizens have been able to make online reservations for the Covid-19 vaccination since February 23. Between February 26 and March 24, there were 403,000 residents receiving the first dose of the Covid-19 vaccine. Around 252,800 people had their first dose of the SinoVac vaccine, while the remaining 150,200 have opted for the vaccine produced by Fosun-BioNTech.

People queued up at Community Vaccination Centre in Hong Kong Central Library to receive a dose of SinoVac Covid-19 vaccine on March 23, 2021 (Photo/ Vanessa Lai)

The packaging issues have caused concern among Hong Kong residents who had already received their first jab and are awaiting their second jab. In response, Patrick Nip, the Secretary for the Civil Service, emphasized that the suspension is a precautionary measure only and there was no evidence showing the risk of product safety. The government also urged people who have already had their first dose of the vaccine not to mix both the Fosun-BioNTech and SinoVac vaccines.

According to recommendations published in January by the Centre for Health Protection, the second shot of the Fosun-BioNTech vaccine needs to be injected after at least 21 days. This means people who have already gotten their first dose will need to receive a second shot of Fosun-BioNTech vaccine starting from March 27. Chan said the government was checking if the affected batch can still be used, or if the government needs to request another batch.

The government said it is also discussing the possibility of lengthening the time between the first and second shot of the Fosun-BioNTech vaccine. In a government release, it said that scientific research suggested the second-dose of the Fosun-BioNTech vaccine can still be administered around 19-42 days after the first dose. Hong Kong is not the only place discussing extensions in gaps between COVID-19 injections. In the United Kingdom, the government decided to lengthen the gap from three weeks to twelve weeks, in order to give more citizens a first dose of the vaccine. Denmark has also extended the gap between injections to six weeks.

William Chui Chun-ming, the president of the Society of Hospital Pharmacists of Hong Kong claimed that it was uncommon for vaccine bottles to have loose caps. He said as long as the rubber stopper is tight enough to cut off the air, the quality of the vaccine will not be affected. Chui also asked the public to be confident in frontline medical staff as they act as gatekeepers and will report any abnormality. 

Up to March 21, there were a total of 793 cases of adverse reactions to COVID-19 vaccines. Around 200 of these reactions were related to the Fosun-BioNTech vaccine. On March 18, the government reported the first death of a 66-year-old man who had received the BioNTech vaccine. The man has been given a dose of the Fosun-BioNTech vaccine on March 16 at the Lung Sum Avenue Sports Centre. He was a chronically ill patient, suffering from diabetes, high blood pressure and hyperlipidemia. An expert committee said, following a preliminary investigation, that the death did not have a direct association with the vaccine.

Screenshot of a concise guide of BioNTech vaccine from the COVID-19 Vaccination Programme Website.

Wong Chi-Kei, a member of the expert committee said that chronically ill patients are a high-risk target group, they have the possibility to have sudden-onset even if they do not receive the injection. The government has advised those with certain long-term illnesses to consult their doctors before taking the Fosun-BioNTech vaccine.

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