SARs temporarily suspend BioNTech vaccine amid ‘packaging defects’

A notice of vaccine suspension is placed outside a vaccination center for BioNTech in Hong Kong, yesterday

The Macau SAR government suspended the BioNTech vaccination from yesterday following a request made during an online meeting with Fosun Pharma. The suspension requested by Fosun Pharm on the batch of the Covid-19 vaccines was due to packaging defects.
The region has immediately suspended, as a precautionary step, any vaccination from the batch numbered 210102 to ensure the safety of the local vaccination program.
Hong Kong also received vials with the lot number of 210102 and has suspended administration of the vaccines.
The vaccines from the batch in Hong Kong comprise a total of 585,000 doses, with the other batch number 210104 holding 758,000 doses.
A statement issued by the Health Bureau (SSM), BioNTech and Fosun Pharma presented information advising there was no reason to doubt the safety of the vaccine.
Currently, Fosun Pharma has only requested suspension of use of the one batch, with immediate effect, until their investigation is concluded. The batch is not being recalled.
According to the SSM, the government remains in close contact with the vaccine supplier, to discuss other alternatives, including transferring another batch from Hong Kong, or shipping newly-produced doses from Germany as an emergency, in order to resume the use of the vaccine as part of Macau’s vaccination program.
“The government learnt the packaging defects mainly involved loose aluminium caps on vaccine bottles. Macau has never administered vaccines from bottles in such condition. Before administering a vaccine, medical staff would carefully examine the vaccine package, and if there were signs of any abnormality, it would not be used in Macau,” the SSM clarified.
Official data shows that as of Tuesday, a total of 6,215 BioNTech doses had been administered in the SAR. In addition, 5,393 individuals had appointments pending for the vaccination. Of those, 1,520 were scheduled to have a first dose, and 3,873 had a booking for a second dose.
The SSM has already sent messages to the people who have opted for the BioNTech vaccine and are awaiting a jab, informing them that the use of this vaccine is suspended until further notice.
The SSM has called on individuals who have not received a Covid-19 jab to choose the other vaccine currently available in Macau, which is produced by Sinopharm.
As cited on SSM’s website, the recommendation is for two shots to be taken of the same vaccine to achieve the expected efficacy as in the clinical trial.

150,000 doses administered in HK from batch 210102

Although about 150,000 doses from the batch 210102 have been administered in the city so far, Hong Kong officials said during a press briefing yesterday that the vaccines were safe to use despite the packaging defects, and that suspending the vaccination was a precautionary measure. Batch number 210104 remains in the warehouse and has not been used.
According to Hong Kong’s director of Health Constance Chan said that there were over 40 instances when medical personnel found defective packaging, such as cracks on the vaccine bottles or leakages when the vaccine was diluted with saline before being administered, as cited in a report by the Associated Press.
None of these vaccines was given to residents and they were thrown away, officials said.
“Fosun has promised to carry out an immediate investigation so they are going to approach the manufacturer in Germany to look into their plant,” Chan said. “When the vaccines arrive in Hong Kong, they will have a review of the whole logistics chain to see if that’s the cause of the current situation.”
She said that officials are urging manufacturers to give a report as soon as possible to check if the batches of vaccines in Hong Kong can be used, otherwise the manufacturers will have to deliver another batch of shots as soon as possible.
Residents who are slated to receive their second BioNTech dose starting on Saturday should get the second shot administered as soon as possible, if new vaccines arrive in Hong Kong after the recommended 19- to 42-day window following the first dose.
BioNTech could not be immediately reached for comment.
Fosun Pharma said in a filing to the Hong Kong stock exchange that it received notice from BioNTech regarding the packaging defects on Tuesday night and informed Hong Kong and Macau authorities yesterday to temporarily suspend the vaccines.
The suspension of the Pfizer jab means the only vaccine currently offered to Hong Kong residents is China’s Sinovac. As of 8 p.m. Tuesday, 403,000 people have received vaccines in the city, of which 150,200 had received the first dose of the Pfizer vaccine, compared with 252,800 who had taken the Sinovac jab.