- The government announced the suspension of the coronavirus vaccination scheme for the German-made jab due to packaging defects
- Health officials say the move was a precautionary measure and there’s no evidence to suggest health risks
People queue for the BioNTech jab at a community vaccination centre in Ap Lei Chau before the announcement of the programme suspension was made. Photo:SCMP/K.Y. ChengHongkongers who had already received their first shot of the BioNTech vaccine for were surprised on Wednesday morning when the government suspended the use of the jab after reports of packaging defects, but many were confused about what to expect next.
Of the 585,000 doses in the first batch dispensed, or “batch 210102”, about a quarter, or 150,000, had been used so far.
In Hong Kong, Fosun Pharma is in charge of delivering the jab jointly developed by Germany’s BioNTech and US-based Pfizer. The vaccines are made in Germany.
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More than 50 defects that included cracks, leakages and stains outside the glass containers were reported, but all potentially spoiled vials had been disposed of, health authorities said.
The abrupt halt has dealt another blow to public confidence in the city’s immunisation scheme – which has recorded a vaccination rate of only about 5 per cent – after several deaths among recipients, all with chronic diseases, were reported. No link between the deaths and the vaccines has been established.
The health minister stressed the halt was a precautionary measure given there was no evidence so far to suggest the shots posed a health risk.
A notice was posted about the suspended BioNTech vaccinations at Sun Yat Sen Memorial Sports Centre. Photo: SCMP / May Tse
How serious were the packaging defects?
Director of Health Dr Constance Chan Hon-yee revealed there were eight incidents of cracked BioNTech vials and 22 air pressure issues resulting in leaks.
Another 16 reports of vial seals being loose or out of position were made, as well as 11 that were linked to the identification of stains or marks on the exterior of the glass containers.
She said all those vials in question had been disposed of after problems were identified and vaccines from those vials were not administered to the public.
Recipients can check their vaccination records to determine whether they had received a dose from the batch in question.
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Are there any health risks for those who have already taken the first dose?
The manufacturers said they could not see any problems related to safety concerning the vaccines, but they would need to conduct a thorough investigation, according to Chan.
“For the sake of caution, they requested Hong Kong suspend the use of this batch,” she said.
William Chui Chun-ming, president of the Society of Hospital Pharmacists of Hong Kong, said pharmacists acted as gatekeepers at community vaccination centres.
“If you ask me whether the quality of the drugs had been affected, [I believe] the chance is very low,” he said.
Chui said if cracks or leakage were found in the vials, medical staff would not use them.
For vial seals that were out of position or loose, he said that as long as the rubber stopper remained tight and intact, the quality would not usually be compromised. But this issue would need further clarification from the manufacturers.
Officers would also clean any stains on the exterior of the glass vials with alcohol, he added.
Laboratory staff demonstrate the dilution, extraction and labelling of BioNTech vaccines at the Community Vaccination Centre at Sai Wan Ho Sports Centre. Photo: SCMP / Nora Tam
What next for those who have taken the first shot?
Do not take any action until you are further notified by the health authorities.
Chan said that for now, anyone who received the first jab would not have to repeat the dose. Even though most appointments for the second jab would be 21 days later – and have now been suspended – the follow-up shot for the BioNTech vaccine could be administered 19 to 42 days after the first injection, she added.
She also advised against switching to another brand of vaccines for the second dose or retaking a first shot of another vaccine.
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Chan said the users of the vaccine most urgently affected would be those needing to receive their second dose on Saturday. They would have been the first to get the BioNTech shots nearly three weeks ago.
“If the current stock in Hong Kong cannot be used, we will request the pharmaceutical firm to deliver another batch as soon as possible,” she said.
What about those who have registered for BioNTech for the coming days and weeks?
The programme is suspended for now. Secretary for Civil Service Patrick Nip Tak-kuen, who oversees the vaccination campaign, said the online booking system for the German-made drugs has been suspended and the arrangements for residents to change their appointment would be announced later.
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Are there initial theories on the cause of the damaged vials and how long will the investigations take?
The BioNTech shots must be kept at minus 70 degrees Celsius and thawed and diluted before injection. Each inoculation centre is equipped with two pharmaceutical fridges to store the vials at temperatures between 2 and 8 degrees for no more than five days. The prepared solutions must be used within six hours and cannot be stored above 30 degrees.
The authorities could not say whether the damaged containers had anything to do with the storage and transportation of the vaccines.
Fosun Pharma, which is distributing the BioNTech jabs in China, pledged to conduct an immediate investigation, covering areas including the manufacturing process and logistical operations. But there was no timeline on when Fosun and BioNTech would complete their investigation into the defects.
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Professor Ivan Hung Fan-ngai, co-convenor of an expert committee monitoring the side effects of vaccines, said that based on current reports the problems involved just minor defects which were unlikely to affect the vaccination programme in the long run.
“Once we have sorted this incident out and also confirmed that’s just a minor defect, I am sure that the vaccination programme will resume as soon as possible,” he said.
As of 8pm on Wednesday, official figures showed a total of 412,800 people, or about 5.5 per cent of the city’s population, had been vaccinated. Of those, 151,300 had received the first dose of the BioNTech vaccine, compared with 261,500 for the Sinovac one.