A sign is posted at a community vaccination center in Kowloon announcing the suspension of vaccination using the BioNTech dose in Hong Kong on March 24, 2021. (PETER PARKS/AFP)
HONG KONG – The Hong Kong and Macao governments suspended batches of vaccines manufactured by BioNTech SE from Wednesday, citing packaging defects related to vial caps of the shots.
BioNTech and Shanghai Fosun Pharmaceutical Group Co, which has the rights to market the mRNA vaccine across the Chinese mainland, the Hong Kong and Macao special administrative regions and Taiwan, have initiated an investigation into the issue but said there is no reason to believe product safety is at risk, according to statements from the Hong Kong and Macao governments.
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For the sake of prudence, the concerned shots of batch 210102, with an expiry date of June 2021, will be suspended immediately for the time being while the investigation is ongoing, said both governments.
Medical staff have found tilted or loose vial caps and minor stains on a small number of bottles. Vaccines in defective packaging were disposed of and not used in the city’s vaccination drive so far, Hong Kong officials said
The Hong Kong government said it is also suspending the administering of batch 210104 as a safety precaution.
As all BioNTech vaccines delivered to Hong Kong belong to the above two batches, all vaccination centers in the city that use the BioNTech vaccine have suspended operations until further notice, the Hong Kong government said.
"Those who have made appointments to receive BioNTech vaccination from today onwards need not go to CVC (Community Vaccination Centres) for vaccination," the Hong Kong government said in its statement.
At a press conference held later on Wednesday, the city's Secretary for Food and Health Sophia Chan Siu-chee said: “Fosun Pharma has told us that they have no reason to find the drugs now have safety risks. But they found some packaging defects, so they need to investigate it.”
Secretary for the Civil Service Patrick Nip Tak-kuen said at the same briefing that affected residents had been notified via SMS messages and any new arrangements will be announced later.
Loose caps
At the briefing, Director of Health Constance Chan Hon-yee said Hong Kong received 585,000 doses of BioNTech vaccine from batch 210102 on Feb 28. So far around 150,000 residents have been inoculated with doses from this batch.
She said medical staff had found tilted or loose vial caps and minor stains on a small number of bottles. Vaccines in defective packaging were disposed of and not used in the city’s vaccination drive so far, she added.
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Vaccine workers had noticed the defective products and reported them to the city’s government, who informed the companies, she said. It was BioNTech and Fosun which then asked Hong Kong and Macao to suspend its rollout.
Doses from batch 210104 have been kept in storage and never been used, she said.
Since some resident will start receiving their second batch of the BioNTech vaccine this Saturday, Constance Chan said the government have requested the producer to advise as soon as possible whether the delivered doses are safe to use.
She cited data from the third phase of the clinical trial as saying that the second BioNTech dose could be administered anytime between 29 and 42 days after the first.
A community vaccination center administering the BioNTech vaccines is temporarily closed in Hong Kong on March 24, 2020. (PHOTO/BLOOMBERG)
For residents who could not receive the second dose on schedule, she said they should get the injection as soon as the vaccine is available. There is no need for them to receive the first dose again, she said.
BioNTech will conduct an investigation at its production facilities, while Hong Kong authorities will look into whether the logistics process, which Fosun is responsible for, caused the defects, she said.
For residents who could not receive the second dose on schedule, they should receive the injection as soon as the vaccine is available and there is no need for them to receive the first dose again, said Director of Health Constance Chan
Also on Wednesday, replying to a question at the Legislative Council, Sophia Chan said there is no basis for the suspension of the vaccination program for now.
"We will also regularly update and publish the relevant report. If citizens have any questions about their physical condition or whether they are fit for COVID-19 vaccination, they should first consult their family doctor or attending doctor before getting the vaccine," Sophia Chan said.
Stocks slide
Macao's Novel Coronavirus Response and Coordination Center also said local residents who have made reservations for inoculation of the vaccine do not need to visit inoculation facilities until further notice.
Macao casinos led declines in the MSCI Hong Kong Index on Wednesday, with Wynn Macau Ltd and Sands China Ltd sinking more than 4 percent. Hong Kong property developers, among the shares most sensitive to the local economy, also slumped.
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The first batch of mRNA vaccines was delivered to Macao on Feb 27. Inoculation started on March 3.
Hong Kong began vaccinating residents with doses from Sinovac Biotech in February and began offering the BioNTech vaccine in March.
Residents have signed up in droves for the shots since the financial hub widened eligibility to adults aged 30-59 earlier this month, an effort to boost vaccination rates and achieve the herd immunity needed to fully reopen the economy.
As of Monday, about 5 percent of the financial hub’s residents had received their first vaccine shots.
With inputs from Agencies