Hong Kong Halts Use of BioNTech Vaccine Over Packaging Issues
Hong Kong health authorities have halted administration of BioNTech’s Covid-19 vaccine after packaging issues were found in a batch of vials being administered in the city.
Macau officials have done the same, citing issues with the same batch.
BioNTech said in a statement that no other region had been supplied with doses from that batch.
BioNTech (BNTX), which developed its Covid-19 vaccine with Pfizer (PFE), partners with Shanghai Fosun Pharmaceutical (600196. China) on the vaccine in greater China, including Hong Kong and Macau.
In a statement on Wednesday, the Hong Kong government said that Fosun alerted the government to “observed deviations in the vial seal” in some bottles from a certain batch on Wednesday morning.
That batch was in the process of being administered to people in the city. Administration of another batch, which Hong Kong authorities had purchased but had not begun to use, is also being put on hold.
According to Bloomberg, Hong Kong officials said at a press conference that they had found loose caps and stains on a number of vials.
“So far, BioNTech and Fosun Pharma have no reason to believe that there is a risk to product safety,” Hong Kong authorities said in a statement. “However, for the sake of prudence, vaccination of the batch 210102 should be suspended until the investigation is completed.”
BioNTech produces the vaccine doses sold to Hong Kong in its manufacturing facilities in Germany, according to a Jan. 25 statement by the company.
In a statement to Barron’s, BioNTech said that it had halted vaccinations in Hong Kong and Macau to investigate the cause of “reported issues with the primary packaging materials for vials in one batch of vaccine supplied to Hong Kong and Macao.”
The company said: “The investigation includes the handling of the batch at the vaccination centers, throughout the supply chain, during re-packaging as well as at the time of fill and finish of the batch. At this point, we have no reason to believe there is any safety risk posed to the population… No other region has been supplied with doses from this batch. No other batches shipped to other regions are affected by this investigation.”
In a filing with the Hong Kong stock exchange, Fosun Pharma said that BioNTech had informed it of the packaging defects on Tuesday night, according to the Associated Press.
BioNTech’s American depository receipts were up 0.4% in premarket trading on Wednesday. Shares of Fosun Pharma were down 5.8% on the Shanghai Stock Exchange.
According to Bloomberg, Hong Kong has administered 397,600 doses of Covid-19 vaccines so far, and only 0.2% of its population is fully vaccinated.
Hong Kong issued an emergency-use authorization to BioNTech and Fosun Pharma for the Covid-19 vaccine on Jan. 25. The companies have been collaborating to develop and commercialize the Covid-19 vaccine in greater China since March 2020.
Write to Josh Nathan-Kazis at [email protected]