BioNTech jabs with packaging defects to be destroyed: govt

2021-04-30 03:56     Comment:0

Macau to get replacement batch 

The Macau government’s Novel Coronavirus Response and Coordination Centre announced in a statement last night that the remaining BioNTech mRNA doses – over 90,000 doses – that have not been administered from the company’s first batch sent to Macau as some of the vials were affected by packaging defects last month will be sent back to Germany where they will be destroyed.

The statement said that the final findings of the manufacturer’s investigation into the packaging defects have concluded that the defects “have not resulted in a major impact on the [vaccine] quality”.

The statement was quick to add that “in order to ensure vaccination safety, the [remainder of the] batch [that has been sealed up] should not be used”.

According to the statement, a replacement batch will be delivered to Macau later, with the number of doses being the same as the number of doses that have not been used from the first batch.

The first batch of 100,425 doses of BioNTech vaccine was delivered to Macau in late February. However, Macau’s BioNTech vaccinations were suspended on March 24 after the manufacturer detected packaging defects in some of the vials in the batch. The inoculations were resumed on April 5 after the second batch of 19,500 doses was delivered to Macau on April 2.

The third batch of 29,250 doses of BioNTech vaccine was delivered to Macau on April 13.

According to a Health Bureau (SSM) announcement last month, a total of 6,215 BioNTech doses from the first batch had been administered in Macau as of March 23, the day before the suspension of the BioNTech jabs on March 24.

Metal ring crimping

Last night’s statement said that BioNTech in Germany, in conjunction with its Shanghai-based distributor Fosun Pharma, have completed their joint investigation into the packaging defects that affected the first batch, according to which “during the packaging of the vaccine, the crimping of the metal ring failed to ensure the integrity of the packaging of the vials”.

The statement noted that as BioNTech mRNA vaccines are stored at an ultra-low temperature, the vaccine in the vials affected by the packaging defects had a low risk of bacterial infection.

“The vaccine supplier has concluded that the packaging defects have not resulted in a major impact on the [vaccine] quality,” the statement said.

“The vaccine supplier will recall the doses from the batch [affected by the packaging defects] as a precautionary measure, and return them to Germany where they will be destroyed,” the statement said.

Last night’s statement also reaffirmed that the packaging defects that affected the first batch mainly involved loose aluminium vial caps. The packaging defects were mainly due to the fact that the aluminium caps on some of the vials were not properly tightened, because of which the caps could be loosened on some occasions,” the statement said.

The statement underlined that before administering COVID-19 jabs, Health Bureau medical workers always carefully check each vaccine package for possible abnormalities. If they defect abnormalities, the vial will not be used, the statement said, adding that consequently none of the vials that had packaging abnormalities in the first batch were used.

Over 102,000 jabs

Meanwhile, the centre announced in another statement yesterday that as of 4 p.m. yesterday, 102,444 doses of COVID-19 vaccine had been administered to 67,115 people in Macau, comprising 31,651 who had received their first jab and 35,464 who had received their second jab.

A total of 11 adverse events were reported in the past 24 hours (until 4 p.m. yesterday). The total number of adverse events since the start of the vaccination drive stood at 461, or 0.45 percent of the total number of jabs, including two serious cases.

A Health Bureau (SSM) medical worker unpacks a box containing BioNTech mRNA vaccines in the public Conde de São Januário Hospital Centre in late February when the first batch of 100,425 doses was delivered to Macau from Germany via Hong Kong. Photo: GCS

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