En Chu Kong Hospital in New Taipei City, which yesterday apologized for having inadvertently administered undiluted doses of the Pfizer-BioNTech COVID-19 vaccine to 25 people, has been suspended from administering vaccines for one week.
Hospital superintendent Wu Chih-hsiung (吳志雄) and other administrative officials held a news conference yesterday morning to explain the incident and apologize to the public.
The incident occurred on Monday when hospital personnel were administering Pfizer-BioNTech vaccines at its vaccination station at Yong Fu Temple (永福宮) in Yingge District (鶯歌), hospital deputy superintendent Wang Chung-cheng (王炯珵) said.
Photo courtesy of En Chu Kong Hospital
At the vaccination station, there were 25 Pfizer-BioNTech vials without packaging and some without caps, so the hospital personnel mistakenly thought that they had been diluted and were ready for injection, he said.
The undiluted vaccine solution was inadvertently injected into the first 25 recipients, Wang said.
The hospital immediately informed them after personnel discovered the mistake at noon, when tracking the number of doses administered.
The fact sheet for those administering the Pfizer-BioNTech vaccine says that a multiple-dose vial contains 0.45ml of the vaccine.
Before being administered, each vial must be thawed and injected with sterile, nonpyrogenic, distilled water after the addition of 1.8ml of 0.9 percent sodium chloride, it says, adding that each vial contains six 0.3ml doses.
The incident involved 11 men and 14 women aged 18 to 65, but none has so far experienced an adverse reaction, even though one of them had a medical history of heart disease, Wang said.
Of the 25 people involved, 11 agreed to an examination before returning home, nine agreed to being hospitalized for observation, and five refused intervention and returned home, Wu said.
The hospital formed an emergency response team, which is to provide examinations and follow-up care, including daily follow-ups by telephone and weekly outpatient checkups for at least one month, he added.
The incident occurred because a mistake was made during the shift handover, so the hospital would review its procedures and ensure that they are carefully implemented, he said.
The hospital had submitted a report on the incident, New Taipei City Department of Health Director Chen Jun-chiu (陳潤秋) said, adding that the department had asked the hospital to monitor the health of the 25 people and to give them follow-up care.
“Due to the incident, the health department has suspended En Chu Kong Hospital’s COVID-19 vaccination operations for one week, effective immediately,” she said. “The department has also gathered specialists to form a task force to look into the case.”
The hospital was asked to improve its training and procedures, or it could have its vaccination contract terminated, Chen said.
Separately, Centers for Disease Control Deputy Director-General Chuang Jen-hsiang (莊人祥), who is the Central Epidemic Command Center’s spokesman, said that reports in other countries showed that people who received excessive doses of the Pfizer-BioNTech vaccine mostly had pain or swelling at the injection site, but no serious adverse reactions.
Asked whether the 25 people might have a higher risk of myocarditis and whether they would need a second dose, Chuang said that myocarditis following vaccination more often occurs after a second dose, and typically more than seven days after getting vaccinated.
The center would consult with specialists regarding a second dose for the 25 people, he added.
Yesterday, the center said that to reduce errors, personnel should remember “three checks” and “five rights” when preparing to administer Pfizer-BioNTech vaccines to people.
The “three checks” are checking the label when retrieving a vial from storage, checking the vial after preparation but before administration, and checking the vial when it is returned to storage.
The “five rights” are verifying that personnel have the “right patient, the right drug, the right dose, the right route and the right time.”
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