DH investigates Comirnaty bivalent vaccine incident at medical centre of Quality HealthCare
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The DH has in place a regular inspection mechanism for the COVID-19 Vaccination Programme, under which the DH obtains regular information on the usage of vaccines by the medical service providers enrolled in the programme.
During an inspection conducted by the DH today at the above-mentioned medical centre, it was noted that Comirnaty bivalent vaccines which had been kept one day to eight days after the suggested use-by-date were administered on a total of 14 members of the public from March 21 to 28 at the centre. As suggested by the vaccine manufacturer (Fosun Pharma), Comirnaty bivalent vaccine should be kept at 2 to 8 degree Celsius and be used within 70 days after thawing.
The DH is highly concerned with the incident and has immediately conducted investigation and reminded the staff members to check regularly the suggested use-by date of the vaccines, store vaccines with different use-by dates separately and handle the expired vaccines in accordance with the DH's guideline at appropriate time. The DH has provided advice to the medical centre to improve its vaccine management procedures and internal communications. The centre is also urged to avoid recurrence of similar incidents.
The DH has consulted local expert, and inquired Fosun Pharma on the safety, efficacy and quality of the vaccine. According to local expert, no re-vaccination is needed for the affected persons. The medical centre concerned should actively follow up the health condition of the affected persons.
The DH has requested the medical centre to contact the affected persons to explain the situation and follow up on their health condition. The centre should also manage any discomfort reported immediately and make notification to the DH. The DH has yet to receive any discomfort reports of the affected persons.
ýÿThe DH will continue its follow-up to see if the medical centre has followed the DH's guideline. If there is any violation of the guideline under the COVID-19 Vaccination Programme or the private clinic agreement, the DH will handle according to established mechanism.
Ends/Wednesday, March 29, 2023
Issued at HKT 20:23
Issued at HKT 20:23
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