其 他 安 全 警 示
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| European Union: Review of risk of encephalitis with varicella vaccines concluded (English only) |
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European Medicines Agency (EMA) announces that its Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its review of the known risk of encephalitis (inflammation of the brain) with the varicella (chickenpox) vaccines Varilrix and Varivax. The review was triggered by a case of encephalitis with fatal outcome after vaccination with Varilrix.
After carefully evaluating the available evidence from clinical trials, the scientific literature and post-marketing exposure, the committee has recommended an update to the product information of Varilrix and Varivax to further describe the severity of the risk of encephalitis. The two vaccines remain contraindicated in immunocompromised people and no additional risk minimisation measures are required.
Varicella vaccines are also authorised as part of measles, mumps, rubella, and varicella (MMRV) vaccines, namely Priorix Tetra and Proquad. PRAC considered that the product information of MMRV vaccines should also be updated in line with varicella vaccines.
The amended product information will give further detail on the known side effect encephalitis which has been observed with live attenuated varicella vaccines, including in a few cases with fatal outcome.
People who receive the vaccine should seek immediate medical attention if they develop signs of infection or inflammation of the brain.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-7-10-july-2025
In Hong Kong, Varilrix Vaccine For Inj (HK-41798) and Priorix-Tetra Vaccine (HK-57798) are pharmaceutical products registered by GlaxoSmithKline Limited, and Varivax Vaccine (HK-39958) and Proquad Vaccine (HK-54831) are pharmaceutical products registered by Merck Sharp & Dohme (Asia) Ltd. All products are prescription-only medicines. So far, the Department of Health (DH), has received 1 case of adverse event following immunisation with Priorix-Tetra, 1 case of adverse event following immunisation with Varilrix and 4 cases of adverse event following immunisation with Proquad, but these cases were not related to encephalitis. The DH has not received any cases of adverse event following immunisation with Varivax.
The current product inserts of locally registered products Varilrix, Varivax, Priorix-Tetra and Proquad include safety information about encephalitis. Related news was previously issued by EMA, and was posted on the Drug Office website on 7 Jun 2025. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Saturday, Jul 12, 2025
Issued at HKT 12:00
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