Other safety alerts
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| European Union: PRAC reviewing risk of encephalitis with varicella vaccines |
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European Medicines Agency (EMA) announces that its safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), is reviewing the known risk of encephalitis (inflammation of the brain) with two varicella (chickenpox) vaccines, Varilrix and Varivax, following a report of a fatal outcome after vaccination with Varilrix.
In the European Union (EU), Varilrix and Varivax are authorised for vaccination of adults and children from 12 months of age, and in certain populations from 9 months of age, against chickenpox. They contain live attenuated (weakened) varicella virus.
Varicella is caused by the varicella-zoster virus, which also causes shingles (herpes zoster). Varicella mainly affects children aged 2-8 years where it is usually a mild disease and children recover quickly. In some cases, varicella can cause complications including bacterial infection of the skin or blood, pneumonia (infection and inflammation of the lungs) and encephalitis. Encephalitis can also be caused by other viral or bacterial infections. While most people with encephalitis recover, the condition can be life-threatening.
This review was initiated by the PRAC following a case report in Poland of a child who developed encephalitis a few days after receiving the Varilrix vaccine. The patient died of the consequences of encephalitis several days later. As a precaution, the Polish medicines agency has suspended the distribution of vaccines from the batch in question.
These vaccines are widely used across the EU, and encephalitis is listed as a side effect in their product information based on rare reports during post-marketing surveillance.
The committee will now assess all available evidence to better understand the risk of encephalitis and to determine if any regulatory action is necessary.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-2-5-june-2025
In Hong Kong, Varilrix Vaccine For Inj (HK-41798) and Varivax Vaccine (HK-39958) are pharmaceutical products registered by GlaxoSmithKline Limited and Merck Sharp & Dohme (Asia) Ltd respectively, and both products are prescription-only medicines. So far, the Department of Health (DH) has received 1 case of adverse drug reaction related to Varilrix, but it is not related to encephalitis. The DH has not received cases of adverse drug reactions related to Varivax. In light of the above EMA’s announcement, the DH will remain vigilant on the review started by EMA and any safety update of the drugs issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, Jun 7, 2025
Issued at HKT 15:30
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