Wednesday, June 11, 2025, Chief Pharmaceutical Inspector (GIF), The Agency for Medicinal Products Registration and the Chief Sanitary Inspector (GIS) issued a joint communication on the suspension of 1 series of varicella vaccine (VARILRIX, A70CD868B series, expiry date 30.06.2026). The decision was made following a single study of a serious adverse event.
Is the vaccine dangerous?
GIS spokesperson Marek Waszczewski calms: ‘Stopping marketing does not yet mean that the vaccine is hazardous to health’. The decision is preventive and results from safety procedures. People who have taken the vaccine of this series do not request to take additional action but should observe their wellness status. If you have any worrying symptoms, consult your doctor.
Why was the turnover stopped?
The GIF decided on 1 adverse reaction (NOP) report. As explained in the Communication, cessation of marketing is simply a standard procedure that allows to clarify whether there is simply a link between the vaccine and the reported event.
‘After verification, the medicine is re-authorised or withdrawn, if necessary’ said GIF in social media.
GIS withdraws a series of varicella vaccine 2How large was the organization stopped?
VARILRIX series A70CD868B has been available in pharmacies and wholesalers since early 2025. In the first quarter, there was no increase in adverse reactions. Around 40,000 doses of this vaccine were distributed across Poland, which was utilized only as part of the recommended vaccination, not as a compulsory vaccination.
What's next?
The decision to suspend trading was made on 2 June 2025. Studies are presently underway to find whether the reported event was related to the vaccine. Until the end of the procedure, the series shall stay withdrawn from distribution.
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GIS withdraws a series of varicella vaccine
