Chief Pharmaceutical Inspectorate

On June 2, 2025, the Chief Pharmaceutical Inspector, after consultation with the Chief Sanitary Inspector, at the request of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, issued Decision No. 8/WS/2025 on the preventive suspension of one batch (No. A70CD868B, expiry date  June 30, 2026) of VARILRIX chickenpox vaccine, on the territory of Poland: responsible entity GlaxoSmithKline Biologicals S.A.

The Chief Pharmaceutical Inspector, based on a single serious signal concerning safety, considered that until the explanatory proceedings are conducted and the test results are obtained, it is advisable to suspend the batch of the medicinal product in question from circulation. Assessment of signals concerning safety is required to determine whether there is a causal relationship between the drug and the reported single adverse event. The action of the Chief Pharmaceutical Inspector is preventive in nature and is a routine part of drug safety supervision.

Persons who have received the above vaccine do not need to take any additional action, and in case of any doubts regarding their health, they should consult a doctor to assess for any adverse reactions following vaccination.

VARILRIX vaccine is indicated for the active immunization against chickenpox of healthy persons aged from 9 months to 11 months inclusive under specific circumstances and of healthy persons aged from 12 months, as well as for the post-exposure prophylaxis of healthy persons susceptible to chickenpox within 72 hours of contact with an infected person and of persons at risk of severe chickenpox. The first approval of this vaccine was on October 17, 1994. Almost 100 million doses of this vaccine have been administered worldwide.

The aforementioned vaccine series was on the market in pharmacies and pharmaceutical wholesalers in Poland from the beginning of 2025. In the first quarter of 2025, there was no increased incidence of adverse events following its administration. By the date of discontinuation, approximately 40,000 doses of this vaccine had been distributed nationwide for recommended vaccination. The vaccine series in question was not distributed by sanitary-epidemiological stations and was not used for mandatory immunization under the Immunization Program.

In accordance with the authorization for marketing in Poland and the regulation of the Minister of Health, mandatory vaccination against chickenpox applies to:

1. children and adolescents up to the age of 19 who have not had chickenpox:
   1. with congenital or acquired immunodeficiency with a high risk of severe disease,
   2. prior to planned immunosuppressive treatment or chemotherapy.
2. children and adolescents up to the age of 19 years who have not had chickenpox, from the environment of persons defined in point 1.
3. children and adolescents up to the age of 19 years, who have not contracted chickenpox, residing, or qualified for a stay in:
   1. nursing and care facilities,
   2. nursing and medical institutions,
   3. family-type children's homes,
   4. homes for mothers with minor children and pregnant women,
   5. social care homes,
   6. care and educational institutions,
   7. regional care and therapy institutions,
   8. pre-adoption intervention centres,
   9. nurseries or children's clubs.

Recommended vaccinations against chickenpox are:

Persons who have not had chickenpox and have not been previously vaccinated under either mandatory or recommended vaccination, in particular:

1. women planning to become pregnant,
2. pupils and students at medical schools and colleges or other schools and colleges providing medical education,
3. health care workers.