In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the evaluation of periodic safety update reports (PSURs) for the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine), PSUSA/00002453/202505, reached the following conclusions.
Based on the available data from spontaneous reports, the PRAC considers that a causal relationship may exist between the use of the pneumococcal polysaccharide vaccine and injection site necrosis. The PRAC concluded that the package insert of the pneumococcal polysaccharide vaccine should be amended accordingly.
Having considered the PRAC recommendations, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the overall conclusions of the PRAC and the grounds for the recommendations.
Based on the scientific conclusions on the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine), the CMDh considers that the benefit/risk balance of the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine) remains unchanged, subject to the proposed changes to the package insert.
Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).
“Adverse reactions” section
The following adverse reaction should be added to the System Organ Class (SOC) "General disorders and administration site conditions" with a frequency of "not known".
Injection site necrosis
Changes to the safety information of pneumococcal polysaccharide vaccine for the prevention of pneumococcal infection following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026
The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026. Based on the results of the meeting, a decision was made on the need to introduce safety-related changes to the registration materials/instructions for medical use of the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine).
Vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine) – PSUSA/00002453/202505
Vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine), is used for the prevention of pneumococcal diseases caused by the pneumococcal types included in the vaccine.
Based on the assessment of Periodic Safety Update Reports (PSURs), PRAC reviewed the benefit/risk balance of the pneumococcal polysaccharide vaccine for the prevention of pneumococcal infection and provided the relevant recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk ratio of the vaccine for the prevention of pneumococcal infection, polysaccharide (pneumococcal polysaccharide vaccine), for the approved indications remains unchanged.
- At the same time, the package leaflet should be updated by adding injection site necrosis as an adverse reaction with a frequency of “not known”. Therefore, the current provisions of the package leaflet must be amended1.
- In the next PSUR, registration certificate holders (RCHs) should provide a cumulative review of cases of erythema multiforme, including, but not limited to, the MedDRA preferred term (PT) "erythema multiforme", cases of streaky redness at the injection site and lymphangitis, including, but not limited to, the MedDRA preferred terms ("Streaky redness at the injection site" and "Lymphangitis"), as well as cases of diarrhea. In addition, RCHs should consider the need to make any potential changes to the instructions for medical use in accordance with the specified cumulative reviews.
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1Update of the “Adverse reactions” section of the instructions for medical use. The risk assessment report and the PRAC recommendation are submitted to CMDh for a decision.
TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS:
