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 European Medicines Agency (EMA) has published the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC) meeting of 09 – 12 February 2026. Following the meeting, a decision was made that safety-related changes are necessary to the registration materials/instructions for medical use of the vaccine for the prevention of rotavirus infection (live) [rotavirus vaccine, live].
Vaccine for the prevention of rotavirus infection (live) [rotavirus vaccine, live] – ROTARIX – PSUSA/00002665/202507
Based on the evaluation of Periodic Safety Update Reports (PSURs), PRAC reviewed the benefit/risk balance of the use of the vaccine ROTARIX (rotavirus vaccine, live) and provided appropriate recommendations.
Summary of recommendations and conclusions
- Based on the analysis of safety and efficacy data, the benefit/risk ratio of the vaccine ROTARIX (rotavirus vaccine, live) for the approved indications remains unchanged.
- At the same time, the instructions for medical use should be updated by adding anaphylactic reaction as a warning and as an adverse reaction with a frequency of “not known”. Accordingly, the existing provisions of the instructions for medical use must be amended1.
- In the next PSUR, the registration certificate holder (RCH) must provide a cumulative review and analyze changes in the dynamics of medication errors over a certain period, including a detailed assessment of trends in the associated adverse reactions, possible causes and their geographical distribution.
- As part of post-registration measures, the RCH must provide a cumulative review of all cases of serious rotavirus gastroenteritis in children without immunodeficiency (DLP July 11, 2025), including data from the literature, post-registration surveillance and clinical studies, as well as an analysis of possible biological plausibility. In addition, the RCH must also provide a cumulative review of cases of vomiting, focusing on serious cases where no other vaccine(s) were administered and no alternative etiology/diagnosis was established, together with an assessment of the causal relationship. The RCH must discuss the need to update the instructions for medical use and/or the risk management plan, as necessary.
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1Update of the sections “Special Precautions for Use” and “Adverse Reactions” of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for decision.
Scientific conclusions of the EMA Committee for Medicinal Products for Human Use (CHMP) and grounds for amending the registration materials
Taking into account the PRAC report on the assessment of the PSUR of the vaccine for the prevention of rotavirus infection, monovalent (live, oral) [rotavirus vaccine monovalent (live, oral)], the scientific conclusions of PRAC are as follows.
In view of the available data from the literature and spontaneous reports, which in some cases indicate a close temporal association, and in view of the plausible mechanism of action, the PRAC considers that a causal relationship between the use of rotavirus vaccine monovalent (live, oral) and anaphylactic reaction is at least reasonably possible. The PRAC concluded that the instructions for medical use of rotavirus vaccine monovalent (live, oral) should be amended accordingly.
Having reviewed the PRAC recommendations, the CHMP agreed with the overall conclusions and grounds for the recommendations.
Based on the scientific conclusions on the vaccine for the prevention of rotavirus infection, monovalent (live, oral) [rotavirus vaccine monovalent (live, oral)], the CHMP considers that the benefit/risk balance of the vaccine for the prevention of rotavirus infection, monovalent (live, oral) [rotavirus vaccine monovalent (live, oral)] remains unchanged, subject to the proposed changes being made to the instructions for medical use.
Comprehensive and up-to-date information on an individual medicinal product (summary of product characteristics, post-registration procedural steps, RMP summary, additional risk minimization measures, etc.) registered through the centralized procedure can be found in the Human medicines European public assessment report (EPAR) on the EMA website.
List of vaccines for the prevention of rotavirus infection (live) (rotavirus vaccine, live) authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 28.05.2026). (12 KB) (Downloaded: 09.06.2026 05:58:15)
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:
