Summary of opinion: Startvac, 16/04/2026 Positive

EMA

2026/04/17

Startvac - opinion on variation to marketing authorisation Opinion EMA has issued an opinion on a change to this medicine's authorisation adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci Post-authorisation Veterinary Opinion On 16 April 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Startvac. The marketing authorisation holder for this veterinary medicinal product is Laboratorios HIPRA S.A. Startvac is an inactivated vaccine for herd immunisation of healthy cows and heifers to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus (S.) aureus , coliforms and coagulase-negative staphylococci in dairy cattle herds with recurring mastitis problems. The vaccine consists of an emulsion for intramuscular injection. The variation concerns G.I.9: other variations not specifically covered elsewhere in chapter G which involve the submission of studies to the competent authority, including additional clinical and non-clinical studies, including BE-studies. The purpose of this variation was to change the immunisation scheme so that the product could be administered independently of the parturition date of the animals. More specifically, the applicant proposed to administer the current primary vaccination consisting of 3 doses regardless of the expected parturition date or gestation phase of the animals followed by booster doses every three months to maintain vaccine protection for longer periods instead of repeating the full primary vaccination scheme (three vaccinations around the third trimester and early lactation) with each gestation. The proposed vaccination regime would result in a rolling vaccination of dairy cattle herds with recurring mastitis problems. Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission. Note: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion. CVMP post-authorisation summary of opinion for Startvac (EMA-VRA-0000288186) Adopted Reference Number: EMADOC-1700519818-3056849 English (EN) (151.89 KB - PDF) First published: 17/04/2026 View Key facts Name of medicine Startvac EMA product number EMEA/V/C/000130 Active substance Escherichia coli J5 inactivated staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime-associated antigenic complex International non-proprietary name (INN) or common name adjuvanted inactivated vaccine for cattle against Staphylococcus aureus, coliforms and coagulase-negative staphylococci Date of opinion 16/04/2026 Status Positive News on Startvac Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 April 2026 17/04/2026 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7-9 November 2023 10/11/2023 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 7-9 September 2021 10/09/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 January 2020 24/01/2020 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017 20/01/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 September 2015 11/09/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014 12/09/2014 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 2013 13/12/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 January 2013 11/01/2013 More information on Startvac Startvac This page was last updated on 17/04/2026 Share this page

Summary

On 16 April 2026, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Startvac. The marketing authorisation holder for this veterinary medicinal product is Laboratorios HIPRA S.A. Startvac is an inactivated vaccine for herd immunisation of healthy cows and heifers to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus (S.) aureus, coliforms and coagulase-negative staphylococci in dairy cattle herds with recurring mastitis problems. The vaccine consists of an emulsion for intramuscular injection. The variation concerns G.I.9: other variations not specifically covered elsewhere in chapter G which involve the submission of studies to the competent authority, including additional clinical and non-clinical studies, including BE-studies. The purpose of this variation was to change the immunisation scheme so that the product could be administered independently of the parturition date of the animals. More specifically, the applicant proposed to administer the current primary vaccination consisting of 3 doses regardless of the expected parturition date or gestation phase of the animals followed by booster doses every three months to maintain vaccine protection for longer periods instead of repeating the full primary vaccination scheme (three vaccinations around the third trimester and early lactation) with each gestation. The proposed vaccination regime would result in a rolling vaccination of dairy cattle herds with recurring mastitis problems. Detailed conditions for the use of this product are described in the updated summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the Union Product Database (UPD) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission. Note: Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.