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

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

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