Strangvac

Opinion

EMA has issued an opinion on this medicine

Streptococcus equi vaccine (recombinant proteins)

Overview

On 17 June 2021 the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion¹, recommending the granting of a marketing authorisation for the veterinary medicinal product Strangvac suspension for injection for horses. The applicant for this veterinary medicinal product is Intervacc AB. The applicant is registered as a small and medium-sized enterprise (SME) pursuant to the definition set out in Commission Recommendation 2003/361/EC.

Strangvac is an immunological medicinal product containing three recombinant protein antigens; the chimeric recombinant proteins CCE and Eq85, which contain amino acid sequences from respectively five (CCE) and two (Eq85) different cell-surface proteins from S. equi, and the S. equi IgG endopeptidase IdeE. It is intended to induce active immunisation in horses from 8 months of age against equine strangles, caused by Streptococcus equi acute infection.

The benefits of Strangvac are the reduction of the clinical symptoms (body temperature increase, coughing, difficulty swallowing, and signs of depression (inappetence, changes in demeanour)) in the acute stage of infection with Streptococcus equi and the reduction in number of abscesses within submandibular and retropharyngeal lymph nodes. The most common side effects are a transient increase in body temperature of up to 2.6°C for one to five days, transient local tissue reactions at the injection site, characterised by heat, pain and swelling (approximately 5 cm diameter) last for up to five days, loss of appetite and demeanour changes for one day and ocular discharge which may be mucopurulent and present from both eyes is very commonly seen for one to five days after vaccination.

The appropriate CVMP guideline on data requirements for veterinary medicinal products intended for minor use or minor species has been applied in the assessment of the application for marketing authorisation.

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¹ 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 summary of positive opinion for Strangvac

AdoptedReference Number: EMA/CVMP/308991/2021

Product details

• Name of medicine:
  Strangvac
• Active substance:
  • Recombinant Streptococcus equi protein CCE
  • Recombinant Streptococcus equi protein Eq85
  • Recombinant Streptococcus equi protein IdeE
• International non-proprietary name (INN) or common name:
  Streptococcus equi vaccine (recombinant proteins)
• Species:
  Horses
• Anatomical therapeutic chemical veterinary (ATCvet) code:
  QI05AB01
• EMA product number:
  EMEA/V/C/005309
• Marketing authorisation applicant:
  Intervacc AB
• Opinion adopted:
  17/06/2021
• Opinion status:
  Positive