Poulvac E. coli - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

Escherichia coli aroA gene deleted, type O78, strain EC34195 (live)

Opinion

On 12 June 2025, the Committee for Veterinary Medicinal Products (CVMP) adopted a negative opinion*, recommending the refusal of a variation to the terms of the marketing authorisation for the veterinary medicinal product Poulvac E. coli. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium.

The scope of the variation was to add new information to the SPC/PI to reflect that administration of the vaccine was shown to reduce the use of antibiotics used to treat colibacillosis in the vaccinated chicken flocks. 

The grounds for the negative opinion relate to the following points:

• The statement that Poulvac E. coli reduces the use of antibiotics used to treat colibacillosis in the corresponding flocks was not considered to be information that qualifies for inclusion in the product information compatible with the provisions of Regulation (EU) 2019/6. 

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*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 negative opinion for Poulvac E. coli (VRA0000243824)

AdoptedReference Number: EMADOC-1700519818-2191067

Key facts

• Name of medicine:
  Poulvac E. coli
• EMA product number:
  EMEA/V/C/002007
• Active substance:
  Live aroA gene deleted Escherichia coli, type 078, strain EC34195
• International non-proprietary name (INN) or common name:
  Escherichia coli aroA gene deleted, type O78, strain EC34195 (live)
• Date of opinion:
  12/06/2025
• Status:
  Negative