Versiguard SARS CoV2: Withdrawal of the marketing authorisation application

The applicant Zoetis Belgium submitted on 16 December 2021 an application for a marketing authorisation to the European Medicines Agency (the Agency) for Versiguard SARS CoV2, through the centralised procedure under Article 3(1) of Regulation (EC) No 726/2004 (mandatory scope).

The eligibility to the centralised procedure was agreed upon by the CVMP on 15 July 2021 as Versiguard SARS CoV2 has been developed by recombinant DNA technology.

The applicant applied for the following indication: Active immunisation of mink from 6 weeks of age to reduce infection and virus shedding following infection with SARS CoV2.

Onset of immunity: 3 weeks after completion of the basic vaccination scheme.

Duration of immunity: Duration of immunity has not been demonstrated but annual re-vaccination is recommended.

The vaccine has also been shown safe in a wide range of susceptible zoo species.

The current proposal for the indication is: Active immunisation of mink from 6 months of age onwards to reduce infection in the respiratory tract and the central nervous system and virus shedding following infection with SARS CoV2.

The active substance of Versiguard SARS CoV2 is a suspension of the extracellular pre-fusion SARS CoV-2 trimer spike protein derived from the Wuhan-1 strain S protein and contains multiple tagged on histidine residues to facilitate purification and detection of the antigen. The target species is mink. The product is intended for administration by subcutaneous use.

The applicant claims that Versiguard SARS CoV2 contains a recombinant cell expressed and purified version of the trimeric spike protein of SARS CoV2 with a histidine tag that is intended for use in veterinary species. There are no vaccines for SARS CoV2 currently authorised for use in animals in the EU therefore the applicant considered the antigen a new active substance. The CVMP considers that the extracellular pre-fusion SARS CoV-2 trimer spike protein derived from the Wuhan-1 strain S protein and containing multiple tagged on histidine residues is a new active substance, as claimed by Zoetis Belgium.

Versiguard SARS CoV2 suspension for injection contains recombinant SARS CoV2 spike protein and is presented in cardboard boxes containing:

• 1 bottle of 10 ml (10 doses)
• 1 bottle of 250 ml (250 doses)
• 1 bottle of 500 ml (500 doses)

The dossier has been submitted in line with the requirements for submissions under Article 12(3) of Directive 2001/82/EC – full application.

On 15 September 2022, during the clock-stop, Zoetis Belgium communicated the withdrawal of the marketing authorisation application to the Agency.