Based on the review of the data, at the time of the withdrawal, the Agency had concerns related to the quality of the medicine and the validation of the tests used to measure the immune response. In addition, the Agency considered that the application for a conditional marketing authorisation, as requested by the company, was not appropriate. Such an authorisation can only be considered when a medicine addresses an unmet medical need, and the Agency noted that other vaccines against the original strain of the SARS-CoV-2 virus are widely available.

Therefore, at the time of the withdrawal, the Agency’s opinion was that the company had not provided enough data to support the application for Skycovion, and its provisional opinion was that Skycovion could not have been authorised for the prevention of COVID‑19.