The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has started a review of the conditional marketing authorisation application for the recombinant COVID-19 vaccine candidate Skycovion, submitted by SK Chemicals GmbH. The applicant submitted data on immunogenicity, safety and quality. One aspect shown by the data is the extent to which the vaccine leads to the formation of antibodies (immunogenicity) against the original strain of SARS-CoV-2 (Wuhan).
After the CHMP assesses the data submitted for the COVID-19 vaccine candidate SKYcovion, it will make a recommendation to the European Commission on whether a conditional marketing authorisation should be granted based on its evaluation.
The European Commission takes the decision on the authorisation, which usually follows the CHMP recommendation.
The review of Skycovion is part of the ongoing evaluations of COVID-19 vaccines. Having a wide range of vaccines and treatment options helps to effectively combat the SARS-CoV-2 pandemic.
Experts at the Paul-Ehrlich-Institut serving on the EMA's scientific committees work to ensure that all data on COVID-19 vaccines and treatments is thoroughly examined.
Skycovion is a recombinant, protein-based vaccine in which genetically engineered, modified spike proteins of the Wuhan strain of the SARS Coronavirus-2 accumulate to form nanoparticles.
The COVID-19 vaccine candidate, like other protein-based vaccines, contains an adjuvant.
Updated: 19.08.2022
