CHMP positive for Kostaive vaccine for the prevention of COVID 19 in adults – CSL Behring + Arcurtus

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kostaive, a vaccine intended for the prevention of COVID-19 in adults.

The applicant for this medicinal product is Arcturus Therapeutics Europe B.V.

Kostaive will be available as a powder for dispersion for injection. Kostaive is a RNA-based COVID-19 vaccine (ATC code: J07BN01). It contains a self-amplifying mRNA that encodes the SARS-CoV-2 spike protein. Self-amplifying means that the mRNA also carries instructions to make a protein called replicase. Once administered into a muscle, the replicase protein makes more copies of the mRNA, which the cell can use to make more spike protein. Vaccination with Kostaive induces the production of neutralising antibodies and a cellular immune response targeting the spike protein, which helps protect people against COVID-19.

The benefit of Kostaive as a primary vaccination against COVID-19 was shown in a large study in which adults received either two doses of Kostaive or placebo. Compared with placebo, vaccination with Kostaive led to a reduction in the proportion of patients who developed symptomatic COVID-19 between one week and 3 months after the second vaccine dose. A smaller immunobridging study also showed that Kostaive is effective as a heterologous booster vaccination (when the primary vaccination was made with another COVID-19 vaccine). The most common side effects with Kostaive are injection-site reactions (pain and tenderness), arthralgia, myalgia, headache, dizziness, fatigue, chills and pyrexia.