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The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union for Ixchiq (Valneva Austria), the first vaccine for EU countries intended to protect adults aged 18 years or older against chikungunya.

Chikungunya is a viral disease caused by the Chikungunya virus (CHIKV), which is transmitted to humans through the bites of infected mosquitoes, primarily Aedes aegypti and Aedes albopictus.

Symptoms of CHIKV infection typically appear within 3-7 days after a bite from an infected mosquito. The most common symptoms of the acute phase of the disease are fever and joint pain. Other symptoms may include headache, myalgia, joint swelling, or rash. 

Most patients recover within a week. However, some individuals may experience joint pain that lasts for several months or longer. A small proportion of patients, most commonly newborns exposed to the virus during childbirth and adults older than 65 years, may develop severe acute disease, leading to multiorgan failure.

CHIKV infections mostly affect people in the tropics and subtropics. Chikungunya is not endemic in Europe, and most cases in the EU involve returning travelers. However, at its May meeting, the EMA's Committee for Medicinal Products for Human Use (CHMP) noted that climate change could lead to affected mosquitos spreading to new areas.

Ixchiq is a live attenuated vaccine designed to trigger the production of neutralizing antibodies at 28 days and up to 6 months following vaccination. It will be available as powder and solvent for solution for injection.

The CHMP's positive recommendation was largely based on data from a placebo-controlled study that assessed the immunogenicity and safety of the vaccine in adults. Immune response was evaluated in 362 participants (266 treated with Ixchiq and 96 with placebo). At 28 days after vaccination, 98.9% of individuals who received the vaccine had antibody titers against CHIKV above an acceptable threshold. At 6 and 12 months after vaccination, antibody titers above the threshold persisted in 99.5% and 97.1% of individuals who received the vaccine, respectively.

The most common side effects from the vaccine are headache, nausea, myalgia, arthralgia, fatigue, fever, vaccination site reactions, white blood cell count decrease, and liver function test increase. Safety was assessed using pooled data from three completed clinical studies involving 3610 participants and a 6-month follow-up.

Ixchiq was reviewed under the EMA's accelerated assessment program.

Influenza Vaccine Approval

Also at its May meeting, the CHMP adopted a positive stance on Fluenz (AstraZeneca) for the prophylaxis of influenza in children and adolescents from 24 months to younger than 18 years of age.

The live attenuated vaccine contains the influenza virus strains A/(H1N1), A/(H3N2), and B from the Victoria lineage.

The most common side effects with Fluenz are nasal congestion/rhinorrhea, decreased appetite, headache, and malaise.

Fluenz will be available as a nasal spray.

Recommendations by the EMA for marketing authorizations are subject to approval by the European Commission.