New Chikungunya vaccine for adolescents from 12 and adults
The review of Vimkunya was expedited because of public health interest
NewsHumanMedicines
EMA has recommended granting a marketing authorisation in the European Union (EU) for Vimkunya, the first vaccine in the EU to protect adolescents from the age of 12 against Chikungunya. This vaccine, also intended for adults, is given as a single dose.
Chikungunya, also called CHIK fever, is a viral disease caused by Chikungunya virus (CHIKV), a virus transmitted to humans by infected mosquitoes (primarily Aedes aegypti and Aedes albopictus).
Most people infected with CHIKV develop symptoms within 3–7 days. The most common symptoms of acute disease are fever and joint pain. Most patients recover within a week, but some develop joint pain for several months or longer, which can be disabling, and a small proportion of patients may develop severe acute disease, which can lead to multiorgan failure.
CHIKV infections affect people mostly in the tropics and subtropics. Chikungunya is not endemic in Europe. The majority of cases in the EU concern travellers who were infected outside of mainland Europe. However, there have been sporadic cases incidents of onward transmission by infected travellers after their return, mainly in Southern Europe where the Aedes. albopictus mosquito is established. Spread of the mosquito due to climate change could lead to cases of Chikungunya in regions so far spared.
Vimkunya was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. The CHMP reviewed the application for marketing authorisation under an accelerated timetable because the vaccine is considered to be of major public health interest.
The CHMP’s opinion is largely based on data from two placebo-controlled studies. Study 1 assessed the immunogenicity and safety of the vaccine in 3,258 individuals from 12 to 64 years of age, and Study 2 in 413 older adults. The immune response was evaluated in 3,355 participants (2,748 with Vimkunya and 607 with placebo). The clinical efficacy of Vimkunya was inferred from a post-vaccination CHIKV-specific neutralising antibody titre threshold selected as a surrogate marker and referred to as seroresponse. Eight days after vaccination, the difference in seroresponse rates (SRRs) between those vaccinated with Vimkunya and those with placebo in Study 1 was 46.1%. This rose to 96% at day 15, 96.6% at day 22 and 84% at Day 183. In Study 2, the difference in SRRs was 79.5% at Day 15, 86.2% at Day 22 and 74.4% at Day 183.
The CHMP has requested a post-authorisation efficacy study to confirm the effectiveness of Vimkunya in preventing Chikungunya in adolescents and adults.
The safety profile of Vimkunya is based on pooled data from five completed clinical studies with 3,522 participants with a 6-month follow-up. The most common side effects reported were tiredness, headache, muscle pain and injection site pain.
The opinion adopted by the CHMP is an intermediary step on Vimkunya’s path to patient access. The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.
Notes:
- The applicant for Vimkunya is Bavarian Nordic A/S.