- Valneva to receive up to $41.3 million from CEPI and
the European Union to expand access to chikungunya vaccine,
IXCHIQ®
- Funding will support
clinical trials in vulnerable groups, such as children and pregnant
women
- Partnership will also
support technology transfer to an additional manufacturer to supply
IXCHIQ® to Asian LMICs
- IXCHIQ®
is already approved for
use in adults 18 years of age and older in the U.S., Canada and
Europe
Oslo, Norway, and Saint-Herblain,
France, July 22, 2024—The Coalition for Epidemic
Preparedness Innovations (CEPI) and Valneva SE (Nasdaq: VALN;
Euronext Paris: VLA), a specialty vaccine company, have expanded
their partnership to support broader access to the world’s first
chikungunya vaccine, IXCHIQ®, in Low- and Middle-Income countries
(LMICs), as well as post-marketing trials and potential label
extensions in children, adolescents and pregnant women.
CEPI will provide Valneva up to U.S. $41.3
million of additional funding over the next five years, with
support from the European Union’s (EU) Horizon Europe programme.
The project will help generate additional data to potentially
support extended IXCHIQ® labels in chikungunya- endemic countries
and vulnerable populations at risk of being infected with this
debilitating mosquito-borne disease.
Several thousand participants are set to take
part in the planned trials, due to start in 2025. The research will
include assessment of the vaccine in children aged 1-11 and
pregnant women in countries that may be affected by a chikungunya
outbreak. Some trials are planned to be conducted in Brazil, which
is currently facing a significant chikungunya outbreak with over
340,000 cases reported so far this year.
The expanded partnership strengthens an earlier
agreement1 which awarded Valneva U.S. $24.6 million in CEPI-EU
funding to develop, manufacture, and market its single-shot vaccine
in certain LMICs affected by chikungunya. Under this initial
agreement, Valneva partnered with Brazil’s Instituto Butantan (IB)
in 2021 and conducted an adolescent clinical trial in Brazil to
support licensure of the vaccine in this country, which would be
the first potential approval for use in endemic populations, as
well as label extension in this age group in the U.S. and other
territories. Review of the marketing authorization application for
IXCHIQ® by the Brazilian Health Regulatory Agency (ANVISA) is
ongoing with potential approval in 2024. IB is committed to
providing the chikungunya vaccine it will develop and produce in
Brazil at an affordable price for distribution in Latin American
countries and selected LMICs.CEPI-EU funding will also support
technology transfer of the vaccine drug product to an additional
vaccine manufacturer to accelerate and expand access to IXCHIQ® in
Asian LMICs that are vulnerable to chikungunya outbreaks.
Dr Richard Hatchett, Chief Executive
Officer of CEPI, said, “Millions of people have been
affected by chikungunya and, today, over a billion people live in
areas where chikungunya outbreaks occur. Access to an affordable
chikungunya vaccine in areas where the burden of disease is the
greatest is a joint priority for CEPI, Valneva and our European
Union partners. These clinical studies and tech transfer to an
additional endemic-region manufacturer will accelerate endemic
country access, inform future vaccine rollout strategies and
alleviate the burden of future chikungunya outbreaks.”
Thomas Lingelbach, Chief Executive
Officer of Valneva, said, “We are extremely pleased to
strengthen our partnership with CEPI. Chikungunya infection is a
major unmet medical need, and we believe that our single-dose
vaccine is uniquely positioned to help protect people living in
areas where chikungunya occurs and for travelers to these regions.
With climate change, more areas across the world are becoming
habitable for the mosquito vectors that transmit the virus, thereby
increasing the size of the human population at risk of
infection.”
Esper Kallás, Director of Instituto
Butantan, said, “Arboviruses have become an increasing
concern worldwide, due to climate change, which favors the
adaptation of mosquitoes in other environments. This is highly
relevant, and Butantan's effort to codevelop the chikungunya
vaccine aligns with our mission to address public health problems
not only in Brazil but worldwide.”
The European Commission’s Laurent
Muschel, Head of HERA, and Irene Norstedt,
Director at DG Research and Innovation, said “Access
to medical countermeasures for the most vulnerable, such as the
vaccine against Chikungunya, is a key priority for the EU when it
comes to health emergency preparedness and response. €38 million
have been mobilised under Horizon Europe, the Union’s funding
programme for research, in partnership with CEPI, to support
clinical studies on the effectiveness of Valneva’s new vaccine in
low- and middle-income countries. Such vaccine, authorised in the
EU since last month, also strongly contributes to improving
preparedness against vector-borne diseases, that due to climate
change, may expand to non-endemic regions such as the EU. Support
for research is essential and the EU remains committed to
strengthening global health.”
IXCHIQ® was granted approval in the U.S. in
November 20232 and in Canada and Europe in June 20243,4. Regulatory
reviews for IXCHIQ® are ongoing in Brazil and the United
Kingdom.
—ENDS—
About the trialsPending
approvals, the new chikungunya vaccine trials will evaluate:
- Effectiveness of IXCHIQ® in Brazil
– Part-funded by CEPI and the EU’s Horizon Europe program, as part
of a larger development program with over 120,000 participants
assessing chikungunya in vaccinated and unvaccinated populations,
as a measure of vaccine effectiveness
- Efficacy of IXCHIQ® in an outbreak
setting in a LMIC – Part- funded by CEPI and the EU’s Horizon
Europe program as part of a trial in 20,000 participants to
determine vaccine efficacy in a randomised-controlled trial outside
of Brazil
- Safety and immunogenicity of
IXCHIQ® in pregnant women in Brazil
- Optimal IXCHIQ® doses in children
aged 1-11 in a low- and middle-income country in Latin America
- Safety and immunogenicity of
IXCHIQ® in children aged 1-11 in a LMIC, potentially located in
Asia
Trial partners, including clinical research
organisations and trial sponsors, are expected to be selected over
the coming months.
About ChikungunyaChikungunya
virus (CHIKV) is a mosquito-borne viral disease spread by the bites
of infected Aedes mosquitoes which causes fever, severe joint pain,
muscle pain, headache, nausea, fatigue and rash. Joint pain is
often debilitating and can persist for weeks to years.5In 2004, the
disease began to spread quickly, causing large-scale outbreaks
around the world. Since the re-emergence of the virus, CHIKV has
now been identified in over 110 countries in Asia, Africa, Europe
and the Americas.6 Between 2013 and 2023, more than 3.7 million
cases were reported in the Americas7 and the economic impact is
considered to be significant. The medical and economic burden is
expected to grow with climate change as the mosquito vectors that
transmit the disease continue to spread geographically. As such,
the World Health Organization (WHO) has highlighted chikungunya as
a major public health risk.8
About CEPICEPI was launched in
2017 as an innovative partnership between public, private,
philanthropic and civil organizations. Its mission is to accelerate
the development of vaccines and other biologic countermeasures
against epidemic and pandemic threats so they can be accessible to
all people in need. CEPI has supported the development of more than
50 vaccine candidates or platform technologies against multiple
known high-risk pathogens or a future Disease X. Central to CEPI’s
pandemic-beating five-year plan for 2022-2026 is the ‘100 Days
Mission’ to compress the time taken to develop safe, effective,
globally accessible vaccines against new threats to just 100
days.
Learn more at CEPI.net. Follow us on X
(@CEPIvaccines), LinkedIn and Facebook.
About ValnevaWe are a specialty
vaccine company that develops, manufactures, and commercializes
prophylactic vaccines for infectious diseases addressing unmet
medical needs. We take a highly specialized and targeted approach,
applying our deep expertise across multiple vaccine modalities,
focused on providing either first-, best- or only-in-class vaccine
solutions.We have a strong track record, having advanced multiple
vaccines from early R&D to approvals, and currently market
three proprietary travel vaccines, including the world’s first and
only chikungunya vaccine, as well as certain third-party
vaccines.Revenues from our growing commercial business help fuel
the continued advancement of our vaccine pipeline. This includes
the only Lyme disease vaccine candidate in advanced clinical
development, which is partnered with Pfizer, as well as vaccine
candidates against the Zika virus and other global public health
threats. More information is available at www.valneva.com.
About Horizon EuropeHorizon
Europe — #HorizonEU — is the European Union's flagship
Research and Innovation programme, part of the EU-long-term
Multiannual Financial Framework (MFF) with a budget of €95,5
billion to spend over a seven-year period
(2021-2027). Under Horizon Europe, health research will
be supported with the aim to find new ways to keep people healthy,
prevent diseases, develop better diagnostics and more effective
therapies, use personalised medicine approaches to improve
healthcare and wellbeing, and take up innovative health
technologies, such as digital ones.
Media Contacts:
CEPIpress@cepi.net+44 7387
055214
ValnevaLaetitia Bachelot-FontaineVP, Global Communications and
European Investor RelationsM +33 (0)6 4516
7099laetitia.bachelotfontaine@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor Relations M +001 917 815
4520joshua.drumm@valneva.com |
|
|
1 CEPI awards up to $23.4 million to Valneva for late-stage
development of a single-dose Chikungunya vaccine2 Valneva
Announces U.S. FDA Approval of World’s First Chikungunya Vaccine,
IXCHIQ® - Valneva3 Valneva Announces Health Canada Approval of the
World’s First Chikungunya Vaccine, IXCHIQ® - Valneva4 Valneva
Receives Marketing Authorization in Europe for the World’s First
Chikungunya Vaccine, IXCHIQ® - Valneva5
https://jvi.asm.org/content/jvi/88/20/11644.full.pdf6
https://cmr.asm.org/content/31/1/e00104-167 PAHO/WHO data: Number
of reported cases of chikungunya fever in the Americas (Cumulative
Cases 2018-2023 and Cases per year 2013-2017).
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 01 Aug 2023.8
https://www.who.int/blueprint/priority-diseases/en/
- 2024_07_22_VLA_CEPI_Grant_PR_EN_Final
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