U.S. CDC Advisory Committee (ACIP) Recommends Use of Valneva’s
Single-Dose Chikungunya Vaccine IXCHIQ®
U.S. CDC Advisory Committee (ACIP)
Recommends Use of Valneva’s Single-Dose Chikungunya Vaccine
IXCHIQ®
- Recommendation for use in travelers
and laboratory workers follows U.S. Food and Drug Administration
(FDA) approval in November 20231
- IXCHIQ® is the first and only
vaccine approved to address this unmet medical need in adults aged
18 years and older who are at increased risk of exposure to the
chikungunya virus
Saint-Herblain (France), February 29,
2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company, announces today that the U.S. Centers
for Disease Control and Prevention’s (CDC) Advisory Committee on
Immunization Practices (ACIP) voted to recommend use of Valneva’s
single-dose chikungunya vaccine IXCHIQ® for the prevention of
disease caused by the chikungunya virus (CHIKV).
ACIP recommends IXCHIQ® for persons aged ≥18
years traveling to a country or territory where there is a
chikungunya outbreak. Additionally, it may be considered for
persons traveling to a country or territory without an outbreak but
with evidence of CHIKV transmission within the last five years, who
are aged >65 years and likely to have at least moderate exposure
to mosquitos (at least two weeks, cumulatively) or who are
traveling for a longer duration (six months or more, cumulatively).
ACIP also recommended chikungunya vaccination for laboratory
workers with potential for exposure to CHIKV.
Juan Carlos Jaramillo, MD, Chief Medical
Officer of Valneva, commented, “Chikungunya poses a
significant risk to individuals journeying to or residing in
regions where the chikungunya virus and its mosquito vectors
thrive. IXCHIQ offers advantages to travelers on vacation and
visiting family and to people engaged in business ventures,
missions, or laboratory duties. We embrace the ACIP endorsement,
marking IXCHIQ® as the only approved and recommended vaccine for
the target population. We will continue collaborating with
regulatory authorities worldwide to increase the accessibility of
IXCHIQ® across regions.”
The ACIP recommendations will be forwarded to
the director of the CDC and the U.S. Department of Health and Human
Services for review and approval. Once approved, the final
recommendations will be published in a future Morbidity and
Mortality Weekly Report (MMWR) to advise healthcare providers on
appropriate use of the vaccine.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Infection leads to symptomatic disease in up to 97% of humans after
four to seven days following the mosquito bite2. While mortality
with CHIKV is low, morbidity is high, and the global market for
vaccines against chikungunya is estimated to exceed $500 million
annually by 20323. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea, rash and
chronic arthralgia. Chikungunya virus often causes sudden large
outbreaks with high attack rates, affecting one-third to
three-quarters of the population in areas where the virus is
circulating. The high-risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia, and
the virus has spread to more than 110 countries4. Between 2013 and
2023, more than 3.7 million cases were reported in the Americas5
and the economic impact is considered to be significant. The
medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to spread geographically. Before
IXCHIQ®, there were no preventive vaccines or
effective treatments available and, as such, chikungunya is
considered to be a major public health threat.
To make the vaccine more accessible to Low- and
Middle-Income Countries (LMIC), Valneva and Instituto Butantan in
Brazil signed an agreement in January 2021 for the development,
manufacturing and marketing of VLA15536. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 20197, which provides funding of up to $23.4
million with support from the European Union’s Horizon 2020
program. Regulatory review by the Brazilian authority ANVISA is
ongoing.
About
IXCHIQ®In the U.S.,
IXCHIQ® is a live-attenuated vaccine indicated for
the prevention of disease caused by chikungunya virus (CHIKV) in
individuals 18 years of age and older who are at increased risk of
exposure to CHIKV. As for all products approved under FDA’s
accelerated approval pathway, continued approval for this
indication is contingent upon verification and description of
clinical benefit in confirmatory studies. Please
click here for full Prescribing
Information for
IXCHIQ®.
About Valneva SEWe 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 as well as certain
third-party vaccines leveraging our established commercial
infrastructure.
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.
Valneva Investor
and Media ContactsLaetitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the approval and use of products and
product candidates. In addition, even if the actual results or
development of Valneva are consistent with the forward-looking
statements contained in this press release, those results or
developments of Valneva may not be sustained in the future. In some
cases, you can identify forward-looking statements by words such as
“could,” “should,” “may,” “expects,” “anticipates,” “believes,”
“intends,” “estimates,” “aims,” “targets,” or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
and delays involved in the development and manufacture of vaccines,
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, the impact
of the global and European credit crisis, and the ability to obtain
or maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release and
disclaim any intention or obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise.
1 Valneva Announces U.S. FDA Approval of World’s First
Chikungunya Vaccine, IXCHIQ® - Valneva2 Staples, J.E. Hills, S.L.
Powers, A.M. "Chikungunya." In CDC Yellow Book 2020: Health
Information for International Travel, by Centers for Disease
Control and Prevention. New York: Oxford University Press, 20203
VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 20204
https://www.who.int/news-room/fact-sheets/detail/chikungunya5
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 2023.6 Valneva and Instituto Butantan Sign
Final Agreement on Single-Shot Chikungunya Vaccine for Low and
Middle Income Countries7 CEPI awards up to $23.4 million to Valneva
for late-stage development of a single-dose Chikungunya vaccine
- 2024_02_28_IXCHIK_ACIP_Recommendation_PR_EN_Final
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