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 Chikungunya
Chikungunya 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 SE
We 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 Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com |
Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.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® - Valneva
2 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, 2020
3 VacZine Analytics Chikungunya virus vaccines Global
demand analysis. February 2020
4
https://www.who.int/news-room/fact-sheets/detail/chikungunya
5 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
Countries
7 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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