Valneva Receives Emergency Use Authorization from the United Arab Emirates for its Inactivated COVID-19 Vaccine
16 Mai 2022 - 7:00AM
Valneva Receives Emergency Use Authorization from the United Arab
Emirates for its Inactivated COVID-19 Vaccine
Saint Herblain
(France), May
16,
2022 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today announced that the United
Arab Emirates (UAE) granted emergency use authorization for
Valneva’s inactivated, adjuvanted COVID-19 vaccine, VLA2001.
Thomas
Lingelbach, Chief Executive Officer of
Valneva, commented, “We are extremely pleased with this
new authorization and would like to thank the UAE for their trust
and confidence. As the only dual-adjuvanted, whole-virus
inactivated COVID-19 vaccine approved by the UAE Ministry of Health
and Prevention, VLA2001 could offer an alternative vaccine solution
to people across the Emirates. This is our second approval in the
Gulf countries, and we are hoping that further approvals of VLA2001
will follow elsewhere.”
This authorization follows Conditional Marketing
Authorization from the UK MHRA1, which was granted last month, and
emergency use authorization from the Bahraini NHRA in March
20222.
About VLA2001VLA2001 is
currently the only whole virus, inactivated, adjuvanted COVID-19
vaccine in clinical development in Europe. It is intended for
active immunization of at-risk populations to prevent carriage and
symptomatic infection with COVID-19 during the pandemic and for
routine vaccination including addressing new variants. Further,
VLA2001 could potentially be suited for boosting, as repeat booster
vaccinations have been shown to work well with whole virus
inactivated vaccines. VLA2001 is produced on Valneva’s established
Vero-cell platform, leveraging the manufacturing technology for
Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001
consists of inactivated whole virus particles of SARS-CoV-2 with
high S-protein density, in combination with two adjuvants, alum and
CpG 1018. This adjuvant combination has consistently induced higher
antibody levels in preclinical experiments than alum-only
formulations and shown a shift of the immune response towards Th1.
CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation
(Nasdaq: DVAX), is a component of the US FDA- and EMA-approved
HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has
already been upscaled to final industrial scale, includes chemical
inactivation to preserve the native structure of the S-protein.
VLA2001 is expected to conform with standard cold chain
requirements (2 to 8 degrees Celsius).
About Valneva SE
Valneva is a specialty vaccine company focused
on the development, production and commercialization of
prophylactic vaccines for infectious diseases with significant
unmet medical need. The Company takes a highly specialized and
targeted approach to vaccine development and then applies its deep
understanding of vaccine science to develop prophylactic vaccines
addressing these diseases. Valneva has leveraged its expertise and
capabilities both to successfully commercialize two vaccines and to
rapidly advance a broad range of vaccine candidates into and
through the clinic, including candidates against Lyme disease, the
chikungunya virus and COVID-19.
Media
& Investor ContactsLaëtitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to the progress,
timing, design, data read-outs, anticipated results and completion
of clinical trials of VLA2001 and with respect to possible
regulatory approval of VLA2001. 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 indicative of future
results. 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 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 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, the ability to
obtain or maintain patent or other proprietary intellectual
property protection and the impact of the COVID-19 pandemic. 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
this press release as of the date hereof and disclaims 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 Receives Conditional Marketing Authorization from UK
MHRA for its Inactivated COVID-19 Vaccine – Valneva2 Valneva
Receives Emergency Use Authorization from Bahrain for its
Inactivated COVID-19 Vaccine VLA2001 – Valneva
- 2022_04_16_VLA2001_UAE_Approval_PR_EN_Final
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