Valneva Confirms Initiation of Rolling Review with EMA and Provides Updates on its COVID-19 Vaccine Program VLA2001
02 Décembre 2021 - 5:45PM
Valneva Confirms Initiation of Rolling Review with EMA and Provides
Updates on its COVID-19 Vaccine Program VLA2001
Saint-Herblain
(France),
December 2,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today confirmed that the
European Medicines Agency (EMA) has started a rolling review of
VLA2001, its whole-virus inactivated, adjuvanted COVID-19 vaccine
candidate.
Valneva remains focused on achieving regulatory
approvals of VLA2001 following its positive Phase 3 trial results.
The Company continues to make progress with the rolling submission
in the UK (MHRA), including verification of the Phase 3 clinical
data integrity (required for finalization of the submission), as
previously disclosed. Potential regulatory approvals are expected
in the first quarter of 2022.
Valneva is also providing an update on VLA2001
in the context of the emergence of the Omicron variant. Valneva
believes that VLA2001 can make an important contribution to the
global fight against the COVID-19 pandemic and potentially play a
role in protecting against the new Omicron variant.
In contrast to other vaccines that target only
the spike protein of the SARS-COV-2 virus, VLA2001 is developed
using the entire SARS-CoV-2 virus envelope. Preserving the whole
virus envelope is expected to elicit a broad immune response and
together with the CpG1018 adjuvant may provide an improved
immunological profile by boosting T-cell responses against
additional SARS-CoV-2 proteins. Valneva will test for
cross-neutralization of VLA2001 against the Omicron variant.
Valneva also confirms that its technology
platform is adaptable for new variants, if required. The Company
has undertaken laboratory development and testing of variants, at
its sites in France and Austria, including the production of viral
seed stock for three earlier variants of concern, including Delta.
Valneva produced a full scale pilot lot derived from the Alpha
variant, validating the suitability of its well-established
manufacturing process for variant-based vaccines.
Valneva has commenced manufacturing for the
European Commission supply contract and has some inventory ready
for labelling and deployment upon regulatory approval. Valneva
expects to have capacity to produce over a hundred million doses of
vaccine per annum through a combination of in house production and
CMO capacity.
Commenting,
Thomas Lingelbach,
Chief
Executive
Officer of
Valneva, said, “The latest COVID-19 wave in Europe
underlines the need for additional vaccines and we continue to
believe that VLA2001 will contribute to addressing the pandemic. We
are hopeful that our vaccine candidate might cross protect against
variants to the SARS-CoV-2 virus and also have the flexibility,
knowledge and resources to adapt if required. Our teams are working
diligently to achieve regulatory submissions so that we can quickly
deploy our vaccine and ensure that it reaches people who need
it.”
About VLA2001VLA2001 is
currently the only whole virus, inactivated, adjuvanted vaccine
candidate against COVID-19 in clinical trials in Europe. It is
intended for active immunization of at-risk populations to prevent
carriage and symptomatic infection with COVID-19 during the ongoing
pandemic and potentially later for routine vaccination including
addressing new variants. VLA2001 may also 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. The manufacturing
process for VLA2001, 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 degrees to 8 degrees
Celsius).
About Valneva SEValneva is a
specialty vaccine company focused on the development 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.
Valneva Investor and Media ContactsLaetitia
Bachelot-FontaineVP, Global Communications and European Investor
RelationsM +33 (0)6 4516
7099investors@valneva.com |
Joshua Drumm, Ph.D.VP, Global Investor RelationsM +001
917 815 4520joshua.drumm@valneva.com |
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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 and regulatory review processes for 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, the
cancellation of existing contracts, including but not limited to
the HMG Supply Agreement, and the impact of the COVID-19 pandemic,
the occurrence of any of which could substantially harm Valneva’s
business, financial condition, prospects and results of operations.
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.
- 2021_12_02_EMA_RR_and_VLA2001_Update_PR_EN_Final
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