Valneva Commences Rolling Submission to MHRA for its Inactivated, Adjuvanted COVID-19 Vaccine
23 August 2021 - 7:00AM
Saint-Herblain (France), August 23,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a
specialty vaccine company focused on prophylactic vaccines for
infectious diseases, today commenced rolling submission, for
initial approval of its COVID-19 vaccine candidate, VLA2001, with
the Medicines and Healthcare products Regulatory Agency (MHRA) in
the United Kingdom (UK). VLA2001 is a whole virus, inactivated,
adjuvanted vaccine candidate and is the only vaccine candidate of
this type currently in clinical trials in Europe.
VLA2001 is currently being studied in the UK in
a pivotal Phase 3 trial, “Cov-Compare” (VLA2001-301), for which
topline results are currently expected early in the fourth quarter
2021. Subject to positive Cov-Compare data and MHRA review, Valneva
believes that initial approval could be granted before the end of
2021.
In September 2020, Valneva announced a
collaboration with the UK Government, which has the option to
purchase up to 190 million doses through 2025. So far, the UK
Government has ordered 100 million doses for supply in 2021 and
2022.
Juan Carlos Jaramillo M.D., Chief
Medical Officer of Valneva, said, “We are pleased to begin
the regulatory review process for our COVID-19 vaccine with the
MHRA. Valneva believes that everyone should have access to
technology best suited to protect them against this virus. We are
working hard to make our vaccine candidate available as soon as
possible. We are grateful to the National Institute for Health
Research (NIHR), Public Health England (PHE), and other partners
for their unstinting support and hard work.”
Valneva recently initiated a further Phase 3
clinical trial, VLA2001-304, to generate data in the elderly and as
part of the Company’s strategy to evaluate variant-based vaccines.
Data from VLA2001-304 will complement Cov-Compare and other
clinical trials. In parallel, the UK Government is funding a
clinical trial, “COV-Boost”, which is evaluating different COVID-19
vaccines, including VLA2001, as potential boosters.
About VLA2001
VLA2001 is currently the only whole virus,
inactivated, adjuvanted vaccine candidate in clinical trials
against COVID-19 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, beginning
with the identification of deadly and debilitating infectious
diseases that lack a prophylactic vaccine solution and for which
there are limited therapeutic treatment options. It then applies
its deep understanding of vaccine science, including its expertise
across multiple vaccine modalities, as well as its established
vaccine development capabilities, to develop prophylactic vaccines
to address these diseases. The Company 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 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 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.
- 2021_08_23_VLA2001_MHRA_PR