Valneva Comments on COV-Boost Clinical Trial Data
Saint Herblain
(France), December
3, 2021 – Valneva SE
(Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company,
today responded to data published from the COV-Boost COVID-19
vaccine trial, which investigated the reactogenicity and
immunogenicity of seven different COVID-19 vaccines at different
dose levels when administered as a third dose, or booster, to
people primed with either Pfizer’s Comirnaty or AstraZeneca’s
Vaxzevria.
The COV-Boost trial, which launched in May 2021
and was led by University Hospital Southampton NHS Foundation
Trust, included Valneva’s inactivated, adjuvanted, whole virus
COVID-19 vaccine candidate VLA2001. The aim of the COV-Boost trial
was to quickly generate data to inform advice from the UK’s Joint
Committee on Vaccination and Immunization on the autumn booster
campaign. Participants were given a booster dose relatively early,
only two to three months after completion of the second dose of the
primary vaccination series, when they did not need a booster from
either an immunological standpoint or under the currently
recommended interval for licensed COVID-19 vaccines. Valneva
believes it is likely that the short interval between the second
shot and booster shot could have adversely impacted the results for
VLA2001, given that a longer interval is generally required for
inactivated vaccines.
The Company has already begun generating data to
inform any regulatory discussions regarding a potential booster
indication for VLA2001. The first data from a continuation of
existing clinical trials (homologous) are expected in the first
quarter of 2022. Additionally, Valneva is in the process of setting
up a dedicated heterologous booster trial. All of Valneva’s trials
will evaluate a booster shot provided at least six months after
primary vaccination, as per the currently recommended interval for
licensed COVID-19 vaccines. The results of the COV-Boost trial were
never intended to be, nor will they be, part of the Company’s
regulatory submissions to the UK Medicines and Healthcare products
Regulatory Agency (MHRA) and European Medicines Agency (EMA), which
seek approvals for VLA2001 in the primary vaccination context
solely based on the positive data from the pivotal Phase 3
Cov-Compare trial.
Juan Carlos Jaramillo, MD,
Chief Medical Officer of
Valneva, said, “The setting in the study leads us to
believe that COV-Boost does not allow any conclusions to be reached
regarding the use of VLA2001 as a booster in a real-life setting.
The protective antibody threshold has not yet been established
therefore relative increases in antibody levels should not be seen
as indicative of efficacy. I concur with Professor Faust’s
statements that the data describe the immune response at 28 days,
not vaccine effectiveness, and that the relationship between that
response and long-term protection is still poorly understood,
especially since several studies have shown that longer periods
between doses improve immune response. Our submissions for
authorization of VLA2001 in a primary vaccination context remain on
track, with the EMA announcing yesterday that it has started its
rolling review of VLA2001, and our teams are working diligently so
that we can quickly deploy our vaccine and ensure it reaches the
people who need it.”
On October 18, 2021, Valneva announced positive
topline results from Cov-Compare, the pivotal Phase 3 comparative
immunogenicity trial of VLA2001. VLA2001 demonstrated superiority
in terms of neutralizing antibody titer levels against the active
comparator vaccine, AstraZeneca’s AZD1222, as well as
non-inferiority in terms of seroconversion rates and a
significantly better tolerability profile. The Company commenced
rolling submission for initial approval of VLA2001 with the MHRA on
August 23, 2021 and rolling review with the EMA on December 2 and
will continue to work very closely with those authorities to
complete their review process.
Valneva announced on November 23, 2021 that the
European Commission signed an agreement for the Company to supply
up to 60 million doses of VLA2001 over two years - including 24.3
million doses in 2022. Delivery of the vaccine is currently
expected to begin in April 2022, subject to approval by the
EMA.
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_03_VLA2001_Cov-Boost_Reactive_PR_EN_Final
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