Valneva Signs Advance Purchase Agreement with Bahrain for Inactivated COVID-19 Vaccine VLA2001
08 Décembre 2021 - 07:00AM
Saint-Herblain
(France),
December 8,
2021 – Valneva SE (Nasdaq: VALN; Euronext Paris:
VLA), a specialty vaccine company, today announced the signing of
an advance purchase agreement with the Kingdom of Bahrain for the
supply of one million doses of the Company’s inactivated COVID-19
vaccine candidate VLA2001. This is the second purchase agreement
Valneva has secured for VLA2001 since reporting positive data for
its Phase 3 clinical trial Cov-Compare.
Valneva has initiated a rolling submission
process with the Bahraini National Health Regulatory Authority
(NHRA).
Franck Grimaud, Chief Business Officer
of Valneva, commented, “We are grateful to the Bahraini
government for their trust and confidence in our vaccine and are
eager to work with them to start helping to address the pandemic
evolution in the Middle-East. Subject to regulatory review and
approval, we plan to start deliveries in the first quarter of
2022.”
A Bahraini
government spokesperson stated, “Bahrain is once
again at the forefront on adopting new measures to protect the
health of citizens and residents against the threat of COVID-19.
Subject to approval, Bahraini citizens and residents will have the
ability to choose from a variety of vaccines in Bahrain that will
have a positive impact on driving up vaccinations rates with 93% of
the eligible population now fully vaccinated in the Kingdom.”
Last month, Valneva announced that the European
Commission signed an advanced purchase agreement for up to 60
million doses of VLA20011. Valneva reported positive Phase 3
results for VLA2001 in October 20212.
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.
1 Valneva Announces European Commission Approval of Advance
Purchase Agreement for up to 60 Million Doses of Inactivated
COVID-19 Vaccine VLA20012 Valneva Reports Positive Phase 3 Results
for Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
- 2021_12_08_Bahrain_APA_PR_EN_Final
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