European Commission Approves Purchase Agreement Amendment for Valneva’s Inactivated COVID-19 Vaccine
20 Juillet 2022 - 06:00PM
European Commission Approves Purchase Agreement Amendment for
Valneva’s Inactivated COVID-19 Vaccine
European Commission
to order 1.25
million doses of Valneva’s whole-virus COVID-19 vaccine
VLA2001 in 2022
Saint-Herblain
(France),
July
20,
2022 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announces that the European Commission (EC) has
approved an amendment to the Advance Purchase Agreement (APA) it
signed in November 20211 for Valneva’s inactivated whole-virus
COVID-19 vaccine, VLA2001. The amendment will be signed after a
mandatory five-day period during which Member States can opt out.
Under this amendment, the Member States’ purchases will consist of
1.25 million doses of VLA2001 in 2022, with the option to purchase
an equivalent quantity later this year for delivery in 2022. This
amendment follows remediation discussions based on the EC’s notice
of intent2 to terminate the initial APA for VLA2001 doses in 2022
and optional doses for 2023.
The first vaccine doses will be delivered to
participating EU Member States (Germany, Austria, Denmark, Finland
and Bulgaria) in the coming weeks. Valneva will retain inventory
for potential additional supply to these EU Member States should
demand increase and, in parallel, will aim to deploy approximately
eight to ten million doses of remaining inventory into
international markets. Given that VLA2001’s shelf life is expected
to reach up to 24 months over time, the Company will aim to deploy
these doses in the next six to twelve months.
Thomas
Lingelbach, Chief Executive Officer of
Valneva, commented, “We welcome the fact
that the EC has decided not to terminate the APA, although we feel
the order volume does not reflect the interest we see from European
citizens. Despite this, we have decided to enter into this
amendment to make our vaccine available to the Europeans who have
been waiting for it. While the pandemic had been declining, the
latest COVID-19 wave in Europe clearly underlines the need for
alternative vaccines. 15% of Europeans over 18 are not yet
vaccinated3 and we continue to receive messages from Europeans who
are awaiting a more traditional vaccine technology. Recent market
studies4 conducted in several EU member states suggest that making
our inactivated vaccine available in Europe could increase vaccine
uptake and have a meaningful impact on public health.”
In light of the reduced order volume from EU
member states, the Company is evaluating the COVID-19 program and
associated operations. Valneva continues discussions on potential
additional supply and financing agreements with various other
countries around the world and will invest in further development
of its current or second-generation COVID-19 vaccine only if it
reaches an agreement with potential customers and receives the
necessary funding over the summer.
Valneva does not expect immediate cash
constraints following this change in the EC order and believes that
its 2022 revenues could still reach the lower end of its previously
communicated guidance5 based on revenue recognition linked to the
EC and UK supply contracts. In light of the amended APA, Valneva
has suspended manufacturing of VLA2001 and is assessing its
COVID-19 related assets with regard to any potential write-down.
The Company will provide a more detailed update on its plans and
financial guidance with its first half results on August 11,
2022.
In parallel, Valneva will continue to progress
its two late-stage assets: its Lyme disease vaccine candidate,
which is partnered with Pfizer and expected to enter its Phase 3
study in the third quarter of 2022, and its single-shot chikungunya
vaccine candidate for which the Company expects to commence
submission of the Biologics License Application with the US FDA in
the second half of 2022. Valneva is also actively working to add
new vaccine candidates to its clinical pipeline, both through the
advancement of its preclinical assets and potential program
acquisitions.
VLA2001 is the first COVID-19 vaccine to receive
a standard marketing authorization in Europe6. The vaccine was also
granted conditional marketing authorization in the United Kingdom7
and emergency use authorization in the United Arab Emirates8 and
Kingdom of Bahrain9.
About VLA2001VLA2001 is the
only whole virus, inactivated, adjuvanted COVID-19 vaccine which
has received marketing authorization in Europe for use as primary
vaccination in people from 18 to 50 years of age. 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 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.
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 possible
purchase agreements and regulatory approval of VLA2001, timing and
plans for clinical programs and product candidates and revenue
forecasts. 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 in this press release 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 Signs Purchase Agreement with European Commission for
its Inactivated COVID-19 Vaccine VLA20012 Valneva Receives Notice
of European Commission’s Intent to Terminate COVID-19 Vaccine
Purchase Agreement – Valneva3 EMA Press Briefing May 5, 2022:
https://www.youtube.com/watch?v=C5DL66-Fb0Q4
https://www.ipsos.com/sites/default/files/ct/news/documents/2022-06/Ipsos-PI_Inaktivierter-Impfstoff-Valneva_2022-06-29.pdf;
https://www.ipsos.com/fr-fr/covid-19-lutilisation-dun-vaccin-inactive-en-france-augmenterait-la-couverture-vaccinale
5 Valneva Reports Q1 2022 Results and Provides Corporate Updates
- Valneva6 Valneva Receives Marketing Authorization in Europe for
Inactivated Whole-Virus COVID-19 Vaccine VLA20017 Valneva Receives
Conditional Marketing Authorization from UK MHRA for its
Inactivated COVID-19 Vaccine – Valneva8 Valneva Receives Emergency
Use Authorization from the United Arab Emirates for its Inactivated
COVID-19 Vaccine9 Valneva Receives Emergency Use Authorization from
Bahrain for its Inactivated COVID-19 Vaccine VLA2001 – Valneva
- 2022_07_20_EC_APA_Amendment_PR_EN_final
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