Valneva Provides Clinical and Regulatory Updates for its COVID-19
Vaccine VLA2001
Saint-Herblain
(France), March
2,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced additional data from remaining clinical
studies and an update on regulatory submissions for its inactivated
COVID-19 vaccine, VLA2001. As previously announced, Valneva will
not invest in further development of the vaccine, in the absence of
a new partnership1. It is, however, completing remaining clinical
studies and submissions as agreed with regulators.
On February 23, 2023, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) issued a positive opinion for the use of VLA2001 in
adults 18 to 50 years of age as a booster dose to be given at least
seven months following primary vaccination (the second dose) with
VLA2001 (homologous booster dose) or with an adenoviral vector
COVID-19 vaccine (heterologous booster dose).
Valneva also provided an update on its pivotal
Phase 3 Study COV-Compare (VLA2001-301). In this study,
neutralizing antibodies on Day 208 (six months after the second
dose of the primary vaccination with VLA2001) were non-inferior
compared to the active comparator AZD1222, an adenoviral vector
vaccine. The fold decline of neutralizing antibodies over six
months after a second vaccination with VLA2001 was similar to the
active comparator, and less pronounced than for other licensed
COVID-19 vaccines2,3. The T-cell response against the spike protein
elicited upon vaccination with VLA2001 was in the same range as for
the active comparator. Moreover, T-cell reactivity against the
nucleocapsid and membrane protein was induced upon vaccination with
VLA2001.
Additionally, results from VLA2001-304, a Phase
3 study in older adults, 56 years of age and above, showed that
VLA2001 was well tolerated by these participants when administered
as a two-dose or three-dose immunization, thus confirming the
previously reported favorable safety profile of VLA20014. In this
age group, a two-dose vaccination with VLA2001 was inferior in
terms of geometric mean titers and seroconversion rates compared to
younger adults aged 30 years and above. After two doses,
immunogenicity in older adults was at a level which could be
correlated with 60-70% vaccine efficacy against ancestral
SARS-CoV-25. A third dose of VLA2001 further increased
immunogenicity in participants aged 56 years and above to the
titers associated with vaccine efficacy of >90% against
ancestral SARS-CoV-26,7.
Finally, VLA2001’s shelf life was recently
extended to 21 months compared to 18 months previously. The Company
will continue to submit data to further extend it.
About VLA2001VLA2001 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 was 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).
VLA2001 was the first COVID-19 vaccine to
receive a standard marketing authorization in Europe8 and the only
whole virus, inactivated, COVID-19 vaccine to receive marketing
authorization in Europe for use as primary vaccination in people
from 18 to 50 years of age. The vaccine was also granted
conditional marketing authorization in the United Kingdom9 and
emergency use authorization in the United Arab Emirates10 and
Kingdom of Bahrain11. Valneva signed agreements to supply VLA2001
to certain EU Member States and the Kingdom of Bahrain12. In August
2022, the World Health Organization (WHO) issued recommendations
for use of VLA200113. In light of current order levels and existing
inventories, Valneva has suspended manufacturing of the vaccine and
is continuing discussions on the potential sale of some of the
remaining inventory. VLA2001 currently has a 21-month shelf life
and the Company will continue to submit data to further extend
it.
About Valneva SEValneva is a
specialty vaccine company focused on the development, manufacturing
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 commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against the chikungunya virus and Lyme disease.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing, results and
completion of research, development and clinical trials for product
candidates, to regulatory approval of product candidates and review
of existing products. 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 sustained in the future. 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 largely 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
and delays 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, and the ability to obtain
or maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
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 these materials as of this press release and
disclaim 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 Reports H1 2022 Results and Provides Corporate Updates
- Valneva2 Pajon R et al. N Engl J Med 2022; 386:1088-10913 Zeng G
et al. Lancet Infect Dis. 2022 Apr;22(4):483-4954 Valneva Reports
Positive Phase 3 Results for Inactivated, Adjuvanted Covid-19
Vaccine Candidate VLA2001 (October 18, 20215 Valneva Reports
Further Positive Phase 3 Immunogenicity and the First Heterologous
Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine
VLA2001 (August 29, 2022)6 S. Feng et al., Nature Medicine
10.1038/s41591-021-01540-1 (2021)7P. B. Gilbert et al., Science
10.1126/science.abm3425 (2021)
8 Valneva Receives Marketing Authorization in Europe for
Inactivated Whole-Virus COVID-19 Vaccine VLA20019 Valneva Receives
Conditional Marketing Authorization from UK MHRA for its
Inactivated COVID-19 Vaccine10 Valneva Receives Emergency Use
Authorization from the United Arab Emirates for its Inactivated
COVID-19 Vaccine11 Valneva Receives Emergency Use Authorization
from Bahrain for its Inactivated COVID-19 Vaccine VLA200112 Valneva
Signs Advance Purchase Agreement with Bahrain for Inactivated
COVID-19 Vaccine VLA200113 Valneva Confirms WHO Recommendations for
its Inactivated COVID-19 Vaccine
- 2023_02_03_VLA2001_Update_PR_EN_Final
Valneva (EU:VLA)
Graphique Historique de l'Action
De Nov 2023 à Déc 2023
Valneva (EU:VLA)
Graphique Historique de l'Action
De Déc 2022 à Déc 2023