- Antibody levels remained above baseline six months after
completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6)
vaccination schedule
- Higher antibody levels were observed in the three-dose
vaccination schedule versus the two-dose vaccination schedule,
further validating the use of this schedule in the ongoing Phase 3
study
- There were no safety concerns observed in this six-month
observational follow up
New York &
Saint-Herblain
(France),
December 1, 2022
– Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext
Paris: VLA) today reported antibody persistence data six months
after the completion of a three-dose (Month 0-2-6) or a two-dose
(Month 0-6) vaccination schedule with their Lyme disease vaccine
candidate, VLA15 in both children and adults. This is the first
time antibody persistence data are reported in pediatric
populations for this vaccine candidate.
Following positive immunogenicity and safety
data for Phase 2 study VLA15-221 in April 20221, Valneva and Pfizer
evaluated the persistence of antibodies six months after the Month
0-2-6 and the Month 0-6 vaccination schedule with VLA15 in healthy
adults and pediatric participants (5 to 65 years of age). Data were
collected in 96 healthy adults and 81 pediatric participants (5-17
years of age) for the Month 0-2-6 vaccination schedule and in 84
healthy adults and 78 pediatric participants (5-17 years of age)
for the Month 0-6 schedule.
As observed in previous clinical studies with
VLA15, antibody levels declined over time in all study groups but
remained above baseline, confirming their persistence six months
after completion of both vaccination schedules. Overall, antibody
levels remained higher with the three-dose vaccination schedule
compared to the two-dose schedule. Geometric mean fold rise (GMFRs)
compared to baseline were 1.9-fold for Serotype 1 (ST1) to 3.2-fold
Serotype 2 (ST2) across all age groups in the Month 0-2-6
vaccination schedule. The highest GMFRs were reported in the 5 to
11 years old age group, with GMFR levels at 2.8-fold (ST1) to
6.6-fold (ST2).
These results further validate the use of the three-dose
vaccination schedule which is also included in the Phase 3
protocols for all participants.
No vaccine-related serious adverse events (SAEs)
and no safety concerns were observed in this six-month
observational follow up.
Juan Carlos Jaramillo M.D., Chief Medical
Officer of Valneva, said, “We are pleased with these antibody
persistence data that further validate the use of the three-dose
vaccination schedule in our ongoing Phase 3 study and the
acceptable safety and tolerability profiles of our vaccine
candidate. Lyme disease continues to spread, representing a high
unmet medical need that impacts the lives of many in the Northern
Hemisphere, and each new report of positive data takes us a step
closer to potentially bringing this vaccine to both adults and
children who could benefit from it.”
Earlier this year, Pfizer and Valneva initiated
a Phase 3 clinical study, Vaccine Against Lyme for Outdoor
Recreationists (VALOR) (NCT05477524), to investigate the efficacy,
safety and immunogenicity of VLA152. Approximately 6,000
participants 5 years of age and older will receive three doses of
VLA15 180 µg or saline placebo as a primary vaccination series
followed by one booster dose of VLA15 or saline placebo (1:1
ratio). Enrollment is ongoing in Europe and the United States and
expected to be completed in the second quarter of 2023. To learn
more, visit www.pfizerclinicaltrials.com/nct05477524. To achieve
the required pediatric safety database, Pfizer and Valneva are
planning to initiate a complementary Phase 3 clinical study in
early December 2022 to collect additional VLA15 safety data in
participants 5 to 17 years of age.
“Rates of Lyme disease continue to increase
globally, underscoring the importance of a vaccine that may help
protect both adults and children,” said Annaliesa Anderson, Ph.D.,
Senior Vice President and Chief Scientific Officer of Vaccine
Research & Development at Pfizer. “These six-month antibody
persistence data are encouraging, and we hope that the data
generated from the Phase 3 studies will further support the
positive evidence for VLA15 to date.”
Pending successful completion of the Phase 3
studies, Pfizer could potentially submit a Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA)
and Marketing Authorisation Application (MAA) to the European
Medicines Agency (EMA) in 2025.
About VLA15
VLA15 is the only Lyme disease vaccine candidate
currently in clinical development. This investigational multivalent
protein subunit vaccine uses an established mechanism of action for
a Lyme disease vaccine that targets the outer surface protein A
(OspA) of Borrelia burgdorferi, the bacteria that cause Lyme
disease. OspA is a surface protein expressed by the bacteria when
present in a tick. Blocking OspA inhibits the bacterium’s ability
to leave the tick and infect humans. The vaccine covers the six
most common OspA serotypes expressed by the Borrelia burgdorferi
sensu lato species that are prevalent in North America and Europe.
VLA15 has demonstrated a strong immune response and satisfactory
safety profile in pre-clinical and clinical studies so far. Valneva
and Pfizer entered into a collaboration agreement in April 2020 to
co-develop VLA15, with updates to the terms within this agreement
made in June 2022.3,4 The terms of the collaboration agreement
include a $25 million milestone payment made to Valneva upon
Pfizer’s initiation of the Phase 3 study. The program was granted
Fast Track designation by the U.S. FDA in July 2017.5
About Clinical Study VLA15-221
VLA15-221 is a randomized, observer-blind, placebo-controlled Phase
2 study. It is the first clinical study with VLA15 which enrolled a
pediatric population (5-17 years old).
585 healthy participants received VLA15 at two
different immunization schedules (month 0-2-6 [N=190] or month 0-6
[N=187]) or three doses of placebo (month 0-2-6 [N=208]). Vaccine
recipients received VLA15 at a dose of 180 µg, which was selected
based on data generated in the two previous Phase 2 studies. The
main safety and immunogenicity readout was performed one month
after the primary vaccination series. A subset of participants will
receive a booster dose of VLA15 or placebo at month 18 (booster
phase) and will be followed for three additional years to monitor
antibody persistence.
VLA15 is tested as an alum-adjuvanted
formulation and administered intramuscularly. The study is being
conducted at U.S. sites located in areas where Lyme disease is
endemic and has enrolled both volunteers with a cleared past
infection with Borrelia burgdorferi as well as Borrelia
burgdorferi-naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by
Borrelia burgdorferi bacteria transmitted to humans by infected
Ixodes ticks.6 It is considered the most common vector-borne
illness in the Northern Hemisphere.7 While the true incidence of
Lyme disease is unknown, it is estimated to annually affect
approximately 476,000 people in the United States and 130,000
people in Europe.8,9 Early symptoms of Lyme disease (such as a
gradually expanding erythematous rash called Erythema migrans or
more nonspecific symptoms like fatigue, fever, headache, mild stiff
neck, arthralgia or myalgia) are often overlooked or
misinterpreted. Left untreated, the disease can disseminate and
cause more serious complications affecting the joints (arthritis),
the heart (carditis) or the nervous system.9 The medical need for
vaccination against Lyme disease is steadily increasing as the
geographic footprint of the disease widens.8
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us on www.Pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as
of December 1, 2022. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking
information about a Lyme disease vaccine candidate, VLA15, and a
collaboration between Pfizer and Valneva for VLA15, including their
potential benefits, antibody persistence data, a Phase 3 clinical
trial and the timing of potential regulatory submissions, that
involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for our clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, including uncertainties relating to the time needed
to accrue cases in the Phase 3 trial, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when drug applications may be filed in any jurisdictions for VLA15;
whether and when any such applications may be approved by
regulatory authorities, which will depend on myriad factors,
including making a determination as to whether the product's
benefits outweigh its known risks and determination of the
product's efficacy and, if approved, whether VLA15 will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of VLA15; uncertainties regarding the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; whether our
collaboration with Valneva will be successful; uncertainties
regarding the impact of COVID-19 on Pfizer’s business, operations
and financial results; and competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2021 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About Valneva SE
Valneva 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
commercialize three vaccines and to rapidly advance a broad range
of vaccine candidates into and through the clinic, including
candidates against Lyme disease and the chikungunya virus.
Valneva Forward-Looking
StatementsThis 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 and estimates for future performance. 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 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.
# # #
Media Contacts
PfizerMedia
Relations:PfizerMediaRelations@pfizer.com212-733-1226
Investor Relations:IR@pfizer.com212-733-4848
ValnevaLaëtitia
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
+1 917 815 4520joshua.drumm@valneva.com
References
- Valneva and Pfizer Report Positive Phase 2 Pediatric Data for
Lyme Disease Vaccine Candidate - Valneva
- Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease
Vaccine Candidate VLA15 - Valneva
- Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available
at: https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/ Accessed:
July 2022 .
- Valneva and Pfizer Enter into Equity Subscription Agreement and
Update Terms of Collaboration Agreement for Lyme Disease Vaccine
Candidate VLA15. June 2022. Available
at: https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/ Accessed:
July 2022.
- Valneva Receives FDA Fast track Designation for its Lyme
Disease Vaccine Candidate VLA15. July 2017. Available
at: https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/ Accessed:
July 2022.
- Stanek et al. 2012, The Lancet 379:461–473
-
Source: https://www.cdc.gov/lyme/stats/humancases.html
- Sykes RA, et al. An estimate of Lyme borreliosis incidence in
Western Europe. Journal of Public Health 2017; 39(1): 74-81
- New Scientist, Lyme disease is set to explode and we still
don’t have a vaccine; March 29,
2017. https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
- 2022_12_01_VLA15-221_6m_Persistence_Data_PR_EN_Final
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