- Participants completed primary vaccination series (3 doses)
with VLA15
- Primary vaccination series to be
followed by a booster approximately one year after completion
New York, NY and Saint-Herblain (France), July 17,
2024 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq:
VALN; Euronext Paris: VLA) today announced that the participants of
the Phase 3 trial “Vaccine Against Lyme for Outdoor Recreationists”
(VALOR) have completed the primary vaccination series (three doses)
of Lyme disease vaccine candidate VLA15. Participants will be
monitored for the occurrence of Lyme disease cases until the end of
the Lyme disease season in 2025.1,
“The completion of the primary series of our VALOR trial is a
critical step toward our goal of providing a safe and effective
vaccine against Lyme disease,” said Annaliesa Anderson,
Ph.D., Senior Vice President and Head of Vaccine Research and
Development, Pfizer. “VLA15, the Lyme disease vaccine
candidate we are co-developing with Valneva, is the one which has
advanced the furthest along the clinical development timeline, with
two Phase 3 trials in progress.”
Juan Carlos Jaramillo, M.D., Chief Medical Officer,
Valneva, said, “We are pleased to see the progress of our
Phase 3 VALOR trial. Lyme disease is the most prevalent
vector-borne disease in the United States and Europe. It can result
in debilitating complications and extensive healthcare treatments.
Given the growing burden, high medical need, and lack of
effectiveness with current interventions, there is an urgent need
for novel approaches to help prevent Lyme disease.”
The VALOR trial, for which Pfizer is the sponsor, is a
multicenter, placebo-controlled, randomized, observer-blinded trial
conducted at sites in areas where Lyme disease is highly endemic
across the U.S., Canada, and Europe. The aim of the trial is to
evaluate the efficacy, safety, tolerability, immunogenicity, and
lot consistency of VLA15, a 6-valent OspA-based Lyme disease
vaccine candidate.1 Trial participants aged 5 years and older were
randomized 1:1 into two trial groups and receive four doses of
either VLA15 or a saline placebo – one dose each at months 0, 2,
5-9 and a booster one year after the third dose, shortly before the
peak of the next Lyme disease season.1
Subject to positive data, Pfizer plans to submit a Biologics
License Application (BLA) to the U.S. Food and Drug Administration
(FDA) and a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) in 2026.
VLA15 has shown a favorable safety profile across all dose and
age groups in all clinical trials to date2,3. No safety concerns
have been observed to date by an independent Data Safety Monitoring
Board (DSMB) in any treatment group.2,3 A second Phase 3 trial
(C4601012), aiming to provide further evidence on the safety
profile of VLA15 in the pediatric population between 5 and 17 years
of age is ongoing; this trial completed enrollment in June
2023.
Pfizer and Valneva entered into a collaboration agreement in
April 2020 to co-develop VLA15, with updates to the terms within
this agreement made in June 2022.4,5
About VLA15
There are currently no approved human vaccines for Lyme disease,
and VLA15 is the Lyme disease vaccine candidate which has advanced
the furthest along the clinical development timeline, with two
Phase 3 trials in progress. 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 candidate covers
the six most prevalent OspA serotypes expressed by
the Borrelia burgdorferi sensu lato species in North
America and Europe.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia
burgdorferi bacteria transmitted to humans by the bite of infected
Ixodes ticks.6 It is considered the most common vector-borne
illness in the Northern Hemisphere.7,8 While the true
incidence of Lyme disease is unknown, the Centers for Disease
Control and Prevention (CDC) has estimated that approximately
476,000 people in the U.S. are diagnosed and treated each year and
129,000 cases are reported annually in Europe.8,9 Early symptoms of
Lyme disease (such as a gradually expanding erythematous rash
called erythema migrans or other nonspecific symptoms like fatigue,
fever, headache, mild stiff neck, muscle and joint paints) are
often overlooked or misinterpreted. Left untreated, the disease can
disseminate and cause more serious chronic complications affecting
the skin, joints (arthritis), the heart (carditis) or the nervous
system.9,10 The medical need for vaccination against Lyme disease
is steadily increasing as the geographic footprint of the disease
widens.11
About Pfizer:
Breakthroughs That
Change Patients’
LivesAt 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 175 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 X at
@Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook
at Facebook.com/Pfizer.
Pfizer Disclosure NoticeThe information
contained in this release is as of July 17, 2024. 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 an
investigational Lyme disease vaccine candidate, VLA15, and a
collaboration between Pfizer and Valneva for VLA15, including their
potential benefits, Phase 3 clinical trials 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 and uncertainties relating to an agreement with
regulatory authorities on any modifications to the clinical trial
plan as needed, 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 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, 2023 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 SEWe are a specialty vaccine
company that develops, manufactures, and commercializes
prophylactic vaccines for infectious diseases addressing unmet
medical needs. We take a highly specialized and targeted approach,
applying our deep expertise across multiple vaccine modalities,
focused on providing either first-, best- or only-in-class vaccine
solutions.
We have a strong track record, having advanced multiple vaccines
from early R&D to approvals, and currently market three
proprietary travel vaccines as well as certain third-party vaccines
leveraging our established commercial infrastructure.Revenues from
our growing commercial business help fuel the continued advancement
of our vaccine pipeline. This includes the only Lyme disease
vaccine candidate in advanced clinical development, which is
partnered with Pfizer, as well as vaccine candidates against the
Zika virus and other global public health threats.
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 the timing for
submission of such product candidates for regulatory approval. In
addition, even if the actual results or developments 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 in this press
release will in fact be realized. Valneva is providing this
information as of the date of this press release 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.
Media
Contacts
PfizerMedia
Relations:PfizerMediaRelations@pfizer.com+1 212-733-1226
Investor Relations:IR@pfizer.com+1
212-733-4848
Valneva Media and Investor Relations
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
+1 917 815 4520joshua.drumm@valneva.com
References
- ClinicalTrials.gov. An Efficacy, Safety, Tolerability,
Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent
OspA-Based Lyme Disease Vaccine (VLA15) (VALOR). July 2022.
Available from:
https://www.clinicaltrials.gov/ct2/show/NCT05477524. Accessed April
2024..
- Bézay N, Hochreiter R, et al. Safety and immunogenicity of a
novel multivalent OspA-based vaccine candidate against Lyme
borreliosis: a randomised, phase 1 study in healthy adults. Lancet
Infect Dis. 2023 Oct;23(10):1186-1196. doi: 10.1016/S1473-
3099(23)00210-4.
- Valneva and Pfizer Report Further Positive Phase 2 Data for
Lyme Disease Vaccine Candidate. February 2022. Available at:
Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme
Disease Vaccine Candidate | Pfizer
- Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15. April 2020. Available
at: Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15 | Pfizer. Accessed April
2024.
- Valneva and Pfizer Enter into Equity Subscription Agreement and
Update Terms of Collaboration Agreement for Lyme Disease Vaccine
Candidate VLA15. June 2022. Available at: Valneva and Pfizer Enter
into an Equity Subscription Agreement and Update Terms of
Collaboration Agreement for Lyme Disease Vaccine Candidate VLA15 |
Pfizer Accessed April 2023.
- Stanek, et al. Lyme Borreliosis. 2012. The Lancet
379:461–473.
- Burn L, et al. Incidence of Lyme Borreliosis in Europe from
National Surveillance Systems (2005–2020). 2023. Vector Borne and
Zoonotic Diseases. 23(4):156–171.
- Kugeler KJ, et al. Estimating the frequency of Lyme disease
diagnoses—United States, 2010-2018. 2021. Emergency Infectious
Disease. 27(2).
- Centers for Disease Control and Prevention. Lyme disease. Signs
and Symptoms. Available from:
https://www.cdc.gov/lyme/signs_symptoms/index.html. Accessed
September 2022.
- Steere AC, Strle F, Wormser GP, et al. Lyme borreliosis. Nature
Reviews Disease Primers. 2016;2:16090.
- Centers for Disease Control and Prevention. Understanding Lyme
and Other Tickborne Diseases. May 2022. Available from:
https://www.cdc.gov/ncezid/dvbd/media/lyme-tickborne-diseases-increasing.html.
Accessed April 2024.
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