New York &
Saint-Herblain (France), February
17, 2023 – Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq:
VALN; Euronext Paris: VLA) today announce that Pfizer, as the study
sponsor, has decided to discontinue a significant percentage of
participants in the U.S. who had been enrolled in the Vaccine
Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase
3 clinical study. The study is investigating the efficacy, safety
and immunogenicity of an investigational Lyme disease vaccine
candidate, VLA15. These study participants, representing
approximately half of the total recruited participants in the
trial, are being discontinued following violations of Good Clinical
Practice (GCP) at certain clinical trial sites run by a third-party
clinical trial site operator. The discontinuation of these
participants was not due to any safety concerns with the
investigational vaccine and was not prompted by a
participant-reported adverse event.
GCP is the international ethical and scientific
quality standard for clinical trials that all clinical researchers
need to follow. These standards are designed to put participants’
interests first and ensure high scientific integrity. Once Pfizer
learned of potential violations of GCP, it conducted a thorough
review of the operations and data collection at the clinical trial
sites run by the third party and followed standard operating
safeguards to determine the correct course of action.
The clinical trial remains ongoing with other
sites not operated by the third party, and Pfizer continues to
enroll new participants at those sites. The companies intend to
work with regulatory authorities, and as previously
announced,1,2 aim for Pfizer to 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, pending successful
completion of the Phase 3 studies and subject to the agreement of
these regulatory agencies to proposed modifications of the clinical
trial plan.
Participants are being notified and Pfizer has
also notified the FDA, other regulatory agencies and the
independent Institutional Review Board for this study.
Integrity of data collected in clinical trials
is critical to provide evidence and confidence in a potential
vaccine or medicine’s safety and efficacy. Pfizer and Valneva are
committed to collecting robust data needed for potential regulatory
submission of VLA15. While VLA15 is still under investigation, to
date the companies have been encouraged by the data from the Phase
2 clinical studies, which demonstrated strong immunogenicity and
acceptable safety and tolerability
profiles.2-4
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
2022.5,6 The program was granted Fast Track designation by the U.S.
FDA in July 2017.7
About Lyme Disease Lyme disease
is a systemic infection caused by Borrelia burgdorferi bacteria
transmitted to humans by infected Ixodes ticks.8 It is considered
the most common vector-borne illness in the Northern Hemisphere.9
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.10,11 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.12 The medical need for vaccination against Lyme
disease is steadily increasing as the geographic footprint of the
disease widens.10
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 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 February 17, 2023.
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, VALOR, a Phase 3
clinical study investigating the efficacy, safety and
immunogenicity of VLA15, 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 recruit and enroll participants, and 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 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 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 Forward-Looking
StatementsThis press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress and recruitment of clinical
trials, discussions with regulatory agencies, modifications to
clinical trial plans, results of clinical trials, and timing for
filing for potential regulatory approval of product candidates. 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 or delays, 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
- Pfizer. Pfizer and Valneva Initiate Phase 3 Study of Lyme
Disease Vaccine Candidate VLA15. August 2022. Available at:
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-valneva-initiate-phase-3-study-lyme-disease.
Accessed: February 2023.
- Valneva. Valneva and Pfizer Report Six-Month Antibody
Persistence Data in Children and Adults for Lyme Disease Vaccine
Candidate. December 2022. Available at:
https://www.pfizer.com/news/press-release/press-release-detail/valneva-and-pfizer-report-six-month-antibody-persistence.
Accessed: February 2023
- Valneva. Valneva Pfizer Report Positive Phase 2 Pediatric Data
for Lyme Vaccine Candidate. April 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/
Accessed: July 2022.
- Valneva. Valneva Pfizer Report Positive Phase 2 Data for Lyme
Disease Vaccine Candidate. February 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-data-for-lyme-disease-vaccine-candidate/
Accessed: July 2022.
- 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. 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. 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 G, Wormser GP, Gray J, et al. Lyme borreliosis. Lancet.
2012; 4;379(9814):461-73.
- Gern L, Falco RC. Lyme disease. Rev Sci Tech. 2000
Apr;19(1):121-35.
- Center for Disease Control and Prevention. Lyme Disease. Data
and Surveillance. April 2021. Available at:
https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html
Accessed July 2022.
- Sykes RA, et al. An estimate of Lyme borreliosis incidence in
Western Europe. Journal of Public Health 2017; 39(1): 74-81
- Center for Disease Control and Prevention. Lyme Disease. Signs
and Symptoms of Untreated Lyme disease. January 2021. Available at:
https://www.cdc.gov/lyme/signs_symptoms/index.html Accessed July
2022.
- 2023_02_17_VLA15_Ph3_Update_PR_EN_Final
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