-- Nine CEOs sign historic pledge to continue
to make the safety and well-being of vaccinated individuals the top
priority in development of the first COVID-19 vaccines --
The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ:
BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson
(NYSE: JNJ), Merck (NYSE: MRK), known as MSD outside the United
States and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc.
(Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY),
today announced a historic pledge, outlining a united commitment to
uphold the integrity of the scientific process as they work towards
potential global regulatory filings and approvals of the first
COVID-19 vaccines.
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All nine CEOs signed the following pledge: We, the undersigned
biopharmaceutical companies, want to make clear our on-going
commitment to developing and testing potential vaccines for
COVID-19 in accordance with high ethical standards and sound
scientific principles.
The safety and efficacy of vaccines, including any potential
vaccine for COVID-19, is reviewed and determined by expert
regulatory agencies around the world, such as the United States
Food and Drug Administration (FDA). FDA has established clear
guidance for the development of COVID-19 vaccines and clear
criteria for their potential authorization or approval in the US.
FDA’s guidance and criteria are based on the scientific and medical
principles necessary to clearly demonstrate the safety and efficacy
of potential COVID-19 vaccines. More specifically, the agency
requires that scientific evidence for regulatory approval must come
from large, high quality clinical trials that are randomized and
observer-blinded, with an expectation of appropriately designed
studies with significant numbers of participants across diverse
populations.
Following guidance from expert regulatory authorities such as
FDA regarding the development of COVID-19 vaccines, consistent with
existing standards and practices, and in the interest of public
health, we pledge to:
- Always make the safety and well-being of vaccinated individuals
our top priority.
- Continue to adhere to high scientific and ethical standards
regarding the conduct of clinical trials and the rigor of
manufacturing processes.
- Only submit for approval or emergency use authorization after
demonstrating safety and efficacy through a Phase 3 clinical study
that is designed and conducted to meet requirements of expert
regulatory authorities such as FDA.
- Work to ensure a sufficient supply and range of vaccine
options, including those suitable for global access.
We believe this pledge will help ensure public confidence in the
rigorous scientific and regulatory process by which COVID-19
vaccines are evaluated and may ultimately be approved. Together,
these nine companies have collectively developed more than 70 novel
vaccines that have helped to eradicate some of the world’s most
complex and deadly public health threats, underscoring their
experience in clinical development and regulatory rigor, as well as
their longstanding commitments to patient safety and public
health.
About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
About BioNTech
Biopharmaceutical New Technologies is a next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. The Company exploits a wide array of
computational discovery and therapeutic drug platforms for the
rapid development of novel biopharmaceuticals. Its broad portfolio
of oncology product candidates includes individualized and
off-the-shelf mRNA-based therapies, innovative chimeric antigen
receptor T cells, bi-specific checkpoint immuno-modulators,
targeted cancer antibodies and small molecules. Based on its deep
expertise in mRNA vaccine development and in-house manufacturing
capabilities, BioNTech and its collaborators are developing
multiple mRNA vaccine candidates for a range of infectious diseases
alongside its diverse oncology pipeline. BioNTech has established a
broad set of relationships with multiple global pharmaceutical
collaborators, including Genmab, Sanofi, Bayer Animal Health,
Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun
Pharma, and Pfizer.
For more information, please visit https://biontech.de/.
About GlaxoSmithKline
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com/about-us.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the
foundation of vibrant lives, thriving communities and forward
progress. That’s why for more than 130 years, we have aimed to keep
people well at every age and every stage of life. Today, as the
world’s largest and most broadly-based health care company, we are
committed to using our reach and size for good. We strive to
improve access and affordability, create healthier communities, and
put a healthy mind, body and environment within reach of everyone,
everywhere. We are blending our heart, science and ingenuity to
profoundly change the trajectory of health for humanity. Learn more
at Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease is a thing of
the past. We're the Pharmaceutical Companies of Johnson &
Johnson, working tirelessly to make that future a reality for
patients everywhere by fighting sickness with science, improving
access with ingenuity and healing hopelessness with heart. We focus
on areas of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases
& Vaccines, Neuroscience, Oncology and Pulmonary
Hypertension.
Learn more at www.janssen.com. Follow us at
www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. Moderna’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing the Company the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases, and
autoimmune and inflammatory diseases, independently and with
strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense; the Biomedical Advanced Research and Development Authority
(BARDA), a division of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS) and the Coalition for Epidemic
Preparedness Innovations (CEPI). Moderna has been named a top
biopharmaceutical employer by Science for the past five years. To
learn more, visit www.modernatx.com.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology
company that promotes improved health globally through the
discovery, development, and commercialization of innovative
vaccines to prevent serious infectious diseases. Novavax is
undergoing clinical trials for NVX-CoV2373, its vaccine candidate
against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its
quadrivalent influenza nanoparticle vaccine, met all primary
objectives in its pivotal Phase 3 clinical trial in older adults.
Both vaccine candidates incorporate Novavax’ proprietary
saponin-based Matrix-M™ adjuvant in order to enhance the immune
response and stimulate high levels of neutralizing antibodies.
Novavax is a leading innovator of recombinant vaccines; its
proprietary recombinant technology platform combines the power and
speed of genetic engineering to efficiently produce highly
immunogenic nanoparticles in order to address urgent global health
needs.
For more information, visit www.novavax.com and connect with us
on Twitter and LinkedIn.
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 150 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.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
For further information, please visit www.sanofi.com
Forward Looking Statements of BioNTech
This press release contains “forward-looking statements” of
BioNTech within the meaning of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may include,
but may not be limited to, statements concerning BioNTech’s efforts
to combat COVID-19. Any forward-looking statements in this press
release are based on BioNTech current expectations and beliefs of
future events, and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: competition to create a vaccine for
COVID-19; the ability to produce comparable clinical results in
larger and more diverse clinical trials; the ability to effectively
scale our productions capabilities; and other potential
difficulties. For a discussion of these and other risks and
uncertainties, see BioNTech’s Annual Report on Form 20-F filed with
the SEC on March 31, 2020, which is available on the SEC’s website
at www.sec.gov. All information in this press release is as of the
date of the release, and BioNTech undertakes no duty to update this
information unless required by law.
GSK Cautionary Statement Regarding Forward-Looking
Statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
"Risk Factors" in the company's Annual Report on Form 20-F for 2019
and as set out in GSK’s “Principal risks and uncertainties” section
of the Q2 Results and any impacts of the COVID-19 pandemic.
Forward-Looking Statement of the Janssen Pharmaceutical
Companies of Johnson & Johnson
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding development of potential preventive and treatment
regimens for COVID-19. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of the Janssen Pharmaceutical Companies and/or Johnson
& Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 29, 2019, including in the sections captioned "Cautionary
Note Regarding Forward-Looking Statements" and "Item 1A. Risk
Factors," and in the company's most recently filed Quarterly Report
on Form 10-Q, and the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies
nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the recent global outbreak of novel coronavirus
disease (COVID-19); the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; global trends toward health care cost containment;
technological advances, new products and patents attained by
competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing
difficulties or delays; financial instability of international
economies and sovereign risk; dependence on the effectiveness of
the company’s patents and other protections for innovative
products; and the exposure to litigation, including patent
litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Forward-Looking Statement of Moderna, Inc., Cambridge, MA,
USA
This news release of Moderna, Inc. (“Moderna”) contains
“forward-looking statements” within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, as amended, including but not limited to: statements
regarding the conduct of clinical trials for Moderna’s vaccine
candidate against COVID-19 (“mRNA-1273”), the process for obtaining
regulatory approval for mRNA-1273 in the United States and other
jurisdictions, and the global supply of mRNA-1273. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements. These risks, uncertainties, and other
factors include, among others: no commercial product using mRNA
technology has been approved, and may never be approved; mRNA drug
development has substantial clinical development and regulatory
risks due to the novel and unprecedented nature of this new class
of medicines; despite having ongoing interactions with the FDA or
other regulatory agencies, the FDA or such other regulatory
agencies may not agree with Moderna’s regulatory approval
strategies, components of our filings, such as clinical trial
designs, conduct and methodologies, or the sufficiency of data
submitted; the fact that the rapid response technology in use by
Moderna is still being developed and implemented; the fact that the
safety and efficacy of mRNA-1273 has not yet been established; and
those risks and uncertainties described under the heading “Risk
Factors” in Moderna’s most recent Quarterly Report on Form 10-Q
filed with the U.S. Securities and Exchange Commission (SEC) and in
subsequent filings made by Moderna with the SEC, which are
available on the SEC’s website at www.sec.gov. Except as required
by law, Moderna disclaims any intention or responsibility for
updating or revising any forward-looking statements contained in
this press release in the event of new information, future
developments or otherwise. These forward-looking statements are
based on Moderna’s current expectations and speak only as of the
date hereof.
Forward-Looking Statements of Novavax
Statements herein relating to the future of Novavax and the
ongoing development of its vaccine and adjuvant products are
forward-looking statements. Novavax cautions that these
forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading “Risk Factors” in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2019, and Quarterly Report on Form
10-Q for the period ended June 30, 2020, as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on forward-looking statements
contained in this press release. You are encouraged to read our
filings with the SEC, available at sec.gov, for a discussion of
these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this
document, and we undertake no obligation to update or revise any of
the statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Pfizer Disclosure Notice
The information contained in this release is as of September
[8], 2020. 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 Pfizer’s
efforts to combat COVID-19 and the collaboration between BioNTech
and Pfizer to develop a potential COVID-19 vaccine, 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 clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
risks associated with preliminary data, including the possibility
of unfavorable new preclinical or clinical trial data and further
analyses of existing preclinical or clinical trial data; the risk
that clinical trial data are subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from current and future preclinical and
clinical studies; whether and when any biologics license and/or
emergency use authorization applications may be filed in any
jurisdictions for any potential vaccine candidates; 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 vaccine candidate’s benefits
outweigh its known risks and determination of the vaccine
candidate’s efficacy and, if approved, whether it 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 a vaccine, including development of products or therapies by
other companies; manufacturing capabilities or capacity, including
whether the estimated numbers of doses can be manufactured within
the projected time periods; uncertainties regarding the ability to
obtain recommendations from vaccine technical committees and other
public health authorities and uncertainties regarding the
commercial impact of any such recommendations; 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, 2019 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.
Forward Looking Statement of Sanofi
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such litigation,
trends in exchange rates and prevailing interest rates, volatile
economic and market conditions, cost containment initiatives and
subsequent changes thereto, and the impact that COVID-19 will have
on us, our customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well
as on our employees and on the global economy as a whole. Any
material effect of COVID-19 on any of the foregoing could also
adversely impact us. This situation is changing rapidly and
additional impacts may arise of which we are not currently aware
and may exacerbate other previously identified risks. The risks and
uncertainties also include the uncertainties discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in Sanofi’s annual
report on Form 20-F for the year ended December 31, 2019. Other
than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
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AstraZeneca Media Contact: Michele Meixell +1 (302)
885-2677 USMediateam@astrazeneca.com
BioNTech Media Contact: Jasmina Alatovic +49 (0)6131 9084
1513 or +49 (0)151 1978 1385 Media@biontech.de
GlaxoSmithKline Media Contact: Simon Moore +44 (0)20 8047
5502 corporate.media@gsk.com
Johnson & Johnson Media Contact: Jake Sargent +1
(202) 569-5086 JSargen3@its.jnj.com
Merck Media Contact: Patrick Ryan +1 (973) 275-7075
Patrick.ryan4@merck.com
Moderna Media Contact: Colleen Hussey +1 (203) 470-5620
Colleen.Hussey@modernatx.com
Novavax Media Contacts: Edna Kaplan kaplan@kogspr.com Amy
Speak amy@speaklifescence.com
Pfizer Media Contact: Amy Rose +1 (212) 733-7410
Amy.Rose@pfizer.com
Sanofi Media Contact: Ashleigh Koss +1 (908) 205-2572
Ashleigh.Koss@sanofi.com
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