The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech SE (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.
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 AstraZenecaAstraZeneca
(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 BioNTechBiopharmaceutical
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 & JohnsonAt
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 & JohnsonAt 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 ModernaModerna 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 NovavaxNovavax, 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’ 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 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 SanofiSanofi 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.
Forward-Looking Statement of the Janssen
Pharmaceutical Companies of Johnson & JohnsonThis
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 NoticeThe
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
SanofiThis 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.
AstraZeneca Media
Contact:Michele Meixell +1 (302)
885-2677USMediateam@astrazeneca.com
BioNTech Media Contact:Jasmina
Alatovic+49 (0)6131 9084 1513 or +49 (0)151 1978
1385Media@biontech.de
GlaxoSmithKline Media
Contact:Simon Moore +44 (0)20 8047
5502corporate.media@gsk.com
Johnson & Johnson Media
Contact:Jake Sargent+1 (202)
569-5086JSargen3@its.jnj.com
Merck Media Contact:Patrick
Ryan +1 (973) 275-7075Patrick.ryan4@merck.com
Moderna Media Contact:Colleen
Hussey+1 (203) 470-5620Colleen.Hussey@modernatx.com
Novavax Media Contacts:Edna
Kaplankaplan@kogspr.com Amy Speak amy@speaklifescence.com
Pfizer Media Contact:Amy Rose+1
(212) 733-7410Amy.Rose@pfizer.com
Sanofi Media Contact:Ashleigh
Koss+1 (908) 205-2572Ashleigh.Koss@sanofi.com
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