NEW YORK–(BUSINESS WIRE)–The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ: BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Merck (NYSE: MRK), often known as MSD exterior the US and Canada, Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc. (NYSE: PFE), and Sanofi (NASDAQ: SNY), as we speak introduced a historic pledge, outlining a united dedication to uphold the integrity of the scientific course of as they work in direction of potential world regulatory filings and approvals of the primary COVID-19 vaccines.
All 9 CEOs signed the next pledge:
We, the undersigned biopharmaceutical corporations, wish to clarify our on-going dedication to growing and testing potential vaccines for COVID-19 in accordance with excessive moral requirements and sound scientific ideas.
The protection and efficacy of vaccines, together with any potential vaccine for COVID-19, is reviewed and decided by professional regulatory companies around the globe, akin to the US Meals and Drug Administration (FDA). FDA has established clear steering for the event of COVID-19 vaccines and clear standards for his or her potential authorization or approval within the US. FDA’s steering and standards are based mostly on the scientific and medical ideas vital to obviously reveal the security and efficacy of potential COVID-19 vaccines. Extra particularly, the company requires that scientific proof for regulatory approval should come from giant, prime quality scientific trials which can be randomized and observer-blinded, with an expectation of appropriately designed research with important numbers of members throughout numerous populations.
Following steering from professional regulatory authorities akin to FDA concerning the event of COVID-19 vaccines, in keeping with present requirements and practices, and within the curiosity of public well being, we pledge to:
- All the time make the security and well-being of vaccinated people our prime precedence.
- Proceed to stick to excessive scientific and moral requirements concerning the conduct of scientific trials and the rigor of producing processes.
- Solely submit for approval or emergency use authorization after demonstrating security and efficacy by way of a Part Three scientific research that’s designed and carried out to satisfy necessities of professional regulatory authorities akin to FDA.
- Work to make sure a ample provide and vary of vaccine choices, together with these appropriate for world entry.
We imagine this pledge will assist guarantee public confidence within the rigorous scientific and regulatory course of by which COVID-19 vaccines are evaluated and will finally be accredited.
Collectively, these 9 corporations have collectively developed greater than 70 novel vaccines which have helped to eradicate a few of the world’s most advanced and lethal public well being threats, underscoring their expertise in scientific growth and regulatory rigor, in addition to their longstanding commitments to affected person security and public well being.
AstraZeneca (LSE/STO/NYSE: AZN) is a world, science-led biopharmaceutical firm that focuses on the invention, growth and commercialisation of prescription medicines, primarily for the therapy of ailments in three remedy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Primarily based in Cambridge, UK, AstraZeneca operates in over 100 international locations and its modern medicines are utilized by hundreds of thousands of sufferers worldwide. Please go to astrazeneca.com and observe the Firm on Twitter @AstraZeneca.
Biopharmaceutical New Applied sciences is a subsequent technology immunotherapy firm pioneering novel therapies for most cancers and different severe ailments. The Firm exploits a big selection of computational discovery and therapeutic drug platforms for the speedy growth of novel biopharmaceuticals. Its broad portfolio of oncology product candidates contains individualized and off-the-shelf mRNA-based therapies, modern chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, focused most cancers antibodies and small molecules. Primarily based on its deep experience in mRNA vaccine growth and in-house manufacturing capabilities, BioNTech and its collaborators are growing a number of mRNA vaccine candidates for a spread of infectious ailments alongside its numerous oncology pipeline. BioNTech has established a broad set of relationships with a number of world pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For extra data, please go to https://biontech.de/.
GSK is a science-led world healthcare firm with a particular goal: to assist individuals do extra, really feel higher, stay longer. For additional data please go to www.gsk.com/about-us.
About Johnson & Johnson
At Johnson & Johnson, we imagine good well being is the muse of vibrant lives, thriving communities and ahead progress. That’s why for greater than 130 years, we have now aimed to maintain individuals effectively at all ages and each stage of life. At this time, because the world’s largest and most broadly-based well being care firm, we’re dedicated to utilizing our attain and measurement for good. We attempt to enhance entry and affordability, create more healthy communities, and put a wholesome thoughts, physique and atmosphere inside attain of everybody, in all places. We’re mixing our coronary heart, science and ingenuity to profoundly change the trajectory of well being for humanity. Study extra at Study extra at www.jnj.com. Observe us at @JNJNews.
Concerning the Janssen Pharmaceutical Corporations of Johnson & Johnson
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Corporations of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers in all places by preventing illness with science, enhancing entry with ingenuity and therapeutic hopelessness with coronary heart. We give attention to areas of drugs the place we will make the largest distinction: Cardiovascular & Metabolism, Immunology, Infectious Ailments & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.
For greater than 125 years, Merck, often known as MSD exterior of the US and Canada, has been inventing for all times, bringing ahead medicines and vaccines for lots of the world’s most difficult ailments in pursuit of our mission to avoid wasting and enhance lives. We reveal our dedication to sufferers and inhabitants well being by growing entry to well being care by way of far-reaching insurance policies, applications and partnerships. At this time, Merck continues to be on the forefront of analysis to stop and deal with ailments that threaten individuals and animals – together with most cancers, infectious ailments akin to HIV and Ebola, and rising animal ailments – as we aspire to be the premier research-intensive biopharmaceutical firm on the planet. For extra data, go to www.merck.com and join with us on Twitter, Fb, Instagram, YouTube and LinkedIn.
Moderna is advancing messenger RNA (mRNA) science to create a brand new class of transformative medicines for sufferers. mRNA medicines are designed to direct the physique’s cells to supply intracellular, membrane or secreted proteins that may have a therapeutic or preventive profit and have the potential to deal with a broad spectrum of ailments. Moderna’s platform builds on steady advances in primary and utilized mRNA science, supply know-how and manufacturing, offering the Firm the potential to pursue in parallel a strong pipeline of recent growth candidates. Moderna is growing therapeutics and vaccines for infectious ailments, immuno-oncology, uncommon ailments, cardiovascular ailments, and autoimmune and inflammatory ailments, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna at present has strategic alliances for growth applications with AstraZeneca PLC and Merck & Co., Inc., in addition to the Protection Superior Analysis Tasks Company (DARPA), an company of the U.S. Division of Protection; the Biomedical Superior Analysis and Improvement Authority (BARDA), a division of the Workplace of the Assistant Secretary for Preparedness and Response (ASPR) throughout the U.S. Division of Well being and Human Providers (HHS) and the Coalition for Epidemic Preparedness Improvements (CEPI). Moderna has been named a prime biopharmaceutical employer by Science for the previous 5 years. To study extra, go to www.modernatx.com.
Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology firm that promotes improved well being globally by way of the invention, growth, and commercialization of modern vaccines to stop severe infectious ailments. Novavax is present process scientific trials for NVX-CoV2373, its vaccine candidate in opposition to SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all major targets in its pivotal Part Three scientific trial in older adults. Each vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to be able to improve the immune response and stimulate excessive ranges of neutralizing antibodies. Novavax is a number one innovator of recombinant vaccines; its proprietary recombinant know-how platform combines the facility and pace of genetic engineering to effectively produce extremely immunogenic nanoparticles to be able to deal with pressing world well being wants.
About Pfizer: Breakthroughs That Change Sufferers’ Lives
At Pfizer, we apply science and our world sources to deliver therapies to individuals that stretch and considerably enhance their lives. We attempt to set the usual for high quality, security and worth within the discovery, growth and manufacture of well being care merchandise, together with modern medicines and vaccines. Every single day, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, therapies and cures that problem essentially the most feared ailments of our time. Per our accountability as one of many world’s premier modern biopharmaceutical corporations, we collaborate with well being care suppliers, governments and native communities to help and increase entry to dependable, inexpensive well being care around the globe. For greater than 150 years, we have now labored to make a distinction for all who depend on us. We routinely submit data which may be necessary to buyers on our web site at www.Pfizer.com. As well as, to study extra, please go to us on www.Pfizer.com and observe us on Twitter at @Pfizer and @Pfizer Information, LinkedIn, YouTube and like us on Fb at Fb.com/Pfizer.
Sanofi is devoted to supporting individuals by way of their well being challenges. We’re a world biopharmaceutical firm targeted on human well being. We stop sickness with vaccines, present modern therapies to battle ache and ease struggling. We stand by the few who are suffering from uncommon ailments and the hundreds of thousands with long-term power situations.
With greater than 100,000 individuals in 100 international locations, Sanofi is reworking scientific innovation into healthcare options across the globe.
Sanofi, Empowering Life
For additional data, please go to www.sanofi.com
Ahead Trying Statements of BioNTech
This press launch comprises “forward-looking statements” of BioNTech throughout the that means of the Personal Securities Litigation Reform Act of 1995. These forward-looking statements could embrace, however is probably not restricted to, statements regarding BioNTech’s efforts to fight COVID-19. Any forward-looking statements on this press launch are based mostly on BioNTech present expectations and beliefs of future occasions, and are topic to various dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embrace, however will not be restricted to: competitors to create a vaccine for COVID-19; the flexibility to supply comparable scientific ends in bigger and extra numerous scientific trials; the flexibility to successfully scale our productions capabilities; and different potential difficulties. For a dialogue of those and different dangers and uncertainties, see BioNTech’s Annual Report on Kind 20-F filed with the SEC on March 31, 2020, which is offered on the SEC’s web site at www.sec.gov. All data on this press launch is as of the date of the discharge, and BioNTech undertakes no obligation to replace this data except required by legislation.
GSK Cautionary Assertion Relating to Ahead-Trying Statements
GSK cautions buyers that any forward-looking statements or projections made by GSK, together with these made on this announcement, are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these projected. Such components embrace, however will not be restricted to, these described beneath Merchandise 3.D “Threat Elements” within the firm’s Annual Report on Kind 20-F for 2019 and as set out in GSK’s “Principal dangers and uncertainties” part of the Q2 Outcomes and any impacts of the COVID-19 pandemic.
Ahead-Trying Assertion of the Janssen Pharmaceutical Corporations of Johnson & Johnson
This press launch comprises “forward-looking statements” as outlined within the Personal Securities Litigation Reform Act of 1995 concerning growth of potential preventive and therapy regimens for COVID-19. The reader is cautioned to not depend on these forward-looking statements. These statements are based mostly on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes may differ materially from the expectations and projections of the Janssen Pharmaceutical Corporations and/or Johnson & Johnson. Dangers and uncertainties embrace, however will not be restricted to: challenges and uncertainties inherent in product analysis and growth, together with the uncertainty of scientific success and of acquiring regulatory approvals; uncertainty of economic success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by rivals; challenges to patents; product efficacy or security issues leading to product recollects or regulatory motion; adjustments in habits and spending patterns of purchasers of well being care services and products; adjustments to relevant legal guidelines and rules, together with world well being care reforms; and tendencies towards well being care value containment. An additional checklist and descriptions of those dangers, uncertainties and different components could be present in Johnson & Johnson’s Annual Report on Kind 10-Okay for the fiscal 12 months ended December 29, 2019, together with within the sections captioned “Cautionary Observe Relating to Ahead-Trying Statements” and “Merchandise 1A. Threat Elements,” and within the firm’s most not too long ago filed Quarterly Report on Kind 10-Q, and the corporate’s subsequent filings with the Securities and Alternate Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Not one of the Janssen Pharmaceutical Corporations nor Johnson & Johnson undertakes to replace any forward-looking assertion because of new data or future occasions or developments.
Ahead-Trying Assertion of Merck & Co., Inc., Kenilworth, N.J., USA
This information launch of Merck & Co., Inc., Kenilworth, N.J., USA (the “firm”) contains “forward-looking statements” throughout the that means of the secure harbor provisions of the U.S. Personal Securities Litigation Reform Act of 1995. These statements are based mostly upon the present beliefs and expectations of the corporate’s administration and are topic to important dangers and uncertainties. If underlying assumptions show inaccurate or dangers or uncertainties materialize, precise outcomes could differ materially from these set forth within the forward-looking statements.
Dangers and uncertainties embrace however will not be restricted to, normal trade situations and competitors; normal financial components, together with rate of interest and forex trade fee fluctuations; the affect of the current world outbreak of novel coronavirus illness (COVID-19); the affect of pharmaceutical trade regulation and well being care laws in the US and internationally; world tendencies towards well being care value containment; technological advances, new merchandise and patents attained by rivals; challenges inherent in new product growth, together with acquiring regulatory approval; the corporate’s capacity to precisely predict future market situations; manufacturing difficulties or delays; monetary instability of worldwide economies and sovereign threat; dependence on the effectiveness of the corporate’s patents and different protections for modern merchandise; and the publicity to litigation, together with patent litigation, and/or regulatory actions.
The corporate undertakes no obligation to publicly replace any forward-looking assertion, whether or not because of new data, future occasions or in any other case. Extra components that might trigger outcomes to vary materially from these described within the forward-looking statements could be discovered within the firm’s 2019 Annual Report on Kind 10-Okay and the corporate’s different filings with the Securities and Alternate Fee (SEC) out there on the SEC’s Web website (www.sec.gov).
Ahead-Trying Assertion of Moderna, Inc., Cambridge, MA, USA
This information launch of Moderna, Inc. (“Moderna”) comprises “forward-looking statements” throughout the that means of the secure harbor provisions of the U.S. Personal Securities Litigation Reform Act of 1995, as amended, together with however not restricted to: statements concerning the conduct of scientific trials for Moderna’s vaccine candidate in opposition to COVID-19 (“mRNA-1273”), the method for acquiring regulatory approval for mRNA-1273 in the US and different jurisdictions, and the worldwide provide of mRNA-1273. If underlying assumptions show inaccurate or dangers or uncertainties materialize, precise outcomes could differ materially from these set forth within the forward-looking statements. These dangers, uncertainties, and different components embrace, amongst others: no industrial product utilizing mRNA know-how has been accredited, and will by no means be accredited; mRNA drug growth has substantial scientific growth and regulatory dangers because of the novel and unprecedented nature of this new class of medicines; regardless of having ongoing interactions with the FDA or different regulatory companies, the FDA or such different regulatory companies could not agree with Moderna’s regulatory approval methods, parts of our filings, akin to scientific trial designs, conduct and methodologies, or the sufficiency of information submitted; the truth that the speedy response know-how in use by Moderna remains to be being developed and applied; the truth that the security and efficacy of mRNA-1273 has not but been established; and people dangers and uncertainties described beneath the heading “Threat Elements” in Moderna’s most up-to-date Quarterly Report on Kind 10-Q filed with the U.S. Securities and Alternate Fee (SEC) and in subsequent filings made by Moderna with the SEC, which can be found on the SEC’s web site at www.sec.gov. Besides as required by legislation, Moderna disclaims any intention or accountability for updating or revising any forward-looking statements contained on this press launch within the occasion of recent data, future developments or in any other case. These forward-looking statements are based mostly on Moderna’s present expectations and communicate solely as of the date hereof.
Ahead-Trying Statements of Novavax
Statements herein regarding the way forward for Novavax and the continuing growth of its vaccine and adjuvant merchandise are forward-looking statements. Novavax cautions that these forward-looking statements are topic to quite a few dangers and uncertainties, which may trigger precise outcomes to vary materially from these expressed or implied by such statements. These dangers and uncertainties embrace these recognized beneath the heading “Threat Elements” within the Novavax Annual Report on Kind 10-Okay for the 12 months ended December 31, 2019, and Quarterly Report on Kind 10-Q for the interval ended June 30, 2020, as filed with the Securities and Alternate Fee (SEC). We warning buyers to not place appreciable reliance on forward-looking statements contained on this press launch. You’re inspired to learn our filings with the SEC, out there at sec.gov, for a dialogue of those and different dangers and uncertainties. The forward-looking statements on this press launch communicate solely as of the date of this doc, and we undertake no obligation to replace or revise any of the statements. Our enterprise is topic to substantial dangers and uncertainties, together with these referenced above. Buyers, potential buyers, and others ought to give cautious consideration to those dangers and uncertainties.
Pfizer Disclosure Discover
The data contained on this launch is as of September , 2020. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new data or future occasions or developments.
This launch comprises forward-looking details about Pfizer’s efforts to fight COVID-19 and the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine, that includes substantial dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and growth, together with the flexibility to satisfy anticipated scientific endpoints, graduation and/or completion dates for scientific trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to dangers related to preliminary knowledge, together with the opportunity of unfavorable new preclinical or scientific trial knowledge and additional analyses of present preclinical or scientific trial knowledge; the chance that scientific trial knowledge are topic to differing interpretations and assessments, together with through the peer evaluate/publication course of, within the scientific neighborhood usually, and by regulatory authorities; whether or not regulatory authorities might be happy with the design of and outcomes from present and future preclinical and scientific research; whether or not and when any biologics license and/or emergency use authorization purposes could also be filed in any jurisdictions for any potential vaccine candidates; whether or not and when any such purposes could also be accredited by regulatory authorities, which can depend upon myriad components, together with making a dedication as as to whether the vaccine candidate’s advantages outweigh its identified dangers and dedication of the vaccine candidate’s efficacy and, if accredited, whether or not it is going to be commercially profitable; choices by regulatory authorities impacting labeling, manufacturing processes, security and/or different issues that might have an effect on the supply or industrial potential of a vaccine, together with growth of merchandise or therapies by different corporations; manufacturing capabilities or capability, together with whether or not the estimated numbers of doses could be manufactured throughout the projected time intervals; uncertainties concerning the flexibility to acquire suggestions from vaccine technical committees and different public well being authorities and uncertainties concerning the industrial affect of any such suggestions; and aggressive developments.
An additional description of dangers and uncertainties could be present in Pfizer’s Annual Report on Kind 10-Okay for the fiscal 12 months ended December 31, 2019 and in its subsequent reviews on Kind 10-Q, together with within the sections thereof captioned “Threat Elements” and “Ahead-Trying Info and Elements That Might Have an effect on Future Outcomes”, in addition to in its subsequent reviews on Kind 8-Okay, all of that are filed with the U.S. Securities and Alternate Fee and out there at www.sec.gov and www.pfizer.com.
Ahead Trying Assertion of Sanofi
This press launch comprises forward-looking statements as outlined within the Personal Securities Litigation Reform Act of 1995, as amended. Ahead-looking statements are statements that aren’t historic info. These statements embrace projections and estimates and their underlying assumptions, statements concerning plans, targets, intentions and expectations with respect to future monetary outcomes, occasions, operations, companies, product growth and potential, and statements concerning future efficiency. Ahead-looking statements are usually recognized by the phrases “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and related expressions. Though Sanofi’s administration believes that the expectations mirrored in such forward-looking statements are affordable, buyers are cautioned that forward-looking data and statements are topic to numerous dangers and uncertainties, lots of that are troublesome to foretell and customarily past the management of Sanofi, that might trigger precise outcomes and developments to vary materially from these expressed in, or implied or projected by, the forward-looking data and statements. These dangers and uncertainties embrace amongst different issues, the uncertainties inherent in analysis and growth, future scientific knowledge and evaluation, together with submit advertising, choices by regulatory authorities, such because the FDA or the EMA, concerning whether or not and when to approve any drug, machine or organic software which may be filed for any such product candidates in addition to their choices concerning labelling and different issues that might have an effect on the supply or industrial potential of such product candidates, the truth that product candidates if accredited is probably not commercially profitable, the longer term approval and industrial success of therapeutic alternate options, Sanofi’s capacity to profit from exterior progress alternatives, to finish associated transactions and/or acquire regulatory clearances, dangers related to mental property and any associated pending or future litigation and the last word end result of such litigation, tendencies in trade charges and prevailing rates of interest, unstable financial and market situations, value containment initiatives and subsequent adjustments thereto, and the affect that COVID-19 may have on us, our prospects, suppliers, distributors, and different enterprise companions, and the monetary situation of any one in all them, in addition to on our workers and on the worldwide economic system as a complete. Any materials impact of COVID-19 on any of the foregoing may additionally adversely affect us. This case is altering quickly and extra impacts could come up of which we’re not at present conscious and will exacerbate different beforehand recognized dangers. The dangers and uncertainties additionally embrace the uncertainties mentioned or recognized within the public filings with the SEC and the AMF made by Sanofi, together with these listed beneath “Threat Elements” and “Cautionary Assertion Relating to Ahead-Trying Statements” in Sanofi’s annual report on Kind 20-F for the 12 months ended December 31, 2019. Apart from as required by relevant legislation, Sanofi doesn’t undertake any obligation to replace or revise any forward-looking data or statements.