Pfizer to provide therapeutics approved in late-stage cancer indications for new micrometastatic patient cohorts

Strata Oncology, Inc . a next-generation precision oncology company enabling smarter and earlier cancer treatment, today announced expansion of its clinical collaboration with Pfizer (NYSE: PFE) in the Strata P recision Indications for A pproved TH erapies (Strata PATH TM ) trial. Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Pfizer will provide Braftovi® (encorafenib), Mektovi® (binimetinib), and Lorbrena® (lorlatinib) for up to six new cohorts of patients with early-stage lung, melanoma, colorectal, and other cancers who have evidence of micrometastatic disease after initial treatment. Pfizer is already providing Strata with Braftovi® (encorafenib), Mektovi® (binimetinib), Lorbrena® (lorlatinib), Talzenna® (talazoparib), and Inlyta (axitinib) for evaluation in four late-stage cohorts of the Strata PATH trial.

"The new cohorts of Strata PATH, supported by Pfizer, afford us a very exciting opportunity to move the advances we've seen in late-stage cancer into earlier stages of the disease," said Dan Rhodes , Ph.D., co-founder and Chief Executive Officer, Strata Oncology. "Our goal is to deliver smarter and earlier treatment to every patient and having the support of Pfizer is a testament to the potential of the clinical trials that we are using to accelerate the impact of precision oncology."

Many of the patients for the new micrometastatic cohorts of Strata PATH will be identified through the Strata Sentinel TM trial, a 100,000-patient, prospective, observational, pan-solid tumor study of Strata Oncology's highly sensitive, tumor-informed circulating tumor DNA (ctDNA)-based MRD test. An advanced molecular therapy selection profile is created simultaneously for every patient assessed with the MRD test. This enables rapid identification of clinical trial opportunities, including Strata PATH, for patients who are positive for ctDNA.

The Strata P recision Indications for A pproved TH erapies (Strata PATH) trial, is a 700-patient prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Strata PATH will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease after initial treatment. All therapies being evaluated in Strata PATH are FDA-approved in oncology with demonstrated safety profiles in the advanced setting. Enrollment for multiple arms in Stata PATH is based on novel quantitative RNA and multivariate algorithms Strata Oncology developed using its clinical molecular database comprising DNA mutation profiles and quantitative RNA expression data from tens of thousands of patients coupled with detailed treatment history and outcomes data. A range of therapeutic classes will be evaluated in Strata PATH including targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

Strata Oncology, Inc. is a precision oncology company dedicated to delivering the best possible treatment for each patient with cancer. The company combines molecular profiling, real-world data, and a large-scale clinical trial platform to identify and deliver optimal treatments for patients with cancer. For more information visit strataoncology.com .

Media Inquiries: Kyle Evans 646.277.1295 kyle.evans@westwicke.com

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Love Pharma Co. ("LOVE" and or "The Company") (CSE:LUV)(FSE:G1Q0), the Company is pleased to announce that it has made a strategic investment in Starton Therapeutics Inc., a New Jersey based clinical stage biotechnology company focused on transforming standard of care therapies in oncology. This first investment in Starton establishes an initial position in the company and provides the starting point for a strategic relationship going forward whereby Love will leverage Starton's advancements and breakthroughs to guide the Company's clinical pursuits

"This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which has just completed its phase 1 clinical trial for its STAR - LLD continuous delivery technology deploying lenalidomide (July 13 press release)," said Mr. Zach Stadnyk, Love Pharma President and CEO. "Starton is also entering a phase 2 trial with its STAR - OLZ transdermal five - day adhesive matrix patch deploying olanzapine, for which the FDA US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV) (press release). With this investment in Starton we are building our relationship, forming an alliance and will look to Starton's expert management team to reduce risk in our own portfolio of clinical pursuits and focus on the addiction space."

The Company is currently identifying and assessing disruptive opportunities within the transdermal biotechnology, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With this initial investment in Starton we believe Love can leverage their expertise and proven success to credibly evaluate potential acquisitions in transdermal field of advanced drug delivery systems.

Love Pharma has invested an initial $592,000 Cdn into Starton for 145,161 common shares of the issuer at a price of $3.10 USD per share. The investment was completed in June 2022.

STAR-LLD, Phase 1: Continuous delivery of lenalidomide in hematologic malignancies (blood cancers)

STAR-OLZ, Phase 2: Transdermal five-day adhesive matrix patch in CINV (cancer supportive care)

Love Pharma's investment in Starton Therapeutics is primarily based upon the Company's interest in innovative drug delivery technology, such as transdermal patches, which can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long term IP protections.

To further accelerate our planned strategic alliance and to bolster the Company's own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory - TRPL is the lab that develops and supports Starton's transdermal drug delivery programs and is a global leader in transdermal delivery systems.

For more information about Starton Therapeutics and their pipeline of development programs, visit www.startontx.com

On Behalf of The Board of Directors,

Zachary Stadnyk, CEO and Director

With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. (CSE: LUV) (FSE: G1Q0) was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.

For further information, please contact:

Investor Relations Telephone: 1 (604) 343-2977 E-mail: investors@love-pharma.com www.love-pharma.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

Certain statements contained in this release may constitute "forward-looking statements" or "forward-looking information" (collectively "forward-looking information") as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "anticipates" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, financing, and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.

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Pfizer (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

As quoted in the press release:

“The Phase 3 top-line results reinforce the efficacy and safety profile of LYRICA for pediatric epilepsy patients,” said James M. Rusnak, M.D., Ph.D., Chief Development Officer, Internal Medicine, Pfizer Inc. “These findings add to the data available for LYRICA in the pediatric patient population for a complex and difficult-to-treat condition.”

The LYRICA Pediatric Epilepsy Program is composed of a total of six studies in patients with epilepsy evaluating LYRICA as adjunctive therapy, four of which have been completed and two of which are actively enrolling.

Click here to read the full press release.

Oxis International (OTCQB:OXIS) appoints new CEO and Chief Medical Officer as it completes acquisition of  Georgetown Translational Pharmaceuticals, which will add new management and a class of close-to-market Central Nervous Systems products. As quoted in the press release:

Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement. Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE). Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer. Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016. Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.

Click here to read the full press release.

ICU Medical Inc. (NASDAQ:ICUI) today announced that it has completed its acquisition of the Hospira Infusion Systems business from Pfizer Inc. (NYSE:PFE). The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with the company’s existing businesses, makes ICU Medical one of the world’s leading pure-play infusion therapy companies. “We are pleased that Hospira Infusion Systems is now part of ICU Medical and welcome our new Hospira colleagues to the ICU team. We look forward to working together to continue providing quality, innovation and value to our clinical customers worldwide,” said Vivek Jain, chairman and chief executive officer at ICU Medical.The Hospira Infusion Systems acquisition complements ICU Medical’s existing business to create a company with a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets. In addition, the acquisition gives ICU Medical a significantly enhanced global footprint and platform for continued competitiveness and long-term growth. With an integrated product offering, the company now holds industry-leading positions in key segments and has access to the full US infusion marketplace with a compelling product portfolio.The company plans to announce full FY 2017 guidance on its Q4 Earnings call in late February.Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future, including our full year 2016 guidance and our acquisition of the Hospira infusion systems business. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers and the Company’s ability to meet expectations regarding the timing, completion and integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2015 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.ICU Medical Investor Contacts: Scott Lamb, ICU Medical, Inc. 949-366-2183 slamb@icumed.com John Mills, ICR, Inc 646-277-1254 John.Mills@icrinc.com Media Contact: Tom McCall, ICU Medical, Inc. 949-366-4368 tmccall@icumed.com

Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced it has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy. Philippe Archinard, Chairman and CEO of Transgene, commented: “We are pleased to enter this collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate our therapeutic vaccine TG4001 in association with avelumab. In previous clinical trials, TG4001 has demonstrated promising activity in terms of HPV viral clearance and was well tolerated. TG4001 is one of the few drugs targeting HPV-associated cancers that can be combined with an immune checkpoint blocker such as avelumab. The preclinical and clinical data that have been generated with both TG4001 and avelumab individually suggest this combination could potentially demonstrate a synergistic effect, delivering a step up in therapy for HPV-positive HNSCC patients.” The combination of TG4001 and avelumab aims to target two distinct steps in the immune response to target cancer cells. This is an exclusive agreement between the parties to study the combination of these two classes of investigational agents in HPV-positive HNSCC. Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at Institut Curie, and a world expert in ENT cancers, will be the Principal Investigator of the Phase 1/2 study. This trial is expected to begin in France, with the first patient expected to be recruited in H1 2017. It will seek to recruit patients with recurrent and/or metastatic virus-positive oropharyngeal squamous cell carcinoma that have progressed after definitive local treatment or chemotherapy, and cannot be treated with surgical resection and/or re-irradiation. Prof. Christophe Le Tourneau said: “HPV-induced head and neck cancers are currently treated with the same regimen as non-HPV-positive HNSCC tumors. However, their different etiology clearly suggests that differentiated treatment approaches are needed for HPV-positive patients. Immunotherapy, and in particular the therapeutic vaccine TG4001 together with the PD-L1 blocker avelumab, by targeting two distinct steps in the immune response, could deliver improved efficacy for patients who have not responded to or have progressed after a first line of treatment.” TG4001 is an active immunotherapeutic designed by Transgene to express the coding sequences of the E6 & E7 tumor-associated antigens of HPV-16 and the cytokine, IL-2. This therapeutic vaccine, which is based on a non-propagative, attenuated vaccinia vector (MVA), has already been administered to more than 300 patients with high grade cervical intra-epithelial neoplasia (CIN 2/3). It has demonstrated good safety, a significant HPV clearance rate and promising efficacy results. Its mechanism of action and good safety profile make TG4001 a particularly appropriate candidate for combinations with other therapies, such as avelumab. Avelumab is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. As a checkpoint inhibitor, avelumab is thought to have a dual mechanism of action that may potentially enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In 2014, the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer signed a strategic alliance to co-develop and co-commercialize avelumab. Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono, commented: “We believe combination regimens show significant promise in the development of novel and efficacious immuno-oncology treatments. Through this study, we hope to discover the potential of avelumab as a combination therapy with TG4001 for patients fighting this recurring cancer.” Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development, and Translational Oncology at Pfizer, said: “Through this collaboration, we hope to better understand how therapeutic vaccines may help support the clinical development program for avelumab as our end goal is to find the best treatment options for patients.” About HPV-mediated Head and Neck Cancer Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group of cancers that can affect the oral cavity, pharynx, and larynx. HPV-16 infection is recognized to participate in the development of a substantial proportion of head and neck cancers and is associated with a subset of HNSCC, especially those arising from the oropharynx (more than 80%), which are the most frequent, and the larynx (~70%). The incidence of HPV-16-related head and neck cancer has significantly increased in recent years. Although there are more than 100 subtypes of HPV, HPV-16 accounts for 90% of all HPV-related head and neck cancers. Global spending on head and neck cancer indications amounted to $1 billion in 2010. Current treatments include surgical resection with radiotherapy or chemoradiotherapy. However, better options are needed for advanced and metastatic HPV+ HNSCC. It is thought that immunotherapy combined with immune checkpoint inhibitors could provide a promising potential treatment option that would address this strong medical need. About TG4001 TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated vaccinia vector (MVA), which is engineered to express HPV-16 antigens (E6 & E7) and an adjuvant (IL-2). It is one of the few therapies targeting HPV+ sub population. TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to HPV-16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV-16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 300 patients, demonstrating good safety, significant HPV clearance rate and promising efficacy results. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in solid tumors. About Avelumab Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab. About Transgene Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a JV in China with Tasly Group. Additional information about Transgene is available at www.transgene.fr. Disclaimer This press release contains forward-looking statements about the future development of TG4001. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Document de Référence, which is available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.fr).

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age. VAXNEUVANCE is currently authorized for use in the European Union (EU) for individuals 18 years of age and older.

The CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year.

"We are committed to advancing protection for those at increased risk for pneumococcal disease, which includes those under the age of 2 years and children of any age who have certain underlying conditions," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We are pleased with the CHMP's positive opinion as it brings us one step closer to our goal of helping to protect against pneumococcal strains that pose substantial risk to infants and children in Europe."

Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae , or pneumococcus. While there are more than 100 different types of S. pneumoniae , called serotypes, a selected number of serotypes are responsible for the majority of pneumococcal infections. Invasive pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord).

The CHMP opinion was based on data from eight randomized, double-blind clinical studies that enrolled approximately 8,400 individuals from a variety of pediatric populations and clinical circumstances; of these, approximately 5,400 received VAXNEUVANCE.

In July 2021, VAXNEUVANCE received approval from the U.S. Food and Drug Administration (FDA) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older, and in June 2022, the FDA approved an expanded indication for VAXNEUVANCE to include individuals 6 weeks through 17 years of age.

About VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)

VAXNEUVANCE, Merck's 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM 197 carrier protein.

VAXNEUVANCE is indicated in the EU for active immunization for the prevention of invasive pneumococcal disease and pneumonia caused by S. pneumoniae in individuals 18 years of age and older.

VAXNEUVANCE is indicated in the U.S. for active immunization of individuals 6 weeks of age and older for the prevention of invasive disease caused by the S. pneumoniae serotypes contained in the vaccine.

Select Safety Information for VAXNEUVANCE

Do not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.

Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant's medical status and the potential benefits and possible risks.

The most commonly reported solicited adverse reactions in children vaccinated with a four-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever ≥38.0°C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).

The most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).

The most commonly reported solicited adverse reactions in adults 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%) and arthralgia (12.7%).

The most commonly reported solicited adverse reactions in adults 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%) and arthralgia (7.7%).

Vaccination with VAXNEUVANCE may not protect all vaccine recipients.

Merck's Commitment to Pneumococcal Disease Protection

Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck's ongoing pneumococcal vaccine development program is designed to provide tailored options to address the specific needs of different populations, including infants and children, healthy adults and at-risk subgroups. This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck's pneumococcal portfolio and pipeline, visit https://www.merck.com .

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, 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. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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 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 Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see Prescribing Information for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf and Patient Information/Medication Guide for VAXNEUVANCE at https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220915006126/en/

Media Contacts: Julie Cunningham (617) 519-6264 Kimberly Petrillo (267) 742-2813 Investor Contacts: Peter Dannenbaum (908) 740-1037 Alexis Constantine (908) 740-1051

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Pfizer Inc. (NYSE:PFE) today announced positive top-line results from the pivotal Phase 3 trial (NCT04440163) assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y. 1 Currently, MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups.

Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba ® + one dose of Menveo ® ). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba ® and one dose of Menveo ® .

Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo ® . Furthermore, in individuals who had not previously received a meningococcal vaccine, the proportion of subjects with ≥4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W and Y compared to one dose of Menveo ® . Finally, the proportion of subjects with ≥4-fold increases in immune responses was also observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba ® . The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.

"We are very pleased with these positive Phase 3 data, which are the first for a MenABCWY vaccine candidate," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the U.S. and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease."

Based on these Phase 3 results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter of this year. Submissions to additional regulatory authorities outside the U.S. are also planned.

"The potential recommendation of a pentavalent vaccine in the U.S. as an alternative to the existing MenACWY vaccines across both the 11- to 12-year-old and 16-year-old vaccination platforms provides a significant opportunity for Pfizer to enter the U.S. MenACWY vaccine market and help protect more young people across the country. Today, we estimate there are approximately 52 million adolescents and young adults who are in the age range for meningococcal vaccination according to CDC guidance," said Angela Hwang, President, Global Biopharma Business, Pfizer. "We look forward to the public health impact a pentavalent vaccine may provide, and to strengthening our position as a global leader in the prevention of meningococcal disease."

Potential Public Health Impact of a MenABCWY Vaccine

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours, and for survivors can result in life-altering, significant long-term disabilities. 2 Together, five serogroups (A, B, C, W and Y) account for 96 percent of all invasive meningococcal disease cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe. 3

In the U.S., the current vaccination recommendations for adolescents and young adults include a MenACWY vaccine and a separate MenB vaccine (total four doses) to help achieve the broadest protection available against meningococcal disease. However, less than a third of U.S. adolescents receive even one dose of a MenB vaccine, and fewer complete the two-dose series, resulting in many adolescents being unprotected against meningococcal disease caused by serogroups A, B, C, W, and Y. 4,5 If approved and recommended, Pfizer's pentavalent vaccine candidate could help simplify the meningococcal vaccination schedule by potentially reducing the total number of doses needed for individuals to be fully vaccinated against the five serogroups. 6 Routine use of a MenABCWY vaccine could help improve meningococcal vaccination rates and coverage, thereby reducing cases of invasive meningococcal disease and associated mortality, the rate of long-term sequelae in survivors, and costs associated with controlling outbreaks. 7

The randomized, active-controlled and observer-blinded Phase 3 trial of Pfizer's pentavalent meningococcal vaccine candidate (NCT04440163) was initiated in June 2020 and enrolled 2,431 healthy adolescents and young adults (10 through 25 years of age) from the U.S. and Europe. The study was designed to compare immune responses in individuals after MenABCWY administration to responses in control groups receiving licensed vaccines Trumenba ® (meningococcal group B vaccine) and Menveo ® (meningococcal group A, C, W-135, and Y conjugate vaccine), as well as to describe the safety profile of the MenABCWY vaccine. Immune responses were assessed by human serum bactericidal assay (hSBA). The study enrolled both individuals who had previously received a MenACWY vaccine and those who had not. All participants had not received any meningococcal group B vaccine prior to enrollment.

Additional information about the trial can be found at www.clinicaltrials.gov . Pfizer plans to present the detailed results from this trial at a future medical congress and submit the results for peer review in a scientific journal.

Pfizer's pentavalent meningococcal vaccine candidate combines its two licensed meningococcal vaccines, Trumenba ® and Nimenrix ® (meningococcal group A, C, W-135, and Y conjugate vaccine). Approvals of Nimenrix ® and Trumenba ® vary by country.

INDICATIONS FOR TRUMENBA ® IN THE U.S.

INDICATION FOR NIMENRIX ® IN THE E.U.

Menveo ® and Nimenrix ® are trademarks of GlaxoSmithKline Biologicals S.A.

Soliris ® is a trademark of Alexion Pharmaceuticals, Inc.

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 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 .

Disclosure Notice : The information contained in this release is as of September 15, 2022. 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 MenABCWY vaccine candidate, including its potential benefits, its potential recommendation and planned 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, 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 any biologic license applications may be filed in any jurisdictions for Pfizer's MenABCWY vaccine candidate; whether and when any such applications may be approved by regulatory authorities, which will depend on a 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 such product candidate 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 Pfizer's MenABCWY vaccine candidate; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities for Pfizer's MenABCWY vaccine candidate and uncertainties regarding the commercial impact of any such recommendations; 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 .

1 National Library of Medicine. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and meta-analysis. September 2019. Available at: https://doi.org/10.1016/j.micpath.2019.103571 . Accessed June 2, 2022.

2 Borg J, Christie D, Coen PG, Pooy R, Viner RM. Outcomes of Meningococcal disease in adolescence: prospective, matched-cohort study. Pediatrics. 2009;123:e502-e509.

3 Purmohamad A, Abasi E, Azimi T, Hosseini S, Hossein S, Nasiri M, Fooladi A. Global estimate of Neisseria meningitidis serogroups proportion in invasive meningococcal disease: A systematic review and meta-analysis. Microbial Pathogensis. 2019

4 Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022;71:1101–1108. DOI: http://dx.doi.org/10.15585/mmwr.mm7135a1 .

5 La EM, Garbinsky D, Hunter S, Poston S, Novy P, Ghaswalla P. Meningococcal B vaccination coverage among older adolescents in the United States. Vaccine. 2021;39(19):2660-2667.

6 National Library of Medicine. Rationale for the Development of a Pentavalent Meningococcal Vaccine: A US-Focused Review. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/35357651/

7 National Library of Medicine. Potential Public Health Impact of a Neisseria Meningitidis A, B, C, W, and Y Pentavalent Vaccine in the Unites States. 2022. Available at: https://pubmed.ncbi.nlm.nih.gov/33615973/

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Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 4:30 p.m. EDT on Wednesday, September 21, 2022. Pfizer Internal Medicine leadership will review the oral GLP-1 data presented at the European Association for the Study of Diabetes (EASD) 2022.

To view and listen to the webcast, visit our web site at www.pfizer.com/investors . Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to register in advance of the conference call.

You can also listen to the conference call by dialing either 800-456-4352 in the United States and Canada or 785-424-1086 outside of the United States and Canada. The passcode is "70409".

The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days.

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 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 .

Disclosure Notice: The webcast may include forward-looking statements about, among other things, Pfizer's oral GLP-1 candidate, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data, revenue contribution, growth, performance, timing of exclusivity and potential benefits, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. A description of these 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 .

The forward-looking statements in the webcast speak only as of the original date of the webcast. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments.

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Pfizer Inc. (NYSE: PFE) announced today that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the company's quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults.

"For years, there has been a need to better address the burden of influenza, despite the use of existing seasonal flu vaccines. Our experience with RNA viruses and mRNA technology has given us an even deeper understanding of the opportunity to potentially provide more efficacious vaccines that could further reduce the yearly rates of the severe outcomes of viral disease like flu, including hospitalization and death," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "We are excited to start the first Phase 3 efficacy study of an mRNA-based influenza vaccine that could potentially deliver an improved flu vaccine to help address the significant burden of this disease."

Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically confer only 40% to 60% protection, with even lower protection in years with poor matching of strains. 2 With circulating influenza strains continually changing, predicting the best match for the next season's vaccine is difficult for global health experts as those strains are chosen more than six months before the start of the influenza season that they target. The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could allow rapid, large-scale manufacturing of vaccines. mRNA-based influenza vaccines require only the genetic sequence of the virus.

Influenza annually causes 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths 3 and about $25 billion in economic loss in the U.S. 4 The impact of flu on racial and ethnic minority groups in the U.S. is even larger. Black Americans are 1.8 times more likely than their white counterparts to be hospitalized for flu while Latino and Indigenous Americans are 1.2 and 1.3 times more likely, respectively. 5 Although vaccination remains one of the best ways to help prevent infection and serious illness, racial and ethnic minority communities in the U.S. continue to be vaccinated at lower rates, 6 and clinical trial enrollment for new or improved vaccines tend to lack diversity. 7 Pfizer made a public commitment to help reduce health disparities through its clinical trials and ensure that Pfizer's clinical study populations fully represent the racial and ethnic diversity of the countries where trials are conducted.

About Pfizer's mRNA-based Flu Vaccine Program

The quadrivalent modRNA vaccine candidate will encode World Health Organization recommended strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines. 8 Additional information about the study can be found at www.clinicaltrials.gov .

This Phase 3 study is informed by previously shared data from the ongoing Phase 2 trial which demonstrates a safety and immunogenicity profile supportive of program advancement and is part of Pfizer's broader influenza vaccine program, focused on leveraging mRNA technology in a vaccine to help protect against the flu. Beyond the modRNA vaccine candidate, Pfizer has ongoing studies exploring more novel mRNA technology like self-amplifying RNA (saRNA), which has the potential to provide added benefit in the future.

In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer's sales.

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 .

The information contained in this release is as of September 14, 2022. 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 single dose quadrivalent modified RNA influenza vaccine candidate, mRNA technology, Pfizer's broader influenza vaccine program, including studies exploring self-amplifying RNA, our commitment to helping reduce health disparities, and manufacturing, including their potential benefits, 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, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim data, including the risk that final results from the ongoing Phase 2 study could differ from the data discussed in this release; 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 biologic license applications may be filed in any jurisdictions for Pfizer's modified RNA influenza vaccine candidate for any potential indications or for any other potential vaccine candidates in Pfizer's influenza vaccine program; 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 Pfizer's modified RNA influenza vaccine candidate or any such other potential vaccine candidates 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 Pfizer's modified RNA influenza vaccine candidate or any such other potential vaccine candidates; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding Pfizer's modified RNA influenza vaccine candidate or any such other potential vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; the impact of COVID-19 on our 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 .

1 Disease Burden of Flu. CDC. Available at https://www.cdc.gov/flu/about/burden/index.html 2 Vaccine Effectiveness: How Well do the Flu Vaccines Work? CDC. Available at https://www.cdc.gov/flu/vaccines-work/vaccineeffect.htm . 3 Disease Burden of Flu. CDC. Available at https://www.cdc.gov/flu/about/burden/index.html 4 Putri et al, Vaccine. 2018 Jun 22;36(27):3960-3966. doi: 10.1016/j.vaccine.2018.05.057 5 Flu Disparities Among Racial and Ethnic Minority Groups. CDC. Available at https://www.cdc.gov/flu/highrisk/disparities-racial-ethnic-minority-groups.html 6 Flu Disparities Among Racial and Ethnic Minority Groups. CDC. Available at https://www.cdc.gov/flu/highrisk/disparities-racial-ethnic-minority-groups.html 7 Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials. JAMA Netw Open. 2021;4(2):e2037640. doi:10.1001/jamanetworkopen.2020.37640 8 Recommended composition of influenza virus vaccines for use in the 2021-2022 northern hemisphere influenza season. World Health Organization. Available at https://www.who.int/publications/i/item/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2021-2022-northern-hemisphere-influenza-season .

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Approval is based on the Phase 3 KEYNOTE-716 Trial

Melanoma is the most serious of all skin cancers, with over 5,000 Canadians diagnosed each year. 1,2

Merck (NYSE: MRK), known as MSD outside the United States and Canada announced that Health Canada has granted approval for KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. 3 This approval is based on the results from the Phase 3 KEYNOTE-716 trial, which demonstrated a statistically significant improvement in recurrence-free survival (RFS). 3

In 2022, an estimated 9,000 Canadians will be diagnosed with melanoma, 4 a form of cancer that takes place when melanocytes, the cells responsible for melanin production, start to grow uncontrollably and develop into a tumour. 5 Although it is the least common of all skin cancers, melanoma is the most serious type and early diagnosis and treatment are critical. 1 , 5

"We welcome the news of a new treatment option for Canadians living with this disease as the incidence of melanoma continues to rise across the country," 6 , 8 said Kathy Barnard , Founder/President of Save Your Skin Foundation. "Having options available right after surgery can help take action against a disease that moves quickly if not caught."

"Melanoma can affect anyone, including children, for whom, although rare, this is the most common amongst pediatric skin cancer types," 7 said Falyn Katz , Executive Director, Melanoma Canada. "Having options available, like this one, can help to make a difference for Canadians facing this particular type of skin cancer, helping them navigate the disease."

About KEYNOTE-716 Trial Health Canada's approval is based on findings from KEYNOTE-716, a multicenter, randomized, double-blind, placebo-controlled clinical trial in patients (n=976) with completely resected stage IIB or IIC melanoma. 3 Only patients that had not been previously treated for melanoma beyond complete surgical resection for their melanoma prior to study entry were included in the trial. 3 Patients were randomized to KEYTRUDA ® 200 mg or the pediatric (≥12 years old) dose of KEYTRUDA ® 2 mg/kg intravenously (up to a maximum of 200 mg) every three weeks (n=487) or placebo (n=489) for up to one year until disease recurrence or unacceptable toxicity. 3 The primary efficacy outcome was investigator-assessed recurrence-free survival (RFS). RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first. 3

The results of KEYNOTE-716 demonstrated a statistically significant improvement in RFS for patients randomized to receive KEYTRUDA ® compared with patients randomized to placebo at the first pre-specified interim analysis. 3 At the time of median follow-up (14.3 months), 11% (n=54/487) of patients who received KEYTRUDA ® had a recurrence or died compared to 17% (n=82/489) of patients who received placebo.

In the study, the safety profile of KEYTRUDA ® was consistent with previously reported studies in patients with solid tumors. The most common treatment-related adverse events (reported in at least 15% of patients) were pruritis, fatigue, diarrhea, and rash. KEYTRUDA ® was discontinued for treatment-related adverse events in 15% of patients in KEYNOTE-716. Refer to the product monograph for complete information. 3

"This approval is important for people living with melanoma and for all of us at Merck," said Marwan Akar , President, and Managing Director, Merck Canada. "With this new indication, KEYTRUDA ® is the first checkpoint inhibitor approved in Canada in the adjuvant space in Stage IIB or IIC melanoma, meaning it can be considered for patients earlier in their journey. We are proud to continue to pursue our passion to save and improve lives as well as reinforce our commitment to finding innovative and effective options for more patients with melanoma."

About Melanoma Melanoma is a form of skin cancer that starts in the melanocyte cells of the skin. 5 Although less common than other forms of skin cancer, melanoma is the most serious type. 5 Incidences of melanoma are higher in men than in women, and the risk tends to increase with age. 8 Major causes include chronic exposure to ultraviolet radiation from sunlight or other artificial sources. 1

About KEYTRUDA ® KEYTRUDA ® is an anti-PD-1 therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. 3 KEYTRUDA ® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. 3

KEYTRUDA ® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma. 3

Our Focus on Cancer Our goal is to translate progressive science into innovative oncology medicines to help people with cancer worldwide. At Merck Canada, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in oncology, and we are accelerating every step in the journey — from lab to clinic — to potentially bring new hope to people with cancer.

About Merck At Merck, known as MSD outside of the United States and Canada , we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information about our operations in Canada , visit www.merck.ca and connect with us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co. Inc., Rahway, NJ , USA This news release of Merck & Co., Inc., Rahway, 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. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. 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 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 2021 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 ).

Please see the product monograph for KEYTRUDA ® (pembrolizumab) at: https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf

1 Canadian Skin Cancer Foundation. Malignant Melanoma. Taken from: https://www.canadianskincancerfoundation.com/skin-cancer/malignant-melanoma/ . Accessed on July 7, 2022. 2 Canadian Skin Cancer Foundation. Skin Cancer. Taken from: https://www.canadianskincancerfoundation.com/skin-cancer/ . Accessed on July 8, 2022. 3 KEYTRUDA ® Product Monograph. Merck Canada Inc. Updated August 18, 2022. Available at: https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf 4 Canadian Cancer Society. Melanoma Skin Cancer Statistics. Taken from: https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/statistics . Accessed on July 7, 2022. 5 Government of Canada . Melanoma Skin Cancer. Taken from: https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/melanoma-skin-cancer.html . Accessed on July 7, 2022. 6 Conte et al. Population-Based Study Detailing Cutaneous Melanoma Incidence and Mortality Trends in Canada. Taken from: https://www.frontiersin.org/articles/10.3389/fmed.2022.830254/full . Accessed on July 7, 2022. 7 St. Jude Children's Research Hospital. Melanoma. Taken from: https://www.stjude.org/disease/melanoma.html . Accessed on July 7, 2022. 8 Canadian Cancer Society. Risk Factors for Melanoma Skin Cancer . Taken from: https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/risks . Accessed on July 7, 2022.

®Merck Sharp & Dohme LLC, used under license.

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Pfizer Inc . (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.

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The Omicron BA.4/BA.5-adapted bivalent vaccine contains 15-µg of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants. Apart from the addition of the mRNA sequence of the BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.

"This recommendation marks another major milestone in the ongoing global fight against COVID-19, bolstering our defenses as we prepare for fall and winter with potential increased exposure to the virus," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will have our bivalent booster options, pending authorization, to facilitate flexible vaccination strategies for maximal coverage across the region."

"If the European Commission follows today's recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant. They aim to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern."

Today's recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance bivalent vaccine candidates, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible. The CHMP recommendation concerning the Omicron BA.4/BA.5 bivalent COVID-19 vaccine is based on data from Pfizer's and BioNTech's Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from the Omicron BA.4/BA.5-adapted bivalent vaccine. Clinical data from a Phase 2/3 trial showed a booster dose of Pfizer and BioNTech's Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies' current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus, while retaining a favorable safety profile.

If an authorization is granted, the Pfizer-BioNTech bivalent Omicron BA.4/BA.5 COVID-19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination campaigns. Local supply may vary based on individual country government requests. In early September, Pfizer and BioNTech were granted a conditional marketing authorization for an Omicron BA.1-adapted bivalent COVID-19 vaccine in the EU. An Omicron-adapted vaccine based on the BA.4/BA.5 subvariant was also authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022. The companies are also planning to file the data with other regulatory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an application for an Omicron-adapted bivalent vaccine in children younger than 12 years of age.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus

COMIRNATY ® (COVID-19 Vaccine, mRNA) INDICATION COMIRNATY ® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

INDICATION Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:

Emergency Use Authorization Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in:

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY ® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine

Tell your vaccination provider about all of your medical conditions, including if you:

Seek medical attention right away if you have any of the following symptoms:

Side effects that have been reported with these vaccines include:

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Click for Fact Sheets and Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5): EUA Fact Sheet for Recipients and Caregivers (12 years of age and older) EUA Fact Sheet for Vaccination Providers (12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older: Recipients and Caregivers Fact Sheet (6 months through 4 years of age) Recipients and Caregivers Fact Sheet (5 through 11 years of age) Recipients and Caregivers Fact Sheet (12 years of age and older) COMIRNATY® Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

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 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 September 12, 2022. 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, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an Omicron-adapted bivalent vaccine candidate, based on the BA.4/BA.5 subvariants, and an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 subvariant,  including a submission pending with EMA for an Omicron-adapted bivalent vaccine candidate, based on the BA.4/BA.5 subvariants, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving 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 preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and 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 and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submissions pending with the EMA for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.4/BA.5 subvariants, and an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 subvariant), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, 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; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; 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; challenges related to public vaccine confidence or awareness; 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 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, bispecific immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com .

BioNTech Forward-looking Statements 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; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an Omicron-adapted bivalent COVID-19 vaccine candidates based on the BA.1 and BA.4/BA.5 subvariants, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants; 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 preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; 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; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTech's trials, business and general operations. 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: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; 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 Quarterly Report as Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, 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.

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Pfizer: Media Relations +1 (212) 733-7410 PfizerMediaRelations@pfizer.com

Investor Relations +1 (212) 733-4848 IR@pfizer.com

BioNTech: Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de

Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074 Investors@biontech.de

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