Merck : and Sanofi to Present Three New Studies Highlighting Combination Pediatric Vaccines at IDWeek 2020

October 20, 2020 6:45 am EDT

KENILWORTH,N.J. and BRIDGEWATER,N.J. - October 14, 2020 - The MSP Vaccine Company, a joint venture between Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines unit of Sanofi, will present new results from three U.S.-based studies at IDWeek 2020, taking place virtually from October 21 to 25. These studies explore combination pediatric vaccines and highlight parents' perceptions of the vaccination schedule and combination vaccines, physicians' attitudes towards combination vaccines, and variations in co-administration of combination and monovalent vaccines.

'By exploring healthcare professional and parental attitudes toward combination vaccines, we are hoping to better understand the potential utilization of combination vaccinations as well as the barriers that may prevent timeliness and completion of the recommended immunization schedule in infants. We believe the healthcare community will find these studies and their results to be very interesting,' says Michelle Goveia, M.D., Executive Director Medical Affairs at Merck.

'These studies provide important insights into perceptions of physicians and parents on the current use of combination vaccines for infants and children and will hopefully help lead to timely and improved vaccination rates. This is important for now, and in the future, as achieving this goal is challenging given the current pandemic,' says Monica Mercer, M.D., Senior Director Scientific and Medical Affairs at Sanofi Pasteur.

The following abstracts are currently available for meeting attendees viewing, and the full presentations (including audio and/or poster PDFs) will become available on October 21, 2020:

• Parental Perceptions of the Childhood Vaccination Schedule and Combination Vaccines in the United States (US) Authors: Tanaz Petigara, Xinyi Ng, Ya-Ting Chen, Jyoti Aggarwal, Jenna Bhaloo, Michelle Goveia, David Johnson, Gary Marshall

Abstract: 1399

Session: Poster Session: Pediatric Vaccines, October 21, 2020

• Physician Attitudes towards Combination Vaccine Use in Infants up to 24 months of age in the United States Authors: Ya-Ting Chen, Xinyi Ng, Tanaz Petigara, Jyoti Aggarwal, Jenna Bhaloo, Michelle Goveia, David Johnson, Gary Marshall

Abstract: 1400

Session: Poster Session: Pediatric Vaccines, October 21, 2020

• Factors Associated with Co-administration of Pentavalent DTaP-IPV/Hib and Monovalent Hepatitis B Vaccine in the United States Authors: Tanaz Petigara, Ya-Ting Chen, Zhiwen Liu, Michelle Goveia, David Johnson, Gary Marshall

Abstract: 1393

Session: Poster Session: Pediatric Vaccines, October 21, 2020

About the MSP Vaccine Company

The MSP Vaccine Company is a U.S.-based joint-partnership between Merck and Sanofi Pasteur, the vaccines unit of Sanofi, and draws upon both companies' experience for the development, manufacturing and marketing of VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).

About VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)

VAXELIS, the first and only hexavalent vaccine in the U.S., was approved by the Food and Drug Administration in December 2018 and includes antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi Pasteur and antigens for H. influenzae type b and hepatitis B from Merck. The vaccine is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Merck and Sanofi are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand. VAXELIS product availability is expected mid-2021.

Important Safety Information

Do not administer VAXELIS to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.

Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine, that is not attributable to another identifiable cause.

Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized.

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

If any of the following events occur after administration of a pertussis vaccine, the decision to administer VAXELIS should be based on careful consideration of potential benefits and possible risks.

• Temperature of ≥40.5°C (≥105°F) within 48 hours, not attributable to another identifiable cause.
• Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours.
• Persistent, inconsolable crying lasting ≥3 hours within 48 hours.
• Seizures with or without fever within 3 days.

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.

If VAXELIS is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on consideration of the infant's medical status and the potential benefits and possible risks of vaccination.

Vaccination with VAXELIS may not protect all individuals.

Urine antigen detection may not have definitive diagnostic value in suspected H. influenzae type b disease following vaccination with VAXELIS.

Rates of adverse reactions varied by number of doses of VAXELIS received. The solicited adverse reactions following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).

About Merck

For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals - including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases - as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. 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 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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Please see the full Prescribing Information for VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) at https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf