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Sanofi and Merck's first and only six-in-one pediatric combination vaccine now available in the United States

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* This combination vaccine may simplify execution and reduce shots needed to complete CDC's recommended child and adolescent immunization schedule

BRIDGEWATER, N.J. and KENILWORTH, N.J., June 1, 2021 /PRNewswire/ -- Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a partnership between Sanofi Pasteur, the global vaccines business unit of Sanofi, and Merck (NYSE: MRK),* known as MSD outside the United States and Canada, is now available in the U.S.

Vaxelis is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. Vaxelis is a vaccine given to protect your child from getting diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, Hib (Haemophilus influenzae type b), and hepatitis B. Your child cannot get any of these diseases from Vaxelis. Vaxelis may not completely protect your child from these diseases. Vaxelis is given to children from 6 weeks through 4 years of age (up to the 5th birthday) and is given as 3 shots, one at 2 months, one at 4 months and one at 6 months of age.

"As the first six-in-one vaccine in the U.S., Vaxelis is now available to help protect infants and children against diseases caused by six infectious agents. We are proud to offer this vaccine to healthcare professionals and the patients they serve," said Elaine O'Hara, Head of Sanofi Pasteur Commercial Operations North America. "Studies have shown that combination vaccines may help reduce the shot burden and improve coverage rates and timeliness."

On February 11, 2021, the U.S. Centers for Disease Control and Prevention's Advisory Committee included Vaxelis as a combination vaccine option in the CDC's recommended Child and Adolescent Immunization Schedule. Vaxelis will be widely available in the U.S. through traditional public and private channels, including directly from Sanofi Pasteur via vaccineshoppe.com.

"Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, Vaxelis represents an important option for healthcare professionals and parents," said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. "Merck and Sanofi have been in contact with the major insurers and the appropriate pricing publications to notify them of the availability of Vaxelis, and we look forward to working with payers and providers to deliver this novel hexavalent vaccine to help protect age-appropriate children. This news should also help to remind providers and parents of the importance of continuing routine vaccinations and recommended well visits."

About Combination Vaccines

Combination vaccines take two or more vaccines that could be given individually and put them into a single shot. Combination vaccines, which have been available for more than 50 years, can help reduce the number of injections needed during a single clinic visit. Public health authorities and leading professional associations generally recommend the use of combination vaccines over separate injections, including the American Academy of Pediatrics, The American Academy of Family Physicians, U.S. Centers for Disease Control and Prevention, The World Health Organization and others.

About Vaxelis

Vaxelis was developed as part of a U.S.-based partnership established in 1991 between Merck and Sanofi Pasteur and draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines. Vaxelis includes ingredients for diphtheria, tetanus (lockjaw), pertussis (whooping cough), and polio from Sanofi Pasteur and ingredients for Hib and hepatitis B from Merck.

Important Safety Information for Vaxelis

Your child should not get Vaxelis, if your child:

  • is allergic to any of the ingredients.

  • had an allergic reaction to any prior shot for diphtheria, tetanus, pertussis, polio, Hib, or hepatitis B.

  • had a serious reaction affecting their brain and nervous system after a whooping cough shot.

  • has a brain and nerve illness that is getting worse.

Before your child gets Vaxelis, tell your healthcare provider if your child:

  • had problems with any shots for these diseases.

  • is taking steroids, getting treatment for cancer, or has another problem that weakens the immune system.

The most common side effects of Vaxelis are:

  • pain, redness, or swelling where the shot was given

  • fever (100.4°F or higher)

  • crying more than usual

  • eating less than usual

  • fussy more than usual

  • sleepy more than usual

  • throwing up

There may be other side effects that are not listed. If your child has any side effects that worry you or seem to get worse, tell your child's healthcare provider right away.

Please read the accompanying Patient Product Information for Vaxelis, and discuss it with your doctor. The physician Prescribing Information also is available.

About Merck

For 130 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 (details with local affiliate)

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

Media Relations Contact

Investor Relations Contacts Paris

Nicolas Kressmann

Eva Schaefer-Jansen

Tel.: +1 (732) 532-5318

Arnaud Delepine

Nicolas.Kressmann@sanofi.com

Nathalie Pham




Investor Relations Contacts North America


Felix Lauscher


Fara Berkowitz


Suzanne Greco




IR main line:


Tel.: +33 (0)1 53 77 45 45


investor.relations@sanofi.com




https://www.sanofi.com/en/investors/contact

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, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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 2020 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).

* Vaxelis™ is the result of the U.S.-based partnership (MSP Vaccine Company) created in 1991 between Merck & Co., Inc., Connaught Laboratories and Pasteur Mérieux Serums & Vaccins, the latter two now known as Sanofi Pasteur, the vaccines unit of Sanofi.

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)

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SOURCE Sanofi