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

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 5^th 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

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^* 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)

SOURCE Sanofi