Merck and Sanofi’s First and Only Six-in-One Pediatric Combination Vaccine Now Available in the United States

This Combination Vaccine May Simplify Execution and Reduce Shots Needed to Complete CDC’s Recommended Child and Adolescent Immunization Schedule

KENILWORTH, N.J. & BRIDGEWATER, N.J.--(BUSINESS WIRE)--$MRK #MRK--VAXELIS™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a U.S.-based partnership between Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Sanofi Pasteur, the global vaccines business unit of Sanofi, is now available in the U.S. VAXELIS is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. indicated for active immunization to help 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 5^th birthday).

“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 age-appropriate children. This news should also help to remind providers and parents of the importance of continuing routine vaccinations and recommended well visits.”

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.

“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 increase vaccination compliance and reduce disease burden by improving vaccine timeliness and coverage rates.

Do not administer VAXELIS to anyone with a history of severe allergic reaction 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, anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause, or anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

About Combination Vaccines

Combination vaccines take two or more vaccines that could be given individually and put them into a single shot. Combination vaccines have been a significant catalyst for change for the healthcare industry since their introduction more than 50 years ago. Public health authorities and leading professional associations generally recommend the use of combination vaccines over separate injections, when appropriate, 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 antigens for diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis from Sanofi Pasteur and antigens for Haemophilus influenzae type b and hepatitis B from Merck.

VAXELIS is a vaccine 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).

Important Safety Information for VAXELIS

Do not administer VAXELIS to anyone with a history of severe allergic reaction 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 within 7 days of a pertussis-containing vaccine with no other identifiable cause.

Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Carefully consider benefits and risks before administering VAXELIS to persons with a history of fever of ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.

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.

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.

Vaccination with VAXELIS may not protect all individuals.

The solicited adverse reactions 0-5 days 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%).

The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.

A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.

Please see 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 and Patient Information for VAXELIS™ at https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_ppi.pdf.

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

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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Sanofi Forward-Looking Statements

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