Merck : CDC’s ACIP Unanimously Votes to Add Merck and Sanofi’s Pediatric Hexavalent Combination Vaccine to its Preferential Recommendation to Help Prevent Invasive Hib Disease in American Indian and Alaska Native Infants - Merck.com

June 27, 2024 3:35 pm ET

RAHWAY, N.J., and BRIDGEWATER, N.J., June 27, 2024 - the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) unanimously voted to add the pediatric hexavalent combination vaccine VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) to the CDC's preferential recommendation for the vaccination of American Indian and Alaska Native infants based on the Haemophilus influenzae type b (Hib) component. VAXELIS is a combination vaccine available from Merck (NYSE:MRK), known as MSD outside the US and Canada, and Sanofi (NASDAQ:SNY). This provisional recommendation will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services.

VAXELIS is a vaccine indicated in the U.S. for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). VAXELIS is contraindicated in 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 Hib vaccine; anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause; and anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

"We are pleased with the ACIP preferential recommendation for VAXELIS in American Indian and Alaska Native infants," said Thomas Grenier, Head, U.S. Vaccines at Sanofi. "With VAXELIS, the only hexavalent combination vaccine in the U.S., health care providers can help prevent invasive Hib disease in these infants while using fewer injections in the first year of life compared to pentavalent plus monovalent vaccine schedules. Public health is at the heart of everything we do, and this vote for the preferential recommendation furthers our commitment to ensuring all communities have access to needed vaccines."

"American Indian and Alaska Native children have historically had higher rates of invasive Hib disease than the general population, and disease onset often occurs at earlier ages," said Dr. Paula Annunziato, senior vice president, Merck Research Laboratories at Merck. "Until now, only one other available Hib vaccine was preferentially recommended in American Indian and Alaska Native infants. The ACIP vote to include VAXELIS in the preferential recommendation recognizes the data supporting the use of VAXELIS in this population and highlights the importance of research in communities that have a higher risk of certain infectious diseases."

Select 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 Hib 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 ≥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.

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%).

Vaccination with VAXELIS may not protect all individuals.

About VAXELIS

VAXELIS is the only hexavalent combination vaccine approved for use in the U.S. VAXELIS was developed as part of a U.S. based partnership, called MSP Vaccine Company, between Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Sanofi.

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, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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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 and Patient Information at https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_ppi.pdf.

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