Sanofi: FDA Approves VAXELIS(TM), Sanofi and MSD's Pediatric Hexavalent Combination Vaccine

FDA Approves VAXELIS(TM), Sanofi and MSD's Pediatric Hexavalent Combination Vaccine  

 

PARIS and KENILWORTH, N.J. - December 26, 2018 - The U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate Meningococcal Protein Conjugate and Hepatitis B Recombinant Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). VAXELIS was developed as part of a joint-partnership between Sanofi and MSD (NYSE: MRK), known as Merck inside the United States and Canada.

Sanofi and MSD are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply will not be available in the U.S. prior to 2020. 

Indication for VAXELIS in the US

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).

Select Safety Information for VAXELIS

VAXELIS is contraindicated in children with a history of 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 pertussis-containing vaccine, that is not attributable to another 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.

Vaccination with VAXELIS may not protect all individuals.

Carefully consider benefits and risks before administering VAXELIS to persons with a history of:

  • fever of greater than or equal to 40.5°C  (greater than or equal to 105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting greater than or equal to 3 hours within 48 hours after a previous pertussis-containing vaccine.
  • 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. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on considerations of the individual infant's medical status and the potential benefits and possible risks of vaccination. 

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

The solicited adverse reactions following any dose were irritability (greater than or equal to 55%), crying (greater than or equal to 45%), injection site pain (greater than or equal to 44%), somnolence (greater than or equal to 40%), injection site erythema (greater than or equal to 25%), decreased appetite (greater than or equal to 23%), fever greater than or equal to 38.0°C (greater than or equal to 19%), injection site swelling (greater than or equal to 18%), and vomiting (greater than or equal to 9%).

 Please see the full Prescribing Information for VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate Meningococcal Protein Conjugate and Hepatitis B Recombinant Vaccine).


Dosage and Administration for VAXELIS

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.

About VAXELIS

VAXELIS is the result of the U.S.-based joint-partnershipi established in 1991 between Merck & Co, Inc and Sanofi Pasteur, the vaccines unit of Sanofi, 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 and antigens for H. influenzae type b and hepatitis B from MSD. 

 

About MSD

For more than a century, MSD, a leading global biopharmaceutical company, known as Merck inside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world - including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer's disease and infectious diseases including HIV and Ebola. For more information, visit www.msd.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

 

Media Relations Contact
Nicolas Kressmann
Tel.: +1 732 532 53 18
Nicolas.Kressmann@sanofi.com

 

Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
 

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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
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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 2017 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).


i VAXELIS(TM) is the result of the U.S.-based business joint-partnership (MCM) 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.

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