FDA Approves New Hexavalent Vaccine (Vaxelis) for Children

The US Food and Drug Administration (FDA)  has approved the new vaccine (Vaxelis) that will immunize children against six diseases, the French pharmaceutical lab said on Wednesday.

Sanofi has developed, together with Merck, the new vaccine called Vaxelis.

Vaxelis uses

It has been developed for children from 6 weeks to 4 years of age and is designed to prevent them from contracting the following diseases

  • Diphtheria,
  • Tetanus,
  • Pertussis
  • Polio,
  • Hepatitis B and
  • Invasive diseases caused haemophilus influenza type B.

Sanofi and Merck are now working on the manufacture and supply of Vaxelis in order to make it available on the market by 2020 or later.

The companies developed through a partnership between Sanofi and Merck are working to maximize vaccine production to create a sustainable supply that meets the expected demand. However, a commercial offer is not expected before 2020.


  • It is contraindicated in children with a history of anaphylaxis to any component of the vaccine
  • Physicians are advised not to administer Vaxelis to persons with a history of encephalopathy within 7 days of a pertussis vaccine,
  • The vaccine should not be administered to people with a history of progressive neurological impairment until a treatment regimen has been established and the condition has stabilized.
  • This vaccine should not be used in Seizures within 3 days after a previous pertussis-containing vaccine.

Vaxelis Adverse Reactions

The adverse reactions 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%).

Vaxelis Dose

The vaccine is approved for serial use of 3 doses consisting of a 0.5 ml intramuscular injection administered at 2, 4 and 6 months of age. This vaccine is not a series of primary vaccines against pertussis.


Combined vaccines like vaxelis provide a solution to the problem of increasing the number of injections by visiting a single clinic, the American Academy of Pediatrics said in a statement.

It is a hexavalent vaccine for active vaccination against diphtheria, tetanus, whooping cough, poliomyelitis, hepatitis B and invasive diseases caused by Haemophilus influenzae type b.

Vaxelis, approved by the FDA for the serial use of 3 doses, consists of an intramuscular injection of 0.5 ml at the age of 2, 4 and 6 months.

It was developed as part of a partnership between Sanofi and Merck (MSD). Vaxelis includes antigens for diphtheria, tetanus, pertussis and polio from Sanofi, as well as antigens for H. influenzae type B and hepatitis B from Merck.

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