EU Regulators Approve Sixfold Childhood Vaccine (Vaxelis)

European Union (EU) regulators have recommended market approval of a combination bacterial and viral vaccine (Vaxelis, Sanofi Pasteur) that immunizes children against six different disorders.

The new injectable vaccine is indicated for diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type B (HiB) in infants older than 6 weeks and toddlers, according to a news release from the European Medicines Agency (EMA). The vaccine will come in the form of a suspension in prefilled syringes.

In the United States, children can receive a single vaccination shot guarding against diphtheria, tetanus, and pertussis and another shot against four other diseases (measles, mumps, rubella, and varicella), but no childhood vaccine covers as many diseases as Vaxelis, according to immunization expert Paul Offit, MD.

"Six would be the current leader," said Dr Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia in Pennsylvania, in an interview with Medscape Medical News. By protecting against more diseases, he said, the new vaccine reduces the number of needed injections, and in turn improves parental compliance.

The EMA described the benefits of Vaxelis as "its ability to elicit immune responses to each antigen, which are above predefined thresholds of protection and non-inferior to immune responses of a comparator vaccine after the booster dose."

Decreased appetite, somnolence, vomiting, crying and irritability, fever, and injection site reactions are the most common adverse events.

The recommendation to allow the new vaccine on the EU market came from the EMA's Committee for Medicinal Products for Human Use. It now goes to the European Commission, the EU's executive branch, for final approval.


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EU Regulators Approve Sixfold Childhood Vaccine (Vaxelis). Medscape.

December 18, 2015

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