FDA News

FDA approves hexavalent combination vaccine for young children

Vaxelis, a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, hepatitis B and invasive disease caused by Haemophilus influenzae type B, has been approved by the FDA for use in children aged 6 weeks to 4 years.

According to a release issued by Sanofi Pasteur and Merck, the intramuscular vaccine should be given in a three-dose series at 2, 4 and 6 months. The manufacturers stated that the series does not complete primary immunization against pertussis and that an additional pertussis-containing vaccine is needed.

Children vaccinated with Vaxelis may experience adverse events, including irritability (55% or more), crying (45%), injection site pain (44%), somnolence (40%), erythema at injection site (25%), decreased appetite (23%), fever (temperature 38°C or 100.4F [19%]), swelling at injection site (18%) and vomiting (9%).

“Sanofi and [Merck] are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated U.S. demand,” a Sanofi spokesperson told Infectious Diseases in Children. “Commercial supply will not be available prior to 2020.” – by Katherine Bortz

Disclosure: Vaxelis was developed through a U.S.-based joint partnership between Sanofi and Merck.

Vaxelis, a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, hepatitis B and invasive disease caused by Haemophilus influenzae type B, has been approved by the FDA for use in children aged 6 weeks to 4 years.

According to a release issued by Sanofi Pasteur and Merck, the intramuscular vaccine should be given in a three-dose series at 2, 4 and 6 months. The manufacturers stated that the series does not complete primary immunization against pertussis and that an additional pertussis-containing vaccine is needed.

Children vaccinated with Vaxelis may experience adverse events, including irritability (55% or more), crying (45%), injection site pain (44%), somnolence (40%), erythema at injection site (25%), decreased appetite (23%), fever (temperature 38°C or 100.4F [19%]), swelling at injection site (18%) and vomiting (9%).

“Sanofi and [Merck] are working to maximize production of Vaxelis to allow for a sustainable supply to meet anticipated U.S. demand,” a Sanofi spokesperson told Infectious Diseases in Children. “Commercial supply will not be available prior to 2020.” – by Katherine Bortz

Disclosure: Vaxelis was developed through a U.S.-based joint partnership between Sanofi and Merck.