In 2015, the Food and Drug Administration licensed an additional combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine (DTaP-IPV) – Quadracel, from Sanofi Pasteur Inc.
Quadracel is now available from Vaccines For Children program. This advisory includes an overview of important information about Quadracel.
Quadracel is the second DTaP-IPV vaccine to be licensed for use for children aged 4 through 6 years in the United States. Quadracel is approved for administration as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series in children aged 4 through 6 years who have received 4 doses of DTaP-IPV-Hib (Pentacel, Sanofi Pasteur) and/or DTaP (DAPTACEL, Sanofi Pasteur) vaccine. Please note that this vaccine is not licensed for use in the primary series, for children younger than 4 years of age or older than 6 years of age.
RECOMMENDATIONS FOR USE
Eligible Groups for Receipt of VFC Supplies of Quadracel
VFC supplies of Quadracel may be given to VFC-eligible children aged 4 years through 6 years. It is approved for use as the fifth dose in the DTaP immunization series and the fourth or fifth dose in the polio immunization series.
Licensed Dosing Schedule
Quadracel is recommended for routine immunization to be given as a booster administered intramuscularly at ages 4 through 6 years. Please note that this vaccine is not licensed for use in the primary series, for children younger than 4 years of age or older than 6 years of age. The Advisory Committee on Immunization Practices (ACIP) recommends that whenever feasible, the same manufacturer’s DTaP brand should be used to complete the series. However, if the previous brand is unavailable or unknown, any brand may be used to complete the series. Do not defer immunization solely to wait for a specific DTaP vaccine brand to be available. Interchangeability of products is allowed and considered valid.
Quadracel should be stored at 2º to 8ºC (36º to 46ºF). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after the expiration date shown on the label. Quadracel is for intramuscular use only.
How Quadracel is supplied
Quadracel is supplied in a single-dose vial in packages of 10 vials (NDC No. 49281-562-10). Quadracel does not contain a preservative. The vial stopper for this product is not made with natural latex rubber.
ORDERING AND BILLING
Quadracel is available for ordering thru the KIDS Plus IIS from today, June 14, 2017. Please contact Christine Wilson (Christine.Wilson@phila.gov or 215-685-6728) or Charma Miller (Charma.Miller@phila.gov or 215-685-6667) if you need assistance adding Quadracel to your next order.
- CVX code: 130
- CPT code: 90696
Vaccine Information Statement (VIS) and fact sheets can be used when administering Quadracel, located at: http://www.cdc.gov/vaccines/pubs/vis/default
Product insert for Quadracel includes additional vaccine information, found at: https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm439856.htm
The VFC resolutions for DTaP- and polio-containing vaccines have been updated and may be found at: https://www.cdc.gov/vaccines/programs/vfc/providers/resolutions.html
Additional information on vaccines and vaccine preventable diseases can be found at: http://www.cdc.gov/vaccines/