Editor's note: This an updated version of the original article which first appeared here in January, 2017.
Sanofi Pasteur announced the release of the new combination vaccine Quadracel, a mixture of DTaP and IPV for use in the 4- to 6-year-old child. This product will compete with GSK’s Kinrex, also a combination of DTaP and IPV with the same age indication.
The press and lawyers like to talk about “off-label” use of FDA-approved medicines and vaccines. The package insert that comes with every medicine and vaccine is rarely read in full by practicing physicians, yet we may be forced to defend ourselves in a court of law explaining why we decided to use the medicine/vaccine in a manner different from what was clearly recommended by the manufacturer. Those recommendations, of course, are usually supported by clinical studies.
Let’s see if you can pick out the off-label use of Quadracel in the following scenario:
A 6-year-old in your office will be going to public school for the first time this year and is only partially vaccinated. He had a fever to 105°F after his 6th-month set of shots and mom decided to defer any further pertussis vaccinations until now. He is otherwise up-to-date including 4 doses of IPV all given before age 4 years. He needs to receive a DTaP and polio today per your state’s requirements and your nurse administers a Quadracel in his left thigh at mom’s request since he is very thin and his deltoid looks too small to her. After the shot is given, the mother mentioned that the child had woken up that morning with a temperature of 101°F and a sore throat.
Which of the following are off-label usages of Quadracel in this child? (More than one answer may be correct.)
Giving it to a child:
A. ... with a fever
B. ... in the thigh instead of the deltoid
C. ... who had been given Pediarix as an infant instead of Pentacel and/or DAPTACEL
D. ... who had already received 4 doses of IPV
E. ... who developed fever of ≥105°F with a previous pertussis vaccine
F. None of the above are off-label uses