Spring has arrived in many parts of the country and the sound of a baseball hitting a bat has joined the chirping birds. Imagine being a base runner standing on second base. The first base coach is giving you the signal to steal third base. The third base coach, however, is giving you the signal to stay put on second. The team owner is watching you from his box and you are not sure if you will get in more trouble with him if you attempt or don’t attempt a steal.
This scenario should sound familiar to pediatricians who give vaccines.
The package insert (PI), regulated by the FDA and based on the clinical trials leading to FDA approval, gives one set of rules for vaccine administration. The Advisory Committee on Immunization Practices (ACIP) recommends vaccine policies for the CDC that federal agencies have to follow (eg, vaccines paid for by Medicaid and Medicare). Most commercial insurance companies will pay for vaccines recommended by the ACIP. These ACIP vaccine rules often vary slightly from what is in the PI and are usually written in an attempt to simplify the schedule when there are competing vaccines; ACIP rules also are sometimes based more on expert opinion than hard science.
In the wings are the plaintiff’s lawyers (comparable to the baseball team owner) who could punish an MD by dragging him or her into court should an adverse event occur when a vaccine is given per the ACIP recommendations but fall outside what the PI recommends.
Glaxo, Merck, the ACIP, and You
For example, Glaxo and Merck both produce a rotavirus vaccine, Rotarix and RotaTeq, respectively. The PI for RotaTeq states that the first dose should be given before 13 weeks of age and the last dose before 32 weeks of age. The current Rotarix PI does not have a limitation on how late the first dose can be administered but says that no dose should be given after 24 weeks of age.
The ACIP, in an attempt to simplify things for the beleaguered pediatrician trying to remember all these different dates, has the same rules for both vaccines: first dose should be given before 15 weeks and last dose before 8 months. But, if you give the final dose of Rotarix at 30 weeks of age, it is officially an “off-label” use, which could be brought up at a malpractice trial by the plaintiffs. Of course, your defense lawyer will have expert witnesses explain how ACIP recommendations are within the standard of care but it can be confusing to a jury of laypersons.
Let’s see how you do with a couple of questions on the indications for the new 9-valent Gardasil, which also have the FDA telling us one thing and the ACIP something else.
Answer: B Females ages 9 to 26 and males 9 to 15
This guidance differs from that in the PI for the quadravalent Gardasil, which is approved for males and females aged 9 to 26. For both of these Gardasil vaccines, routine age for administering the first dose is 11 to 12 years. So, if you are going to switch over to the 9-valent vaccine, as you should since it works better, and you want to stay “on-label,” you may want to give those 15-year-old boys who have not received Gardasil yet a call and get them in the office.