DR. BOBS DAILY: ANOTHER VACCINE SOON TO BE ADDED TO THE SCHEDULE? Dont get too excited yet. It isnt officially added to the schedule. But Im guessing it will be sometime this year or next. Its called Trumenba, and is made by Wyeth Pharmaceuticals. Its designed to prevent meningococcal group B disease. This disease is the type of meningitis that you hear about going around in colleges. Youve probably heard about a few outbreaks at universities over the past few years. Each outbreak was very small (10 to 20 people), with only one fatality in two of the outbreaks. College outbreaks are only a very small percentage of this disease. Virtually all cases simply occur randomly and sporadically one-case-at-a-time. The peak season is December and January, but it can occur year-round. We already have one meningococcal vaccine on the schedule at ages 12 and 17 to help prevent four other strains of this disease (groups A, C, Y, and W-135). This new vaccine will add coverage for group B, which happens to be the most common strain and the one for which a vaccine is most needed. It is approved as a three-dose series between ages 10 and 25. If added to the schedule, it will likely be recommended around age 12. A little history on meningococcal disease (lets just called it MC disease so you can stop trying to figure out how to pronounce it; but if you want to sound smart, its men-in-joe-kock-al). There used to be about 3000 cases of this disease in the U.S. every year, and most of these occurred during infancy. Researchers never could get a vaccine to work for young kids, so we never had one. About 250 of these yearly cases occurred in older teens/college kids, so the teenage MC vaccine was born about 10 years ago to reduce the risk for these older kids. Interestingly, over the past 5 years MC disease has dropped considerably. There are now fewer than 1000 cases every year: in 2012 there were only 500 reported cases, 160 of them being group B. This disease is fatal in about 10% of children, and for teens its about a 20% fatality. Some survivors will suffer permanent complications, like organ failure or loss of a limb from infection. Its probably the most potentially-severe disease that we vaccinate against. It is spread like the common cold or flu. It is treatable with antibiotics, and those who are exposed to a sick person can take antibiotics to prevent the disease from taking hold. A major concern about the vaccine is this: it was fast-tracked through the FDA. This means that it didnt go through the usual extensive research and scrutiny that most vaccines do before they are approved. It was actually tested and approved in well under six months, whereas most will required several years. The recent outbreaks and fatalities prompted the rush for approval, although the disease isnt any more common than it used to be. In fact, its less common. But the FDA allows for a fast-track approach whenever theres a major threat from a very serious disease. Ebola vaccine will probably be fast-tracked as well. The last vaccine to be fast-tracked was HPV because, well, you know, suddenly HPV was a huge threat that was suddenly breaking out everywhere and we had to fast-track a vaccine to put a stop to it. Anyway, the new MC vaccine was tested for efficacy in 2800 teens, and it was found to work (produce protective antibodies) in 82% of test subjects, although we dont yet know how well this protection works in real-life exposure scenarios. Safety testing was performed on 4500 people, and the most commonly-reported effects were pain, swelling, and flu-like symptoms - about what youd expect. So, for now theres nothing to do because the CDC and AAP havent yet decided how to work it into the schedule. I will let you know if and when this is officially added to the schedule, and I will offer my opinion on how to work it into your plans. The vaccine has been made available on University campuses where outbreaks are occurring, but it isnt available to the general public. As with all new vaccines, however, I usually wait a couple years before I begin recommending it or using it in my office. So, I will let you know. For now, nothing to do. Dr. Bob
Posted on: Thu, 30 Oct 2014 15:46:32 +0000
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