Flu vaccine update

Given reports circulating today about the JAMA article "proving" flu vaccine safety in young children, and with the flu season upon us, I thought it was time for a flu vaccine update.

I’ve expressed my frustration about the flu vaccine supply issues previously, but we’re in worse shape than I thought.  Previously my rants were theoretical, but now that flu season is here, I’m convinced we’re in trouble.  As of last week, the CDC is reporting flu "activity" in seven states, including Florida, Texas, and California.  Media outlets all over are reporting that flu vaccine is plentiful for all comers.  The shortages of yesteryear are old news, we’re led to believe.  Recommendations are replayed over and over for parents to immunize their children, especially those between 6 months and 5 years old.  The State of New Jersey (my home state – and I’m usually proud of it) has decided in its infinite wisdom to use bird-flu hysteria to promote its "Get flu ready, NJ" campaign.  You have to read the whole press release to get the flavor – there are multiple Avian flu references, and the last time I checked, the flu vaccine doesn’t work against avian flu.  Oh yeah, and there have been no Avian flu cases in the U.S. to date.  Ok, so we’ve scared people into doctor’s offices, demanding their flu shot NOW.

Yet in my office, as in many pediatric practices across the country, flu vaccine is scarce.  After creating parental hysteria yet again about the universal need to get a vaccine that is of questionable efficacy for kids under two, and that for much of the supply still contains thimerosal, media sources are finally catching up to the distribution debacle.

With impeccable timing, the Journal of the American Medical Association (JAMA) with its rich recent history of conflict-of-interest debate, today releases an article titled "Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old" (Hambidge SJ et al, JAMA 2006;296:1990-1997).  The good news?  45,000 tots under two were relatively unharmed after observation for six weeks after vaccination.  The bad?  Well, six weeks is not exactly a long-term observation period.  And if we’re immunizing millions of kids in the U.S. alone, studying only 45,000 may not detect a significant side effect.  Oh, and back to that conflict of interest stuff that editor-in-chief Dr. Catherine DeAngelis is supposedly cracking down on – nine of the study’s 19 co-authors reported financial ties to vaccine manufacturers.  No wonder the public trust in the medical establishment is eroding.

Here’s the real story.  Sanofi Pasteur, who makes the only truly thimerosal-free flu shots for kids (0.25 ml doses for those under 3 years old, and 0.5ml doses for those older), botched its pre-order process months ago, and still to this day cannot figure out who ordered how many doses of what type of vaccine.  They claim they are shipping in allotments, and we’ve received some of our 0.25 ml supply, but none of the 0.5 ml supply.  "Will we get it? When will we get it?"  We’ve asked several company representatives and received different answers each time.  "Yes" or "Probably" is the common first answer, and anywhere from "Tomorrow" to "Sometime in December" is the second.  That give me lots of confidence in reassuring my patients (many with children at high risk, with chronic immune-related illnesses) that we’ll be able to protect their children.  Fortunately, MedImmune makes a terrific nasal flu vaccine, FluMist, and supply is predictable and timely.  Unfortunately, you have to be over 5 years old and have no respiratory or immune problem (i.e asthma – our biggest population of high-risk kids) in order to get it.  And some insurances cover it, and others do not.  What a mess.

So here’s what you’re faced with if you’re a parent of a high-risk 4 year-old.  Wait for the thimerosal-free shot – if you dare.  Or give a vaccine with 25 mcg thimerosal per dose; by our own EPA’s estimate, not recommended unless you weigh over 250 kilograms (that’s over 500 pounds for the metrically-challenged.)  We can get into a debate about types of mercury – but since no basic science safety trials of ethyl mercury (thimerosal) in children have ever been performed, we’ll just have to guess based on methylmercury data.  I’m not making this stuff up.

Oh wait- if you live in California or other states where thimerosal thankfully cannot be given to children, you have no other option.  Just wait.  And wait.