Wednesday, June 6, 2012

New Report from HHS on Vaccine Storage

I heard something on the news this morning that I figured would get the anti-vaccine crowd into a fervor of excitement. It is something that they could spin to make it seem like vaccines really are dangerous or that they really don't protect people. Images leapt to mind of writers and commenters alike over at Age of Autism crying out, "See! We're not dumb for refusing vaccines!" Barbara Loe Fisher at the National Vaccine Information Center floated before my eyes, declaiming that vaccines are not safe. I could almost hear Mike Adams or Gary Null snidely claiming that this report proves (proves, I tell you!) that vaccines are ineffective. And so, I figured I should probably take a closer look into it before the wacky misinterpretations and outright lies began to flow.

What brought all this to mind? As reported by ABC news, some doctors may not be storing vaccines properly. The story is based on a new report from the Department of Health and Human Services' Office of Inspector General (OIG), titled Vaccines for Children Program: Vulnerabilities in Vaccine Management (the PDF of the full report can be found here). Briefly, the OIG found that providers of vaccines made available through the CDC's Vaccines for Children Program (VFC) (a program that provides free vaccines to kids whose families might otherwise be unable to afford to get their child immunized) were frequently storing vaccines in inappropriate conditions, potentially reducing their potency and efficacy.

There are a couple ways that I could see this report being spun by opponents of vaccination. Let's take a look...

What did the study find?

Inspectors from OIG selected 45 health providers from the 5 VFC grantees with the highest volume of vaccines ordered in 2010: California, Florida, Georgia, New York and Texas. They found that 34 of the providers stored vaccines at temperatures outside their proper range (below 5°F or between 35°F and 46°F, depending on the vaccine) for at least 5 consecutive hours during the 2-week visit. Additionally, 13 of the providers had expired vaccines (some nearly 2 years past their expiration date) mixed in with non-expired vaccines. Both of these situations could lead to children not being fully protected after receiving an immunization.

Vaccines aren't safe!

Okay, let's get one thing clear, right off the bat. For all intents and purposes, vaccines are safe, meaning that the benefits they provide far, far outweigh any risks they might have. It bears repeating, since anti-vaccine types love to argue against straw men, that although vaccines, like every single thing in life, are not 100% safe, when used as directed, they are one of the safest medical interventions ever developed.

Although some may try to argue that this report shows that vaccines are actually dangerous, the report does nothing of the kind. In the U.S., nearly all vaccines are supplied in sealed, single-dose vials. As long as the seal is intact, storing the vaccine beyond its expiration date or outside of the required storage temperatures will not, as far as I know, lead to an increased risk of injury from the vaccine itself. The reason that improper storage of this manner is an issue is because the risk becomes that children will not be adequately protected from disease. Which brings us to the next issue.

Vaccines aren't effective!, or, We didn't start the outbreak!

As I mentioned, the longer a drug is exposed to temperatures outside the proper storage range, the more of a decline we'll see in its effectiveness. Likewise, the further past a drug's expiration date, the less potent and effective it will be. With vaccines, this means that they do not provide as much of an immune response in the recipient, meaning that they may not develop immunity from the disease the vaccine is meant to protect against.

Folks that want to believe that they don't need to immunize their children against diseases could try to argue that the report's findings show that vaccines really are not effective and that all those outbreaks we keep hearing about aren't their fault. Despite an abundance of ample evidence to the contrary (and I mean lots and lots of evidence to the contrary) that the unvaccinated are at the start of or exacerbate disease outbreaks, they might try to assert that this report somehow vindicates them and their decision not to vaccinate, that it's really bad, ineffective vaccines that are the primary culprits in disease outbreaks. Therefore, they might claim, it doesn't matter whether or not you get vaccinated and that, in fact, it's better not to do so at all.

Don't get me wrong; the findings in the report are certainly a concern. That is not to say, however, that the outbreaks of measles and pertussis we see around the U.S. are due to improperly handled vaccines. As I already pointed out, the evidence shows that, more often than not, outbreaks are started by those who, for whatever reason, are not immunized at all against a disease. While expired or incorrectly stored vaccines can have decreased efficacy, that doesn't mean that they are entirely ineffective nor that they are primary contributors to outbreaks. Minor digressions from proper handling might not have a significant impact on efficacy, while egregious divergence from protocol could render a vaccine dose essentially useless. There is a range of effects; vaccine efficacy is not like a light switch, either on or off. That means that it is better to receive a vaccine, even if it was improperly stored, than to eschew it altogether, since there is still a chance that it will provide some level of protection (again, assuming no other flaws with the vaccine).

The other problem with the anti-vaccine argument above is that this study is quite limited and not necessarily representative of how vaccines are handled in the rest of the VFC program, nor, indeed, how they are handled in total. The authors of the report are very careful to note this limitation:

Our results apply only to our sample of 5 grantees and 45 providers and are not projectable to the population of 61 VFC grantees or approximately 44,000 providers.
Anyone who tries to extrapolate the results of the study to vaccines in general is, therefore, being dishonest.

So what does all this mean?

You might be wondering why this report is important or what impact it will really have. For health providers within the VFC program, it means they really need to take a closer look at how they are doing things and make sure they are complying with all of the requirements of the program as noted in the VFC Operations Guide. In fact, this report serves as a sort of wake up call to all providers of vaccines, whether they are part of the free vaccine program or not. Ensuring the proper storage of vaccines means that not only will the health of recipients be improved, but fewer vaccines will go to waste. Providers owe it to their patients to do their best to ensure they maintain vaccine integrity.

What about parents? I wouldn't recommend asking to see the actual freezers or refrigerators where vaccines are stored in your doctor's office, for a few reasons. First, a single look is essentially useless, since what you see may not be representative of the doctor's practice in general or even representative of the day up to that point. Second, unless you have been properly trained in what to look for, you are unlikely to get any meaningful information from paying a visit to the refrigerator or freezer where the vaccines are stored. Third, you might, unwittingly, do something that could affect the vaccines' quality (i.e., keep your hands to yourself!). Ultimately, asking to actually see the storage conditions is likely going to be a waste of your time and that of your doctor. However, you should feel free to ask questions. If you have any concerns, it is far better to voice them and talk about it than to sit in silence, wondering and coming to potentially erroneous conclusions. Go ahead and ask what the expiration date is on that vaccine your child is about to get.

Above all, get your child vaccinated. Stay up to date with their immunizations, as well as your own.

1 comment:

  1. Hi Todd, Shot of Prevention also has a post on the cold-chain failure issue, Concerns about vaccine storage.

    ReplyDelete

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