I got the right temperature

Over the past couple weeks, there have been 3 notable incidents involving publicly available (and administered) vaccine efficacy being compromised.  In two separate events MedImmune and Sanofi Pasteur recalled hundreds of thousands of H1N1 vaccine because of lower than expected antigen levels while in Ohio, a clinic had to inform over 2000 people that the H1N1 vaccine they received could have been frozen, thus potentially destroying the effectiveness of the shot to protect against swine flu.  While these occurences are likely unrelated, they still represent a serious issue in the vaccine supply chain.  The manufacturers all work as quickly as they can to produce a quality product that will protect patients from influenza, but sometimes things go wrong and in this case they went wrong at the worst possible time.

The Ohio incident could happen in any clinic, but what is bothersome to me is that the vaccination site claims that the vaccine was received in good order and was stored properly, thus indicating that the vaccine was either not packaged properly (eg with too much coolant) or was stored improperly at the distribution center.  The other problems with low antigen levels are a strictly a sponsor problem, but they still shouldn't happen, especially when the public expects a quality vaccine to be produced that is not only safe, but also does what it is supposed to do.  How do clinical trials factor into this?  Well, as anyone involved in trials knows, sites and sponsors spend a large amount of time ensuring that the investigational product is shipped, stored, and administered properly.  This includes strict temperature monitoring requirements in storage and shipping with the potential for significant consequences from sponsors and regulatory agencies if these requirements are not met.  Temperature excursions can even compromise a site's ability to conduct vaccine trials because of the fast paced enrollment requirements of many studies (the mantra for many vaccine studies is: you snooze, you lose.).  Sponsors must also adhere to strict temperature monitoring requirements because the FDA would likely not look favorably upon any submitted data that did not contain sound storage/shipping documentation (don't forget that ICH GCP guidelines and FDA regulations require this).  The same goes for efficacy testing of investigational products, but that does not affect the sites to the same degree as temperature monitoring.

My message here is twofold:

1) Just because sponsors have an approved product, does not mean that a product should be shipped/stored/evaluated with any less diligence than in a clinical trial.  Yes, the FDA won't pull a product off the shelves because of a temperature deviation (maybe a big fine for some egregious error), but public safety is still on the line.  Please note that I'm not saying this happened with the recent issues, but it is a possibility

2) Research sites should look at these events and learn from them.  Take the time to review practices for receiving, storing, and dispensing investigational products so that all federal and sponsor guidelines are met.  Temperature monitoring is a really big deal, and it should never be overlooked or undervalued as somehow less important aspect of clinical trial conduct