New Rules for Expedited Flu Vaccine Licensing

CNN is reporting that on Thursday the FDA will announce new draft rules intended to accelerate the approval of new flu vaccines.  This is excellent news.  According to the story, "Eventually, the guidelines could knock one to two years off the time it takes to develop and license a new flu vaccine."

Here is all the good stuff:

...The guidelines make clear there are a variety of approaches to creating vaccines to fight the next pandemic.

The guidelines allow for emergency approval if a completely new super-strain of flu suddenly appears. Or, manufacturers could systematically create and stockpile a library of vaccines against brewing new strains.

They even allow for the possibility of one day vaccinating people against a potential future pandemic strain at the same time they get their regular winter flu shot.

The last point is interesting, because it is an example of explicitly trying to get out in front of a pandemic strain before it appears.  The biggest reason H5N1 is a threat is that humans have never been exposed to a virus like it.  We are "immune naive", which means we have no preexisting antibodies or lymphocytes primed to respond to this particular virus.

Additional interesting policy tidbits:

In the case of a previously approved flu vaccine, manufacturers could tweak the vaccine for use against a new flu strain without having to seek a new license from the FDA, according to the draft documents.

Additionally, a manufacturer could receive "accelerated approval" for a new flu vaccine by performing studies showing that recipients experienced a surge in protective immune-system cells.

This is all good stuff, and comes not a moment too soon.  Okay, it comes a couple of years late.  We're way behind in preparing technological responses either to large outbreaks of infectious disease or to bioterror attacks.  The draft rules are putatively open for comment for 90 days -- if the rules turn out to be as well constructed as CNN is reporting, then everyone should enthusiastically support these proposed changes.

I'll post more when the official documents are released.