Swine Flu?

So it's well known that clinical trials of H1N1 Flu (Swine flu as it was formerly known) vaccines have already begun with more to start in the next few months. That is excellent news and it looks like that with the wide variety of vaccine producing companies fighting for a piece of this potential cash cow, there will hopefully be no shortage of vaccine when it comes time to mass produce the shot. As per the usual, I have a couple questions....

1) How can the regulatory approval process be expedited so much that the clinical trials will essentially be ongoing when the vaccine is expected to still be delivered to the general population? I know that for most of the trials, the manufacturing process is very similar/identical to typical seasonal vaccines, but this is still a new strain of virus that we're dealing with here. How can we know that the vaccine will confer enough immunity to protect the population or how can it be ensured that the vaccine is actually safe (see 1976 Swine Flu fiasco)? After all the primary purpose of the clinical trials is to prove and/or verify the safety of pharmaceuticals in human participants. I don't think there is a real solution for this situation other than to put our trust in the scientists charged with developing the H1N1 vaccine because if the standard approval process is applied to this situation, then by the time a successful vaccine is approved for use, the need for it will be long gone.

2) What's going to happen to those participants in the H1N1 trials if vaccination is either mandated by the government or offered in mass quantities? Some of these studies will presumably have a placebo arm, so one cannot argue at all for protecting the scientific integrity of the trial when the health of the population is at stake. If the H1N1 vaccine does become available in mass quantities as expected, then participants of clinical trials will definitely be interested in knowing not only which treatment they received, but also if the actual vaccine would be available to those who received a placebo. One thought is that the short term safety/immunogenicity analysis might be complete by the time large numbers of shots are available (as long as the trial was started in late summer), so it may not impact the trial that much if unblinding occurred in the fall. The other is that a trial may have a safety valve built into it where if the safety and antibody tests are successful after the first dose is completed, then everyone on a placebo would return for the actual study vaccine prior to the end of the trial. If those tests were not successful, then everyone in the trial would receive an approved vaccine from the general public stockpile as a precaution.

This is certainly an interesting situation that is unfolding, but hopefully the powers that be in the realm of clinical research have had the forethought enough to consider all the options for successfully developing a H1N1 jab while at the same time keeping the general health of the participants at the forefront. Additionally I think the public perception of the vaccine development process will hinge on how these trials are handled. It is definitely a unique opportunity for manufacturers to demonstrate that clinical trials can be beneficial to both the participants themselves as well as future populations.