While I generally agree with the author's stance favoring development of new vaccine technolgies, I am frankly surprised by a number of his positions / recommendations vis a vis the current H1N1 pandemic. Specifically the following passages give me pause:

There was another alternative that was not considered here in the States. Baxter Pharmaceuticals' H1N1 vaccine Celvapan utilizes the much speedier process of culturing mammalian (monkey) cells rather than hen eggs. Despite some early concerns that this vaccine could provoke antibodies against our own cells, vaccine trials demonstrated the vaccine to be safe in clinical trials, and it has been approved for use in Europe, where it will be given to millions of people, particularly those with severe egg allergies. But here in the United States, the FDA won't dare fast-track a new, useful vaccine like Celvapan, even in a pandemic, for fear of public criticism.

I am not sure whether this candidate was considered here in the States or not. If it was, I think it was dismissed because to date the combined clinical experience with Celvapan vaccines is on the order of 10,000 subjects or less. The majority of that is with the H5N1 avian influenza variant, which may or may not reflect the safety profile of the H1N1 swine influenza version. To date less than 2,000 subjects have been enrolled in clinical studies of H1N1 Celvapan. In light of the 1976 pandemic vaccine experience where a rare side effect led to a cessation of immunization and loss of public trust I am sure that there was extreme reticence on the part of the public health establishment to risk the use of a product that has such a small safety database. Moreover, it should be noted that the product has never been demonstrated to decrease the incidence of influenza. It is presumed efficacious because the immunological responses observed following administration are believed to correlate with protection. However, prior to approving novel influenza vaccine technologies (e.g. culture based vaccines like Celvapan) the US FDA has typcially required a true efficacy study demonstrating not only immune response, but disease prevention.

I think the product can be justified for use in those who are contraindicated for any of the conventional vaccines (e.g. people with egg allergies) but broad population use is premature.

Going forward, the first step is to re-educate the public about which flu to be concerned about before more people die or are hospitalized unnecessarily. More than 20,000 have been hospitalized so far from H1N1, with close to 4,000 unconfirmed deaths. We must realize that the seasonal flu vaccine is currently useless or, worse, a diversion in the way of getting the H1N1 vaccine.

Although currently seasonal influenza is not an issue, that is not necessarily a static condition. The author may be correct that H1N1 will crowd out the predicted seasonal variants or he may be wrong - we will not know for a few months. While predicting how an influenza season will play out is notoriously difficult hindsight is always 20/20. In addition the author ignores a couple of important factors. First, we do not know if the seasonal strains would have been more prevalent absent the use of the vaccine and second that there may be some degree of cross protection from the seasonal vaccine that reduces disease severity. Given that product of the seasonal vaccine was well on its way in April when the H1N1 virus was identified, public health officials were certainly justified in proceeding with manufacture.

Second, we must put pressure on the FDA to approve the safe and effective Baxter vaccine, and the CDC and HHS should put in an order for millions of additional doses immediately. Simonsen told me that cell-culture flu vaccines are a high priority for the NIH but that the "regulatory world may not be on the same page."

I am quite suprised that the author is recommending this. Given that the current H1N1 on what basis could you justify ordering "millions of doses" of a product tested in less than 10,000 subjects when supplies of the conventional vaccine are now becoming available? How long would it take to fulfill the order? Does the author not understand that public trust of the medical establishment is the foundation on which acceptance of immunization programs is based? Does he understand the degree of blowback that would result if use the product proved to have side effects that were not detectable in the initial few thousand subjects tested? The "regulatory world" recognizes that the implementation of novel technolgies needs to be firmly rationalized by cost benefit analysis and right now that clearly favors use of the conventional vaccine.

Third, our public health officials should encourage the use of the inhaled Medimmune FluMist vaccine, which is safe for everyone healthy between the ages of 2 and 50. Medimmune has had a very good yield, and millions of more doses can be made in a hurry. Our national vaccine program must be responsive to a pandemic that has now been declared a national emergency. We must be pro-active, and we must be fearless.

I think the Flumist product is a good one for children (my son will be getting it next week). It has been through extensive clinical trials. However, Medimmune does not have the capacity to produce the quantities of vaccine that are required for the number of doses the U.S. requires. In addition, there is compelling evidence that Flumist is significantly less effective in adult populations than the conventional egg based vaccines. See for example N Engl J Med. 2009 Sep 24;361(13):1260-7. Unanticipated results like these provide strong ammunition for those who say that the "tried and true" methods should be preferred unless there are medical needs not addressed by current techniques or until there is sufficient data available to justify transitioning to the newer technologies.