Thursday, November 19, 2009


From a policy perspective, three new events have emerged with respect to the public response to the H1N1 swine flu. One is the realization that public health officials have been under-reporting the number of infected people, hospitalizations and deaths. This has since been corrected so that it is now estimated that 22 million people have thus far contracted the H1N1 swine flu. This contracting of data has also resulted in the CDC reporting that they now people that we have had 540 pediatric deaths (i.e. youth 18 years and younger) and 4000 overall deaths from the H1N1 swine flu thus far. This is a wake-up call - since it is a significantly larger number of deaths and infected persons than had previously been reported.

The second policy event that has emerged is the realization that significantly less than the projected amount of H1N1 swine flu vaccine has been produced and distributed. Because what has been distributed as been freely distributed to almost anyone who wanted it given the assumption that there would be an ample supply, the result is that many (if not most) of the people at the highest risk of death from the H1N1 swine flu have not been able to receive the vaccine as promised. This is the opposite experience in Europe and other developed countries where the flu vaccine is being distributed through appointments so that all individuals at the highest risk of death receive the vaccine first. In the U.S., however, basically no priority has been given to those individuals at the highest risk - leaving high risk individuals to do what they can to find the vaccine given the chaotic distribution system in the U.S. and the resultant long lines where often more people are turned away than receive the vaccine.

The third policy even that has emerged is a realization that the U.S. errored in not developing U.S. manufacturing capacity, and instead relying upon foreign company suppliers. In this regard, because the U.S. had been reduced to only one licensed flu vaccine manufacturer in the United States when the H1N1 swine flu pandemic hit - the U.S. turned to overseas manufacturers to provide the additional required supply of the H1N1 swine fluvaccine. Unfortunately, signing up new manufacturers led to unexpected production problems. Also, the use of overseas manufacturers led to the unexpected problem of Canada and Australia block the shipment of the contracted for vaccines to the U.S. until such time as the total vaccine demand for their own countries could be filled. All of this led to the current crisis where the federal govenment expected to deliver 120 million doses of the H1N1 swine flu vaccine by mid-October, but was only able to deliver 28 million doses by mid-October.

Together, these new policy issues raise significant questions as to what should be done to correct this problem of not enough vaccine being available and of the fact that the highest risk individuals are not being given priority, and thus are not receiving the vaccine (which predictably will lead to a higher death rate than what otherwise would be the case). All of these new policy issues also raise the question as to how the government should respond if the high number of H1N1 swine flu hospitalizations and deaths continue - or even increase - as we get into December and January. There are also two even more frightening possibilties. One is that the H1N1 swine flu mutates, so that we need to produce a new vaccine - or that experience shows that a second shot needs to be given. But the even more frightening possibilitiy is the potential for the H1N1 swine flu to mutate and merge with the Avian flu virus, since the H1N1 swine flu actually already contains elements from the Avian flu virus. This would be a disastrous scenario since the current death rate for the Avian flu virus is that 70 percent of the people who contract it die from it.

Following are the companies currently licensed by the U.S. to produce the H1N1 swine flu vaccine for distribution in the U.S.:

(1) Sanofi Pasteur is located in the United States in Pennsylvania. It has produced 50 percent of the H1N1 swine flu vaccine thus far distributed in the U.S. It is the great success story of the vaccine suppliers for the U.S.

(2) CSL is located in Australia. It "was" expected to be one of the primary suppliers of the H1N1 swine flu vaccine to the U.S., but was blocked by the government of Austrialia from shipping any vaccine to the U.S. until all of the demand in Australia was satisfied.

(3) GlaxoSmithKline is another company contracted to supply the vaccine and is located in Canada. Unfortunately, the Canada govenment blocked it from supplying any of its H1N1 swine flu vaccine to the American market until demand in Canada was fully satisfied.

(4) Novartis Vaccines is located in Liverpool, England. It was also expected to be one of the primary supplies of the H1N1 swine flu vaccine to the U.S., but encountered production problems. It nevertheless has shipped 18 million vaccine doses to the U.S.

(5) Medimmune is the principal producer of the nasal mist form of the vaccine and has shipped all of the 42 million doses of the nasal mist vaccine it was contracted to supply - but a significant amount of the supplies shipped to the U.S. have yet to be distributed.
One additional issue that has arisen is the fact that all other industrialized countries have contracted for an "adjuvanted" version of the H1N1 swine flu vaccine. This allows for a quadruple the amount of vaccine that can be produced and has the added benefit of potentially providing for protection in case the H1N1 swine flu virus mutates. Even though the use of the adjuvant was approved for use in Europe as far back as 1999, the FDA in the U.S. has yet to license its use in the U.S. Ironically, the U.S. has purchased a large supply of the adjuvant that it is not using - but is keeping in storage in Louisville, Kentucky. Given the shortage of vaccine in the U.S. and the unexected number of people infected this early in the season with the H1N1 swine flu, many urge that the U.S. shift to the use of an adjuvant vaccine.