Co-authored by Stephen Morrison and Phillip Nieburg, CSIS
The unusual clinical characteristics of the H1N1 virus and the uncertainties about H1N1 vaccine production have brought home powerfully the unpredictability -- the “slippery” nature -- of influenza virus and of the vaccines designed to reduce its disease burden. And it has revealed the complexities and risks in making numerical projections, amid great uncertainty, and communicating them effectively to the American people.
As of October 17, the Centers for Disease Control and Prevention (CDC) have reported that more than 1,000 people in the U.S., almost 100 of them children have died from H1N1 (swine) flu virus. The number may be higher, but not all flu-associated deaths were tested for specific influenza type. Hospitals do not test every flu case, so there isn't an accurate count of the total number of infections. CDC Director Thomas Frieden estimated that many millions have already had H1N1 and over 20,000 have been hospitalized.
The President’s October 23rd Declaration of a National Emergency because of the H1N1 epidemic has raised both anxieties and additional questions about H1N1 influenza and about the H1N1 vaccine intended to protect us.
A formal declaration of a National Emergency provides Department of Health and Human Services Secretary Sebelius with the legal authority to relax federal administrative requirements so that hospitals facing large – and potentially overwhelming - numbers of swine flu patients may use alternative facilities for treating such patients or could more easily transfer them to other, less overburdened, hospitals.
This anticipatory step is reasonable, given the real possibility of an enlarged crisis, although it would be preferable to handle as a strictly administrative measure, free of the drama and anxiety created by the President directly engaging to declare an emergency. It is worth reexamining the legal requirements for a purely administrative declaration along with the strategy to communicate that decision.
The drama of that National Emergency announcement and of the growing H1N1 death and severe illness toll has been compounded by the inability of many people, including those in high-risk categories, to gain access to the H1N1 vaccine that they had been told would be available by now. The announcement earlier this month of significant delays in production – and resulting shortfalls, however temporary - of H1N1 (swine) influenza vaccine were frustrating and alarming to those who had been convinced by effective public health messages and by individual providers to believe that the disease risk was severe enough that they should be immunized soon. Communications, public expectations, and production shortfalls were in collision, generating considerable confusion and anxiety.
The current situation has arisen as a result of several technical glitches in vaccine production combined with over-optimism among those responsible for projecting vaccine production and availability.
The major technical glitch in recent months is that the virus being used to produce the H1N1 vaccine has not been multiplying as quickly as expected in the chicken eggs used to incubate it. Since far less H1N1 virus than expected was becoming available to put into the vaccines, fewer vaccine doses could be produced.
Because the test material used to measure the amount of virus production has itself to be manufactured from scratch, using the same H1N1 flu virus stocks, it was only after that test material became available last month that the true magnitude of the shortfall became evident.
The United States has not experienced this level of public concern and uncertainty about influenza since 1976, when swine flu was last considered to be a major threat. Although influenza disease surveillance, anti-viral drugs and clinical care of ill people have all improved over the intervening 33 years, we still rely on an antiquated system of egg-based influenza vaccine production, with all of its uncertainties. A future policy priority should be accelerating technological improvements in vaccine production.
To learn more about H1N1's classification as a 'slippery disease' and the government's management of the 1976 swine flu scare, see Harvey Fineberg and Richard Neustadt's 1976 book The Swine Flu Affair: Decision-Making on a Slippery Disease.
Image courtesy Samantha Celera