The Commission on Smart Global Health Policy

Stephen Morrison and Phillip Nieburg of CSIS recently co-authored a piece on uncertainties surrounding the H1N1 vaccine supply and President Obama’s decision to declare H1N1 a national emergency. The post produced many questions about vaccines and highlighted much of the confusion surrounding the flurry of information from health experts, government agencies and various news outlets.

Comment from the blog:

Schools are closing, parents are terrified, and much of this is being fueled by the fact the quality of reporting on 24 hour news stations is alarmist and detached from reality. Interviews are being given to random opinionated individuals with an "MD" by their name in favor of credited public health and influenza experts.

Should we be concerned that we aren't even trying to effectively track this disease? What you're saying is that numerical projections are completely bogus so any number spewed out to the population, in the thousands or millions, is a shot in the dark and heavily subject to political manipulation and sensational media. If hospitals aren't even testing for H1N1 on a large scale, how does Thomas Frieden presume to make any estimation at all?

Meanwhile, the Obama Administration will cover its tracks by declaring a national emergency because they are fearful of being viewed as unresponsive in an increasingly treacherous political climate of declining public support and accusations of ineffectiveness.

Americans are just looking for honesty. What are the actual projections for this disease? How bad is it really? Should parents be pulling their children out of school in droves? Should we be investing in protective masks for our families? Beyond washing our hands and avoiding public places while sick, are there any other preventative measures U.S. citizens can take?

Response from Phillip Nieburg:

The commenter is correct about the sometimes unhelpful quality of media reporting about H1N1, including the comments of people with limited understanding of disease surveillance and of public health in general.

Regarding the decision of the Centers for Disease Control and Prevention (CDC) to stop trying to count every person infected with H1N1, influenza is a disease with a wide spectrum of severity, from mild “cold” symptoms that do not include fever to overwhelming pneumonia and death. Once the existence of an influenza epidemic has been confirmed, as it has in this situation, the goal of influenza surveillance shifts from counting every infected person to gathering information on the severity and impact of disease. These latter data can better help guide decisions about the subsequent public health response. At this point, since infected people in the U.S. may ultimately number in the tens of millions, and since many mildly infected people with mild disease will not seek medical attention, and since confirming an H1N1 diagnosis requires an expensive laboratory test, it no longer makes sense to try to count every person infected with H1N1.

However, although the CDC has stopped counting every individual H1N1 infection, it is keeping close track of – and is making publicly available on a weekly basis - a number of other measures of epidemic influenza severity in the United States: (1) visits to doctors for influenza-like illness; (2) total influenza-related hospitalizations; (3) the proportions of weekly deaths recorded as being from pneumonia and influenza; (4) state health department estimates of the magnitude of influenza activity within each state; (5) the numbers and proportions of influenza viruses identified in laboratories as H1N1 viruses; (6) any resistance of circulating H1N1 viruses to oseltamivir, the principal anti-viral drug being recommended for high risk people infected with H1N1; and (7) influenza-associated pediatric mortality. Each of these disease indices is updated weekly and can be found online.

The swine flu epidemic has not spared China. According to the latest available numbers, the country has registered 48,748 infections on the mainland and another 31,544 in Hong Kong. The Chinese government quickly implemented prevention and containment policies in response to early cases, even receiving some criticism for its extreme measures. In June, the People’s Republic commissioned 11 biotech companies to develop a swine flu vaccine. Sinovac succeeded, creating the world’s first approved vaccine with its Panflu 1. These efforts, described as the world’s most active response to the virus, earned substantial praise from the World Health Organization.

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

Last week’s important decision by the Obama administration to take a global leadership position in sharing a significant proportion of the U.S. H1N1 (swine) influenza vaccine supply with the people of developing countries is likely to help save many lives. However, its longer term importance may well be the major shift in U.S. global health policy suggested by the decision.

In brief, the United States has agreed to donate 10% of its hundreds of millions of contracted doses of H1N1 flu vaccine to the World Health Organization (W.H.O.) for distribution to various developing countries. The U.S. vaccine donations will be made on a rolling basis so that resource poor-countries can begin receiving and administering vaccine relatively soon. A number of other industrialized countries (Australia, Brazil, France, Italy, New Zealand, Norway, United Kingdom) also announced similar vaccine donations nearly simultaneously. (The Swiss government had already committed in June 2009 to donate US$4.8 million directly to W.H.O. for the latter to purchase H1N1 vaccine at concessionary prices.) GlaxoSmithKline and Sanofi-Aventis, two large vaccine manufacturers, had also committed earlier to donations of more than 100 million H1N1 vaccine doses to W.H.O.

The ability of the United States and other countries to make these vaccine donations was helped by several factors. First, it has become clear within the last week that a single dose of the new H1N1 vaccine will provide satisfactory protection for adults and older children with normal immune systems, making a second (booster) dose unnecessary except for children under 10 years old. Since the U.S. H1N1 vaccine supply had been planned and requested to include the possible need for a two-dose series for most people, U.S. swine flu vaccine supplies will be more ample than it appeared earlier.

One of the greatest misconceptions about global health is that it only matters to developing nations. Global health deeply affects the economy and security of the United States, and that was the central message of Admiral Fallon's keynote address for a gathering of global health experts and North Carolina businesspeople and policymakers.

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