The swine flu pandemic didn't turn out to be the scourge international health agencies predicted. On Jan. 29 the World Health Organization declared that even though the H1N1 virus is still spreading in parts of Europe, Africa, and Asia, the number of confirmed cases worldwide is declining. About 14,000 deaths from swine flu have been reported. That's a tragic loss, but it's a small number considering that the run-of-the-mill seasonal flu kills up to 500,000 people each year, according to the WHO.
So what have health authorities, scientists, and vaccine makers learned from the global catastrophe that wasn't? That viral outbreaks of this sort are even less predictable than scientists thought and that the defenses in place today would have been utterly inadequate against a more virulent strain. "The overwhelming expression of [H1N1] was mild," says Gregory Hartl, a spokesman for the WHO in Geneva. "Now a process has been established to help us learn."
The first priority, many experts say, is overhauling the antiquated vaccine production system. The current technology, which involves growing flu vaccines in eggs, is so cumbersome that drugmakers have to start in February to ensure they'll have enough for the following fall. H1N1 didn't emerge until April 2009, forcing the Centers for Disease Control and drug companies to scramble. There was too little of the vaccine when the virus was peaking, and too much when it started to wane. "We're very limited by this egg technology, and we've been working on the issue since 2006," says Dr. Stephen C. Redd, director of the CDC's influenza coordination unit.
Companies and universities are racing to upgrade the approach. Baxter International (BAX), for example, tested a new cell-culture technique and was able to begin producing vaccine in just 12 weeks, once it had the virus specifications from the CDC. Baxter sold some of the vaccine in Europe and is working to get its technology approved for use in the U.S. Similarly, Texas A&M University System is breaking ground on a manufacturing research plant that will house several different vaccine-making technologies—any of which could be started up on the fly and adapted to whatever pathogen comes along.
Manufacturing is just one bottleneck. When the swine flu vaccine finally became available last fall, some doctors had no clue how much they would get or when it would arrive—if ever. Many states opted for mass-vaccination clinics, then failed to move high-risk groups such as pregnant women and health workers to the head of the line. Jeanne S. Ringel, a senior economist for the RAND Corporation who studies pandemics, was surprised by the poor preparation at the vaccination clinic near her Los Angeles home. Even though clinics were supposed to focus on priority patients, "they didn't turn anyone away," she says.
McKesson (MCK), which worked with the CDC to get the H1N1 vaccine to clinics, had just eight weeks to build a new distribution network, says Jeff Reinke, a vice-president at the company. Orders came from states through the CDC and then to McKesson—a process the company realized was too slow. McKesson tightened its packaging and shipping time lines. In an e-mail, Reinke said he welcomes the CDC's input on continuing to improve the process.
Flawed communications also stymied vaccination efforts. Many people at high risk were afraid to get the H1N1 vaccine because they thought it was unproven. In reality, it was manufactured just like the seasonal flu vaccine and tested enough to reassure the Food & Drug Administration that it was safe. Responding to misconceptions, the American Medical Assn. launched an educational Web site and AMA members hopped on YouTube (GOOG), Facebook, and Twitter to reassure the public. Next time, consumer outreach needs to start earlier and be more aggressive, perhaps including TV ads, says Mary Anne McCaffree, an Oklahoma City pediatrician and AMA board member. "The bottom line is, we came, we saw, but I'm not sure we conquered," McCaffree says.
Some miscues came from the WHO. It initially assumed each patient would need two shots to get protection. One dose proved adequate for adults, which meant that most European countries had enough vaccine on hand to immunize all their residents. But because of confusion and public apathy, those countries ended up protecting no more than 10% of their populations.
As for vaccine makers, Morgan Stanley analysts initially predicted the three largest—Novartis (NVS), Sanofi-Aventis (SNY), and GlaxoSmithKline (GSK)—would sell a combined $5.3 billion of vaccine during the six months ending Mar. 31. In a December report, they said actual sales may be as much as 15% lower. France has cut back its orders to Novartis and Sanofi. And on Jan. 26, Novartis' vaccine chief, Andrin Oswald, said 2010 sales of H1N1 vaccine would be less than half of the $1 billion the shot generated in 2009.
Even with infection rates dropping, many flu experts are concerned about some facets of swine flu. While mortality is low, children make up many of the victims. And even though next year's seasonal flu vaccine will likely include protection against swine flu, virulent new strains could emerge.
As scientists puzzle over epidemiological questions, the WHO has been accused of unnecessarily fanning public fears. One critic is Wolfgang Wodarg, a doctor and former German parliamentarian who is on the Council of Europe, an organization in Strasbourg, France, that promotes human rights. During a Jan. 26 council meeting, Wodarg accused the WHO of fabricating a pandemic that led to little more than revenues for the pharmaceutical industry. It was, he said through a translator, "dangerous nonsense."
The WHO's Dr. Keiji Fukuda, who also spoke at the hearing, defended the agency's response. Flu policies and responses recommended by WHO "were not improperly influenced by the pharmaceutical industry," he said in a statement. But, he added, "there is much to learn about how the world can improve its handling of such events."
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We're Not Ready
Are the surveillance systems the U.S. government uses to track diseases adequate to protect the public during a pandemic? Not exactly, conclude researchers from the RAND Corporation in an article in the journal Disaster Medicine and Public Health Preparedness. The authors examined six systems for disease monitoring and found shortcomings. In one case, for example, there was a three-month lag from when a safety issue affecting a flu vaccine was reported and when it was investigated. "Were a potential safety signal to be detected with the use of pandemic vaccine, several months would be far too long to provide the needed information to health officials or to reassure the public," the authors write.
To read the full paper, go to http://bx.businessweek.com/swine-flu/reference