With less than 6 percent of already purchased H1N1 vaccine doses shipped as of Oct. 21, researchers at Purdue University have released a study suggesting the pandemic has peaked and could decline rapidly in the next several weeks.
If it does, that means a "significant amount" of vaccine doses, bought at a federal price tag of about $1.8 billion, might not be used and could be discarded, according to a Centers for Disease Control official.
The entire issue has several U.S. Senators, specifically, Joe Lieberman (I-Connecticut) and Susan Collins (R-Maine), wanting answers.
The Purdue researchers - Sherry Towers and Zhilan Feng - acknowledged that, after a summer wave of infection in the United States, health officials had anticipated a second, larger wave of the H1N1 virus this fall, similar to that seen in 1918.
"We examine the prevalence of H1N1 in the U.S. during summer 2009," the researchers wrote. "In a unique study, we use this information, along with what we know about the seasonal behavior of influenza, to predict the prevalence of influenza during fall 2009, and examine the efficacy of the planned CDC H1N1 vaccination campaign."
What they did specifically was compare several statistical models, one of which accounted for the CDC's planned H1N1 vaccination program of six million doses by the end of the first full week in October, followed by 10-20 million doses every week thereafter.
"The (statistical) model that best fits the summer H1N1 data predicts that the peak of the fall wave will occur near the end of October," they concluded. "This is similar to the behavior of the 1918 pandemic. Without vaccination, between 59 percent to 69 percent of the population will be infected with H1N1, although it is possible that a significant fraction (up to 60 percent of those infected) will be asymptomatic."
Between 5 percent and 19 percent of the population will be infected during the peak week of the pandemic, the researchers stated, and the government's response will come up short.
"The CDC vaccination campaign will somewhat reduce the number of people infected, but will not have the full efficacy officials have hoped for, due to the early fall peak of the pandemic," they concluded.
To be sure, the latest CDC numbers indicate H1N1 is raging in most parts of the nation.
According to the CDC, during the week of Oct. 11-17, the latest week for which data was available, visits to doctors for influenza-like illness increased steeply in the United States, and were much higher than what is expected for this time of the year.
The proportion of deaths attributed to pneumonia and influenza has been higher than normal as well. Eleven flu-related pediatric deaths were reported in the week; nine of those deaths were confirmed 2009 H1N1. Since April, CDC has received reports of 95 laboratory-confirmed pediatric 2009 H1N1 deaths.
Forty-six states, including Wisconsin, were reporting widespread influenza activity. That many reports of widespread activity are unprecedented during the seasonal flu season, the CDC stated.
Collins wants answers
While H1N1 was rampaging, the flu vaccine was trickling out.
The government has already contracted for 195 million doses from five manufacturers, but only a fraction of that has made it into circulation. As of Oct. 21, 14 million doses had been allocated, 12.5 million had been ordered, and 11.3 million had been shipped.
This week the government was still projecting the availability of 28-30 million doses by week's end, but that was far from original estimates.
Those numbers were enough to get Collins' attention. The senator wrote an Oct. 26 letter to Department of Health and Human Services secretary Kathleen Sebelius demanding an explanation.
"As the President acknowledged just a few days ago, the nation is facing an emergency in responding to the H1N1 epidemic," Collins wrote. "A primary concern for nearly every American at this time is the lack of sufficient vaccine supply even for those at high risk for serious complications, including children, young adults, and pregnant women."
The lack of sufficient supply, she said, was alarming.
"I am troubled that HHS has assured the public since August that the government would have enough vaccine to meet demand," she wrote. "It now appears that much of the vaccine could arrive only after many people have already been infected with H1N1. Indeed, an October 15, 2009 Purdue University study predicts that nearly 60 percent of the American population will be infected with H1N1, that a third of them will fall ill, and most disturbingly, that the peak week of infection was this past week."
Collins criticized the department for making a commitment to have an adequate supply when it lacked the information necessary to do so. She also stated that HHS should have announced that an adequate supply also depended on whether one or two doses were needed - something she said wasn't known until September.
Collins asked Sebelius for, among other things, a revised schedule for distributing all 250 million doses. The senator also said other things bothered her, such as the nation's reliance on outdated manufacturing processes to make vaccine.
"There are longer-term issues as well that affect our response capability," Collins wrote. "Most experts agree that a significant limiting factor in the production of any type of flu vaccine is our dependence on egg-based production rather than cell-based technology to produce the vaccine more quickly. How soon does HHS anticipate that the United States government can shift to cell-based technology for the production of flu vaccine? What effort is HHS making to ensure that this shift in production occurs rapidly and safely?"
Of the five H1N1 vaccine manufacturers, she said, only one is based in the United States, while the other four are foreign.
"In the case of a pandemic, a foreign vaccine producer will likely be compelled to prioritize the bulk of their production for their own country's consumption," she said. "What investment or policy changes should the United States undertake to ensure that the U.S. can manufacture a sufficient percentage of flu vaccine domestically?"
Sebelius has testified before Congress, assuring lawmakers enough vaccine will be available.
Throwing it all away
A key question, though, is whether the vaccination campaign will be necessary if the pandemic will have largely passed. That could mean throwing away significant batches of the vaccine.
"It is likely also as we produce more vaccine and as both people are given the opportunity to get vaccinated, and as disease maybe wanes in the future, we will have significant amounts of vaccine that can't be used," CDC director Dr. Thomas Frieden told Reuters last week. "One of the messages for states, localities and health providers is not to reserve vaccine that they have available, to give it out as soon as it comes in, because more is on the way."
In one sense, the potential for high amounts of unused doses recalls the 1976 swine flu scare, when the government set out to vaccinate every American but abandoned the effort after 40 million vaccinations because no pandemic developed and numerous side effects were reported.
Back then, though, the government refused to reimburse the pharmaceutical companies for the unused portions.
The difference today is that a pandemic has developed, though there is still no indication it is any more dangerous than seasonal flu.
Seasonal flu vaccine shortages have also become a staple of recent political debate. In 2004, during that year's presidential campaign, Democratic presidential nominee John Kerry blamed President George W. Bush for shortages.
Bush blamed the shortage on manufacturing defects; Democrats called it incompetence.
"If you can't get flu vaccines to Americans, how are you going to protect them against bioterrorism?" Kerry told National Public Radio. "If you can't get flu vaccines to Americans, what kind of health care program are you running?"
Meanwhile, massive H1N1 vaccination campaigns are taking more heat in Europe than in the United States.
This past week, for example, the chairman of the German Medical Association's Drug Commission, Wolf-Dieter Ludwig, expressed his unhappiness in an interview with the news magazine Spiegel, questioning whether the mass vaccination campaigns were ever necessary.
"The health authorities have fallen for a campaign from the pharmaceutical companies, who simply want to earn money with an alleged threat," he told the magazine.