WHO declares a pandemic, health officials brace for the fall season

WHO officials last month declared the world is now officially in the midst of a pandemic — the first since 1968 — prompting many health officials to look ahead to the fall and question exactly how much preparation will be enough.

A report issued last month by the Trust for America’s Health, the Center for Biosecurity and the Robert Wood Johnson Foundation said that although the initial U.S. response to the influenza A (H1N1) outbreak showed strong coordination and communication, it also demonstrated how quickly the nation’s public health capacity would be overwhelmed if an outbreak became more severe or widespread.

Many in the public health community are concerned that the novel strain of influenza will reemerge in the fall at the same time that seasonal influenza makes its appearance. Many health officials fear the two viruses circulating simultaneously could lead to the novel strain becoming resistant to the neuraminidase inhibitors or that the virus could mutate into something more lethal.

At press time, there were reportedly about 60,000 confirmed cases and 263 deaths attributed to the H1N1 virus in more than 100 countries. Until late last month, several states were reporting widespread influenza activity, including Arizona, Connecticut, Delaware, Hawaii, Maine, New Jersey, New York, Pennsylvania, Rhode Island, Utah and Virginia. Mathematical models put the actual number of infections in the United States alone at upward of 1 million cases.

Most hospitalizations in the United States have been among people aged 5 to 25 years. This demographic is troubling as children head back to school in the fall, as both the seasonal and the novel types of influenza seem easily transmissible between people.

An influx of patients into physicians’ offices, a steady stream of influenza specimens into microbiology labs and cuts in public health staffing during this tight economic time could pose significant challenges for clinicians this fall, according to the deputy director of the Trust for America’s Health, Kimberly Elliott.

“The current recession and cuts in state and local budgets have caused a serious negative impact on the health workforce at state and local levels,” Elliott said. “While those who are still employed are better prepared than they would have been before pandemic planning, the response would have been even stronger had we had more people in those jobs.”

Practicing physician Richard Lander, MD, concurred. “More people die every year from seasonal influenza, but people are so frightened by this illness. It doesn’t matter that it has been a relatively mild disease so far. Parents are worried,” said Lander, a pediatrician in New Jersey.

That worry is driving many more parents into Lander’s office and overwhelming staff. He expects the fall will be worse. “It’s going to be a nightmare no matter how you slice it,” he said. “Staffing flu clinics, dealing with managed care and budgeting for another vaccine are all going to be major challenges.”

Gaps in response

Lander’s experience is indicative of similar problems across the country, according to the Trust’s report. The report noted that many public health departments did not have enough resources to carry out plans. Sick leave and policies for limiting mass gatherings were problematic and communication between the public health system and health providers was not well coordinated, according to the report.

“One of the lessons learned so far from the epidemic is that communications are absolutely critical. What we learned from this outbreak is that despite all the preparedness, there are still areas that aren’t functioning as well as they should,” said Andrew Pavia, MD, chair of the Pandemic Influenza Task Force for the Infectious Diseases Society of America.

Translating guidance written by public health into clinical practice is a problem for many practitioners, he said. “What do you do when your antiviral supply is different than what is expected?”

The report also took aim at WHO’s pandemic alert system, saying it caused public confusion. The change to pandemic level six warns all WHO nations to prepare for the new flu strain. In making the announcement, WHO Director General Margaret Chan, MD, MPH, said, “We anticipate this action will raise many questions and that often these questions do not have simple answers.”

Declaring an official pandemic will be advantageous, she said. Because no previous pandemics have been monitored at such an early stage, this action will give the world a “head start” on combating the disease.

Better preparation

While the report pointed out some gaps in response, it also reported that “investments in pandemic planning and stockpiling antiviral medications paid off.”

After the H5N1 avian influenza emerged in Asia in 2003, many countries drew up pandemic preparedness plans to respond if it became a worldwide problem. U.S. health officials opened additional vaccine factories and stockpiled 50 million courses of Tamiflu.

In a press conference, Anne Schuchat, MD, interim deputy director for the CDC’s Science and Public Health Program, said that the first cases of the novel virus would not have been detected were it not for those pandemic planning efforts.

Fernando Guerra, MD, director of health for the San Antonio Metropolitan Health Department, said that those pandemic preparations helped his community prepare for the late-season outbreak of the novel virus. The department processed about 1,300 influenza specimens at the peak of the outbreak.

Guerra said that preparedness plans enabled health officials to distribute antivirals quickly when they were needed and enabled them to train additional staff as vaccinators. He anticipates that this fall he will require even more staff. His office is now identifying additional people to train as influenza vaccinators, including school personnel.

Gail Demmler-Harrison, MD, professor of pediatrics at Baylor College of Medicine and director of the diagnostic virology laboratory at Texas Children’s Hospital in Houston, said that in a regular influenza season, her laboratory receives and processes about 30 to 50 samples a day and up to 100 during the peak influenza season. At the peak of the novel influenza in early May, the laboratory received about 300 in a two-hour period. Although that rate had slowed significantly within the last month, she said an increase is expected this autumn.

“Any type of influenza is predictably unpredictable. The best we can do is be as prepared as we can be and hopefully take heed from the warning we may be getting now,” Demmler-Harrison said.

During the novel strain’s peak in the spring, the Texas Children’s Hospital Emergency Center created a mobile pediatric emergency response team (MPERT), a triage system based on Hurricane Katrina contingency plans. MPERT converted a hospital parking lot into an emergency center where patients were triaged, issued color-coded arm bands and then assigned specific areas for assessment and treatment based on their illness severity.

MPERT had a child-friendly waiting area, stations for patient assessment, point-of-care testing for influenza, and a spot for hand-washing. Rapid influenza tests were performed on site, and, since the ability of the rapid test to detect the novel strain was still not known, samples were also tested in the laboratory by viral culture and PCR. Physicians wrote and filled antiviral prescriptions immediately as positive rapid results were reported. They also provided educational materials about the influenza outbreak.

Demmler-Harrison said that MPERT provided valuable experience in pandemic preparedness as well as laboratory data, comparing the performance of rapid influenza tests with viral culture and influenza molecular subtyping PCR tests, which should help them be better prepared in the fall.

Looking ahead

Schuchat said world health officials are watching the influenza situation closely in the southern hemisphere to guide them about vaccine decisions in the northern hemisphere this fall.

At press time, there were several reports of the new H1N1 virus cocirculating with the seasonal H3N2 as well as other influenza viruses in the southern hemisphere.

“There are significant numbers of cases that have been reported in particular from Australia, Argentina and Chile. In some of these places we have heard reports that the health care settings are actually having difficulty coping with the numbers of people coming in,” Schuchat said during a press briefing. “Just as we saw some challenges here in cities around the country in the United States, some of the southern hemisphere countries are also having that type of challenge with the onslaught of these new cases of illness.”

HHS officials have earmarked $1 billion for vaccine development and manufacturing — $650 million for antigen and $287 million for adjuvant — and five manufacturers are developing vaccine. But clinical trials of their first runs will last throughout this summer, and federal regulators must wait until those are finished, Schuchat said.

At the Advisory Committee on Immunization Practices Meeting last month, committee members began their discussions on priority groups for vaccination.

“We want states, communities and health care providers to be thinking about how they would be able to vaccinate younger people, pregnant women, people who have underlying health conditions like diabetes and conditions that put them at higher risk from severe complications from this new influenza virus,” Schuchat said.

She added that people with heart disease, chronic lung disease, and people who are severely obese are at increased risk for all types of influenza, including the novel strain. Most of the people who have died from this virus in the United States — about 75% — have had underlying conditions.

Several vaccine manufacturers at the meetings said at the meeting that an H1N1 vaccine may be possible by the fall if several factors, including safety, dose-finding and adjuvant questions, can be answered in time.

Novartis officials announced last month that they successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations, using cell-based manufacturing technology.

“The good news is, we’ve tested a number of isolates from around the world and the strains that are being used for vaccine development seem to match what is circulating,” Schuchat said. “But how well this will work is the million dollar question.”

Schuchat said the new H1N1 virus is making up more than 99% of all the typed isolate’s in the United States.

Reimbursement an issue

If a novel H1N1 vaccine is released in time, another issue will be reimbursement for physicians who administer it, Lander said.

“We’re going to have to go to all the managed care organizations ahead of time and know up front what we’ll be paid for it,” Lander said. “That’s a major issue. And it is something that will have to be resolved quickly. Pediatricians are no longer just willing to give a vaccine and take a loss on it.”

Elliott said adolescents and young adults will need to be a priority if the vaccine becomes available, as this age group has been the most severely affected by the virus to date.

Schuchat said that CDC officials plan to work closely with state and local health departments to initiate vaccination plans. She expects that a vaccine campaign will require close collaboration between the private sector, community vaccinators, school systems and private businesses.

“The seasonal influenza vaccination campaigns have become a community thing. Many people are not vaccinated in their doctors’ offices. They’re vaccinated in other places that just work better for them, but the doctors’ offices are an important part of the seasonal influenza vaccination campaign, so I think it’s a point of intense planning that we’re looking at different solutions in rural communities versus big cities,” Schuchat said. “We’re at a point where we really want to understand how to reach people who want to be vaccinated and need to be vaccinated and make it as easy as possible for people to have access to a vaccine.”

Another issue is reimbursement for performing rapid influenza tests. Although there is a CPT code, some insurance companies are not reimbursing for these tests, so many physicians are offering the tests, charging patients directly and having them sign waivers.

Guerra said the key for determining who to rapid test is more a precise clinical diagnosis. “This outbreak held some important lessons for us. We learned we don’t have to collect samples from everybody with an influenza-like illness. There needs to be some selection criteria, and then if the screen is positive, do a confirmatory test.” High-risk individuals, particularly pregnant women, need to be carefully screened, Guerra said.

Staffing is another issue. Typically the flu clinics that Lander’s office hosts have not required all of their staff, but he expects this year will require additional staff time and effort.

“People are going to come out for that flu vaccine,” Lander said. He said he would like to see individual state chapters of the AAP compile a list of available vaccination staff so that additional nurses and physicians can be called in as needed to assist town health clinics or clinics servicing Medicaid patients.

Guerra said his office is preparing its new budget for the coming year and is pointing to the late outbreak as a rationale to maintain and strengthen staff.

“We’re using this experience to make the case that we have to protect the positions we have, even in these tough economic times,” Guerra said. He said his office is expecting some additional funds this year from the federal stimulus package to obtain funding for its immunization programs, some of which may be used for the novel influenza vaccine pending approval.

According to Pavia, IDSA officials are advocating for increased funding at the state and local levels, particularly to increase laboratory capacities.

“We know the money isn’t going to be easy to find,” Pavia said. “Many people in Congress and state legislatures don’t realize how dire the situation is in terms of public funding. We need to help them understand that they may have to look at cuts in their budgets in other areas, but this is not one of them. Lives are at stake here.” – Colleen Zacharyczuk

The full analysis is available on the Trust’s website at www.healthyamericans.org.

For up-to-date information about the novel H1N1 flu, visit the InfectiousDiseaseNews.com Breaking Influenza A (H1N1) Updates page.

Looking ahead to vaccine development

Do we need two doses of the new flu vaccine for first-time vaccinees? If so, two new plus two regular or will the vaccines be combined so that only two need be given to new vaccinees? The feasibility of combining the vaccines will need to be evaluated as reactivity in those patients aged younger than 5 years is greatest.

– Philip Brunell, MD

Infectious Disease News Editorial Board Member