BETHESDA, MD—Federal officials are gearing up for a possible H1N1 vaccination campaign this fall, said top Administration leaders at a federal government flu summit held last month. “At the risk of understatement, we need your help now to prepare for the likelihood of a fall vaccination campaign. We know that a mass vaccination program, even of a modest scale, will involve an extraordinary effort throughout this country,” HHS Secretary Kathleen Sebelius told an audience of more than 500 people from the federal, state, and private sector.

While there is currently no FDA approved vaccine for H1N1, the government is hoping that a vaccine will be ready for initial distribution in mid-October. NIH is planning to help evaluate the first vaccine candidates in August. It will determine whether the candidates are safe, have the ability to produce protective immunity response, what the appropriate dose is, and the number of doses needed. “This information will be critical in the decision of how and if to implement an H1N1 vaccination program in the fall,” said Dr Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.

While Sebelius said that “no final decision” had been made about the scope of a vaccine campaign, young people would likely be first in line since they were disproportionately affected by H1N1 in the spring. In addition, non-elderly adults with health conditions and health care workers would also be priority groups. “We anticipate that school-age children, non-elderly adults with underlying health conditions, pregnant women, and healthcare emergency workers who are likely to come into contact with the virus are current priority groups to whom the vaccine will be offered,” she said.

No Typical Outbreak

CDC Director Dr Thomas Frieden, MD, said that the H1N1 outbreak in the spring was different than the regular seasonal flu in that teens and young adults were most affected by the H1N1 outbreak, while there were relatively few cases among the elderly. The majority of those who have been hospitalized with the virus have been under the age of 50, and the median age of hospitalized cases is 19 years old. “The transmissibility of H1N1 is something we are still trying to understand from a basic scientific and epidemiological perspective,” he said. “But clearly it has caused large, explosive outbreaks in some schools. It really has a different pattern—in terms of increased age and decreasing risk of infection and severe disease.”

Individuals with underlying health conditions such as asthma, diabetes, heart disease, and chronic lung disease have also been at increased risk. “Those underlying health conditions are important because they identify those who are particularly at risk in the future, which if and when H1N1 returns, need to be protected—whether that is by prompt treatment to reduce the risk of progression to severe illness or death, or by vaccination,” he said.

The level of severity of H1N1 appears to be similar to seasonal flu, but Dr Frieden warned that seasonal flu is a major killer every year. “It is important to recognize that seasonal flu kills 36,000 people every year in this country,” he said. Dr. Frieden said that while H1N1 has not been in the news as frequently recently, outbreaks have continued from the spring throughout the summer. He cited more than 50 outbreaks that have occurred in US summer camps.

Vaccine Campaign

Health officials acknowledged that the development of a vaccine may not come quickly enough to stop illnesses in the fall. Dr Anne Schuchat, director for CDC’s National Center for Immunization and Respiratory Diseases, said that there is a “reasonably high likelihood” that there will be a surge of illness from H1N1 in the fall prior to the availability of a vaccine. “We really need to be thinking of other ways to protect ourselves and how to manage that issue,” she said.

Even with a vaccine, there will be potential challenges in distribution that must be addressed. For example, Dr Schuchat said that vaccination for H1N1 may coincide with the time that regular seasonal flu shots are given. The distribution of these vaccines, though, may be targeting different populations. “It is very likely that our seasonal influenza vaccine campaign season will be ongoing in a time that is overlapping with this new H1N1 vaccination efforts that we are planning. We may have different target populations,” she said.

Vaccine safety is another issue. Some cases of adverse events are expected with any vaccine. There must be preparation in order to deal with and interpret adverse reactions from an H1N1 vaccine that is formulated, Dr Schuchat said. The National Vaccine Advisory Council, an HHS group that makes recommendations on vaccine issues, will address vaccine safety. “If we intend to vaccinate lots of people in a relatively short time, adverse events will be detected and we need to be able to interpret them,” she said. “If people have gotten both the seasonal vaccine and the H1N1 vaccine, and have adverse events, we need to interpret all of that.”

HHS Preparedness Grants

Underscoring the concern that H1N1 might return in a more potent form in the fall, a number of federal agency heads spoke at the summit about agency planning underway and the need for states, tribes, and health facilities to also plan for a potential H1N1 outbreak in the fall. “We need to make sure that plans are in place, and hopefully, have actually been exercised, so that if there are different rates of absenteeism, operations continue,” said DHS Secretary Janet Napolitano.

Health care providers need to prepare for a large number of people who are simply worried they have H1N1, as well as those who truly have it. “We need for our healthcare providers to begin preparing for what is going to happen in the case of a surge. Plan now to deal with an influx of patients that could come with an outbreak,” said Sebelius.

Sebelius said that HHS was also making available preparedness grants worth a total of $350 million to help state and local public health offices and health care systems’ resources step up their preparedness efforts.

The government is also centralizing communications about H1N1 and seasonal flu on the federal government’s new Web site www.flu.gov. This site brings together flu-related information from across HHS and other federal agencies. The expanded site builds on the pandemic planning information, long presented on www.pandemicflu.gov, and incorporates information about the novel H1N1 flu as well as the seasonal flu.

HHS is also launching a new PSA campaign contest to encourage more Americans to get involved in the nation’s flu preparedness efforts by making a 15-second or 30-second PSA. HHS will evaluate submissions and will present the best PSAs back to the public so everyone can vote on their favorite submission. The winning PSA will receive $2,500 in cash and will appear on national television. Contest details as well more information about the larger effort to plan and prepare for the flu season are available at www.flu.gov.

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