The government is asking thousands of men, women and children to agree to test out the first swine flu shots. The tests will help determine whether people should be given one shot or two and also will consider the optimal time for shots to be administered.
As the United States readies for a potential fall surge of the virus, today an advisory committee to the Food and Drug Administration is meeting to further discuss the clinical trials for potential vaccines.
The meeting is happening as Homeland Security Secretary Janet Napolitano, Health and Human Services Secretary Kathleen Sebelius and Secretary of Education Arne Duncan brief members of Congress about the state of the H1N1 swine flu pandemic.
On Wednesday, the government announced eight medical centers where testing will take place, likely next month.
Meantime, the virus continues in the United States. Flu viruses typically disappear in warm weather, but this year, swine flu has swept through camps and summer schools. At the U.S. Coast Guard Academy in Connecticut, dozens of cadets are ill.
"It certainly isn't over," said Will Humble, interim director of the Arizona Department of Health Services. "And in fact, my whole career in public health, over 20 years, I've never seen flu circulating in the middle of the summer. None of my staff has seen it. Public health hasn't ever seen what is happening right now."
Swine flu is expected to spread rapidly in the U.S. once the fall flu season gets under way just as kids go back to school, the same time that germs typically spread more rapidly.
So what do public health officials anticipate for the season ahead?
"Best case: The vaccine would be in early, all of us would be vaccinated, and when H1N1 comes along we will have mitigated its impact," said Dr. William Schaffner, chairman of Vanderbilt University Medical Center's department of preventive medicine.
Ideally, Schaffner said, vaccinations would begin in mid-October.
But infectious disease experts also pointed out the possibility of a much worse outcome.
"A worst case scenario would be more like the 1918-1919 pandemic," said Dr. Susan Rehm, vice chair of the department of infectious disease and executive director of physician health at the Cleveland Clinic. "We prepare for the worst and hope for the best."
Dr. Peter Holbrook, chief medical officer at Children's National Medical Center in Washington, D.C., told ABC News Wednesday that a worst case scenario also could mean, "Somewhere along the line [the virus] mutates and becomes a much more severe virus."
Testing a Swine Flu Vaccine
A key weapon in the battle to keep people healthy will be a swine flu vaccine.
Clinical trials in the U.S. will be conducted at eight medical centers -- Vanderbilt University in Nashville, Emory University in Atlanta, University of Iowa in Iowa City, Children's Hospital Medical Center in Cincinnati, University of Maryland School of Medicine in Baltimore, Saint Louis University in St. Louis, Baylor College of Medicine in Houston and Group Health Cooperative in Seattle.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health, told ABC News the government hopes to enroll about 2,500 volunteers in the trials -- including about 1,200 children between the ages of 6 months and 17 years old.
Fauci said trials will begin in the first or second week of August -- first on adult volunteers and then on children.
"Before you put anything into a child, you really need to know some preliminary safety data in adults," Fauci said Wednesday. "We're not talking about safety data measured over months and months. We're talking about two days to a week-and-a-half. If that looks clear, then we will move on to the children."
Vaccine development has proven difficult. The virus grows slowly and there's always concern about rare but dangerous side effects with a new vaccine that's being rushed into production.
It will take about six weeks to get results back from all of the clinical trials.
This week, tests began on a vaccine in Australia. Adelaide, Australia-based Vaxine Pty Ltd. and Melbourne-based CSL Biotherapies injected the first adult volunteers this week in separate trials starting days apart.
Hospitals and Schools Prepare for Swine Flu Surge
There's also concern about how hospitals and schools will handle an onslaught of H1N1 cases that could overwhelm the health system and force school closures.
Hospitals have plans in place to prep for a surge of patients coming through the doors and the possibility of doctors and nurses falling ill.
At Children's National Medical Center in Washington, D.C., health workers have ordered additional masks, respirators and anti-flu medication. They have plans to double up patients if need be, and put cots in public areas.
"By all means, we need to be very concerned about the possibility that this is gonna come back in a big way," Holbrook said.
Schools also have "what if" plans in place in case teachers -- as well as students -- are too sick to come to work.
Some of the preparedness plans readied in 2006 to battle a potential outbreak of bird flu are now being dusted off and updated for swine flu.
But Dan Domenech, executive director of the American Association of School Administrators, a group that represents 14,000 school administrators around the country, said most schools are in the dark about when to make the call and how long to keep kids home.
Domenech clarified that local school boards will always make the call about whether to close schools due to an outbreak.
But he also added Wednesday, "We'd like to have a uniform set of criteria to understand what schools should look for. This is a national issue. It's being dealt with nationally. We should all be looking at the same set of guidelines."
"I think the public, in terms of preparation, ought to think of their own personal plans," Rehm said. "What if the schools were closed? What about work? Can we work distantly? Telecommuting might be not the exception but the rule."
Med Page Today's Todd Neale contributed to this report.