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Medical alert: Short on vaccine, state prepares for flu pandemic

If you think the flu season is fast approaching, think again – health authorities say it never really left.

Active cases of swine flu are popping up in virtually every Arizona county, which is especially unusual during the state’s hot summer months.

Federal, state and county officials, along with hospitals and medical teams, are among those gearing up for what is already being called a pandemic. The immediate focus is on protecting youngsters, especially school-age children. They’re the carriers. Also, pregnant women are among the most vulnerable.

What really concerns authorities is this year’s version of swine flu, which now goes by the moniker of Novel H1N1. It is a new or novel strain of the disease. That means our bodies aren’t prepared for it. Right now, there is no H1N1 vaccine available, and when it becomes available, probably in mid-October, there won’t be enough for everybody.

At the federal level, flu fears go right to the top. On Aug. 10, President Obama flew to Mexico for a two-day summit with Mexican President Felipe Calderon and Canadian Prime Minister Stephen Harper, focusing among other things on a joint plan of attack for swine flu.

When Obama visited Mexico City in April, the first swine flu cases were just surfacing. Now, it’s a global pandemic, which the World Health Organization describes as an epidemic of an influenza virus that spreads on a worldwide scale and infects a large proportion of the human population. The organization estimates that as many as 2 billion people worldwide could become infected over the next two years.

Earlier this month, Homeland Security Secretary Janet Napolitano warned that swine flu probably will flare up soon after schools open. She acknowledged there would not be enough pandemic flu vaccine for everyone, at least in the early stages of the flu season.

Napolitano said this year’s flu season probably won’t be as severe as the 1918 pandemic, the world’s worst, when at least 675,000 people died in the United States. It is more likely, Napolitano said, that the pandemic would mirror 1957, when flu killed 70,000 in the U.S.

An advisory committee of the Centers for Disease Control and Prevention (CDC) recommends targeting five groups with a total estimated population of 159 million for initial vaccination against H1N1 flu. They are: pregnant women; people who live with or care for children under six months old; health care and emergency services personnel who have direct contact with patients; children and young adults aged six months through 24 years and adults aged 25-64 with chronic health disorders or compromised immune systems.

Will Humble, interim director of the Arizona Department of Health Services and the state’s flu guru, says those five groups will be among the first in Arizona to receive doses of the vaccine when it arrives.

Humble credits the federal officials for their aggressive efforts to get manufacturers to produce large quantities of pandemic strain H1N1 vaccine for this fall. But because there won’t be enough vaccine for everyone initially, the need to prioritize is vital, Humble says, “to make sure that we get the biggest bang for our buck public health-wise.”

Surprisingly, adults 65 and older face the least risk from the H1N1 virus, but should receive the seasonal flu vaccine as soon as it’s available, health experts say. “Because they received some protection over the years, they have antibodies or some other immune response that is ready to go,” Humble says. “Normally you would expect a higher risk for people 65 and older, but not in this case.”

Educating seniors on their place in line for swine flu vaccine could be challenging, officials agree.

Since the H1N1 vaccine campaign is controlled and paid for by the federal government, budget cuts at the state level will have no impact whatsoever, according to Humble. But the feds leave it up to state officials to determine which entities receive the vaccine and how many doses will be allocated.

Health care providers in private doctor’s offices, community health centers, hospitals, clinics, urgent care centers, and mass immunization clinic planners associated with the local health departments are required to electronically fill out forms, providing information that includes their best estimate of how many vaccine doses they need initially.

Humble emphasizes that because the federal government is paying 100 percent of the cost of the vaccine, needles and other materials, providers will not be permitted to charge people for the vaccine itself, but could charge health plans for administration fees.

“Fortunately, because of the federal government’s investment over the last several years in public health readiness, we’re in decent shape to put on a good response in Arizona, both financially and the fact that we’ve got a lot of planning and infrastructure in place,” Humble says.

The state received $12 million from the federal government specifically for swine flu planning efforts. In addition, the state is expected to receive another $12 million for a massive vaccination program in the months ahead. The federal money is not part of the $787 billion American Recovery and Reinvestment Act.
“Honestly, our response capability would be primitive, because, in terms of investment at the state level, it is not adequate,” Humble says. “Fortunately we’re OK. The federal government recognized this as a priority.”

Most of the money will be passed through from the state to the counties to make sure they have the resources necessary for prevention activity and, more importantly, the mass vaccinations upcoming, Humble says.

Laura Oxley, spokeswoman for DHS, says planning expenditures could include such things as salaries for the hiring of additional employees and expert consultants, plus supplies. Though the feds are paying for the vaccines, needles and swabs, but not Band Aids, the counties may also purchase hand sanitizers to be distributed at major events as a preventative measure.

“Registering people for the vaccine will create a lot of paperwork and executing those plans will take more people,” Oxley says.

Clinics will be allowed to charge an administrative fee, perhaps ranging from $10 to $25, Oxley says. The second wave of federal money would reimburse clinics or counties for people without insurance who are unable to pay the fee. Other expenses could involve paying rent for use of a facility, possibly a gymnasium, for mass vaccinations, renting chairs and tables, and providing bottled water for staff and the public.

Dr. Bob England, who heads the Maricopa County Department of Public Health, e-mailed a letter to school officials on Aug. 7, updating them on CDC guidelines for schools and strategies for vaccinating students.
Under the new guidelines, England notes that the length of time that sick kids should stay home is shorter. Previously it was seven days from the onset of symptoms, but now children may return to school once they’ve been fever-free for 24 hours.

“I like this,” England says, “because it gives us all greater flexibility.”

But England says between 10 percent and 40 percent of kids with Novel H1N1 don’t get a fever. “So how will we decide when they are well enough to return to school?” he says. “This will need to be a judgment call on the part of your school nurse, and we’ll try and get them some clarification soon. Kids can still shed virus even beyond seven days. So it’s not that they won’t be infectious after 24 hours without fever, it’s just that they’ll be much less infectious.”

Jeanene Fowler, spokeswoman for the Maricopa County health department, says the main point is that “sick kids need to stay home.” The same goes for adults who work outside the home, and a special caution applies to families with two working parents.

“They have to make plans about what to do if they get that call from the school nurse that their sick child needs to go home,” Fowler says. “The kid could be out of school for a week.”

The county has taken on the role of adviser to the schools. “We’re asking schools to monitor absenteeism, and if they see higher absenteeism rates than normal, they need some advice on how to deal with it,”
Fowler says.

In some cases, schools might have to close, but a percentage of flu cases that would trigger such a move has not been determined. “We talked a lot about that and it doesn’t make sense,” Fowler says. “One number doesn’t fit all schools. The schools know their population better than we do.”

Estimates are that one in four people could come down with either swine or seasonal flu this fall and winter. “That’s one million people in Maricopa County,” Fowler says. “We’re trying to prepare for societal disruption and how people will cope with that.”

The Arizona Hospital and Healthcare Association is teaming up with other health care associations as well as the Arizona Department of Health Services and county public health departments to help prepare the public for the flu season and the Novel H1N1 virus. With schools back in session, public health officials are concerned about a spike in cases of Novel H1N1 virus.

Basically, the hospital group is trying to spread the word about combating the flu before the virus spreads. The association is recruiting health care professionals to participate in a state-backed speakers’ bureau that will include news media interviews.

Debbie Johnston, director of regulatory affairs and policy for Arizona Hospital and Healthcare Association, says in addition to sharing information, plans call for sharing such assets as ventilators and human resources. The association is taking the lead in working with the state Department of Health Services and all regulatory boards, including those that oversee pharmacies, nursing and osteopathic medicine, to identify regulations that may impact the ability of hospitals to treat flu victims on an out-patient basis, Johnston says.

“We’re also working to ensure that hospitals have the most up-to-date clinical guidance for use of anti-viral medication,” she says. “The state determines whether to modify CDC guidelines for what’s going on locally. Our role is to ensure that all clinicians, doctors and nurses in hospitals, have the current Arizona information. Those guidelines have yet to be decided.”

All decisions should be made by the end of August or early September, by which time all children will be back in schools. “As we know,” Johnston says, “children are the primary carriers of viruses.”

Humble of DHS says he generally agrees with the groups identified by the CDC as being first in line for swine flu vaccinations, but he cautions, “There’s nothing like a shortage of vaccine to make everybody want it. As we progress through October and more vaccine becomes available to the rest of the kids and health care workers, then we’ll start working on adults with chronic medical conditions.”

But he emphasizes the early shortage of doses will make for some difficult choices. If a medical facility orders 100 doses, the state might only be able to provide 20 doses, Humble says. “We will make those decisions in coordination with local health departments, not the feds,” he says. “We signed an agreement with the feds to assure that we’re focusing on the priority groups. They have some oversight, some say, but at a micro level, how many doses this hospital will get and this practice won’t, those public health decisions are state and local.”

Whether hospitals will administer anti-viral medication to outpatients will be a decision for the hospitals to make. “Will they want to use their scarce doses of vaccine on that particular patient?” Humble says. “The primary responsibility should be for toddlers, and in our view the primary place where those vaccinations should happen is in pediatric offices, rather than an ER (emergency room) or community health center.”

The individuals in the best positions to make those decisions, he says, are physicians who have seen the patient over time and know if the youngster has another ailment, such as asthma. “We won’t have enough vaccine for all 6 months-to 4 year olds. They’ll have to make some decisions on a case-by-case basis about which kids to vaccinate,” Humble says.

By January, if there are no surprises, there should be enough vaccine available for the general public, Humble says. Even so, everyone should get their regular flu shot this fall.

Humble predicts there will be a fair amount of confusion among people who see signs for flu clinics, but will be told they won’t be eligible for a pandemic flu shot. “Nurses will get a lot of questions,” he says, “but if someone is not in one of the priority groups they will be denied.”

Like any vaccination, the Novel H1N1 vaccine is strictly for prevention. It doesn’t help once you’ve got the bug. “To be effective, you need a shot ten days to two weeks before you’re exposed, for it to do any good,” Humble says. “It needs that much time to build the antibodies.”

There is a good news/bad news aspect to the anti-viral medication. The good news, according to Humble, is that eventually there will be plenty of doses for everybody.

“But the major question outstanding that will affect our response is whether it’s going to take one or two doses to provide protection,” Humble says. “We don’t know the answer. The vaccine still is in its clinical trials. I’m hoping one dose will be enough to give protection, but that might not be the case. In that case, logistically the challenges multiply by two. Parents would be responsible for bringing the kids back for a second shot. And number two, it would reduce the number we can vaccinate by 50 percent.”

Tests are underway at select locations around the country to determine whether one or two doses will be needed.

Without any available vaccine, swine flu continues to spread across the state, even during the summer months. “It’s really unprecedented,” Humble says. “I’ve been doing this for 20 years and I’ve never seen influenza passing in the community in the middle of summer, to say nothing of late August. We have regional flu activity in just about every county, and we’re getting the new pandemic strain. Normally, with regular seasonal flu, it just drops off to zero by June, and we don’t see an uptick until late fall or even winter. But, we know that’s not the case this year. We are going to see a very early flu season because it never left.”

That has implications. “Most likely,” Humble says, “we will see an increase in cases before the pandemic strain flu vaccine is available. It will be more important for people to take seriously the things we say over and over – don’t go out in public when you’re sick, don’t send the kids to school when they’re sick, wash your hands frequently, cover a cough or sneeze with a sleeve. In the absence of a vaccine, those basic public health measures are really all we have.

“If everyone does that, we’ll all be better off. It doesn’t mean that we’re going to be able to stave this thing off. It’s going to be here. What we have control over is if, as a community, we follow those recommendations, we’ll have fewer cases and it won’t be as bad for as long, but it will still be out there and it will still be spreading.”

Fowler of Maricopa County agrees that an outbreak of flu in the summer is rare. “It’s widespread,” she says.
County officials spent the summer meeting with various stakeholders, including city emergency managers, first responders, the business community, individual businesses, schools and the news media.

“It’s a little out of the Health Department’s control,” Fowler says. “The way we get through this pandemic is all in the hands of the people. If they come to the decision that they are sick and they stay home, that’s going to help the rest of the community. All we can do is provide enough information to help make it easy for them to make that decision.”

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