To have and have not: ICPs scramble to find flu vaccine for workers, patients

CDC: Worst-case scenario actually happened

The loss of roughly half the nation’s flu vaccine supply for the 2004-2005 season has infection control professionals scrambling to revamp their programs and secure adequate doses for health care workers and high-risk patients.

"This is really a tough time," Julie Gerberding, MD, MPH, director of the Centers for Disease Control and Prevention (CDC), said in testimony at a recent congressional hearing. "There will be many frustrated people. Not all people who need flu vaccine are going to be able to get it. We are going to have to work together to do the very best we can to match the supply that we do have with the demand among the people who are the most vulnerable to the serious complications of the flu. This is not going to be perfect. We are going to have to rely on prioritization."

The severity of the coming flu season will have a lot to say about the success or failure of a national effort to immunize high-risk groups — including health care workers. Healthy people will be forced to skip the shot and take their chances.

"The biggest concern we have is what kind of an impact it’s going to have on our community and how that might affect [the hospital]," says Susan Kraska, RN, CIC, an ICP at Memorial Hospital of South Bend, IN. "I spoke with our local health department officials and discovered that that they have only received about 60% of the vaccine that they have ordered. They have been told that they probably will not receive the remainder of the order. They have implemented the CDC recommendations, and the clinics are actually screening folks and asking them not to come unless they meet the CDC recommendations. The community seems to be cooperating."

Having experienced a vaccine shortfall several years ago, Kraska ordered early and has her stock in-house. "We’re looking pretty smart right now. We are making sure that all of the vaccine that we have available gets to our bedside caregivers. We’re following the CDC guidelines for direct patient caregivers first and then on the back end of our flu clinics, we will welcome the rest of our employees. But this is really unfortunate. As a nation, we have just got to do a better job in vaccine preventable diseases. We have to."

Serratia gums up the works

Oct. 5, 2004, Chiron Corp. in Emeryville, CA, notified the CDC that its vaccine (Fluvirin) would not be available for distribution in the United States for the 2004-05 influenza season. As a result, the United States will receive only about one-half the expected supply of trivalent inactivated vaccine for this season. Health regulatory officials in the United Kingdom, where Chiron’s Fluvirin vaccine is produced, suspended the company’s license. Published reports indicate Chiron confirmed that bacterial contamination involving Serratia species led to suspension of vaccine manufacturing at its Liverpool facility. Serratia marcescens has caused outbreaks in hospitals, dialysis centers, and other settings for years. The bug is particularly adept at contaminating multidose vials, pooled medicines, and even — in one outbreak — liquid soap.

The first signs of problems at the plant arose last August, but there was hope the contamination was limited to a few lots of vaccine. The CDC began preparing for a worst-case scenario, and unfortunately, that is exactly what happened.

"The initial contingency plan was to assume worse-case scenario — that we wouldn’t get vaccine from Chiron," Gerberding told the House Government Reform Committee at an Oct. 8, 2004, special hearing on the crisis. "Then identify what is the most restricted number of people who must get vaccine. That is about 50 million, based on the numbers in the high-risk groups [and] on patterns for request for vaccination that we have observed in previous years."

While there appears to be enough vaccine left to target the priority groups — including health care workers — the margin is razor thin. The remaining supply of influenza vaccine that is expected to be available in the United States this season is about 54 million doses of Fluzone, manufactured by Aventis Pasteur.

Based in Lyon, France, Aventis Pasteur has a branch in Swiftwater, PA. In addition, approximately 1.1 million doses of the live attenuated influenza vaccine FluMist is available. The manufacturer, Medimmune Inc. in Gaithersburg, MD, is trying to add another 1 million doses to that total in light of the shortage. Meanwhile, the scramble is on for those hospitals and health departments that ordered vaccine from Chiron.

"At the moment, we are struggling to find vaccine because we had ordered ours from Chiron," says William Schaffner, MD, chairman of the preventive medicine department at Vanderbilt University Medical Center in Nashville, TN.

"Aventis is for all intents and purposes committed. But half of the vaccine that is made in this country doesn’t go directly from the manufacturer to the end user. It goes into that amorphous distribution system of pharmacy and medical supply jobbers and distributors. We are also trying to work that system to see how much vaccine is there."

With regard to patients, Vanderbilt is considering linking up with a local supermarket chain in a novel partnership, he says. "Our primary focus has been on our patients," Schaffner says. "I think we will partner with a large supermarket chain and supply the personnel to help them do the screening, That is something they are uncomfortable doing and they are not staffed to do. So we will help them with the screening part, and in turn, we will send our patients to those locations. So that works for our patients, and it’s good for the pharmacy and supermarket chains because some of those patients may buy a little bread and milk. This is a win-win."

A fragile system

But while innovation may prevail at the local level, many observers point to the Chiron debacle as a clear indicator of how vulnerable the nation is to disruptions in flu vaccine. Some have even expressed concern that, in the event of a pandemic, U.S. supplies produced overseas could be nationalized and effectively seized by the producing country.

"We have a fragile system that affects virtually all vaccines in this country," Schaffner points out. "It is extraordinary when you contemplate that we are the richest and most developed country in the world, but we have this fragile vaccination manufacturing system. We need to take a very careful look at that. It is a simple fact that vaccines are a low-profit product line for pharmaceutical manufacturers."

Indeed, the situation is similar to production of antibiotics, an essential medicine that yields little bang for the buck to pharmaceutical firms. "It’s the same story," he says. "We need to find a way to provide incentives for the pharmaceutical manufacturers to stay in antibiotic research and to invest more heavily in vaccine production."

Gerberding said as much to Congress, emphasizing in the hearing that, "The situation has gone on far too many years. We continue to have a complete fragile vaccine production capability in this country and it is getting more and more fragile every year." She also warned that the guidelines for immunization were interim in nature and could made stricter if supplies and emerging flu warrant further restrictions. While there is much emphasis currently on voluntary compliance by healthy adults, there is the question of whether such recommendations actually can be enforced.

"People are being asked to forgo or defer [immunization], but this is a question that has come up in pediatricians’ offices, clinics, pharmacies and supermarkets," Schaffner says. "Some providers are being a little more forceful in trying to discourage people who are not in the priority group, but physicians aren’t police. It’s difficult for them to turn away, to deny a preventive health service to a patient who really wants it."

In that regard, California state health officials took the unprecedented step of putting some teeth behind the recommendations — ordering all health care providers to limit flu shots to the priority groups. However, state officials said in published reports that they would not be "policing vaccine lines" or asking providers to turn over unused supplies to the state.

"We have experience with this because of similar problems that have occurred in the past," says Patrick Joseph, MD, chief of epidemiology at San Ramon (CA) Regional Medical Center. "The model that we have developed is asking clinicians to prioritize the high-risk people compared to the healthy adults. Once you prioritize the recipients, then you immunize those with the highest priority who are at the greatest risk of complications [from flu infection]. That has worked in the past when we have had shortages. Health care workers are [still] a top priority, and that has to be emphasized."

An explosion on the launch pad

Indeed, while the many public health questions currently are taking precedence, the loss of the vaccine undermines the fledgling national effort to immunize all health care workers. With its seasonal recurrence, flu is met with a strange complacency and both the general population and health care workers remain undervaccinated in any given year. That despite the fact the flu kills more than 30,000 people annually and hospitalizes many more. But with a pandemic brewing in Asia and national efforts to stir health care workers to action there were signs that the apathy was waning. Indeed, some hospitals had geared up to immunize all health care workers — including clerical and ancillary staff. The effort was part of a National Foundation for Infections Diseases (NFID) call to action urging health care workers to get immunized to protect patients.

"We were just about ready to kick off our employee vaccination campaigns in concert with the NFID call to action," says Tammy Lundstrom, MD, hospital epidemiologist at Detroit Medical Center.

"Over the last year, we completely expanded our plans. We had roving clinics, and we were going to [immunize] everybody. We were going to [immunize] clerks, administrators, medical records — essentially anybody who works in any department at our facility. Now we are scaling back to those groups that provide direct patient care or have risk conditions themselves."

Workers who do not qualify for vaccine this year are being advised to follow basic infection control measures such as hand hygiene and respiratory etiquette, she said. But some wonder if the flu vaccine, already dogged by rumors and misconceptions, will suffer more perception problems for years to come.

"We will still have the same infection control recommendations that we have always had, but unfortunately, we are going to have to disappoint some individuals who may have assumed they were getting free vaccination from us," Lundstrom says. "Now we have to scale that back. The concern for me is that we have done so much to promote vaccination to everybody in our facility and now having to turn people away it may disincent them next year when there is more vaccine available."

[Editor’s note: Aventis Pasteur has established a waiting list of providers who request new or additional influenza vaccine shipments. Health care providers can place their name on the waiting list via the company’s web site at www.vaccineshoppe.com or by calling (800) VACCINE or 822-2463.]