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Influenza Vaccine Shortage: The Ethics of RationingBy Sarah Ludwig
Alison is a 19-year-old university student with moderately severe asthma. She was hospitalized once when she was twelve and caught a bad cold, and she has had some serious attacks in the past few years. If Alison were to catch the flu, it would likely cause an even more severe inflammation of the lungs than a cold, leading to even more severe asthma attacks 1. Alison would be unable to breathe and her fast-acting inhaler might not be enough to clear her airways. Getting a flu vaccine is Alison's best defense against getting the flu in the first place; it can cut her risk of getting the flu by up to 90 percent. When she was a child, her mother always took her to get her flu vaccine, and since she has been away at school she has been careful to get her own yearly vaccination. Unfortunately, this year there is a shortage, making it difficult to obtain the seasonal flu vaccine. Influenza vaccines are not considered very profitable to make, because they are expensive and any extra has to be thrown away at the end of the flu season, since a new vaccine must be produced every year. Consequently, not many companies produce the flu vaccine. Given that no single person or agency is in charge of ensuring that the United States has an adequate supply of influenza vaccines, it is not surprising that shortages do occur. This year, one of the companies, in charge of producing nearly half of the United States' supply, had a bacterial contamination that forced them to shut down all vaccine production.
Alison is very afraid of catching the flu. Her worst asthma attacks have been when she had a cold, and she is terrified of not being able to breathe. Alison wants to be sure to still get her yearly flu vaccine, but there is currently no system in place to ensure that at-risk populations receive the limited supply of vaccines available. It is entirely dependent on each clinic to try to ration their limited supply. To do this, some clinics attempt to use medical necessity criteria, which are challenging to define; Medicare defines medical necessity as "services or supplies that are needed for the diagnosis or treatment of your medical condition and meet accepted standards of medical practice." This is a subjective standard, and is frequently assessed by an insurance company that never sees the patient, to determine if payment will be issued. Alternatively, many clinics avoid the issue by using a lottery. The most common method of distribution, however, is a "first-come first-served" basis, with some consideration of medical necessity requirements.
In Santa Clara county in the 2009 H1N1 vaccine distribution, the initial shipment to arrive was a nasal form of the vaccine, so it was limited to healthy children 2 years and older, especially those younger than 10 years who are recommended to receive two doses; and healthy household contacts (2 - 49 years) of infants younger than 6 months 2. The next shipments of the injection vaccine were then directed towards high risk groups such as pregnant women, household contacts and caregivers for children younger than 6 months of age, health care professionals, all people from 6 months of age to 24 years old (due to their particular vulnerability to H1N1), and people aged 25 to 64 who have medical conditions such as asthma that put them at a higher risk of complications from the flu.
To ensure that is she is among the lucky few who receive a vaccination this year, Alison gets up at 4:00 in the morning on a Friday and drives to the nearest clinic, which opens at 6:00 a.m. This clinic is the only clinic within 50 miles of Alison's home to have received any vaccine supply, so everyone from the surrounding area is also coming here for their supply. Arriving shortly after 4:30 a.m., she is number 62 in line for the vaccine. If she does not make it to the front of the line before all the shots are gone, she will not receive a vaccine. If she makes it to the front, but is determined not to be "enough" at-risk because she is not a senior, she will not receive a vaccine. Seniors are especially at risk for contracting pneumonia or bronchitis given their generally lowered levels of activity and weaker immune systems.
Alison finds herself in line behind a sixty-three year old man who doesn't have any money to pay for the vaccine, but is not yet eligible for Medicare. Seniors are generally considered one of the high-priority groups for getting the flu vaccine, because they tend to have weaker immune systems and therefore develop more complications that are frequently fatal. He tells Alison that he is nervous that he will be turned away because he cannot pay, even though he is very close in age to the at-risk population. He also mentions his daughter who wanted to bring her two young children to try and get the vaccine, but she works at a nearby canning factory and couldn't get the time off to bring them to the clinic. Up at the front of the line there is some commotion over a young man being turned away because he is not considered at-risk. He can be heard shouting, "I'll pay anything, just give me the vaccine!"
Resources:Ethical Issues in Dealing With Seasonal Influenza
Comments on The Ethics of Rationing
Sarah Ludwig created these case studies on seasonal influenza when she was a senior at Santa Clara University as her Honzel Fellowship project at the Markkula Center for Applied Ethics.June 2012
1. Flu Symptoms & Severity." Centers for Disease Control and Prevention, 29 June 2011. Web. 22 May 2012. http://www.cdc.gov/flu/about/disease/symptoms.htm.
2. Martin, Colleen. "Various Actions Related to the Public Health Preparedness Program - H1N1 Supplemental Allocation." Message to Board of Directors. County of Santa Clara, Santa Clara Valley Health & Hospital System. Oct. 2009.