Dr. Yi-Wei Tang stands in the chemistry lab at The Vanderbilt Clinic where the new Molecular Infectious Diseases lab will be installed. Tang will head the new facility, a collaborative venture among the Department of Pathology, Department of Medicine, and Hospital Administration. Testing is expected to begin by Dec. 1. (photo by Dana Johnson)
Flu vaccine shortage possible: Elderly, health care providers a priority
There is one possibility and one given about this year’s flu vaccine. There may be a shortage. The vaccine will be late.
Each year the four flu vaccine manufacturers in the United States try to anticipate which flu virus strains are going to be circulating during the upcoming year. So formulation of the vaccine, which contains both A and B components, varies from year to year.
This year one of the strains involved in the vaccine replicates slowly. The vaccine is made in embryonated eggs, one egg per dose. Last year, between 75 and 80 million doses were manufactured in the United States.
“It’s a very elaborate operation. You have to generate a new vaccine each year and each lot must be tested by the FDA, so timing is very critical,” said Dr. William Schaffner, professor and chair of Preventive Medicine.
Adding to the delay, the FDA has taken regulatory action against two of the four manufacturers of the flu vaccine. This required the companies to stop and make the required corrections, thus causing a delay in their production of flu vaccine.
Normally, the first of the flu vaccine is delivered in late August or early September, Schaffner said. Traditionally, the distribution of the flu vaccine by Vanderbilt University Medical Center to its patients, faculty and staff occurs in October. But this year, the vaccine isn’t expected to arrive until November. The goal is to have all medical center faculty and staff who need or want the flu vaccine to be immunized by the middle of December. Those who will be immunized first are those considered at risk – patients who are likely to suffer the most severe complications of the flu – and faculty and staff with direct patient contact.
Dr. Mary Yarbrough, Director for Health and Wellness at Vanderbilt, of which the Occupational Health Clinic is a part, said that the vaccine will be distributed on a high-risk priority basis at the medical center.
“When we receive the vaccine, it will be distributed based on those at greatest risk for the complications of the flu – patients in our clinics and those involved in direct patient care,” she said. “Those faculty and staff in patient care areas will be our first priority – those who work in our intensive care units, and hospital and clinical staff who work with patients,” she said. Individual departments will be notified when that allocation has been completed so that departmental inoculations can be scheduled.
Those considered at risk by the Centers for Disease Control are: those 65 and older; those under 65 with underlying heart disease, lung disease, a metabolic disease, such as diabetes, or those who are immunosuppressed due to illness and medication; all health care providers; anyone under 65 who has regular contact with or who provides care to individuals with these high risk conditions; children six months to 18 years with underlying disorders of the cardiovascular or pulmonary system, including asthma; children who are receiving long-term aspirin therapy because of the risk of getting Reye’s Syndrome due to the combination of aspirin and the flu; and women who are in the second and third trimesters of pregnancy during the flu season.
“We’re asking providers to be sensible and encourage those folks who are high risk to get to the head of the line, and that includes health care workers,” Schaffner said.
Schaffner said although the vaccine is usually given in October, November or even December is not too late. There will still be ample time for the body to make its antibodies before the flu strikes. The flu season usually begins in January, is most active in February and can extend into March and April.
“We just need people to understand that no matter who your provider is – Vanderbilt, your private physician, your employer, or Kroger – it’s going to be late,” Schaffner said. “We’re asking for understanding, flexibility and assertiveness. There’s a concern that because of the delay people will be immunizing less because of the holidays. So you need to do two things: be especially flexible about when you get your shot, and be a bit more assertive about getting the vaccine. You’re just going to have to put a bit more energy into it. If you call and find out the vaccine isn’t in, just smile and call back a week later.”
In addition to the delay, there is some fear that there will also be a vaccine shortage.
“Since the virus used in the vaccine is so slow, and there is this added delay with the FDA regulatory action, there’s a concern that there may be fewer doses produced this year than last. The two companies, who are not under review, are trying to keep up with the demand but it’s not easy. Since providers haven’t normally purchased the vaccine in December, the companies are trying to figure out exactly how much to make this year. It’s a paradox and everybody’s crystal ball about this is completely cloudy.” n