Shortage of flu vaccine creates public health crisis

Just as the annual influenza season is beginning to ramp up, a major supplier of flu vaccine has halted production.

The action creates a critical shortage of flu vaccine in the U.S. Only people in high-risk categories will qualify to get a flu shot this year, and there will not be enough vaccine to meet even those needs.

Prior to the onset of the current shortage, the Center for Disease Control (CDC) had long recommended that US residents of all ages be immunized against influenza.

Priority groups for influenza vaccination:

•All children aged six-23 months;
•Adults aged 65 years and older;
•Persons aged two-64 years with underlying chronic medical conditions;
•All women who will be pregnant during the influenza season;
•Residents of nursing homes and long-term care facilities;
•Children aged 6 months-18 years on chronic aspirin therapy;
•Health-care workers involved in direct patient care; and
•Out-of-home caregivers and household contacts of children aged < 6 months.

Last week the CDC created new priority recommendations for flu vaccination, with the goal being to make sure that the existing supply of vaccine reaches those who are most vulnerable (see the “Priority groups for influenza vaccination” box).

The State of Oregon plans to levy fines of up to $500 against those who violate the CDC priority directives.

On Oct. 5, 2004, the CDC was notified by the Chiron Corporation that none of its influenza vaccine (Fluvirin(r)) would be shipped to the United States for the 2004-05 flu season.

The decision followed suspension of Chiron’s license to manufacture Fluvirin(r) in its Liverpool factory for three months. The suspension-enacted by the Medicines and Healthcare Products Regulatory Agency (MHPRA) of Great Britain-was based on quality control issues involving bacterial contamination at Chiron.

Recently released records show that Chiron first notified the U.S. Food and Drug Administration (FDA) of contamination problems in late August 2004. The problem then was felt to be of limited scope. In weekly updates during late August and early September, Chiron’s memos to the FDA suggested that the problems were being corrected.

On Sept. 13, Chiron notified the MHPRA that it had sent a contamination alert to the FDA. After that, neither the FDA nor the MHPRA heard from Chiron until the MHPRA’s suspension announcement on Oct. 5.

“What happened was unexpected,” said Howard Pien, the president and chief executive of the California-based Chiron. Pien said that he did not anticipate that the MHPRA would suspend Chiron’s license to manufacture Fluvirin(r).

Of interest is the fact that at some time following the Sept. 13 memo, the MHPRA ordered contingency supplies of flu vaccine for use in Britain. The agency has not answered questions publicly regarding when it ordered the additional supplies. However in a story in the Oct. 10 New York Times, the MHPRA said that it expected to have enough vaccine to meet the United Kingdom’s winter influenza campaign.

The situation is much less rosy for the US, where the Fluvirin(r) loss has reduced by over one half the expected supply of injectable influenza vaccine available for the upcoming season.

Almost 54 million doses of Fluzone(r) vaccine – manufactured by the French company Aventis Pasteur, Inc. – are already in the United States. Thirty million of those doses have already been distributed.

Chiron and Aventis are the world’s only manufacturers of injectable influenza vaccine.

In addition to the injectable vaccine, approximately 1.1 million doses of nasal spray vaccine (LAIV/FluMist (r); MedImmune) are available. However, because the nasal spray involves an active (“live”) virus, it can only be used by healthy people between the ages of 5 and 49.

Flu vaccine is made new every year, its composition based on epidemiological assessment of the viruses most likely to be involved in the annual flu pandemic. Designing and producing the vaccine – which is grown in chicken eggs – takes months. Because of this, additional vaccine cannot easily be created on short notice to meet an increase in need.

Influenza is a dangerous viral illness that causes a high fever and severe respiratory distress. Health officials can’t predict the severity of a given flu season, but the main viruses expected this year are known to cause high rates of hospitalization and death. In an average year, 10-20 percent of those in the U.S. contract flu, with the illness killing 36,000 and hospitalizing another 114,000.

According to Dr. Grant Higginson, Oregon’s public health officer, approximately 500 Oregonians are killed by flu each year. This year Oregon has only 25 percent of the vaccine needed for its high-risk groups, and hospitalization and death rates for the coming season are expected to be much higher than usual.

Governmental advisors point out that the crisis spotlights the vulnerability of the U.S. influenza vaccine supply and indicates the need for a program overhaul. Congress allotted $50 million in its 2004 budget for this purpose. Health officials are asking that this figure be doubled for 2005.

Here in Oregon local hospital systems are also feeling the pinch. Kaiser Permanente has only received half of its vaccine order, while Legacy Health System has received none. Providence Health System will not offer employee flu shots due to the shortage.

Planned flu shot clinics at PSU, Oregon State University and the University of Oregon have been suspended.

Flu shot programs in the U.S. usually start in October, a month before the flu season begins. A visit to a Portland area Fred Meyer store on Oct. 8 found lines of people braving a two-hour wait in order to receive their vaccine.

Persons in the priority immunization groups are advised to contact their health care provider immediately, or to call 1-800-723-3638 to make other arrangements. It is imperative that this action is taken soon, so that those in the high-risk groups may be immunized before the local supplies run out.

Those who are not in one of the priority groups are asked to voluntarily forego immunization.

Some people should not receive flu vaccination (either injected or nasally) under any circumstances. These include people with a severe allergy (i.e. anaphylactic allergic reaction) to chicken eggs or those who have previously had onset of Guillain-Barr퀌� syndrome within six weeks after receiving influenza vaccine.

To avoid catching the flu, avoid crowds, avoid anyone who is obviously ill, wash your hands often and avoid touching your own eyes, nose or mouth.

Most importantly, if you develop symptoms of influenza – fever, joint pain, extreme fatigue, cough, sore throat, runny nose, headache – stay home and avoid infecting others.

For the most current recommendations, visit the CDC Influenza web site at