You asked for information on the flu vaccine shortage, including availability and distribution of the vaccine in Connecticut.

SUMMARY

According to the National Conference of State Legislatures (NCSL), the influenza virus infects 10 to 20 % of the U. S. population each year, killing an average 36,000 Americans and causing almost 115,000 hospitalizations. Certain individuals are at high risk from severe flu complications including children six to 23 months of age, all adults 65 years and older, and persons with chronic diseases and compromised immune systems (see NCSL, State Health Notes, November 1, 2004).

Last month, the Chiron Corporation, one of only two manufacturers to produce flu vaccine for the U. S. market, had its license suspended for three months by British regulators for manufacturing problems. The effect was to cut roughly in half the supply of injectable vaccine available to the U. S. to about 55 million doses, all supplied by Aventis Pasteur.

Around the country, state and local health officials are trying to locate the vaccine, so that it can be reallocated to those populations at greatest risk. This is proving to be difficult, in part, because for proprietary reasons vaccine makers do not generally make available information about who their product is sold to (see State Health Notes).

Most of the doses of flu vaccine in Connecticut are provided by private medical providers while the rest is provided through local health departments. Local health departments have recently begun receiving shipments of vaccine purchased from Aventis Pasteur.

BACKGROUND

General Distribution and Monitoring of Flu Vaccine in the State

Private health care providers traditionally provide the majority of flu vaccinations in the state. The remainder are given through local health departments that conduct public flu clinics and other related activities within their respective jurisdictions. Each year, Connecticut surveys the “mass immunizers” to determine how many doses of influenza vaccine they administer in the state. Mass immunizers include local health departments, visiting nurse associations, home health care agencies, hospitals and long term care facilities.

DPH estimates that between 800,000 and 1 million Connecticut residents received flu shots last year. Of that total, private medical providers gave approximately 85% of the flu shots, while about 15% were given through local health departments.

Reasons for This Year’s Shortage

There have been significant disruptions of various vaccine supplies (not just influenza vaccine) in the country in recent years. For example, between November 2000 and May 2003, there were shortages of eight of the 11 vaccines for childhood diseases in the United States, including those for tetanus, diphtheria, whooping cough, measles, mumps, and chicken pox. Flu vaccine shortages or other problems have occurred for the last four years (see “ With Few Suppliers of Flu Shots, Shortage Was Long in Making,” The New York Times, October 17, 2004, p. 1).

In recent years, many drug companies in the Unites States discontinued the manufacture of vaccines, finding them expensive to make, underpriced, and not profitable, according to the New York Times article. And because a new flu vaccine must be made each year to deal with changing strains of the virus, the variance from year to year in its demand makes it all the more risky. Companies must throw away what they do not sell. An Institute of Medicine report issued last year noted that 30 years ago, 25 companies made vaccines for the United States. In 1994, there were five manufacturers. Today there are two with a third supplying doses in the form of a nasal spray.

While the number of vaccine manufacturers has decreased, the public demand for flu vaccine has increased as health officials have recommended wider use. Demand for flu vaccine has increased from around 20 million a year in the early 1990s to over 85 million last year.

On October 5, 2004, British regulators announced the suspension of the license of a flu vaccine plant in Liverpool, England because of bacterial contamination. The plant is owned by Chiron Corporation, an American (California-based) company. The United States was depending on this company for nearly half (46 to 48 million doses) of the country’s supply for this flu season. The suspension was for three months, effectively preventing any release of the vaccine for this flu season.

A second supplier, Aventis Pasteur, with a Pennsylvania plant, is providing about 55 million doses, while a third company (Medimmune) is supplying two million doses in the form of a nasal spray. But that leaves the country with only about half of the supply it needs.

RECENT SHIPMENTS OF FLU VACCINE TO THE STATE AND DISTRIBUTION OF THE VACCINE

On October 29, 2004, Governor Rell announced that shipments of flu vaccine purchased by the state from Aventis Pasteur had started to arrive and remaining shipments were expected in early November. The vaccine, about 77,570 doses, is being shipped from the manufacturer directly to more than 100 local health agencies and visiting nurse associations. This amount is about half of what the state ordered. It is up to these organizations to determine when to distribute the vaccine.

With the arrival of the vaccine, DPH has distributed updated guidance for health care professionals to make sure that people at risk from serious complications from the flu have first priority for the vaccine. Information about the guidelines is available at the DPH website at http: //www. dph. state. ct. us/BCH/fluvac/flu. htm. (We have also attached the DPH guidance documents on flu vaccine distribution. )

Both the federal Centers for Disease Control and Prevention (CDC) and DPH recommend the following priority groups for influenza vaccination this flu season:

persons aged 2 to 64 with underlying chronic medical conditions,

DPH and CDC recommend that the following not receive flu vaccine this year:

(*except those who are in a priority group because of age or medical condition)

CDC’s goal is to vaccinate 40 to 50 million people nationwide in the high-risk groups. Based on Connecticut’s population, about 480,000 to 600,000 high-risk individuals live in the state. Those who cannot get a flu shot from local health departments can still try to get them from their physicians or from privately run clinics such as those operating in supermarkets or pharmacies. The state is attempting to acquire more doses and has asked physicians and large companies that have been planning flu clinics for their employees to donate vaccine supplies to the state and local agencies or visiting nurse associations. The state is also working with the CDC on the possibility of securing some doses from a national stockpile.

On October 20, 2004, Governor Rell directed DPH to immediately formalize a plan to establish the state as a clearinghouse for excess supplies of vaccines for private providers. The state plan should “strongly encourage physicians with excess supply to contribute any and all excess vaccine they may have to the state and to reinforce the Governor’s directive that vaccine be supplied only to high-risk individuals and young children. The plan should reimburse doctors only for the costs they paid for the vaccine. The plan must provide for the distribution of the vaccine in a manner that guarantees that the needs of at risk and very young patients are met as quickly as possible” (DPH, “Influenza Advisory #3: Recommendations for Adult Use of Influenza Vaccine,” October 29, 2004).

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