Report to Congressional Requesters

United States General Accounting Office

GAO

May 2001 FLU VACCINE

Supply Problems

Heighten Need to

Ensure Access for

High-Risk People

GAO-01-624
Page i GAO-01-624 Influenza Vaccine Delay

Letter 1

Results in Brief 2

Background 4

Manufacturing Problems Caused Temporary Shortages and Spikes

in Price 5

Distribution of Vaccine Does Not Ensure Priority to High-Risk

Individuals 11

HHS Has Initiatives Under Way to Prepare for Future Vaccine

Delays and Shortages 17

Conclusions 22

Recommendations For Executive Action 22

Agency Comments 23

Appendix I CDC Advisory Committee Recommendations on Target

Groups For Influenza Vaccination, 2000-01 26

Appendix II Comments From the Department of Health and Human

Services 28

Appendix III GAO Contact and Staff Acknowledgments 32

Tables

Table 1: Flu Vaccine Orders Placed in 2000 by the State of Alabama 7

Table 2: Prices Paid for Influenza Vaccine by Physician Groups

Surveyed by GAO 9

Table 3: Percentage of Population Receiving Influenza Vaccination 12

Table 4: Percentage of Influenza Vaccine Shipped by

Manufacturers Compared with Percentage Received by

Surveyed Physician Groups, by Month, 2000-01 Flu Season 16

Table 5: HHS Initiatives in Response to the 2000-01 Flu Season 18

Table 6: Updated ACIP Recommendations on Target Groups for

Influenza Immunization, 2000-01 27

Contents
Page ii GAO-01-624 Influenza Vaccine Delay

Abbreviations

ACIP Advisory Committee on Immunization Practices

CDC Centers for Disease Control and Prevention

FDA Food and Drug Administration

HCFA Health Care Financing Administration

HHS Department of Health and Human Services

NVPO National Vaccine Program Office

PRO Peer Review Organization
Page 1 GAO-01-624 Influenza Vaccine Delay

May 15, 2001

Congressional Requesters

Each year, influenza contributes to approximately 20,000 deaths and

110,000 hospitalizations in the United States. Influenza itself may not be

the reason for death or hospitalization, but it weakens the body’s defenses

against other diseases, such as pneumonia. Those individuals aged 65

years or older, people with chronic medical conditions, and pregnant

women are at particular risk for medical complications. Annual

vaccinations, commonly known as flu shots, are currently the best defense

for these high-risk populations. About one in every three adults in the

United States receives a flu shot, according to 1999 survey data. Of these,

the Centers for Disease Control and Prevention (CDC) estimates that

about half are at high risk for medical complications from influenza.

Until the 2000-01 flu season, production and distribution of flu vaccine

generally occurred without major difficulties. The fall of 2000, however,

produced many stories about delays in obtaining flu vaccine. News media

reported instances in which medical providers were unable to get vaccine

for patients at high risk for hospitalization or death from complications

resulting from the flu, while other providers had enough vaccine to give

shots even to younger, healthier people at lower risk for medical

complications. The media also reported stories in which vaccine was

apparently available for providers willing to pay considerably higher

prices, while providers that had ordered vaccine at lower prices were still

waiting to receive their orders. You asked us to examine these issues. Our

review focused on the following questions:

• What circumstances contributed to the delay, and what effects did the

delay have on the prices paid for vaccine?

• How effectively do current distribution channels ensure that high-risk

populations receive vaccine on a priority basis?

• What is the federal government doing to better prepare for possible

disruptions of influenza vaccine supply?

In response to your request, we reviewed relevant documents and

interviewed officials from three agencies within the Department of Health

and Human Services (HHS): CDC, Food and Drug Administration (FDA),

and Health Care Financing Administration (HCFA). In addition, we

interviewed officials from HHS’ National Vaccine Program Office (NVPO).

We also interviewed and obtained documents from all vaccine

United States General Accounting Office

Washington, DC 20548
Page 2 GAO-01-624 Influenza Vaccine Delay

manufacturers, two trade associations for medical supply distributors, as

well as several distributors, companies that provide flu shots at retail

outlets and work sites, physician and other professional associations, and

other purchasers. Because physicians are the main source of flu shots for

the elderly (who comprise about half of the high-risk population), we

surveyed 58 physician group practices to determine how readily they were

able to obtain vaccine and the prices they paid for the 2000-01 season. The

groups we selected included a diverse array of primary care groups

nationwide, but they were not a statistically representative sample that

can be generalized to all physician groups.1

 We also interviewed officials of

health departments in all 50 states about their vaccine purchase and

distribution activities. We conducted this work from November 2000

through April 2001 in accordance with generally accepted government

auditing standards.

For the 2000-01 flu season, manufacturing difficulties resulted in an overall

delay of about 6-8 weeks in shipping vaccine to most customers, creating

an initial shortage and a temporary price spike. Manufacturing difficulties

illustrate the fragility of the system to produce a new flu vaccine each year

on a timely basis. Manufacturers experienced problems growing a new

viral strain. At the same time, two of the four manufacturers halted

production—one permanently—to address safety and quality control

concerns. While the roughly 78 million doses eventually produced were

about the same amount produced in the previous year, the delay resulted

in a shortage of vaccine during October and November when people

normally receive their flu shot. Many purchasers who had placed orders

received only partial shipments—and in some cases, no vaccine at all—by

this period of high demand. During the shortage period, providers who

wanted to purchase vaccine often faced rapidly escalating prices from

distributors with an available supply. For example, orders placed by

physicians in our sample during the peak vaccination months of October

and November cost an average of $7 per dose, compared with less than $3

per dose for orders that had been placed before the end of June 2000. State

health officials and providers who had placed orders early often waited for

 1

We selected physician practices that were members of the Medical Group Management

Association. Association members represent 7,000 to 8,000 physician group practices

nationwide that include an estimated 38 percent of office-based physicians who practice in

the United States. Because primary care practices routinely order flu vaccine, we randomly

selected from those group practices that were coded in the association’s membership

database as family practice and internal medicine specialties.

Results in Brief
Page 3 GAO-01-624 Influenza Vaccine Delay

delivery of their lower-priced vaccine from manufacturers and distributors

until late November or December. By December, when roughly one-third

of the vaccine became available, vaccine prices declined. However,

because the usual time for vaccination had passed and flu outbreaks were

relatively mild, demand for vaccine had also subsided and about 10

percent of vaccine eventually produced—or more than 7 million doses—

went unsold.

Currently, there is no system to ensure that high-risk people have priority

when the supply of vaccine is short. In a typical year, enough vaccine is

available in the fall to meet total demand, both from high-risk individuals

and from others who simply want to avoid the flu. When the supply

became short in the fall of 2000, however, there was no mechanism to

target vaccine to those who needed it most. For example, while more

elderly people tend to receive flu shots in physicians’ offices than at any

other location, our survey of physician practices found that on the whole

these physicians received their shipments at about the same delayed rate

that vaccine was generally available on the market. Efforts to target scarce

vaccine are complicated because all types of purchasers serve at least

some high-risk people. When shortages developed, manufacturers and

distributors had limited ability to identify and give priority to those

providers serving more high-risk individuals.

HHS has several initiatives underway to help mitigate the adverse effects

of future influenza vaccine shortages and delays. For example, CDC

revised its guidelines to extend the recommended timeframe for receiving

immunizations, and is helping bring together manufacturers, distributors,

providers, and others in the private and public sectors to explore ways to

improve distribution to high-risk individuals. The success of these

initiatives relies to a great extent on the cooperation of the many

organizations involved because the federal government has no direct

control over how influenza vaccine is purchased and distributed by the

private sector and state and local governments. This cooperation could be

fostered by HHS’ completion of its national plan to distribute scarce

vaccine during severe influenza epidemics—called pandemics. A related

step that could help mitigate the adverse effects of influenza during a

shortage of flu vaccine is to increase immunization rates against

pneumococcal pneumonia, one of the primary causes of deaths and

hospitalizations associated with influenza. HHS has initiated activities to

improve these immunization rates, but it has a long way to go to meet the

immunization goals it has set for the year 2010.
Page 4 GAO-01-624 Influenza Vaccine Delay

We are making recommendations to the Secretary of HHS to better

prepare for possible future disruptions to the influenza vaccine supply. In

commenting on a draft of this report, HHS identified ongoing or planned

actions related to two of our recommendations, and in response to our

third recommendation commented that CDC supports efforts to use

pneumococcal vaccine more widely.

Vaccination is the primary method for preventing influenza and its more

severe complications. Flu vaccine is produced and administered annually

to provide protection against particular influenza strains expected to be

prevalent that year. When the match between the vaccine and the

circulating viruses is close, vaccination may prevent illness in about 70-90

percent of healthy people aged 64 or younger. It is somewhat less effective

for the elderly and those with certain chronic diseases but, according to

CDC, it can still prevent secondary complications and reduce the risk for

influenza-related hospitalization and death.2 CDC estimates that during the

average flu season, for every 1 million elderly persons that are vaccinated

approximately 1,300 hospitalizations and 900 deaths are prevented.

Information on which groups are at highest risk for medical complications

associated with influenza and recommendations on who should receive a

flu shot are issued by CDC’s Advisory Committee on Immunization

Practices (ACIP).3

Because the flu season generally peaks between December and early

March, and because immunity takes about 2 weeks to establish, most

medical providers administer vaccinations between October and midNovember. CDC’s ACIP recommended this period as the best time to

receive a flu shot. However, if flu activity peaks in February or March, as it

has in 10 of the past 19 years, vaccination in January or later can still be

beneficial.

Producing the vaccine is a complex process that involves growing viruses

in millions of fertilized chicken eggs. This process, which requires several

steps, generally takes at least 6 to 8 months between January and August

each year. Each year’s vaccine is made up of three different strains of

influenza viruses, and typically each year, one or two of the strains is

 2

Limited studies have shown influenza vaccine may be about 30 to 70 percent effective in

reducing hospitalization among the noninstitutionalized elderly population.

3

See app. I for additional information on the recommendations for the 2000-01 flu season.

Background
Page 5 GAO-01-624 Influenza Vaccine Delay

changed to better protect against the strains that are likely to be

circulating during the next flu season. FDA decides which strains to

include and also licenses and regulates the manufacturers that produce

the vaccine.4

 Three manufacturers—two in the United States and one in

the United Kingdom—produced the vaccine used during the 2000-01 flu

season.5

Much like other pharmaceutical products, flu vaccine is sold to thousands

of purchasers by manufacturers, numerous medical supply distributors,

and other resellers such as pharmacies. Purchasers then administer flu

shots in medical offices, public health clinics, nursing homes and

pharmacies, as well as in less traditional settings such as grocery stores

and other retail outlets, senior centers, and places of employment. For the

1999-2000 flu season, about 77 million doses of vaccine were distributed

nationwide.6

 CDC estimates that about half of the vaccine was

administered to people with high-risk conditions and to health care

workers, and the balance was administered to healthy people younger

than 65 years.

Overall, manufacturing problems led to vaccine production and

distribution delays of about 6-8 weeks in 2000-01. Although the eventual

supply was about the same as the previous year’s, the delay limited the

amount of vaccine available during October and early November, the

period when most people normally receive their flu shot. While the effect

of the delay and initial shortage in terms of the number of high-risk

persons vaccinated will not be known for some time, other effects can be

observed, particularly in terms of the price of the vaccine. Providers who

decided to purchase vaccine from those distributors who had it available

during the October and November period of limited supply and higher

demand often found prices that were several times higher than expected.

Many providers who decided to wait for their orders placed earlier

eventually received them, and at the lower prices they had initially

 4

FDA decides which strains to include in the annual influenza vaccine based on the

recommendations of its Vaccines and Related Biological Products Advisory Committee.

5

The two manufacturers with facilities in the United States were Wyeth-Ayerst

Pharmaceuticals, Inc. and Aventis Pasteur Inc. The manufacturer with facilities in the

United Kingdom was Medeva Pharma Ltd.

6

About 3 million doses were returned to manufacturers at the end of the season, for a net

distribution of 74 million doses.

Manufacturing

Problems Caused

Temporary Shortages

and Spikes in Price
Page 6 GAO-01-624 Influenza Vaccine Delay

contracted for. By December, as vaccine supply increased and demand

dropped, prices declined.

For the 2000-01 flu season, manufacturers collectively took about 6-8

weeks longer than normally expected to produce and distribute all of the

flu vaccine. This delay meant that the bulk of the vaccine was not ready

for market during the period of October and early November that CDC

recommended as the best time to receive flu shots. This is also the time

when most practitioners are used to administering the vaccine and when

most people are used to receiving it. In 1999, more than 70 million doses of

vaccine were available by the end of October; in 2000, fewer than 28

million doses were available by that date.

Two main factors contributed to the delay. The first was that two

manufacturers had unanticipated problems growing one of the two new

influenza strains introduced into the vaccine for 2000-01. Because

manufacturers must produce a vaccine that includes all three strains

selected for the year, delivery was delayed until sufficient quantities of this

difficult strain could be produced. The second factor was that two of the

four manufacturers that produced vaccine the previous season shut down

part of their manufacturing facilities because of FDA concerns about

compliance with good manufacturing practices. One manufacturer

temporarily closed on its own initiative to make facility improvements and

address quality control issues raised during an FDA inspection; the other

was ordered by FDA to cease production until certain actions were taken

to address a number of concerns, including issues related to safety and

quality control. The former reopened its facilities but the other

manufacturer, which had been expected to produce 12-14 million doses for

the 2000-01 flu season, announced in September 2000 that it would cease

production altogether and, as a result, supplied no vaccine for 2000-01.

These problems did not affect every manufacturer to the same degree. In

particular, the manufacturer that produced the smallest volume of vaccine

did not experience production problems or delays in shipping its vaccine.

By the end of October, this manufacturer had distributed nearly 85 percent

of its vaccine, while the two other manufacturers had shipped only about

40 percent and less than 15 percent, respectively. Purchasers who ordered

their vaccine from the manufacturer with no major production problems

were far more likely to receive their vaccine on time. For example, the

state of Alabama ordered vaccine directly from all three manufacturers

before July 2000 at a similar price per dose. As table 1 shows, the state

received its shipments at markedly different times, reflecting how soon

Most Vaccine Was Not

Ready During Period of

Peak Demand
Page 7 GAO-01-624 Influenza Vaccine Delay

each manufacturer was able to get its vaccine to market. Purchasers that

contracted only with the late-shipping manufacturers were in particular

difficulty. For example, health departments and other public entities in 36

states banded together under a group purchasing contract and ordered

nearly 2.6 million doses from the manufacturer that ended up having the

greatest delays from production difficulties.7

 Some of these public entities,

which ordered vaccine for high-risk people in nursing homes or clinics, did

not receive most of their vaccine until December, according to state health

officials.

Table 1: Flu Vaccine Orders Placed in 2000 by the State of Alabama

Manufacturer

Manufacturer’s

rank to market

Dates

orders

placed

Number

of

vaccine

doses

ordered

Price

per dose

Date when at

least 75% of

order

received

Manufacturer #1 First May 3/

June 23

50,000 $2.49 October 3

Manufacturer #2 Second May 1 40,000 $2.37 October 25

Manufacturer #3 Third May 1/

June 23

35,030 $2.37 December 20

Source: Manufacturers’ rank based on data provided by influenza vaccine manufacturers. Alabama’s

specific order information based on data from the state of Alabama’s Department of Public Health.

The 2000-01 experience illustrates the fragility of the vaccine supply.

Because influenza virus strains take a certain period of time to grow, the

process cannot be accelerated to make up for lost time. When

manufacturers found that one strain for the vaccine was harder to produce

than expected, they adjusted their procedures to achieve acceptable

yields, but it still took months to produce.8

 Because only three

manufacturers remain, the difficulties associated with vaccine production,

and the need to formulate a new vaccine involving one or more new

strains each year, the future vaccine supply is uncertain. Problems at one

or more manufacturers can significantly upset the traditional fall delivery

of influenza vaccine.

 7

These included nearly 1,000 orders from state health departments, city and county health

departments, and other public institutions such as hospitals, universities, and prisons.

8

While each manufacturer produces the same three strains as the others for the annual

influenza vaccine, each manufacturer has its own production processes. As a result, one

manufacturer’s experience in producing a particular strain can differ from another

manufacturer’s experience with the same strain.
Page 8 GAO-01-624 Influenza Vaccine Delay

Because supply was limited during the usual vaccination period,

distributors and others who had supplies of the vaccine had the ability—

and the economic incentive—to sell their supplies to the highest bidder

during this time rather than filling lower-priced orders they had already

received. According to distributors, and purchasers, a vaccine order’s

price, quantity, and delivery might not be guaranteed. When no guarantee

or meaningful penalty applies, orders can be cancelled or cut and

deliveries can be delayed when vaccine is in short supply.9

Because of the production delays, many purchasers found themselves with

little or no vaccine when the peak time came for vaccinations. Many of

these purchasers had ordered vaccine months earlier at agreed-upon

prices, with delivery scheduled for early fall. While some orders were

cancelled outright or cut substantially, many purchasers were told that the

vaccine was still being produced and that their full order would be delayed

but delivered as soon as possible. This left many purchasers with a choice:

they could take a risk and wait for the vaccine they had ordered, or they

could try to find vaccine immediately to better ensure that patients were

vaccinated before the flu season struck. Most of the physician groups and

state health departments that we contacted reported that they waited for

delivery of their early orders.10 For example, of the 53 physician group

practices we surveyed that ordered vaccine before the end of June 2000,

34 groups waited for delivery of these original orders.11

Those who purchased vaccine in the fall—because they did not want to

wait for their early orders to be delivered later, had orders canceled or

reduced, or just ordered later—found themselves paying much higher

prices. The following examples illustrate the higher prices paid to make up

for reduced orders or delayed delivery:

• The state of Hawaii initially ordered 12,000 doses of vaccine from one

distributor in June at $2.80 per dose. When the distributor cut the order

 9

Alternatively, if meaningful guarantees or penalties are in place, manufacturers and

distributors may have less flexibility to redirect vaccine in the event of a shortage.

10Some state health officials, such as those in New York and Delaware, also ordered

additional vaccine to counter the potential effects of availability problems.

11The 34 physician groups placed 36 orders before the end of June 2000 that resulted in

shipments. They waited until November 2000 or later to receive the first shipments for

most of these orders.

Limited Availability During

Peak Demand Created

Temporary Price Spikes
Page 9 GAO-01-624 Influenza Vaccine Delay

by one-third, the state purchased vaccine from another distributor in

September at a price between $5.00 and $6.00 per dose.

• One physician practice ordered flu vaccine from a supplier in April

2000 at $2.87 per dose. When it received none of that vaccine by

November 1, the practice placed three smaller orders in November

with a different supplier at the escalating prices of $8.80, $10.80, and

$12.80 per dose. By the first of December, the practice ordered more

vaccine from a third supplier at $10.80 per dose. The four more

expensive orders were delivered immediately, before any vaccine had

been received from the original April order.

The data we collected from 58 physician group practices around the

country provide another indication of how prices spiked during the period

of high demand in October and November. Overall, the price paid by these

practices averaged $3.71 per dose. However, as table 2 shows, the average

price paid for orders placed by these practices in October and November

was about $7 per dose, compared with about $3 per dose for advance

orders placed in June or before.

Table 2: Prices Paid for Influenza Vaccine by Physician Groups Surveyed by GAO

Date order was placed Range of price per dose Average price per dose

June 2000 and earlier $1.90 to $6.35 $2.90

July through September 2000 $2.27 to $4.90 $4.01

October and November 2000 $2.50 to $12.80 $6.98

December 2000 and later $1.50 to $10.80 $3.48

Note: The 58 physician group practices we surveyed purchased a total of 89,245 doses of flu vaccine

during the 2000-01 season. This table is based on prices the groups paid for nearly 77,000 doses of

vaccine received in multidose vials. (The groups received a total of 77,240 doses of vaccine in vials,

but 350 doses were provided at no cost by a state health department and for 200 doses the price was

not known.) The physician groups also received 12,005 doses of vaccine in prefilled syringes, which

are excluded from this table because vaccine in prefilled syringes costs roughly double the price per

dose of vaccine sold in vials.

While some vaccine was available to those willing to pay a higher price in

October and November, some purchasers trying to buy vaccine reported

that they were unable to find vaccine from any supplier at any price during

that time. For example, one large health maintenance organization told us

that when delivery of its early order was delayed, it could not find any

source with the large number of doses it needed and ended up waiting

until November and December for delivery of more than a million doses it

had ordered in the spring.
Page 10 GAO-01-624 Influenza Vaccine Delay

Vaccine prices came down as a large quantity of vaccine was delivered in

December, after the prime period for flu vaccinations had passed. Vaccine

became increasingly available in December and manufacturers and

distributors delivered the orders or parts of orders that had been

postponed. In addition, recognizing the potential shortfall in production,

CDC contracted in September 2000 with one manufacturer to extend

production into late December for 9 million additional doses.12 Providers

buying vaccine in December could do so at prices similar to those in place

during the spring and summer. Among the physician groups we contacted,

none of which ordered under the CDC contract, the price for orders placed

in December or later averaged about $3.50 per dose—somewhat above the

average price paid through June, but about half of the average price of

orders placed in October and November.

Although vaccine was plentiful by December, fewer people were seeking

flu shots at that time. According to manufacturers and several large

distributors, demand for influenza vaccine typically drops by November

and it is difficult to sell vaccine after Thanksgiving. Despite efforts by CDC

and other public health officials to encourage people to obtain flu shots

later in the 2000-01 season, providers and other purchasers still reported a

drop in demand for flu shots in December 2000.

A reason people did not continue to seek flu shots in December and later

may have been that the 2000-01 flu season was unusually light. Data

collected by CDC’s surveillance system showed relatively low influenza

activity and mortality. While mortality due to influenza and pneumonia—

one indicator of the severity of a flu season—had surpassed CDC’s

influenza epidemic thresholds every year since 1991, it had not done so by

April of the 2000-01 season.13 Had a flu epidemic hit in the fall or early

winter, the demand for influenza vaccine may have increased

substantially.

As a result of the waning demand, manufacturers and distributors reported

having more vaccine than they could sell. Manufacturers reported shipping

about 70 million doses, or about 9 percent less than the previous year.

More than 7 million additional doses produced under the CDC contract

 12The manufacturer began accepting orders under this contract in early November, and

began shipping vaccine from these orders in mid-December 2000. Prices were $2.99 per

dose for public-sector purchasers and $5.00 per dose for private-sector purchasers.

13CDC monitors influenza activity through May of each year.

When More Vaccine

Became Available, Demand

and Prices Had Already

Dropped
Page 11 GAO-01-624 Influenza Vaccine Delay

were never shipped at all because of lack of demand. None of the

physician practices that we contacted had ordered from the CDC contract,

mainly because they were waiting for earlier orders to arrive or they had

already received some or all of their vaccine. In addition, some physicians’

offices, employee health clinics, and other organizations that administered

flu shots reported having unused doses in December and later. For

example, the state of Oklahoma reported having more than 75,000 unused

doses of vaccine.

While it is difficult to determine if any of these events will affect the price

of vaccine in the future, prices for early orders for the upcoming 2001-02

flu season have increased substantially over prior years’ prices. Physician

practices, state public health departments, and other purchasers reported

that their suppliers are quoting prices of $4 to $5 per dose, or about 50 to

100 percent higher than the early order prices for the 2000-01 season.

Citing expenses associated with expanding the production capacity and

the costs of maintaining a modern and compliant facility, one

manufacturer notified customers of a significant price increase for 2001-

02.

There is no mechanism currently in place to distribute flu vaccine to highrisk individuals before others. In a typical year, there is enough vaccine

available in the fall to give a flu shot to anyone who wants one. When the

supply was not sufficient in the fall of 2000, focusing distribution on highrisk individuals was difficult because all types of providers served at least

some high-risk people. Lacking information to identify which orders

should be filled first to serve the population most in need, manufacturers

and distributors who did attempt to target higher-risk persons used a

variety of approaches to distribute the limited vaccine. According to public

health officials and providers, there was confusion in many communities

as some providers were able to administer flu shots to anyone requesting

one, while at the same time, other providers had no vaccine for even their

highest-risk patients.

Like other pharmaceutical products, influenza vaccine is distributed

largely through multiple channels in the private sector that have evolved to

meet the specific needs of different types of purchasers. Those selling and

delivering vaccine include the manufacturers themselves, distributors of

general medical supplies and pharmaceuticals, and other types of resellers

such as pharmacies. According to data from the manufacturers, about half

Distribution of

Vaccine Does Not

Ensure Priority to

High-Risk Individuals

Influenza Vaccine Is

Distributed Through

Multiple Channels
Page 12 GAO-01-624 Influenza Vaccine Delay

of all flu vaccine is purchased by providers directly from manufacturers

and roughly half is purchased through distributors and resellers.

As a general practice, manufacturers said they pre-sell almost all of their

planned production volume by May or June of each year. Major

distributors and other large volume purchasers, including state health

departments, can obtain the most favorable prices by ordering directly

from manufacturers during this early order period. The distributors and

other resellers can then offer smaller purchasers such as physicians’

offices the convenience and flexibility of buying flu vaccine along with

their other medical supplies. Most experts we interviewed agreed that

when the supply of vaccine is sufficient, reliance on these varied

distribution channels allows for the successful delivery of a large volume

of influenza vaccine in time for the annual fall vaccination period.

Providers of flu vaccine also represent a diverse group. The annual

influenza vaccine is widely available as a convenience item outside the

usual medical settings of physicians’ offices, clinics, and hospitals. Millions

of individuals, including those who are not at high risk, receive flu shots

where they work or in retail outlets such as drugstores and grocery stores.

Some of these providers order their own flu vaccine from a manufacturer

or distributor, others participate in different types of purchasing groups,

and others contract with organizations such as visiting nurse agencies to

come in and administer the vaccine.

The widespread availability of flu shots at both traditional medical settings

and at convenience locations where people shop, work, and play may

contribute to increased immunization rates. HHS survey data show that

between 1989 and 1999, influenza immunization rates more than doubled

for individuals aged 65 and older (see table 3). During that same period,

however, immunization rates increased more than five-fold for the 18-49

year age group, which includes individuals who are likely to be at lower

risk and to receive flu shots in nonclinical settings.

Table 3: Percentage of Population Receiving Influenza Vaccination

Percent vaccinated

 Age group 1989 1995 1999

18-49 years 3.4 13.1 18.8

50-64 years 10.6 27.0 35.8

65 years and older 30.4 58.2 66.9

Sources: CDC’s 1989 and 1995 National Health Interview Surveys and 1999 Behavioral Risk Factor

Surveillance System data.
Page 13 GAO-01-624 Influenza Vaccine Delay

While access to flu shots in a wide range of settings is an established mass

immunization strategy, some physicians and public health officials view it

as less than ideal for targeting high-risk individuals. Because of the

expected delay or possible shortage of vaccine for the 2000-01 season,

CDC and ACIP recommended in July 2000 that mass immunization

campaigns be delayed until early to mid-November.14 CDC issued updated

guidelines in October 2000 which stated that vaccination efforts should be

focused on persons aged 65 and older, pregnant women, those with

chronic health conditions that place them at high risk, and health care

workers who care for them. Regarding mass immunization campaigns,

these updated guidelines stated that while efforts should be made to

increase participation by high-risk persons and their household contacts,

other persons should not be turned away.15

Although some vaccination campaigns open to both high-risk and lowerrisk individuals were delayed as recommended by CDC, many private

physicians and public health departments raised concerns that they did

not have vaccine to serve their high-risk patients at the time these

campaigns were underway. The following are a few examples of

promotional campaigns held across the nation that created controversy:

• One radio station sponsored a promotional event where a flu shot and a

beer were available at a local restaurant and bar for $10 to whoever

wanted one.

• One grocery store chain offered a discounted flu shot for anyone

bringing in three soup can labels.

• Flu shots were available for purchase at a professional football stadium

to all fans attending the game.

We interviewed several retail outlets and employers and the companies

they contract with to conduct mass immunization clinics. While some

reported that they disseminated information on who was at high risk and

stressed the need for priority vaccination among high-risk groups, they

generally did not screen flu shot recipients for risk. The perspective of

 14See CDC, “Delayed Supply of Influenza Vaccine and Adjunct ACIP Influenza Vaccine

Recommendations for the 2000-01 Influenza Season,” Morbidity and Mortality Weekly

Report, Vol. 49, No. 27 (July 14, 2000), pp. 619–622.

15See CDC, “Updated Recommendations from the Advisory Committee on Immunization

Practices in Response to Delays in Supply of Influenza Vaccine for the 2000-01 Season,”

Morbidity and Mortality Weekly Report, Vol. 49, No. 39 (Oct. 6, 2000), pp. 888-892.

Availability of Vaccine for

Mass Immunization

Campaigns Created

Controversy
Page 14 GAO-01-624 Influenza Vaccine Delay

these companies was that the burden lies with the individual to determine

his or her own level of risk, not with the provider. Moreover, they said that

the convenience locations provide an important option for high-risk

individuals, because physicians’ offices would have difficulty vaccinating

all high-risk individuals during the optimal time period of October through

mid-November. Other organizations held flu clinics open to lower-risk

individuals in the early fall before realizing the extent of the vaccine

supply problems.

Because there generally has been enough vaccine to meet demand in

recent years, there was little practical need for the fragmented distribution

process to develop the capability to determine which purchasers might

merit priority deliveries based on serving high-risk individuals. When the

supply of vaccine was delayed in the fall of 2000, the manufacturers and

distributors we interviewed reported that it was difficult to determine

which of their purchasers should receive priority vaccine deliveries in

response to the ACIP’s July and October 2000 recommendations to

vaccinate high-risk groups first. Although some types of providers are

more likely than others to serve high-risk individuals, it is likely that all

types of providers serve at least some high-risk individuals. CDC and ACIP

did not provide guidance about how to implement priority deliveries, and

manufacturers and some distributors reported that they often did not have

enough information about their customer base to make such decisions. As

a result, they reported using various approaches in distributing their

vaccine.16

• One manufacturer reported that it initially followed its usual policies of

distributing vaccine on the basis of initial order date—that is, orders

were filled on a first in, first out basis—and honoring contracts with

specific delivery dates. According to the manufacturer, a few contracts

in which purchasers paid a premium price for an early delivery date

received priority in distribution. However, less than halfway through its

season’s distribution, this company notified customers at the end of

October that it changed its policy in order to make partial shipments to

all purchasers as a way of ensuring more equitable treatment for all.

 16In addition to their specific approaches to distributing vaccine, two manufacturers also

sent letters notifying customers of the delays in distribution and the recommendations by

CDC and ACIP for the 2000-01 flu season.

Manufacturers and

Distributors Reported

Difficulty Determining

How to Get Vaccine to

High-Risk Individuals
Page 15 GAO-01-624 Influenza Vaccine Delay

• One manufacturer reported that it first shipped vaccine to nursing

home customers (where such customers could be identified) and then

made partial shipments to other customers.

• One manufacturer sold all of its vaccine in the United States through

one distributor. That distributor, which also sold vaccine from the

other manufacturers, told us that it attempted to give priority to orders

from physicians and then orders from state and local governments.

Other distributors we contacted also used varied approaches to distribute

vaccine in 2000. For example, officials from one large medical supply

distributor said that after a manufacturer cut its order substantially, the

distributor gave priority to the medical practices that ordered early. The

distributor reported that it cancelled all orders from resellers and

pharmacies, cancelled all orders that came in after June 21, and reduced

all orders from medical practices that came in before June 21 by an equal

percentage. Another medical supply distributor said it did not sell vaccine

to any providers that were not regular customers until it had filled the

early orders of its regular customers. Officials from the Health Industry

Distributors Association, a national trade association representing medical

products distributors, said that distributors are limited in their ability to

target certain types of people because they can only target distribution by

type of provider, such as physicians’ offices, nursing homes, or hospitals.

All of the manufacturers and distributors we talked to said that once they

distributed the vaccine it would be up to the purchasers and health care

providers to target the available vaccine to high-risk groups.

The success of these various approaches to reach high-risk groups was

limited by the wide variety of paths the vaccine takes from the

manufacturers to the providers who administer the flu shots. For example,

although one manufacturer shipped available vaccine to the nursing

homes it could identify in its customer base as first priority, this did not

ensure that all nursing homes received vaccine for their high-risk patients

on a priority basis. State health officials reported that nursing homes often

purchase their flu vaccine from local pharmacies or rely on public health

officials to provide the vaccine. In those cases, how quickly nursing homes

received vaccine for their high-risk residents depended on the practices

along the distribution chain—in some cases involving the practices of

manufacturers, distributors, pharmacies, and public health providers.

Attempts to Target HighRisk Groups Were

Complicated by the Variety

of Distribution Channels
Page 16 GAO-01-624 Influenza Vaccine Delay

Physicians also reported that they did not receive priority, even though

nearly two-thirds of the elderly who had flu shots in 1998-99 received them

in medical offices.17 The American Medical Association and other

physicians told us that in some communities vaccine was available at retail

outlets and other sources before physicians’ offices. The 58 physician

group practices we surveyed, which received nearly 90,000 doses from

manufacturers, distributors, and other resellers reported receiving their

vaccine at about the same time or slightly later than when manufacturers

shipped more than 70 million doses (see table 4). Thus as a group these

physician practices appeared to experience no priority in vaccine

distribution.

Table 4: Percentage of Influenza Vaccine Shipped by Manufacturers Compared With

Percentage Received by Surveyed Physician Groups, by Month, 2000-01 Flu Season

Month shipped/received

September 2000

and earlier

October

2000

November

2000

December 2000

and later

Vaccine

shipped by

manufacturers

20 19 29 31

Vaccine

received from

all sources by

surveyed

physician

groups

20 18 25 38

Note: Percentages may not total 100 percent because of rounding. Table does not include over 7

million unsold and unshipped doses retained by manufacturers. Vaccine received by physician

groups includes vaccine in vials and prefilled syringes from all sources.

Source: Vaccine shipped by manufacturers based on data provided by influenza vaccine

manufacturers. Vaccine received by physician groups based on data from GAO’s survey of 58

physician group practices.

 17Data collected by states through the CDC Behavioral Risk Factor Surveillance System

during 1999 indicated that among persons aged 65 years or older reporting receipt of

influenza vaccine in the past 12 months, about 63 percent reported receiving their last

influenza vaccination at physicians’ offices and health maintenance organizations; followed

by other types of clinics (9 percent); senior, recreation, or community centers (7 percent);

health departments (6 percent); hospitals (6 percent); stores (5 percent); workplaces (1

percent); and other locations (2 percent).
Page 17 GAO-01-624 Influenza Vaccine Delay

While HHS has no direct control over how influenza vaccine is purchased

and distributed by the private sector and local governments during the

annual influenza season, it has several initiatives under way to help

mitigate the adverse effects of any future shortages and delays.18 Success

of these various efforts, however, relies on collaboration between the

public and private sectors. Completion of HHS’ national plan to respond to

an influenza pandemic could help foster this type of collaboration and

provide a foundation to deal with vaccine shortages or delays in nonpandemic years. In the meantime, increasing immunization rates against

pneumococcal pneumonia, which can follow the flu, may help reduce

influenza-related illness and death.

In response to the production and distribution problems experienced with

flu vaccine for the 2000-01 flu season, HHS has undertaken several

initiatives. As shown in table 5, these initiatives include (1) conducting

clinical trials on the feasibility of using smaller doses of vaccine for

healthy 18- to 49-year-olds, (2) working with public and private sector

entities involved in vaccine distribution to explore ways of better targeting

vaccine to high-risk groups, (3) recommending state and local health

department actions to prepare for a vaccine delay or shortage, and (4)

revising guidelines to expand the recommended timing of influenza

immunizations.

 18Under the Federal Food, Drug and Cosmetic Act, FDA has only limited authority to

regulate the resale of prescription drugs, including influenza vaccine, that have been

purchased by health care entities such as public or private hospitals. This authority does

not apply to wholesale distributors, who are excluded from the definition of health care

entities.

HHS Has Initiatives

Under Way to Prepare

for Future Vaccine

Delays and Shortages

Several Initiatives

Undertaken in Response to

the 2000-01 Flu Season
Page 18 GAO-01-624 Influenza Vaccine Delay

Table 5: HHS Initiatives in Response to the 2000-01 Flu Season

Initiative How this would help Status

The National Institutes of Health,

working with FDA and CDC,

conducted a clinical trial to evaluate

the immune responses in healthy

adults aged 18-49 years who received

a half-dose of vaccine.

Reducing the dosage of vaccine given to healthy

adults may be an acceptable strategy to increase

the number of doses available in the event of

shortages.

Preliminary results that were

disseminated in October 2000 indicated

that a half-dose of one manufacturer’s

vaccine appears to offer an acceptable

level of protection for healthy adults

aged 18-49 years. Final results are due

in the fall of 2001.

Discussion among private- and publicsector entities involved in vaccine

distribution regarding options to

improve distribution of influenza

vaccine when in short supply.

Private- and public-sector entities involved with

vaccine distribution could agree to consistent

strategies and approaches to direct vaccine to

high-risk groups in times of delay or shortage.

On March 27, 2001, CDC and the

American Medical Association

cosponsored a meeting with

representatives from physician groups,

manufacturers, distributors, and public

health officials to discuss the problems

experienced in 2000-01 and distribution

of flu vaccine in the event of a future

shortage.

Recommending state and local

government actions and requesting

that states develop draft contingency

plans to maximize influenza

vaccination in the event of a delay or

shortage of vaccine.

State and local health officials could work with

private- and public-sector entities involved in

providing vaccine to develop strategies and

approaches to direct vaccine to high-risk groups if

a vaccine delay or shortfall occurred.

CDC has recommended actions for state

and local health departments. These

include developing contingency plans to

address delays in distribution or

shortages of vaccine if they occur and

collaborating with other groups or

coalitions involved in adult immunization

efforts. CDC requested that states

provide draft plans before June 2001.

Revising guidelines on timing of

influenza vaccination to extend the

optimal time for vaccination after midNovember.

Extending the demand past mid-November could

help during temporary shortages. Most flu

seasons do not peak until late December through

early March and vaccine can be an effective

intervention if given 2 weeks before exposure.

CDC’s ACIP issued revised guidelines

for the 2001-02 flu season on April 20,

2001. These guidelines extend the

optimal time for vaccination through the

end of November.

Success of these initiatives relies to a great extent on the willingness of

manufacturers, distributors, private physicians, other vaccine providers,

and the public to cooperate. For example, if manufacturers requested and

FDA approved the use of half-doses of vaccine for certain healthy adults

while full-doses of vaccine were given to high-risk adults, implementation

strategies may have to address provider concerns about any associated

administrative burden. And if distribution guidelines are agreed upon and

implemented, vaccine sellers may have to sacrifice the additional revenue

of selling to those willing to pay higher prices regardless of relative need.

The importance of collaboration between the public and private sector to

develop and implement initiatives to address flu vaccine shortages at the

state and local level was highlighted by state public health officials we

interviewed. States where public- and private-sector entities collaborated
Page 19 GAO-01-624 Influenza Vaccine Delay

early to deal with the delay in vaccine shipments reported some success in

targeting high-risk people for vaccination. For example:

• Before the fall 2000 vaccination period, health officials in Utah had

partnered with Medicare’s local Peer Review Organization (PRO) and a

private managed care organization and others to form an Adult

Immunization Coalition.19 This coalition had already identified the

number and location of high-risk people living in the state and worked

to target vaccine first to these locations.

• New Mexico health officials participated in a consortium with public

and private providers that purchased about 90 percent of vaccine in the

state. After nursing home residents were vaccinated, this consortium

implemented a three-tiered vaccination strategy. This strategy first

targeted the elderly, people with chronic disease and health care

workers. Next it targeted household members or close contacts of the

first group. Finally, it targeted vaccine to everyone else.

CDC officials acknowledge that outreach and educational efforts are

needed to change the behavior of both providers and the public to

recognize the benefit of flu shots administered after mid-November. For

the 2000-01 flu season, CDC undertook several outreach and educational

efforts, including issuing guidelines and notices in its Morbidity and

Mortality Weekly Report, posting information on a CDC web site, and

conducting a media campaign in selected cities. However, the relative

effectiveness of these various efforts remains unknown.20

In addition, CDC has planned various projects to evaluate the impact of

the delay of flu vaccine availability on immunization rates and the

vaccination practices of providers for the 2000-01 season. For example,

CDC is surveying providers about the risk level of the people they

vaccinated, providers’ responses to the delays in obtaining vaccine, and

the methods they used to target vaccinations.

 19PROs promote quality of care improvements for Medicare beneficiaries in every state.

20One example of the difficulties of outreach to provider groups is that fewer than half of

the 58 physician group practices we contacted had heard about the CDC contract that

made available 9 million doses in December.
Page 20 GAO-01-624 Influenza Vaccine Delay

HHS has been working since 1993 to develop a national response plan that

would outline actions to be taken to address vaccine delays or shortages

during an influenza pandemic.21 While such a plan is expected to be used

only in cases of public health emergencies, advance preparation by

manufacturers, distributors, physicians, and public health officials to

respond to a pandemic could provide a foundation to deal with some of

the problems experienced during the 2000-01 flu season. For example,

while some manufacturers and distributors tried various methods to target

vaccine first to people who were at high risk for complications, they were

often unable to identify these populations. The development of a

methodology to identify and target various population groups under the

pandemic plan could be a useful tool in this regard. In addition, pandemic

planning activities could build collaborative relationships among affected

parties that could be useful in dealing with vaccine shortages in nonpandemic years. As we reported in October 2000, HHS has not completed a

national pandemic response plan that would, among other things, address

how to deal with shortages of vaccine.22 While HHS has set a completion

date of June 2001 for the body of the plan, it has not set specific dates for

completing the detailed appendixes needed to implement the plan should

vaccine be delayed or in short supply.

Another ongoing HHS effort that could mitigate the impact of an influenza

vaccine shortage is to increase adult immunization rates against

pneumococcal disease, which causes a type of pneumonia that frequently

follows influenza.23 The population most at risk for pneumococcal

pneumonia includes the elderly and those with chronic illnesses—the

same groups at high-risk for complications or death following infection

with influenza. Because pneumococcal vaccine provides immunity for at

least 5 to 10 years, it can provide some protection against one of the

serious complications associated with influenza if the annual influenza

vaccine is unavailable.

 21Occasionally, worldwide influenza epidemics—called pandemics—cause exceptionally

high levels of illness and mortality in the population. The worst flu pandemic occurred in

1918 and killed half a million U.S. citizens. More recent pandemics occurring in 1957 and

1968 were responsible for 70,000 and 34,000 U.S. deaths, respectively.

22See Influenza Pandemic: Plan Needed for Federal and State Response (GAO-01-4, Oct.

2000).

23CDC officials generally attribute about one-third of the 20,000 flu-related deaths each year

to influenza-related pneumonia, and most of these deaths are attributed to a type of

bacterial pneumonia that may be prevented with the pneumococcal vaccine.

Pandemic Response Plan

Is Still Incomplete

Increased Pneumococcal

Immunizations Could

Mitigate the Impact of an

Influenza Vaccine Shortage
Page 21 GAO-01-624 Influenza Vaccine Delay

Although pneumococcal vaccine provides added protection against a

major influenza-related illness, widespread use among the high-risk

population remains relatively low. HHS has set its goal for 2010 to achieve

90 percent immunization against pneumococcal disease among the elderly

and 60 percent among other high-risk adults.24 Available data show that

only 54 percent of the elderly and 13 percent of younger high-risk adults

have been vaccinated against pneumococcal disease.25 For the population

65 years and older, HCFA, which administers the Medicare program, has

activities directed toward increasing both pneumococcal and influenza

vaccination rates. For example, HCFA has contracted with its 53 PROs to

work within communities to raise immunization rates. The extent that

state immunization rates for pneumococcal vaccine and influenza vaccine

improve over time is a factor that HCFA will consider in evaluating PRO

performance.

CDC also supports efforts to increase adult immunizations, such as

influenza and pneumococcal immunizations, for people aged 65 and older

and others with medical conditions placing them at high risk for influenza

and pneumococcal pneumonia. In 2001, CDC awarded $159 million for

Preventive Health Services Immunization grants to support state

infrastructures for childhood and adult immunization. However, because

CDC considers activities to support childhood immunization a priority for

these grants, only 5 of the 64 grantees targeted more than 10 percent of

grant funds to support adult immunization efforts.

While HCFA and CDC have taken some steps to coordinate many of their

adult immunization activities, including efforts to increase pneumococcal

immunization, their performance goals may differ. For example, in their

fiscal year 2001 performance plans, HCFA set a target of vaccinating 55

percent of those 65 years and older against pneumococcal disease, while

CDC set a more ambitious target of 63 percent.

 24For the year 2000, HHS had set a target of 60 percent immunization against pneumococcal

disease among noninstitutionalized people aged 65 and older.

25The estimated rate for those aged 65 and older is based on preliminary data from CDC’s

1999 Behavioral Risk Factor Surveillance System. The estimated rate for the high-risk

population aged 18-64 years is based on 1998 baseline data from CDC’s National Health

Interview Survey, as reported in Department of Health and Human Services, “Immunization

and Infectious Diseases,” Healthy People 2010, Second Edition, November 2000.
Page 22 GAO-01-624 Influenza Vaccine Delay

The circumstances that led to the delay and early shortage of flu vaccine

during the 2000-01 flu season could repeat themselves in the future.

Ensuring an adequate and timely supply of vaccine, already a difficult task

given the current manufacturing process, has become even more difficult

as the number of manufacturers has decreased. Now, a production delay

or shortfall experienced by even one of the three remaining manufacturers

can significantly impact overall vaccine availability. The effects of

production delays in 2000-01 were exacerbated by the expectation of

providers and the public that flu shots should be received by Thanksgiving

or not at all, even though a flu shot after this time would provide a

reasonable level of protection in most years. In the event of a future delay

or shortage, determining the most effective means of changing this

traditional behavior will be beneficial.

The purchase, distribution, and administration of flu vaccine are mainly

private-sector responsibilities. Consequently, HHS’ actions to help mitigate

any adverse effects of vaccine delays or shortages need to rely to a great

extent on collaboration with private-sector participants. By completing its

own planning efforts for dealing with these issues during a pandemic, as

we previously recommended, HHS would provide a foundation for

building collaboration among suppliers and purchasers of flu vaccine that

could help improve the vaccine distribution process. The March 2001

meeting with public health officials, vaccine manufacturers, distributors,

physicians, and others is a potentially useful first step towards developing

voluntary guidelines for distribution in the event of a future delay or

shortage, but more work is needed before consensus is achieved. Success

is contingent on consensus and continued commitment by all parties.

In addition, to maximize results federal and state agencies need to fully

coordinate their pneumococcal vaccination efforts to set and achieve

common goals. While pneumococcal vaccination is not a substitute for the

annual flu shot, it can provide protection against a major complication of

influenza if the flu vaccine is not available. In the event that future

shortages of influenza vaccine cannot be avoided, coordination among

HCFA, CDC, and state programs designed to increase pneumococcal

immunizations now may contribute to lowering future hospitalization and

death rates due to influenza-related pneumonia.

We recommend that the Secretary of HHS take the following actions:

• To prepare for potential delays or shortages in flu vaccine, instruct the

Director of CDC to assess the relative success of its past outreach and

Conclusions

Recommendations for

Executive Action
Page 23 GAO-01-624 Influenza Vaccine Delay

education efforts and identify those means that are most effective in

changing behavior to meet public health priorities. When appropriate,

these means should be used as the primary method to educate flu

vaccine providers and the general public well before the start of the

traditional fall vaccination period.

• To improve response to future vaccine delays or shortages, instruct the

Director of CDC to continue to take a leadership role in organizing and

supporting efforts to bring together all stakeholders to formulate

voluntary guidelines for vaccine distribution. Specifically, in

formulating guidelines for getting vaccine to high-risk individuals first

in times of need, work with stakeholders to pursue the feasibility of

steps that showed promise in the 2000-01 flu season.

• To maximize use of federal resources, instruct the Director of CDC to

work to complement HCFA’s ongoing activities to improve

pneumococcal immunization rates among the Medicare population and

focus CDC’s funded efforts on increasing pneumococcal immunization

in the high-risk non-Medicare population.

We provided a draft of this report to HHS for review. In its written

comments (see app. II), HHS identified actions that it had initiated or

planned to undertake related to two of our recommendations. For

example, HHS stated that CDC had efforts underway to assess the relative

success of the outreach and educational efforts for the 2000-01 flu season,

and that it was working with stakeholders to try to develop contingency

plans for vaccine distribution in the event of future supply problems.

Regarding our third recommendation, HHS stated that pneumococcal

immunization could be part of a broader plan for the government to

reduce the overall impact of influenza in case of vaccine supply problems.

HHS also commented that our draft report overstated HHS’ authority to

exercise greater control over vaccine purchase and distribution in the

event of a public health emergency such as an influenza pandemic. We

have revised the report language to better reflect our point, which was not

about the extent of HHS’ authority to respond to a pandemic, but rather

about using pandemic planning activities to better prepare for vaccine

shortages in non-pandemic years as well. HHS also provided technical

comments, which we incorporated where appropriate.

We are sending copies of this report to the Honorable Tommy G.

Thompson, Secretary of HHS; the Honorable Jeffrey P. Koplan, Director of

CDC; the Honorable Bernard A. Schwetz, Acting Principal Deputy

Commissioner of FDA; Michael McMullan, Acting Deputy Administrator of

Agency Comments
Page 24 GAO-01-624 Influenza Vaccine Delay

HCFA; Martin G. Myers, Director of NVPO; and others who are interested.

We will also make copies available to others on request.

If you or your staffs have any questions, please contact me at (202) 512-

7119. An additional GAO contact and the names of other staff who made

major contributions to this report are listed in appendix III.

Janet Heinrich

Director, Health Care—Public Health Issues
Page 25 GAO-01-624 Influenza Vaccine Delay

List of Requesters

The Honorable Tim Johnson

The Honorable Ron Wyden

United States Senate

The Honorable Sherrod Brown

The Honorable Lois Capps

The Honorable Gary A. Condit

The Honorable Joseph Crowley

The Honorable Peter A. DeFazio

The Honorable Lloyd Doggett

The Honorable Jo Ann Emerson

The Honorable Bob Filner

The Honorable Martin Frost

The Honorable Charles A. Gonzalez

The Honorable Dennis J. Kucinich

The Honorable Sander M. Levin

The Honorable Frank A. LoBiondo

The Honorable Nita M. Lowey

The Honorable James H. Maloney

The Honorable James P. McGovern

The Honorable Patsy T. Mink

The Honorable Earl Pomeroy

The Honorable Lucille Roybal-Allard

The Honorable Thomas C. Sawyer

The Honorable Janice D. Schakowsky

The Honorable Christopher H. Smith

The Honorable Fortney Pete Stark

The Honorable Mike Thompson

The Honorable Tom Udall

The Honorable Henry A. Waxman

The Honorable Anthony D. Weiner

House of Representatives
Appendix I: CDC Advisory Committee

Recommendations on Target Groups for

Influenza Vaccination, 2000-01

Page 26 GAO-01-624 Influenza Vaccine Delay

For the 2000-01 flu season, the CDC Advisory Committee on Immunization

Practices (ACIP) issued guidance in April 2000 that strongly recommended

influenza vaccination for those persons who—because of age or

underlying medical condition—are at increased risk for complications of

influenza. For the first time, the committee lowered the age for universal

vaccination from 65 years to 50 years of age, adding an estimated 28 to 31

million persons to the target population. The reason for this expansion

was to increase vaccination rates among persons aged 50-64 with high-risk

conditions, since age-based strategies have been more successful than

strategies based on medical condition. The committee also recommended

that health-care workers and other individuals in close contact with

persons in high-risk groups should be vaccinated to decrease the risk of

transmitting influenza to persons at high risk.

Because of expected delays or possible shortages of influenza vaccine for

the 2000-01 flu season, the committee issued adjunct recommendations on

July 14, 2000. In addition to recommending that mass immunization

campaigns be delayed, these adjunct recommendations said that (1)

vaccination of high-risk individuals should proceed with available vaccine,

(2) provider-specific contingency plans should be developed for possible

vaccine shortages, and (3) vaccine administered after mid-November can

still provide substantial benefits.

Updated recommendations were issued on October 6, 2000, stating that a

shortage had been averted but distribution would be delayed. These

updated recommendations placed highest priority on those persons aged

65 and older, pregnant women and those persons with chronic health

conditions that placed them at high risk, and health care workers who care

for them. Table 6 shows the target groups for influenza immunization from

these updated recommendations. The update also recommended that mass

vaccination campaigns should be scheduled later in the season and that

these campaigns should try to enhance coverage among those at greatest

risk for complications of influenza and their household contacts. However,

the recommendations stated that other persons should not be turned

away. The updated recommendations also emphasized that special efforts

should be made in December and later to vaccinate persons aged 50-64

and that vaccination efforts for all groups should continue into December

and later when vaccine was available.

Appendix I: CDC Advisory Committee

Recommendations on Target Groups for

Influenza Vaccination, 2000-01
Appendix I: CDC Advisory Committee

Recommendations on Target Groups for

Influenza Vaccination, 2000-01

Page 27 GAO-01-624 Influenza Vaccine Delay

Table 6: Updated ACIP Recommendations on Target Groups for Influenza

Immunization, 2000-01

Target group Estimated population

All persons aged 65 and older 35 million

Persons under age 65 with chronic underlying medical

conditions 33-39 million

Residents of nursing homes and other chronic-care facilities 2 million

Pregnant women (in 2nd or 3rd trimester during the flu season) 2 million

Health care workers 7-8 million

Close contacts of those at high risk 40-60 million

Note: Categories are not mutually exclusive.

Source: CDC, “Updated Recommendations from the Advisory Committee on Immunization Practices

in Response to Delays in Supply of Influenza Vaccine for the 2000-01 Season,” Morbidity and

Mortality Weekly Report, Vol. 49, No. 39 (Oct. 6, 2000), pp. 888-892; CDC, “Prevention and Control

of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP),”

Morbidity and Mortality Weekly Report, Vol. 49, No. RR-3 (April 14, 2000), pp. 1-38; and National

Immunization Program, CDC, unpublished data, 2000.
Appendix II: Comments From the Department of Health and

Human Services

Page 28 GAO-01-624 Influenza Vaccine Delay

Appendix II: Comments From the

Department of Health and Human Services
Appendix II: Comments From the Department of Health and

Human Services

Page 29 GAO-01-624 Influenza Vaccine Delay
Appendix II: Comments From the Department of Health and

Human Services

Page 30 GAO-01-624 Influenza Vaccine Delay
Appendix II: Comments From the Department of Health and

Human Services

Page 31 GAO-01-624 Influenza Vaccine Delay
Appendix III: GAO Contact and

Staff Acknowledgments

Page 32 GAO-01-624 Influenza Vaccine Delay

Frank C. Pasquier, (206) 287-4861

Other major contributors to this report were Lacinda Ayers, George

Bogart, Ellen M. Smith, Stan Stenersen, and Kim Yamane.

Appendix III: GAO Contact and Staff

Acknowledgments

GAO Contact

Staff

Acknowledgments

(290011)
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