Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?

Inf r a s t ru c t u r e
Why Are Pharmaceutical

Companies Gradually
Abandoning Vaccines?
Congress has the power to protect vaccines, a product that is vital to
the health of the United States and the rest of the world.
by Paul A. Offit
ABSTRACT: During the past fifty years, the number of pharmaceutical companies making
vaccines has decreased dramatically, and those that still make vaccines have reduced re-
sources to make new ones. Pharmaceutical companies are gradually abandoning vaccines
because the research, development, testing, and manufacture of vaccines are expensive
and because the market to sell vaccines is much smaller than the market for other drug
products. Congressional action could assure both a steady supply of existing vaccines and
the promise of vaccines for the future.
P
h a r m ac e u t i c a l c o m pa n i e s a r e b u s i n e s s e s , not public health agen-
cies; they are not obligated to make vaccines. Events during the past fifty
years have made the manufacture of vaccines more expensive and their sale
less profitable. What follows here are case studies of two important vaccines, one
for polio and the other for influenza, and the factors that either encouraged or dis-
couraged their production.
n Polio vaccine, 1955. In mid-1953, the National Foundation for Infantile Paral-
ysis (the March of Dimes) was ready to test Jonas Salk’s polio vaccine. Made by
treating live polio virus with formaldehyde, the Salk vaccine was initially tested in
161 children in and around Pittsburgh.1 When it was time to determine whether
Salk’s vaccine worked in a field trial involving hundreds of thousands of children,
Basil O’Connor, the foundation’s director, turned to the two largest vaccine makers
in the United States: Eli Lilly of Indianapolis and Parke Davis of Detroit.2 O’Connor
realized that only pharmaceutical companies had the expertise, facilities, experi-
ence, and skill required to make that much vaccine. After the field trial proved suc-
cessful—and the polio vaccine was ready to be sold to the public—three more phar-
maceutical companies entered the field: Pitman-Moore of Zionville, Indiana; Wyeth
Laboratories of Marietta, Pennsylvania; and Cutter Laboratories of Berkeley, Cali-
Paul Offit (offit@email.chop.edu) is chief of the Division of Infectious Diseases and director of the Vaccine
Education Center at the Children’s Hospital of Philadelphia. He is also a professor of pediatrics at the University of
Pennsylvania School of Medicine in Philadelphia.
622 May/ June 2005

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D ru g Com pani e s
fornia.3 Between 1955 and 1962, physicians and public health agencies administered
400 million doses of polio vaccine across the United States, and the incidence of
polio decreased by 90 percent.4
n Influenza vaccine, 2003–2005. The commitment by five pharmaceutical
companies to make polio vaccines in 1955 stands in sharp contrast to companies’
lack of commitment to making influenza vaccines today. For 2003–04, drug compa-
nies made eighty-three million doses of influenza vaccine for the United States:
forty-eight million doses were made by Aventis in Swiftwater, Pennsylvania, and
thirty-five million doses, by Chiron in Liverpool, England.5 Because the influenza
epidemic of 2003–04 started early and because cases were particularly severe, the
media broadcast stories daily of those who were hospitalized for and died of the dis-
ease. Demand for the flu vaccine quickly exceeded supply, and many people who
wanted and needed the vaccine could not get it.
The flu vaccine shortage was repeated a year later. For 2004–05, Aventis made
fifty-five million doses and Chiron made forty-eight million. But because of a
manufacturing error, British regulatory authorities prohibited the sale of
Chiron’s vaccine. As a consequence, about thirty million fewer doses of influenza
vaccine were available for 2004–05 than the year before. The U.S. Centers for Dis-
ease Control and Prevention (CDC), the U.S. Food and Drug Administration
(FDA), and drug companies were all blamed for their inefficiencies, and during
the presidential debate on 13 October 2004 between George W. Bush and John
Kerry, each candidate accused the other of failing to provide the nation with
needed influenza vaccine.
The flu vaccine shortages of 2003–2005 are just one example of what has been
a steady, unrelenting series of vaccine shortages.6 Since 1998, nine of twelve vac-
cines routinely recommended for young children have been in short supply: spe-
cifically, vaccines to prevent measles, mumps, rubella (German measles), vari-
cella (chickenpox), tetanus, diphtheria, whooping cough (pertussis), influenza,
and pneumococcal disease. All of these shortages have caused children to miss
vaccines that they needed, and some children never caught up when the short-
ages were over.
Factors That Discourage Vaccine Making

Recent vaccine shortages are not coincidental, nor do they represent short-lived,
easily fixable problems in the vaccine industry. Rather, several market forces ex-
plain why pharmaceutical companies are gradually abandoning vaccines.
n Small market for vaccines compared with drugs. Vaccines are used at most
several times in a lifetime; drugs are often used every day. Therefore, the market for
drugs is much greater than the market for vaccines. For example, the conjugate
pneumococcal vaccine for children (Prevnar), the highest-revenue-generating vac-
cine, has annual gross U.S. sales of about $1 billion. But markets for cholesterol-
lowering agents; hair-loss products; potency drugs; and drugs for heart disease,
H E A L T H A F F A I R S ~ Vo l u m e 2 4 , N u m b e r 3 623

obesity, or neurological problems are often $7 billion per drug or more. (Annual rev-
enues for Lipitor, a cholesterol-lowering agent, are greater than revenues for the en-
tire worldwide vaccine industry.)7
Because of the large private market for drugs, many companies compete to
make similar products; however, no other company has made a pneumococcal
vaccine for children. Of the twelve vaccines routinely recommended for infants
and young children, seven are made by one company, and only one is made by
more than two companies.
n Effect of mergers. During the past fifty years, companies devoted solely or
primarily to manufacturing vaccines (such as Lederle and Praxis) have been ac-
quired by other pharmaceutical companies; the number of companies making vac-
cines has decreased from twenty-six in 1967 to seventeen in 1980 and to five in 2004
(GlaxoSmithKline, Sanofi-Aventis, Merck, Wyeth, and Chiron).8 Previously, among
companies that made vaccines only, resources for development of one vaccine would
compete with resources for the development of another. Now, because of mergers,
vaccines compete for resources with drugs and most often lose.
To determine where they should invest research and development (R&D) dol-
lars, pharmaceutical companies evaluate a product’s potential to contribute to
their bottom line. Among the four large companies still making vaccines (Chiron
accounts for less than 1 percent of the worldwide vaccine industry), none has rev-
enue from vaccines that exceeds 10 percent of total revenue.9 All four companies
could stop making vaccines tomorrow without much impact on their bottom
lines. In 2002, Wyeth stopped making its combination diphtheria–tetanus–
acellular pertussis (DTaP) and influenza vaccines. The decision had little impact
on shareholders but a major impact on stakeholders; it precipitated vaccine
shortages and vaccine rationing for both DTaP and influenza vaccines.10
n Dramatic reduction in the private vaccine market. In 1955, after the field
trial of Jonas Salk’s polio vaccine found it to be safe and effective, a large private mar-
ket was available to sell the polio vaccine. Today the largest single U.S. purchaser of
vaccines is the federal government through the Vaccines for Children (VFC) pro-
gram. This program—launched in 1994 to provide vaccines to all uninsured and
some underinsured children in the United States—purchases 55–60 percent of all
vaccines.11 As a large single purchaser, the federal government creates a functional
cap on vaccine prices and, more importantly, has contributed to shrinking the pri-
vate market—a market consisting almost entirely of insurance companies.
n Low or inconsistent insurance reimbursements. In 1995 the FDA licensed a
vaccine to prevent chickenpox (varicella). The varicella vaccine was the first vaccine
to be licensed and recommended in a private market dominated by insurance com-
panies. Many insurance companies initially refused to reimburse doctors for the vac-
cine, and some reimbursed doctors below the cost of the vaccine. As a consequence,
doctors bought large quantities of varicella vaccine out of their own pockets with-
out a clear understanding of whether and at what level they would be reimbursed.
624 May/ June 2005

D ru g Com pani e s
Predictably, within one year of licensure, only about 10 percent of children recom-
mended by the CDC to receive varicella vaccine got it.
n Lack of infrastructure support. In 1955 doctors bought the polio vaccine for
$1.50 per dose and sold it to their patients for $5. In the late 1970s doctors bought the
combination measles-mumps-rubella vaccines for $25 per dose and sold them for
$75. Because people paid for vaccines out of their own pockets, doctors could de-
pend on reimbursements that offset the enormous infrastructure required to pur-
chase, store, administer, and record vaccines.
Reimbursements for the polio vaccine fifty years ago are at variance with reim-
bursements for the influenza vaccine today. In 2004 the CDC changed its recom-
mendation for the influenza vaccine; it recommended that all children ages 6–23
months, and all family members living in the home of children less than two years
of age, receive a flu vaccine.12 The CDC’s recommendation was difficult to imple-
ment. Doctors had to create an infrastructure within their practices that in-
cluded hiring receptionists to schedule appointments and hiring nurses to ad-
minister a yearly, seasonal vaccine. But reimbursements by insurance companies
for vaccines, including “administration fees,” were about 5–10 percent above the
cost of the vaccine, compared with a 300 percent markup for vaccines when the
private market consisted of direct out-of-pocket payments. By refusing to pay for
the infrastructure required to administer vaccines, the federal government and
insurance companies are asking doctors to pay for the infrastructure themselves.
As a consequence, doctors often view new vaccines, or expanded recommenda-
tions for existing vaccines, as yet another burden to be borne by their practices.
n Public buy-in versus public buy-out. On 31 May 1954 a Gallup poll showed
that more Americans knew about the field trial of Jonas Salk’s polio vaccine than
knew the full name of the U.S. president, Dwight David Eisenhower.13 This was be-
cause more Americans participated in the funding, development, and testing of the
polio vaccine than in the nomination and election of the president. The March of
Dimes increased awareness of polio and anticipation of a polio vaccine through ce-
lebrity spokespersons; “poster” children; and short, poignant films shown in movie
theaters across the country. As a consequence, before the vaccine’s licensure, Ameri-
cans understood the horrors of polio and were anxious to prevent the disease.
The March of Dimes was successful because polio was a dramatic disease. But
many diseases potentially preventable by vaccines today are also dramatic. For
example, respiratory syncytial virus (RSV) causes pneumonia, croup, and lower
respiratory tract infections; as many as 90,000 children are hospitalized for and
5,000 killed every year by RSV. Group A streptococcus causes rheumatic fever
and severe skin infections; cytomegalovirus causes mental retardation, impaired
vision, hearing loss, and cerebral palsy; adenovirus and parainfluenza virus cause
severe pneumonia; and enteroviruses, herpesviruses, and arboviruses (like West
Nile virus) cause meningitis. All of these infections routinely cause children and
adults in the United States and throughout the world to be hospitalized and to

“The public buy-in to the introduction of a polio vaccine in 1955

has, fifty years later, been replaced by a public buy-out of vaccines.”
die. Although the technology is available to prevent much of this suffering, most
people are unaware of the names of these specific diseases or of the possibility for
their prevention.
The public buy-in to the introduction of a polio vaccine in 1955 has, fifty years
later, been replaced by a public buy-out of vaccines. Groups opposing vaccines
have proliferated, and many people see information campaigns about new vac-
cines as just more hype to increase pharmaceutical companies’ revenues.
n Regulatory issues: moving from relative to absolute safety. The cost to de-
velop and make many vaccines is greater than that to make most drugs, because
products given to healthy people are often held to higher standards of safety than
those given to people who are sick. In 1998 the FDA licensed a vaccine to prevent
rotavirus, a common cause of fever, vomiting, and diarrhea in young children.14 After
the vaccine had been on the market for one year—and was given to about one mil-
lion children—the CDC detected a rare adverse event: About one of every 10,000
children who received the vaccine developed intussusception, a blockage of the in-
testine.15 As a consequence, the rotavirus vaccine was withdrawn.
Before it was licensed, the rotavirus vaccine had been given to about 11,000
children in placebo-controlled prospective studies. Because intussusception was
very rare, studies performed prior to licensure were not big enough to determine
that rotavirus vaccine caused the condition. Following the withdrawal of the
rotavirus vaccine in 1999, children have continued to be hospitalized for and
killed by rotavirus. Although many more children would have been helped by a
rotavirus vaccine than hurt by it, the current culture does not allow for any seri-
ous side effects from a vaccine. As a consequence, pharmaceutical companies are
now asked to disprove even very rare adverse effects prior to licensure. Two com-
panies, Merck and GlaxoSmithKline, are now testing rotavirus vaccines in pre-
licensure trials that include more than 140,000 children. The cost of these two
large trials is about $400 million. The added financial burden of now disproving
rare adverse events before licensure is another disincentive to making vaccines.
n Product liability. Vaccines were the first group of medical products that were
nearly eliminated by lawsuits. In 1974 a British researcher published a paper claim-
ing that the pertussis vaccine caused permanent brain damage in twenty-two chil-
dren.16 Stories that pertussis vaccine harmed children soon appeared in the United
States, and personal-injury lawyers sued vaccine makers. American lawyers claimed
that the pertussis vaccine caused epilepsy, mental retardation, learning disorders,
unexplained coma, Reye’s syndrome (the sudden onset of coma later found to be as-
sociated with aspirin), and sudden infant death syndrome (SIDS, unexplained death
in the first year of life later found to be associated with sleep position). By 1987, 800
626 May/ June 2005

D ru g Com pani e s
lawsuits totaling more than $21 million were filed, and new claims were filed every
week. To meet the demand for increased liability insurance, and to pay for legal fees
and settlements, the cost of the pertussis vaccine increased from $0.17 per dose to
$11.00 per dose.17
By the late 1980s and early 1990s many investigators had examined the ques-
tion raised by the British researcher and found that the pertussis vaccine did not
cause permanent brain damage.18 The researcher’s hypothesis was wrong, but the
damage was done. The number of companies making pertussis vaccine for U.S.
children decreased from four (Wyeth, Connaught, Sclavo, and Lederle) to one
(Lederle).19 In the mid-1980s a lawsuit against Lederle claiming that pertussis
vaccine caused paralysis in a young boy ended with an award of $1.13 million.20
This award was equivalent to more than half of the entire pertussis vaccine mar-
ket. Although there was no scientific evidence to support the claim, pharmaceu-
tical companies looked at this situation and decided to leave the vaccine busi-
ness.21
Threatened by a return to the prevaccine era—when hundreds of thousands of
children were routinely hospitalized for, permanently harmed by, or killed by
vaccine-preventable diseases—the U.S. government stepped forward. In 1986
Congress passed the National Childhood Vaccine Injury Act (NCVIA), which in-
cluded the National Vaccine Injury Compensation Program (NVICP), designed
to protect companies from lawsuits not supported by scientific evidence. The
program was funded by a federal excise tax on every dose of vaccine.
In many ways, the NVICP was a model system to prevent abuses by personal-
injury lawyers. Scientists, epidemiologists, virologists, microbiologists, clini-
cians, and statisticians reviewed scientific studies and recommended to the
courts which problems were caused by vaccines and which coincidentally fol-
lowed vaccines. If a child suffered a reaction caused by a vaccine, the program was
designed to compensate the family for medical expenses and damages quickly,
generously, and fairly. Because of the NVICP, manufacturers remained in the vac-
cine business and the number of lawsuits against vaccine makers declined sub-
stantially.
Unfortunately, three important weaknesses in the NVICP discourage vaccine
makers. First, if dissatisfied with the outcome, people can always opt out of the
NVICP and take their case to a jury. Parents claiming that their children were
harmed by thimerosal (an ethylmercury-containing preservative in some vac-
cines) have sued vaccine makers; about 300 separate lawsuits are now pending in
U.S. courts. Although four large epidemiologic studies found that children re-
ceiving thimerosal-containing vaccines were not at increased risk for the neuro-
logical problems claimed, plaintiffs’ lawyers are pressuring pharmaceutical com-
panies for a large settlement.22
Second, the NVICP does not cover all vaccines—only those routinely recom-
mended for all children. For example, the Lyme vaccine, licensed by the FDA in

1998, was not covered by the program. After licensure, many people claimed that
the Lyme vaccine caused chronic arthritis as well as muscle pain, headaches, for-
getfulness, memory loss, paralysis, and fatigue. Although two large epidemiologic
studies found no evidence that the vaccine caused chronic disease, GlaxoSmith-
Kline was spending millions of dollars defending its product.23 Further, the me-
dia raised fears that the Lyme vaccine caused permanent harm. Predictably, sales
decreased, and the vaccine was taken off the market in 2002. Now, people at risk
for Lyme infection can only hope that they are not among those permanently
harmed by the disease.
Third, the NVICP does not include the unborn child when the mother is im-
munized. For example, very young infants are occasionally infected by a bacte-
rium called group B streptococcus (GBS). GBS infects the bloodstream, the
brain, and the spinal cord. Every year, about 2,000 U.S. babies are infected with
GBS and 100 die; more newborns die from GBS than any other infectious disease.
Unfortunately, most vaccines in the United States and the world are not given
until one or two months of age—too late to prevent GBS infections. Therefore,
the most effective strategy to prevent GBS would be to immunize pregnant
women. Researchers have already shown that a GBS vaccine given to pregnant
women would work to protect newborns.24 However, because of concerns about
litigation following immunization of pregnant women, no pharmaceutical com-
pany is willing to make a GBS vaccine or any vaccine that would include maternal
immunization.
Finally, in addition to weaknesses in the federal compensation program, phar-
maceutical companies have abandoned lower-revenue products such as vaccines
because liability insurance has dramatically increased the cost of making all
medical products.
Factors That Would Encourage Vaccine Making

The CDC and the IOM have recognized the importance of finding ways to fi-
nance vaccines for the twenty-first century.25 We discuss several possible solu-
tions below.
n Increase payments for vaccines. Pharmaceutical companies could be en-
couraged to make vaccines if the federal government provided more assurances that
the VFC entitlement program was robust, allowed for a mechanism to increase the
fixed price of certain vaccines, offered tax breaks to companies that chose to make
vaccines, and supported more testing centers (such as the Vaccine Evaluation and
Testing Units [VETUs]) for commercial vaccines prior to licensure. Further, the
burden of assuming the cost of creating and maintaining an infrastructure for vac-
cines by health care professionals could be supported by adequate administration
fees through both the VFC program and private insurers.
n Decrease costs of making vaccines. The cost of making vaccines for phar-
maceutical companies could be reduced by strengthening weaknesses in the
628 May/ June 2005

D ru g Com pani e s
NVICP—specifically, disallowing opt-out of the program when scientific studies

do not support a claim; covering all vaccines; covering the unborn child when a vac-
cine is given to a pregnant woman; and indemnifying academic medical centers
(AMCs) that test vaccines prior to licensure.
The cost of making vaccines could also be reduced by encouraging public-
private partnerships for vaccine R&D. The first and best example of a public-
private partnership was that between the National Foundation for Infantile Pa-
ralysis and polio vaccine manufacturers in the 1950s. Between 1938 and 1962 the
foundation raised $630 million; $70 million was spent on research. The amount of
money spent by the March of Dimes to understand one disease—ten times more
than spent on polio research by the National Institutes of Health during the same
period—was unprecedented.26 By paying for research that determined how to
make a polio vaccine and by paying for a large clinical trial that showed that the
vaccine worked and was safe, the foundation took the risk out of vaccine R&D.
Further evidence for this model for vaccine development is found today in the re-
lationship between the Gates Foundation and pharmaceutical companies for the
development of AIDS and malaria vaccines.
V
ac c i n e s a r e d i f f i c u lt a n d e x p e n s i v e to make and, because they
are used once or at most several times during one’s life, have revenues that
are dramatically less than products that are used every day. As a conse-
quence, many pharmaceutical companies have abandoned vaccines in favor of
drugs. However, the technology is in hand to prevent many infections that rou-
tinely hospitalize and kill people in the United States and the world. By increasing
funding for vaccines through the VFC program; by offering tax breaks to compa-
nies that develop less profitable but life-saving products; by supporting clinical
testing centers for commercial vaccines; by strengthening protection against liti-
gation unsupported by scientific evidence; and by ensuring that health care pro-
fessionals are reimbursed for the infrastructure required to administer vaccines,
Congress has the power to protect a product that is vital to our nation’s health.
The author thanks Edgar Marcuse for his contributions to this paper.
NOTES
1. J.E. Salk, “Studies in Human Subjects on Active Immunization against Poliomyelitis, I: A Preliminary
Rreport of Experiments in Progress,” Journal of the American Medical Association 151, no. 13 (1953): 1081–1098.
2. Poliomyelitis: Papers and Discussions Presented at the Third International Poliomyelitis Conference (Philadelphia and
Montreal: Lippincott, 1955), 171.
3. J. Smith, Patenting the Sun: Polio and the Salk Vaccine (New York: William Morrow and Company, 1990), 221.
4. N. Nathanson, “Eradication of Poliomyelitis in the United States,” Reviews of Infectious Diseases 4, no. 5
(1982): 940–950.
5. Phil Hosbach (Aventis) and Clem Lewin (Chiron), personal communication, 2004.
6. National Vaccine Advisory Committee, “Strengthening the Supply of Routinely Recommended Vaccines
in the United States: Recommendations from the National Vaccine Advisory Committee,” Journal of the
American Medical Association 290, no. 23 (2003): 3122–3128.

7. Anthony Fauci, National Institute of Allergy and Infectious Diseases, personal communication, 2004.
8. J. Cohen, “Public Health: U.S. Vaccine Supply Falls Seriously Short,” Science 295, no. 5562 (2002): 1998–
2001.
9. Hosbach, personal communication, 2004.
10. NVAC, “Strengthening the Supply of Routinely Recommended Vaccines.”
11. Institute of Medicine, Financing Vaccines in the Twenty-first Century (Washington: National Academies Press,
2003).
12. S.A. Harper et al., “Prevention and Control of Influenza: Recommendations of the Advisory Committee on
Immunization Practices (ACIP),” Morbidity and Mortality Weekly Report 53, no. RR06 (2004): 1–40.
13. R. Carter, The Gentle Legions: National Voluntary Health Organizations in America (New Brunswick, N.J.: Transac-
tions Publishers, 1992), 133.
14. “Rotavirus Vaccine for the Prevention of Rotavirus Gastroenteritis among Children—Recommendations
of the Advisory Committee on Immunization Practices,” Morbidity and Mortality Weekly Report 48, no. RR-2
(1999): 1–23.
15. T.V. Murphy et al., “Intussusception among Infants Given an Oral Rotavirus Vaccine,” New England Journal of
Medicine 344, no. 8 (2001): 564–572.
16. M. Kulenkampff, J.S. Schwartzman, and J. Wilson, “Neurological Complications of Pertussis Inoculation,”
Archives of Diseases of Childhood 49, no. 1 (1974): 46–49.
17. R. Manning, “Economic Impact of Product Liability in U.S. Prescription Drug Markets,” International Busi-
ness Lawyer (March 2001): 104–109; R. Manning, “Changing Rules in Tort Law and the Market for Child-
hood Vaccines,” Journal of Law and Economics 37, no. 1 (1994): 247–275; and S. Garber, Product Liability and the
Economics of Pharmaceuticals and Medical Devices (Santa Monica, Calif.: RAND, Institute for Civil Justice, 1993).
18. G. Marshall et al., The Vaccine Handbook: A Practical Guide for the Clinician (Philadelphia: Lippincott Williams
and Wilkins, 2004), 396.
19. “Diptheria-Tetanus-Pertussis Vaccine Shortage—United States,” Morbidity and Mortality Weekly Report 33,
no. 14 (1984): 695–696.
20. Toner v. Lederle Laboratories, 779 F.2d 1429 (9th Cir. 1986).
21. G. Evans, D. Harris, and E.M. Levine, “Legal Issues,” in Vaccines, ed. S.A. Plotkin and W.A. Orenstein (Phila-
delphia: Saunders, 2004), 1591–1617.
22. A. Hviid et al., “Association between Thimerosal-Containing Vaccine and Autism,” Journal of the American
Medical Association 290, no. 13 (2003): 1763–1766; T. Verstraeten et al., “Safety of Thimerosal-Containing Vac-
cines: A Two-Phased Study of Computerized Health Maintenance Organization Databases,” Pediatrics 112,
no. 5 (2003): 1039–1048; J. Heron, J. Golding, and the ALSPAC Study Team, “Thimerosal Exposure in In-
fants and Developmental Disorders: A Prospective Cohort Study in the United Kingdom Does Not Sup-
port a Causal Association,” Pediatrics 114, no. 3 (2004): 577–583; and N. Andrews et al., “Thimerosal Expo-
sure in Infants and Developmental Disorders: A Retrospective Cohort Study in the United Kingdom Does
Not Support a Causal Association,” Pediatrics 114, no. 3 (2004): 584–591.
23. A.C. Steere et al., “Vaccination against Lyme Disease with Recombinant Borrelia Burgdorferi Outer-Sur-
face Lipoprotein A with Adjuvant: The Lyme Disease Vaccine Study Group,” New England Journal of Medicine
339, no. 4 (1998): 209–215; and L.H. Sigal et al., “A Vaccine Consisting of Recombinant Borrelia Burgdorferi
Outer-Surface Protein A to Prevent Lyme Disease: A Recombinant Outer-Surface Protein A Lyme Disease
Vaccine Study Consortium,” New England Journal of Medicine 339, no. 4 (1998): 216–222.
24. C.J. Baker et al., “Immunization of Pregnant Women with a Polysaccharide Vaccine of Group B Strepto-
coccus,” New England Journal of Medicine 319, no. 18 (1988): 1180–1185.
25. IOM, Financing Vaccines.
26. Smith, Patenting the Sun, 229.
630 May/ June 2005


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Inf r a s t ru c t u r e

Why Are Pharmaceutical

622 May/ June 2005

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Factors That Discourage Vaccine Making

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624 May/ June 2005

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“The public buy-in to the introduction of a polio vaccine in 1955

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Factors That Would Encourage Vaccine Making

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NVICP—specifically, disallowing opt-out of the program when scientific studies

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