Pertussis and Rubella Vaccines: A Brief Chronology
Jules Bordet and Octave Gengou of the Pasteur Institute of Brussels are able to grow the pertussis bacterium in artificial media. The bacterium, originally called Haemophilus pertussis, is found to be sufficiently different from Haemophilus to be classified as a new genus. It becomes known as Bordetella pertussis in honor of Bordet. When the description of the Bordet-Gengou technique is published, numerous researchers begin to experiment with vaccines made from killed whole-cell B. pertussis. In ensuing years, such vaccines are developed, and used in children, by Bordet and Gengou in 1912, Charles Nicolle of the Pasteur Institute in Tunis in 1913, and Thorvald Madsen of the Danish State Serum Institute in Copenhagen in 1914, among others (Chase, 1982).
Pertussis vaccine is listed in the American Medical Association publication New and Nonofficial Remedies (Council on Pharmacy and Chemistry, 1914, 1931).
Madsen is the first to describe the use of whole-cell pertussis vaccine on a large scale (Madsen, 1925, 1933). Although his vaccine successfully controls two outbreaks in the Faroe Islands,
his 1933 account reports two deaths within 48 hours of immunization, the first published report of serious adverse effects after pertussis vaccination. In the same year, Louis Sauer of Northwestern University Medical School, Chicago, describes minor reactions to a whole-cell pertussis vaccine being used in the United States (Sauer, 1933a,b).
Pearl Kendrick of the State of Michigan Health Department further refines and uses whole-cell pertussis vaccines in children (Kendrick, 1942, 1943; Kendrick and Eldering, 1936, 1939). In 1942, she and colleagues combine her improved killed vaccine with diphtheria and tetanus toxoids to produce the diphtheria-tetanus-pertussis (DTP, also known as DPT) combination vaccine. In 1944, the Committee on Infectious Diseases of the American Academy of Pediatrics suggests routine use of pertussis vaccine and, in 1947, recommends its use in the form of the DPT combination (American Academy of Pediatrics, 1944; Cherry, 1984). In the United States, vaccination of children against pertussis becomes a routine procedure and is made compulsory in some states.
The first published reports appear of irreversible brain damage after whole-cell pertussis vaccine (Brody and Sorley, 1947; Byers and Moll, 1948). Although the Brody and Sorley report describes one case only, it leads to the first warnings that pertussis vaccine should not be administered to those with a known neurologic disorder.
Approximately a dozen companies are manufacturing DPT vaccine (Coulter and Fisher, 1985).
The Parke-Davis Quadrigen vaccine (DPT combined with the Salk polio vaccine) is licensed. The vaccine is alleged to be particularly reactive because of the effect of the preservative on the pertussis component. Several lawsuits ensue. The vaccine is withdrawn from the market in 1968 (Coulter and Fisher, 1985).
By the mid-1960s, many states have passed laws requiring that all children be immunized with DPT vaccine prior to entering school (Coulter and Fisher, 1985).
In Great Britain, questions about the safety of whole-cell pertussis vaccines are widely publicized in the popular press after news-
paper accounts of a study (Kulenkampff et al., 1974) suggesting adverse reactions. The Association of Parents of Vaccine Damaged Children is formed (Alderslade et al., 1981). Between 1974 and 1978, the proportion of children vaccinated against pertussis falls from 80 to 30 percent (and as low as 9 percent in some areas) (British Medical Journal, 1981).
Japan temporarily stops using pertussis vaccine after publicity about deaths following vaccination. Later in the year, pertussis vaccination is reinstituted in children age 2 years and above. The proportion of immunized children drops from 70 percent in 1974 to 20 to 40 percent in the following years. Reported cases of pertussis increase from 393 with no deaths in 1974 to more than 13,000 with 41 deaths in 1979 (Coulter and Fisher, 1985).
The government-funded National Childhood Encephalopathy Study (NCES) begins in Great Britain, largely as a result of rising public concern about the safety of pertussis vaccine. The study is case-control in design and runs for 3 years (Alderslade et al., 1981).
An epidemic of pertussis occurs in Great Britain. More than 100,000 cases and 36 deaths are reported (Koplan and Hinman, 1987).
In the United States, public health clinics using federally purchased vaccines are required to have parents sign an ''important information statement" before their child can be vaccinated (Coulter and Fisher, 1985).
The Monitoring System for Illness Following Immunization (MSIFI) is established by the Centers for Disease Control (CDC). The system is an outgrowth of the monitoring of adverse events following the swine flu vaccine incident.
Two lawsuits are filed in U.S. courts alleging that children were harmed by pertussis vaccine (Koplan and Hinman, 1987).
Meetings are held at the Food and Drug Administration (FDA) Bureau of Biologics and at the CDC to discuss reports of sudden infant death syndrome (SIDS) in Tennessee following pertussis vaccination. No evidence of a causal relationship is found. Wyeth Laboratories, the manufacturer, withdraws the questioned vaccine lot nonetheless (Coulter and Fisher, 1985).
FDA funds a study to evaluate adverse reactions to DPT vaccines. The study is to be carried out at the University of California, Los Angeles (UCLA).
The Vaccine Damage Payment Act is passed in Great Britain. The act provides a mechanism for government compensation to those with vaccine-associated injuries (Griffith, 1989).
Sweden stops using whole-cell pertussis vaccine because of reported reactions and a lack of vaccine efficacy. The number of pertussis cases increases (Coulter and Fisher, 1985).
The findings of the FDA-sponsored UCLA study are published (Cody et al., 1981). The rate of minor reactions and serious short-term reactions following DPT is found to be higher than that following DT.
The British "Blue Book" (Department of Health and Social Security, 1981) is published. It includes the findings of the NCES (Alderslade et al., 1981) and reports from several panels. The NCES concludes that both DPT and measles vaccines can cause acute neurologic reactions and permanent brain damage but that the latter is a very rare complication. The attributable risk (see Glossary of Terms) of serious neurologic illness in the 7 days following pertussis vaccination is estimated to be 1 in 110,000 immunizations, and that of persistent neurologic damage after 1 year is estimated to be 1 in 310,000 immunizations (with wide confidence limits in both cases).
The television program "DPT: Vaccine Roulette," first broadcast by NBC affiliate WRC-TV in Washington, D.C., is widely publicized. The program depicts children with severe injuries reported to be associated with pertussis vaccine (Griffith, 1989; Koplan and Hinman, 1987).
An advocacy group, Dissatisfied Parents Together, is formed in the United States. Its members call for research toward a safer pertussis vaccine and mandatory reporting of adverse reactions. Some in the group call for a cessation of use of the whole-cell vaccine (Coulter and Fisher, 1985; Koplan and Hinman, 1987).
The Senate Subcommittee on Investigations and General Oversight, chaired by Senator Paula Hawkins, holds hearings "to examine adverse drug reactions from immunization, federal efforts in preventive medicine, and characteristics of certain diseases" (Coulter and Fisher, 1985; Gonzalez, 1982).
The British Child Health and Education Study is published (Butler et al., 1982). The study compares immunization rates,
hospitalization rates, neurologic illness, and school performance among a cohort of more than 13,000 children followed up at age 5. Long-term neurologic problems are not found to be related to pertussis immunizations.
The Task Force Report on Pertussis is submitted to the U.S. Senate Labor and Human Resources Committee by the U.S. Department of Health and Human Services (DHHS). The committee holds hearings on the report.
The American Academy of Pediatrics and Dissatisfied Parents Together conduct more than 8 months of discussions to develop recommendations for a federal compensation program for children with vaccine-related illnesses and injuries (Coulter and Fisher, 1985). The National Childhood Vaccine Injury Compensation Act (S-2117) is introduced in the U.S. Senate by Senators Paula Hawkins and Orrin Hatch.
The Communicable Diseases Surveillance Centre Study, or North West Thames Study, is published by Pollock and Morris (1983). The study, which followed a large group of children after pertussis vaccination, finds no convincing evidence relating DPT vaccine to neurologic damage.
Senate hearings are held by Senator Paula Hawkins on the National Childhood Vaccine Injury Compensation Act.
Wyeth Laboratories discontinues its marketing of whole-cell pertussis vaccine. Only two pharmaceutical companies in the United States continue to sell pertussis vaccines.
The National Childhood Vaccine Injury Compensation Act is introduced in the U.S. House of Representatives by Representative Henry Waxman.
A total of 219 lawsuits are filed in U.S. courts alleging harm to a child from pertussis vaccine. The average amount of compensation sought (when specified) is $26 million (Koplan and Hinman, 1987).
The book DPT: A Shot in the Dark is published. Authors Harris L. Coulter and Barbara Loe Fisher (a founder of Dissatisfied Parents Together) describe numerous case histories of children reportedly injured or killed by the DPT vaccine. The book criticizes laws requiring vaccination, calls for further research on and testing of acellular pertussis vaccines, and urges additional research to identify children at particular risk of reacting to vaccines.
The Oversight and Investigations Subcommittee of the House Committee on Energy and Commerce conducts hearings on vaccine development as part of a series of hearings on biotechnology. Some witnesses call for better coordination of vaccine activity at the federal level.
Public Law 99-660, the National Childhood Vaccine Injury Act, is passed by the U.S. Congress. The law calls for the establishment of the National Vaccine Program (NVP) ("to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines"); the National Vaccine Advisory Committee (NVAC) to advise the director of the NVP; the National Vaccine Injury Compensation Program (VICP) to evaluate claims of injury from vaccines and provide compensation where justified; and the Advisory Commission on Childhood Vaccines (ACCV) to advise the Secretary of DHHS and the VICP on vaccine policy. It also mandates a scientific review of possible adverse effects of whole-cell pertussis vaccine by the Institute of Medicine (IOM) of the National Academy of Sciences.
The NVP, established under Public Law 99-660, begins operation. The NVP Director is the Assistant Secretary for Health of DHHS.
The Study of Neurologic Illness in Children (SONIC) begins at the University of Washington in Seattle. The CDC-sponsored study includes the states of Washington and Oregon and consists of two population-based case-control pilot studies to determine the risk and frequency of serious acute neurologic illness and a sample survey to estimate the number of doses of vaccine given during the surveillance period.
The NVAC, established under Public Law 99-660, is appointed in April and meets for the first time in June. As specified in the law, the IOM is consulted during the appointment process. The committee reports to the Assistant Secretary for Health of DHHS and is administered by staff of the NVP.
Two important legal cases are decided: the Loveday judgment in Great Britain's High Court of Justice, Queen's Bench Division (Stuart-Smith, 1988), and the Rothwell judgment in the Supreme Court of Ontario, Canada (Osler, 1988). In both cases, the justices rule that there is insufficient evidence to demonstrate that pertussis vaccine can cause permanent brain damage
in children. Both are considered as "test cases" in their respective jurisdictions, meaning that other lawsuits claiming permanent neurologic effects from pertussis vaccine are effectively excluded.
The ACCV, established under Public Law 99-660, is appointed early in the year and meets for the first time in March. The commission reports to the Secretary of DHHS and is administered by staff of the Health Resources and Services Administration, DHHS.
The VICP begins operation. It is administered by the Secretary of DHHS through the staff of the Health Resources and Services Administration. By the end of the year, it has received 201 petitions for compensation, of which 165 are related to DPT vaccine.
The National Vaccine Information Center sponsors a workshop on the neurologic complications of pertussis and pertussis vaccination (Menkes and Kinsbourne, 1990).
The IOM holds a CDC-sponsored workshop on the National Childhood Encephalopathy Study (Marcuse and Wentz, 1990).
The IOM Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines is appointed in December 1989 and meets for the first time in January 1990. In the same month, the committee sponsors a public meeting in Washington, D.C., to solicit medical and other scientific data and comments on the nature, frequency, and circumstances of adverse events following pertussis and rubella vaccines. In May, it sponsors a workshop, Possible Adverse Consequences of Pertussis and Rubella Vaccines. The IOM study, mandated by Public Law 99-660, is sponsored by a consortium of federal agencies through the National Institute of Allergy and Infectious Diseases.
The Sixth International Symposium on Pertussis is held in Bethesda, Maryland (Manclark, 1990a,b).
A. F. Hess suggests that rubella is caused by a filtrable virus (Chase, 1982).
Y. Hiro and S. Tasaka succeed in transmitting rubella by inoculating healthy nonimmune children with filtrates taken from children
with active cases of rubella. The causative agent remains unidentified (Chase, 1982).
Norman McAlister Gregg, an Australian ophthalmologist, notes after a rubella epidemic that women who have had rubella during pregnancy seem unusually likely to give birth to children with cataracts and other birth defects (Gregg, 1941). He finds confirmation of his observations in a survey of other physicians in Australia. The defects described include cataracts, deafness, congenital heart disease, microcephaly, cerebral palsy, and mental retardation. Similar reports from other countries ensue. World War II interferes with research to follow up on these observations (Chase, 1982). Studies of Australian census and disease records later suggest that congenital damage from rubella during pregnancy had occurred for at least 40 years before being recognized (Burnet and White, 1972).
Macfarlane Burnet and colleagues use gamma globulin from patients with rubella to confer short-term passive immunity on pregnant women recently exposed to rubella (Chase, 1982). The practice becomes common in a number of industrialized countries.
The rubella virus is isolated by Thomas Weller at the Harvard School of Public Health and, independently, byPaul Parkman and colleagues at the Walter Reed Army Institute of Research (Chase, 1982).
One of the worst rubella outbreaks in U.S. history occurs. Rubella is not, at that time, a notifiable disease, so it is not known with certainty how many people contract the disease or how many children suffer congenital or developmental damage caused by prenatal infection. It is estimated that 20,000 children suffer prenatal damage caused by rubella infections during the epidemic and that the cost of their rehabilitation 5 years after the epidemic ends is $1.5 billion to $2 billion in 1969 U.S. dollars. The epidemic and its aftermath lend impetus to the search for a rubella vaccine and are instrumental in the initial approval of Title XIX (the Medicaid provisions) of the Social Security Act of 1965 and in subsequent amendments to Title XIX, the Early and Periodic Screening, Diagnosis, and Treatment program. The latter make comprehensive pediatric care, including necessary vaccinations, the "mandated birthright" of every child regardless of ability to pay (Chase, 1982).
Several vaccines made from attenuated rubella strains are developed and tested in clinical trials (Plotkin, 1988).
Three rubella vaccines are licensed in the United States: HPV-77 (grown in dog kidney), HPV-77 (grown in duck embryo), and Cendehill (grown in rabbit kidney). Many states add rubella vaccines to the list of immunizations required for school entry. RA 27/3, a human diploid fibroblast vaccine developed in the United States, is licensed in several European countries (Plotkin, 1988).
Reports of possible serious adverse events following rubella vaccination begin to be published. Two types of events are reported: neuropathies (Gilmartin et al., 1972; Grand et al., 1972; Kilroy et al., 1970; Schaffner et al., 1974) and acute and chronic arthralgia and arthritis (American Journal of Diseases of Children, 1969; Barnes et al., 1972; Fox et al., 1976; Freestone et al., 1971; Horstmann et al., 1970; Lerman et al., 1971; Rowlands and Freestone, 1971; Spruance and Smith, 1971; Spruance et al., 1972; Swartz et al., 1971; Weibel et al., 1972). Because the HPV-77 dog kidney vaccine appears to be associated with a higher proportion of such adverse events, that vaccine is withdrawn from the market in the United States and other countries.
The human diploid cell culture, RA 27/3, is licensed in the United States. The last U.S. manufacturer of the HPV-77 duck embryo vaccine replaces it with RA 27/3, which becomes the only rubella vaccine available in the United States (Plotkin, 1988).
Systematic investigations are undertaken of the possible association between rubella vaccines and chronic arthritis or arthropathies, leading to an increased level of concern on the part of some investigators and others (Cunningham and Fraser, 1985; Tingle et al., 1979, 1983, 1985, 1986, 1989).
Public Law 99-660, the National Childhood Vaccine Injury Act, is passed by the U.S. Congress (see description above in the section on pertussis vaccines). The law mandates a scientific review of possible adverse effects of rubella vaccines by the IOM of the National Academy of Sciences.
The NVP begins operation. The NVP Director is the Assistant Secretary for Health for DHHS.
The NVAC meets for the first time in June. The committee reports to the Assistant Secretary for Health of DHHS and is administered by staff of the NVP.
The Advisory Commission on Childhood Vaccines meets for the first time in March. The commission reports to the Secretary of DHHS and is administered by staff of the Health Resources and Services Administration, DHHS.
The National Vaccine Injury Compensation Program begins operation. It is administered by the Secretary of DHHS through the staff of the Health Resources and Services Administration, DHHS. By the end of the year, it has received 201 petitions for compensation, of which 11 are related to measles-mumps-rubella vaccine.
The IOM Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines meets for the first time in January. In the same month, the committee sponsors a public meeting in Washington, D.C., to solicit medical and other scientific data and comments on the nature, frequency, and circumstances of adverse events following pertussis and rubella vaccines. In May, it sponsors a workshop on Possible Adverse Consequences of Pertussis and Rubella Vaccines.
The ABC News program "20/20" presents a report entitled "Why Am I So Sick?," detailing the chronic and disabling symptoms reported by some women after rubella immunization.
A randomized, double-blind, placebo-controlled trial of rubella vaccine and chronic arthritis begins in Vancouver, British Columbia, Canada.
As of April, the CDC is considering issuing a request for proposals for a study of chronic arthritis following rubella vaccination that would include laboratory studies of participants.
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