December 18, 2001
by Carol Ruppel

Today House and Senate conferees are negotiating a final agreement on the conference report that will determine appropriations for the Departments of Labor, Health and Human Services and Education for the rest of fiscal year 2002 that ends on September 30.  The conferees agreed to fund the National Immunization Program at $628 million.  This represents a total increase of $76 million.  The House had requested an increase of  $47 million; the Senate, $84.5 million, so the compromise is good news for immunization advocates. 
      The state immunization grant program, authorized under Section 317 of the Public Health Services Act, will receive an increase of about $22 million for the purchase of vaccines, bringing the vaccine purchase appropriation to $222.3 million.  The 317 state grants received an increase of $19 million for program operations and infrastructure, bringing that total to $200.7 million.  Global immunization activities received a $27 million increase for a total of $133.8 million, and CDC received a $7 million increase for a total of $71.1 million to administer the National Immunization Program. 
      (The conference committee had delayed its work until Congress completed reauthorization of the Elementary and Secondary Education Act, because of the direct effect on education appropriations.  One of the sticking points on that bill, H.R. 1, was the federal contribution to funding students in special education.  The Individuals with Disabilities Education Act (IDEA) (P.L. 94-142) authorizes a 40 percent federal match to states, but the federal match has never been met.  Some Members wanted to make special education an entitlement program, but did not succeed.  Overall federal education spending will increase by $8 billion for fiscal year 2002.)
      (Another sticking point on the Labor/HHS/Education conference report has been the addition of the Mental Health Parity Act (Wellstone/Domenici), which would require health plans that already cover some mental health services to offer coverage on parity with physical health services coverage.  This is controversial with some House members, both because of anticipated costs to employers and because it is an authorizing piece amending an appropriations bill.  However there is strong Senate support to pass this amendment.  At this writing there is no word on whether the amendment is included in the conference report.) 
      Once the conference report is complete, it will go to each house for an up or down vote, and then to the President to be signed into law. 
      Congress should finally recess on December 21, having settled the remaining three appropriations bills-Labor/HHS/Education, Defense and Foreign Operations.   The second session of the 107th Congress begins in late January, coinciding with the President's State of the Union address.  Meanwhile, the federal agencies have been formulating their fiscal year 2003 budgets for submission to the Office of Management and Budget.  OMB "passes back" to the agencies their respective proposals with OMB's changes, and the President submits his budget shortly after his State of the Union.  That begins the Congressional budget process reconciling projected revenues with projected overall federal spending.  The appropriations process starts after the House and Senate Budget Committees have set allocations for the 13 appropriations subcommittees.

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A Critical Look at the Vaccine Injury Compensation Program
by Carol Ruppel

On November 1 and 12, the House Government Reform Committee a held two-part hearing on the National Vaccine Injury Compensation Program.  The purpose was to hear witnesses who feel they've been unfairly treated by the program, government officials who defend the program but welcome recommendations to improve it, and the chairman of the advisory commission that oversees the program.
      The National Vaccine Injury Compensation Program was created under the National Childhood Vaccine Injury Act of 1986 (PL 99-660) and went into effect in 1988.  Congress established the program to stem the loss of pharmaceutical companies willing to manufacture vaccines.  Reports of harmful side-effects of the Diphtheria-Tetanus-Pertussis vaccine had caused widespread concern over vaccine safety, and manufacturers and health care providers both were faced with potential liability costs.  Congress was committed to ensuring adequate vaccine supply while also compensating families adversely affected by vaccines.  The Vaccine Injury Compensation Program offers parents a no-fault alternative to the traditional tort system for resolving vaccine injury claims.  It was built with input from private and public health providers, industry, government and parents. 
      The program works as follows.  A parent or guardian who feels that his child has suffered severe vaccine-induced injury (illness) files a petition with the U.S. Federal Claims Court.  The petitioner must show that either (1) the injury is listed on the Vaccine Injury Table that lists specific conditions and associated time frames, (2) the vaccine significantly aggravated a pre-existing condition or (3) the vaccine caused the condition. 
      The parent or guardian files the petition and the Secretary of the Department of Health and Human Services (HHS) is named the respondent.  A physician at HHS reviews the petition to determine whether it meets the medical criteria for compensation.  The HHS Secretary is represented by a Department of Justice attorney, who files a report with the Court.  The Court appoints a "special master," a Court attorney, to hear the case and decide on compensation.  If the case is found eligible for compensation, the amount is usually negotiated between the Department of Justice attorney and the petitioner. Attorneys' fees are reimbursable even if the claim is found non-compensable.  The Table includes all recommended childhood vaccines.  The program requires the input of a nine-member Advisory Commission on Childhood Vaccines, which has provided oversight and recommended improvements. 
      Chairman Dan Burton (R-IN) noted that his Committee colleague and ranking member Henry Waxman (D-CA) authored the 1986 bill creating the program.  Burton contends that the program "hasn't lived up to expectations" and has threatened to hold hearings on the issue throughout the year.  The witnesses certainly confirmed Burton's contention.  Families have suffered protracted legal cases that have dragged on over as many as 10 years, with no compensation for expenses throughout the ordeal, some disregard even for Table-listed injuries and adversarial conduct on the part of government lawyers. 
The three government witnesses-Director of the Vaccine Injury Compensation Program for the Department of Health and Human Services, Thomas Balbier; Director of the National Vaccine Injury Compensation Program for the Department of Justice, John Euler, and his Deputy Director, Paul Harris, Sr.-claim that in the vast majority of cases the program works well, and they presented convincing data. 
      The government recognizes that there is room for improvement, and in 1999 HHS drafted a bill amending the program that addressed the concerns raised at this 2001 hearing.  Although the bill didn't pass, HHS adopted some of the changes through administrative action.  The Office of Special Masters at the Federal Claims Court issued an order for alternative dispute resolution, which is in effect. 
      Dr. David Block, pediatrician, medical school pediatrics department chairman, chairs the Advisory Commission on Childhood Vaccines that monitors the program.  "There is no doubt in my mind that the Program works well, but with some adversity, or differences of opinion, especially in the non-Table injury cases.  However, I have been continually impressed over the last three years with the efforts of HHS and DOJ to decrease the adversarial process."  Based on three years of experience with the (Committee), I do feel these cases, while compelling, are isolated, unusual, and emotional representations of a definite minority of cases coming through the Program." 
      Congressman Dave Weldon (R-FL), a member of the Government Reform Committee, is sponsoring H.R. 1287, a bill that would ease the burden of proof for petitioners to receive compensation from the program.  Congressman Burton supports the bill. 
      Congressman Waxman believes that H.R. 1287 would over-reduce the burden of proof, and he opposes it.  But he is amenable to working with the Administration to further improve the program to make sure all families are fairly and timely compensated.  If the bill moves out of the House Energy and Commerce's Health Subcommittee, we will keep you informed.

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Senators Take a New Look at the National Immunization Program
by Carol Ruppel

Senator Kennedy (D-MA) opened the Health, Education, Labor and Pensions Committee November 27 hearing on the readiness of the National Immunization Program for handling "new public health challenges" sounding a familiar note.  "Our concerns about bioterrorism have also reminded us of the overall importance of immunization, one of the great public health victories of the 20th century."  "We must be vigilant, however, to preserve these successes.  If we fail to appreciate the value of vaccines or become complacent in our immunization efforts, we could witness sudden new epidemics.."   Kennedy then turned over his chairman's gavel to Senator Reed (D-RI).  Reed has been a dedicated immunization proponent in the Senate who has sponsored legislation broadening access and increasing federal funding. 
      Dr. Walter Orenstein, director of the Centers for Disease Control's National Immunization Program (NIP), testified.  Orenstein reported that the program is "well-poised to face the challenges of the 21st century," though "challenges remain."  He noted the outstanding immunization achievements of the 20th century, including:

• Reduction in the annual reported cases of diphtheria, measles, mumps, rubella, congenital rubella syndrome, and Haemophilus influenzae type b (Hib) by over 99 percent since these vaccines were made available.
• A greater than 100 percent increase in childhood immunization coverage from 1991, when only 37 percent of U.S. children received a combined series of four doses of DTP, three doses of polio, and one dose of measles-mumps-rubella (MMR) vaccine, to 2000, when the coverage level for the series plus three doses of Hib, was 76 percent.
• A more than 99 percent decrease in global polio incidence from 1988, when there were 350,000 cases, to the year 2000, when there were fewer than 3,000 cases. 

Dr. Orenstein described six challenges to the National Immunization Program: (1) a fragile supply of vaccines, (2) increased vaccine costs and gaps in paying for them, (3) stresses on local and state health departments to provide the "infrastructure"-supply, distribution, service delivery, education, disease surveillance, record-keeping; (4) concerns about adverse reactions to vaccines requiring more research, evaluation and treatment; (5) low adult immunization rates and (6) improving global immunization. 
      CDC is addressing several of these challenges by cooperating in studies conducted by outside groups.  For example, CDC awarded the Institute of Medicine a contract to develop a study on vaccine financing in the United States, which is due to be published in April of 2003.  And CDC is cooperating with the General Accounting Office, an arm of Congress, in studying vaccine shortages. 
      More immediately, CDC has been conducting projects to study and address vaccine risks.  It is continuing to study what are adverse events that result from vaccines, versus adverse events attributable to other causes; what is the magnitude of risk of vaccine-related adverse events; who is at greatest risk of suffering adverse events and how are they best treated. 
      Senator Judd Gregg (R-NH), ranking member of the Committee, asked Orenstein why so few manufacturers produce vaccines.  Is it liability concerns?  Orenstein answered no, the Vaccine Injury Compensation Program eliminated the liability concerns, but the research and development costs are very high.  Senator Kennedy asked if we need a National Vaccine Authority.  Dr. Orenstein responded that the National Vaccine Advisory Committee is already in place and doing the job.  Senator DeWine (R-OH) asked what the federal government should do to solve flu vaccine shortages.  Orenstein said CDC is recommending prioritizing delivery according to risk.  Senator Jeff Bingaman (D-NM) wanted an explanation for state disparities in immunization rates.  Dr. Orenstein suggested they are caused by disparate delivery systems.  Bingaman commented that in the same Albuquerque newspaper article on a shortage of diphtheria-tetanus vaccine to immunize 11-15-year-olds, the reporter noted there'd been no cases of tetanus in the area in 10 years.  What are the priorities?  Orenstein answered that tetanus is not contagious; diphtheria is, and that the top priority is disease surveillance. 
      Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) testified.  He was asked to provide the status of vaccine research at NIH.  His agency conducts research leading to improving existing vaccines and developing new ones, including research on potential agents of bioterrorism. 
      Fauci, echoing Orenstein and Kennedy, said, "Vaccination has been recognized as the greatest public health achievement of 20th century.  Without question, vaccines have been our most powerful tools for preventing disease, disability and death and controlling health care costs."  NIAID's role includes conducting research in collaboration with industry and academia and transferring the technology to the private sector for commercialization.  NIAID also supports research that might not prove lucrative to private industry.
      Fauci mentioned the Dale and Betty Bumpers Vaccine Research Center at NIH, dedicated to finding new vaccines.  One study currently underway at the Center is testing a new DNA-based HIV vaccine on humans.  NIAID research support led to the licensing of Haemophilus influenzae type b (Hib) vaccine for children in 1987 and for infants in 1990, resulting in a 99 percent decline in Hib, which was the leading cause of childhood bacterial meningitis and postnatal retardation. 
      NIAID still confronts the challenge of developing a safe vaccine against "the three greatest microbial killers worldwide: HIV/AIDS, malaria, and tuberculosis."  And now it has developed a smallpox vaccine research agenda to respond to both immediate and longer-range scenarios.  NIAID is working with the Defense Department "to support the development of the next generation of anthrax vaccines." 
      Senator Frist (R-TN), a heart-lung surgeon who has taken the lead in much of the bioterrorism response in Congress, asked Dr. Fauci a series of questions about vaccine supply.  What are the federal agencies doing to anticipate shortages?  Frist partially answered his own question here by noting that when passing the Children's Health Act last year that included reauthorization of the National Immunization Program, the Committee requested a Government Accounting Office report on trends in vaccine manufacturing so that the problem could be diagnosed and fixed.  Are long-term contracts with manufacturers necessary to maintain adequate supplies?  Yes they are.  Is the private sector an important player?  Yes.  Senator Clinton (D-NY) was the last to question Dr. Fauci.  Do we need an increased federal role and more federal funding?  Yes.
      Dr. Ed Thompson, Mississippi State Health Officer, testified on behalf of the Association of State and Territorial Health Officers.  He noted that he was speaking in the Dirksen Senate Office Building, which adjoins the Hart Senate Office Building, which has been closed since September 11 because of anthrax-contaminated mail.  "Yet in this room, there are also bacteria that can cause disease and death: some of us carry in our noses or throats Bordetella pertussis, which causes whooping cough.  Others carry Neisseria meningitides, which causes an often fatal form of meningitis."  "Our national attention is riveted by 11 cases of inhalational anthrax, with a case fatality rate of 45 percent.  Yet every year we have three to six thousand cases of Streptococcus pneumoniae meningitis, with a case fatality rate of 30 to 80 percent, and we have, and do not use, vaccines that can prevent most of them."
      "From ASTHO's perspective there are two key pillars of our immunization system that are especially cracked and in danger of crumbling: vaccine availability and the public health infrastructure."  The pneumococcal conjugate vaccine to prevent meningitis, pneumonia, blood and ear infections is very costly, and CDC is not adequately funded to provide adequate supplies.  Not only are states under-funded.  They are also under-supplied, forcing changes in routine vaccine recommendations.  The long-term effect of these changes is often habit-forming.  [This has been the case with Hepatitis B vaccine that was temporarily not recommended at birth.  While the recommendation was restored, the uptake has been slow.]
      One of the glaring holes in immunization programs is inattention to adult immunization.  Thompson reported that of the 64 CDC-funded immunization programs in all states, territories and some cities, only 43 have a coordinator of adult immunization activities.  "We should note that if and when a decision is made to immunize some or all of our population against smallpox, it will be state and local health departments that will organize, coordinate, and carry out these efforts."  Senator Reed asked Dr. Thompson about Mississippi's immunization registry.  Thompson said it's been in use for a long time, but that the interface between private provider offices and public health is "tough."  Mississippi relies on phones and bar codes for registry data.  "You get technology by paying for it."
      Betty Bumpers, co-founder of Every Child By Two, testified for the organization (to view testimony please go to http://www.ecbt.org/Bumpers.html).  Asked to address what's working and what could be improved in the National Immunization Program, Bumpers, like Thompson and a few Senators, rued the episodic nature of attention to immunizations both in Congress and the general public.  The federal and state funding waxes and wanes, and health departments struggle to get the job done.  She is particularly concerned about the fits and starts in developing statewide immunization registry systems.  Since registries have proven themselves so useful in aiding immunization, why has it taken so long and cost so much to develop a system that is so uneven?  And in the development of new health information systems to answer  bioterrorist strikes, are we sure that the advances made in registry development are getting incorporated into whatever new systems we produce?  Bumpers seeks more accountability from CDC, and suggests one way to achieve it is to tie state grant funding to evidence of progress.  That way CDC, Congress and the public can rest assured that we are not throwing good money after bad.

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The Advisory Committee on Immunization Practices (ACIP) Votes to Temporarily Revise Recommendations for Pneumococcal Conjugate Vaccine and Votes to Continue Previously Issued DTaP Recommendations

December 7, 2001

Pneumococcal Conjugate Vaccine Vote

The Advisory Committee on Immunization Practices (ACIP) voted today to temporarily revise recommendations for the pneumococcal conjugate vaccine due to continued shortages of the vaccine that are insufficient to allow full implementation of the 4 dose schedule for infants.
      Pneumococcal conjugate vaccine is highly effective in preventing invasive pneumococcal disease in young children.  Prior to the introduction of PCV-7, pneumococcal infections caused approximately 700 cases of meningitis, 17,000 cases of bacteremia - blood stream infections - and 200 deaths each year in children under age five.  Meningitis is the most severe type of pneumococcal disease.  About five percent of children under 5 years old with pneumococcal meningitis will die of their infections.
      The ACIP had previously revised recommendations for the vaccine on September 14, 2001, for shortages, which at the time were anticipated to be brief.  However, according to manufacturer estimates, about 1.2 million doses of vaccine will be distributed per month through March 2002, less than the 1.5 million doses per month needed, based on current demand.
      The shortage of the vaccine is due to a rapid increase in demand and manufacturing problems that have prevented the manufacturer from producing at full capacity.  The shortage is expected to continue until mid-2002, depending on adherence with the revised recommendations.
      The ACIP is making revised recommendations to limit pneumococcal conjugate vaccine use until supplies are adequate.  Two key principles underlie the revised recommendations.  First, providers should conserve vaccine supply by decreasing the number of doses administered to healthy infants, rather than leaving some children in the group recommended for vaccination completely unprotected.  Second, changes in pneumococcal conjugate vaccine use and ordering should be made by all providers, regardless of the current vaccine supply in their own practice.
      The ACIP revised recommendations are as follows:

1) High risk children less than 5 years of age should continue to be vaccinated as recommended by the ACIP in October 2000.

2) Healthy infants and children less than 24 months old should receive a decreased number of pneumococcal conjugate doses based on the age at which vaccination is initiated and the providers estimate of vaccine supply in their practice.  All providers should defer the 4th dose for infants who are vaccinated beginning at less than 6 months of age.  Additional recommendations to decrease vaccine use are included in the specific recommendations adopted by the Committee. (Guidelines will be given when the recommendations are published in CDC's Morbidity and Mortality Weekly Report).

3) Further studies should be done to evaluate the immune response to a pneumococcal polysaccharide vaccine booster dose among children 12-15 months of age.  Polysaccharide vaccine is recommended for children more than 2 years old who are at increased risk of invasive pneumococcal infection.  It is not licensed for use in children less than 2 years old.

4) Providers should maintain a list of children for whom PCV-7 has been deferred so that it can be administered when the supply situation improves.
DTAP Vote

The ACIP voted to continue prior CDC recommendations (published March 16, 2001) for providers who had insufficient quantities of DTaP vaccine due to spot shortages of the vaccine.  The recommendation applies only to providers with insufficient quantities of DTaP vaccine and recommends that they prioritize vaccinating infants with the initial three DTaP doses, and if necessary, to defer the fourth DTaP dose.  The ACIP also added that if deferring the fourth DTaP dose still does not provide enough vaccine to vaccinate infants with three DTaP doses, then the fifth DTaP dose can be deferred.  When adequate DTAP vaccine becomes available, steps should be taken to recall all children who did not receive a DTaP dose for remedial immunization.  Children should be vaccinated in accordance with existing ACIP recommendations to assure immunity to pertussis, diphtheria and tetanus during the elementary school years.
      The vaccine protects against Diphtheria, Tetanus, and Pertussis or whooping cough.  Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.  Diphtheria and pertussis are spread from person to person.  Tetanus enters the body through cuts or wounds.

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Did You Know?
Revised ACIP Recommendations

On December 14, 2001, the CDC published a "Notice to Readers: Revised ACIP Recommendation for Avoiding Pregnancy After
Receiving a Rubella-Containing Vaccine" in the Morbidity and Mortality Weekly Report (MMWR).
The full text of the notice, minus references is below:

On October 18, 2001, the Advisory Committee on Immunization Practices (ACIP) reviewed data from several sources indicating that no cases of congenital rubella syndrome (CRS) had been identified among infants born to women who were vaccinated inadvertently against rubella within 3 months or early in pregnancy. On the basis of these data, ACIP shortened its recommended period to avoid pregnancy after receipt of rubella-containing vaccine from 3 months to 28 days.
      Data were available from the U.S. Rubella Vaccine in Pregnancy Registry, the U.K. National Congenital Rubella Surveillance Programme (National Congenital Registry Surveillance Programme, unpublished data, 2001; P. Tookey, Ph.D., Center of Paediatric Epidemiology and Biostatistics, Institute of Child Health, London, personal communication, April 2001), and Sweden and Germany (G. Enders, M.D., Laboratory of Enders and Partners, and Institute for Virology, Infectology, and Epidemiology, personnel communication, September 2001) on 680 live births to susceptible women who were inadvertently vaccinated 3 months before or during pregnancy with one of three rubella vaccines (HPV-77, Cendehill, or RA 27/3).  None of the infants was born with CRS. However, a small theoretical risk of 0.5 percent (upper bound of 95 percent confidence limit = 0.05 percent) cannot be ruled out.  Limiting the analysis to the 293 infants born to susceptible mothers vaccinated 1-2 weeks before to 4-6 weeks after conception, the maximum theoretical risk is 1.3 percent. This risk is substantially less than the >20 percent risk for CRS associated with maternal infection during the first 20 weeks of pregnancy.
      Measles-mumps-rubella (MMR) vaccine and its component vaccines should not be administered to women known to be pregnant. Because a risk to the fetus from administration of these live virus vaccines cannot be excluded for theoretical reasons, women should be counseled to avoid becoming pregnant for 28 days after vaccination with measles or mumps vaccines or MMR or other rubella-containing vaccines.
      The goal of the U.S. rubella vaccination program is to prevent congenital rubella infection. ACIP recommended that MMR vaccine should be offered to all women of childbearing age (i.e., adolescent girls and premenopausal women) who do not have acceptable evidence of rubella immunity.
      Most rubella cases in the United States occur among young Hispanic adults born outside the United States, and most infants with CRS are born to foreign-born mothers.  Ensuring immunity in women of childbearing age, especially those at highest risk for exposure, will help to prevent CRS.

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Worth Repeating...

It's not too late to register for the Fourth National Conference on Immunization Coalitions that will be held in San Antonio, Texas from January 9 - 11, 2002.  The deadline for pre-registration ($125) has been extended to December 24th.
      You may view the conference brochure in PDF format by going online to  http://www.choa.org/immunization/iglg2.pdf.

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Office Update
The offices of Every Child By Two will be closed from December 24, 2001 through December 28, 2001 and on January 1, 2002 for the holidays.

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Receive Morbidity and Mortality Weekly Report (MMWR) FREE via Email.  Sign up by going to http://www.cdc.gov/subscribe.html.

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And Don't forget...

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This edition of the Every Child By Two Newsletter was written and edited by Amy Pisani, Carol Ruppel, and Rich Greenaway, and formatted by Rich Greenaway.

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