Maintaining Vaccine Supply

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Flu Shots Join the Pediatric Lineup

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Vaccine shortages and what the federal government can do about them was the subject of a September 17 hearing, chaired by Senator Jack Reed (D-RI) of the Senate Health, Education, Labor and Pensions Committee’s subcommittee on Public Health.  Last year’s unprecedented shortages of five of the eight recommended childhood vaccines prompted Senators Kennedy (D-MA), Bingaman (D-NM), Clinton (D-NY), Durbin (D-IL), Frist (R-TN) and Reed and Congressmen Waxman (D-CA) and Condit (D-CA) to request that the U.S. General Accounting Office (GAO) study the causes and make recommendations for long-term solutions.  The shortages have abated, with the exception of the pneumococcal conjugate vaccine, but U.S. production capacity to maintain a constant supply is in doubt.
      The hearing provided GAO a forum to release its report, Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges.  GAO’s Director of Health Care and Public Health Issues, Janet Heinrich, presented the findings.  The other witnesses were Dr. Timothy Doran, chairman of Greater Baltimore Medical Center’s Department of Pediatrics, speaking for himself and for the American Academy of Pediatrics, and Wayne Pisano, executive vice president of Aventis Pasteur of North America, maker of DTaP, DT, Hib, flu and polio vaccines.   
      The General Accounting Office is a Congress-serving agency that reports on federal program performance.  Its mission states, “GAO examines the use of public funds; evaluates federal programs and policies and provides analyses, recommendations, and other assistance to help Congress make informed oversight, policy and funding decisions.”  Members of Congress asked GAO to address three concerns: 1) impact of the shortages on immunization policies and programs, 2) causes for shortages and whether those causes persist and 3) a federal plan to mitigate against future shortages.
      To compile its report, GAO sent surveys to the National Immunization Program grantees (50 states, the District of Columbia, several cities and some territories).  Forty-nine state immunization programs reported having to ration one or more vaccines during the shortage period.  Thirty-one programs reported shortages of five or more recommended vaccines.  Some states had no supply of certain vaccines for months.  Most states amended school and day care requirements to conform to diminished supply.  There is no data yet available on the impact of missed vaccinations resulting from the delays, or consequent incidents of disease. 
      As was uncovered by the National Vaccine Advisory Committee (NVAC) and reported in this newsletter in June (see www.ecbt.org), the causes vary with each vaccine.  Only four U.S. manufacturers produce all children’s vaccines, and five out of the eight vaccines have only one manufacturer.  Some manufacturers suffered production problems that caused shortages, and some discontinued production.  The preservative thimerosal was removed from several vaccines as a precaution because it contains mercury.  Its removal proved difficult for DTaP production, so one company discontinued its manufacture and the remaining manufacturer was able to produce only three-fourths of the supply it had promised.  Producing a thimerosal-free hepatitis B vaccine took 10 months for one manufacturer.  Reformulation to remove it required a new FDA approval that is time and resource-consuming.
      Over time, shortages are likely to recur for a number of reasons.  Vaccines, because they are biologics and not synthetics, require special growing conditions that cannot necessarily be sped up on demand.  “Strict control is needed over the entire manufacturing process and each lot of vaccine is carefully tested for its purity and potency.”  Production disruptions cause delays.  A potential threat to production is the growth of lawsuits pending that are related to past use of thimerosal, many claiming that adverse events caused by thimerosal do not have to be heard through the Vaccine Injury Compensation Program (see December 2001 and July 2002 newsletters) because thimerosal is not an ingredient of the vaccine but an additive.  It has not been determined that these claims must first be filed with the Vaccine Injury Compensation Program before going to court.  Manufacturers are worried that if these cases do go to court, they will be so costly that vaccine production will become a company liability.        
      As agencies and advisory committees such as NVAC study the situation, long-term solutions have not yet surfaced.  New vaccines are being developed that should ease the burden. Vaccine stockpiles offer some relief, and the best solution available.  CDC is required to stockpile a six-month supply of recommended childhood vaccines and is considering expanding its supply.  However, stockpiling has its limitations—the obvious one being that if vaccines are in short supply then there is no capacity to stockpile.  GAO recommends that CDC develop a strategic plan for stockpiling.  GAO also recommends that the Food and Drug Administration (FDA) improve its communication to manufacturers about changes in regulations and that FDA consider revising its policies to expedite vaccine approval.  For a copy of the report go to http://www.gao.gov and find GAO-02-987, Childhood Vaccine Shortages.
      Dr. Doran reported that his private practice suffered shortages, and that recall systems for getting patients back to offices once supplies are in are not reliable, even with his middle-class practice.  He agreed with GAO’s recommendations to improve on stockpiling and to strengthen liability protections in the Vaccine Injury Compensation Program.
      Mr. Pisano called for a national policy to address and avert future shortages.  He suggested that the regulatory process is too burdensome and discourages entry into the market.  He reported that federal purchasing of 50 percent of childhood vaccines at   negotiated lower prices “may produce short-term savings for government but ultimately contributes to the supply problem.”  And, that “We are today facing liability problems that dwarf what we saw two decades ago, which potentially pose a threat to future supplies.”  Therefore he suggested that congress pass Senator Frist ‘s S. 2053 to amend the Vaccine Injury Compensation Program so that all vaccine injury cases must first use the program as was intended when Congress authorized it in 1986.
      There are several proposals in Congress to boost CDC stockpiles and to amend the Vaccine Injury Compensation Act to make the alternative dispute program even more effective, offering better compensation for victims and their families and better liability protection for vaccine manufacturers.  These proposals are likely to die in the 107th Congress which is tentatively scheduled to adjourn on October 4.  However, they are also likely to be introduced into the 108th.