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Senate Committee Examines Vaccine Shortage

The Senate Governmental Affairs Committee held a hearing on June 12 to examine the recent shortage in childhood vaccines. Witnesses appearing before the committee included representatives from the pharmaceutical industry, government, and medicine.

In his testimony, Dr. Timothy Doran of the Greater Baltimore Medical Center said, “Immunization is one of the greatest public health achievements of the 20th century and…has reduced by more than 95 to 99 percent the vaccine-preventable infectious diseases in the country.” He stressed that the “real-life impact” of the vaccine shortages “cannot be denied.” According to Dr. Doran, “an estimated 11,000 babies are born each day in the United States, each requiring 20 doses of vaccine by age 18 months to be protected against 11 childhood diseases.” As a result, he said, “A vaccine shortage quickly impacts thousands of families every day.”

Agreeing with Dr. Doran, Dr. Mary Anne Jackson of Children’s Mercy Hospitals and Clinics in Kansas City, Missouri, said that the message of an educational program to “empower parents to insist that their child be immunized on time…becomes muddled when we document the scope of disease that can be prevented by immunization and then delay and defer opportunities.”

According to Dr. Walter Orenstein of the Centers for Disease Control and Prevention (CDC), there are currently supply problems with “five vaccines that provide protection against eight of the eleven vaccine preventable childhood diseases: Diphtheria, Tetanus, Pertussis, Pneumococcal infection, Measles, Mumps, Rubella, and Varicella.” He added that four of the five vaccines with supply problems had relatively high prices, “ranging from $11.75 per dose to $45.99 per dose.” On the other hand, he said, “The three vaccines without supply problems range in price from $7.63 to $9.43 per dose.”

In an effort to solve these supply problems, Dr. Orenstein said that the CDC is “in constant communication with vaccine manufacturers regarding the status of vaccine production.” In addition, the CDC communicates often with other agencies within the Department of Health and Human Services, including the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services.

He also said that the CDC has established “Storage and Rotation Contracts,” or stockpiles, with the vaccine manufacturers and these stockpiles provide a six-month supply for each recommended vaccine. Dr. Orenstein explained that “stockpiles have been very effective in the past in alleviating brief disruptions in vaccine supply, and are an important resource to maintain.” He added that any vaccines taken from the stockpile are replaced within a year.

Dr. Lester Crawford of the FDA outlined four factors contributing to the vaccine shortages, including:

  • the withdrawal from the market of one manufacturer;
  • difficulties in the manufacturing processes;
  • temporary shutdowns of facilities for upgrades or maintenance, or to correct manufacturing deficiencies observed by the manufacturer or FDA during inspections; and
  • other factors, such as transition to thimerosal-free vaccine formulations.


He added that like the CDC, the FDA meets routinely with manufacturers “prior to submission of a licensing application to facilitate the regulatory process and provide guidance on requirements for new vaccines.” Dr. Crawford stressed that the FDA works with the National Institutes of Health, the CDC, and the vaccine manufacturers “to take whatever steps possible to prevent and alleviate vaccine shortages.”

Wayne Pisano of the Pharmaceutical Research and Manufacturers of America said that “cooperation between government and industry providers…will have a positive impact” on strengthening vaccine supplies. He recommended that the CDC’s stockpiles be expanded in the event of “unforeseen fluctuations or the loss of a manufacturer for which advance notice cannot be provided.”

Mr. Pisano also recommended strengthening the Vaccine Injury Compensation Program, which provides financial compensation for medical expenses, pain and suffering, and lost wages to individuals injured by childhood vaccines, as an alternative to traditional civil litigation. He made clear that although most of the vaccine shortages will be resolved this year, it is important for such a hearing to address “what can be done to minimize the chances of recurrences and how best to act if there are recurrences.”

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