Current Vaccine Shortages (Exit Site)
This web page provides the latest national information about vaccine supply, shortages, and delays.

Communications from Manufacturers about Supply

• Haemophilus influenzae type b (PedivaxHIB®) Vaccine Shortage
  Merck & Co., Inc. has reported that its H. influenza type b conjugate vaccine, PedivaxHIB® (PRP-OMB), is currently unavailable for shipment. Merck expects that PedivaxHIB® will be available again sometime in the first quarter of 2008 but the exact timing will depend upon resolution of a manufacturing issue. Merck has an adequate amount of ComVax® (PRP-OMP/hepatitis B) to meet current demand, but not to meet an increased demand.

  To partially address this shortage, the Centers for Disease Control and Prevention plans to make limited amounts of PedivaxHIB® available from its vaccine stockpile. Vaccine from the stockpile will be available to the private sector through Merck & Co. and through VFC for the public sector. The quantity of vaccine being released from the stockpile will not be of sufficient to meet current demand for PedivaxHIB®.

  Sanofi pasteur is working to provide additional ActHib® (PRP-T) to meet current needs for H. influenzae (Hib) vaccine. Physicians should plan to utilize to ActHib® to keep infants and children up-to-date with the Hib vaccination schedule. It is possible that backorders may result from a marked increase in demand.

  At this time, no changes are being considered in H. influenzae (Hib) immunization recommendations. Red Book, 2006 states that available monovalent Hib conjugate vaccines are considered interchangeable for primary and booster immunization and if PRP-OMB is administered as only part of a primary series, the recommended number of doses to complete the series is determined by the other Hib conjugate vaccine. Therefore, if only one dose of PRP-OMB was given, 2 doses of PRP-T will be necessary to complete the primary series. Any available Hib conjugate vaccine can be used for the booster dose at 12-15 months. The catch up Hib immunization schedule is also available in Red Book, 2006.

  Clinics serving predominantly American Indian/Alaskan Native children may wish to consider using ActHib® for subsequent Hib doses as soon as possible to enable them to use their remaining supplies of PRP-OMB for the first dose of Hib vaccine until the vaccine becomes available again. PRP-OMB is recommended for these children because of their high risk of Hib disease and the more rapid protective antibody response seen with PRP-OMB.

  Updates on vaccine availability will be provided as more information becomes available. Information on current vaccine supply issues may be found on the CDC Web site.

• Hepatitis A Vaccine Supply
  Merck & Co., Inc., has temporarily stopped accepting orders for its pediatric hepatitis A vaccine, Pediatric VAQTA®. Merck will continue to ship back-ordered vaccine until the available supply is exhausted. All back-ordered vaccine is expected to be delivered by early November. Merck estimates that Pediatric VAQTA® could be available late in the first quarter of 2008, and will provide additional information as it becomes available. GlaxoSmithKline has adequate supplies of their hepatitis A vaccine, Pediatric Havrix®, to meet current demand; therefore a shortage of hepatitis A vaccine is not expected.
  
  AAP recommends that pediatricians continue to follow current recommendations for use of hepatitis A vaccine in children and adolescents. Although completion of the recommended 2-dose immunization regimen with the same product is preferable, data indicate that hepatitis A vaccines from the two manufacturers can be used interchangeably. Thus, either of the vaccine preparations licensed for children can be given as the second dose.

• ProQuad (Merck): Merck & Co., Inc. has notified the American Academy of Pediatrics and the Centers for Disease Control and Prevention (CDC) that, based on current market demand, the company projects the existing supply of ProQuad is likely to be depleted by July 2007. Once depleted, ProQuad is not expected to be available at least for the remainder of 2007. Vaccine providers should begin transitioning from ProQuad to MMR and Varivax according to their current supply of vaccine.

  In its April issue, AAP News reported that Merck (Whitehouse Station, N.J.) had temporarily suspended production of bulk varicella, which is used in the preparation of its three varicella-containing vaccines, due to lower than expected yields in recent production lots. Varicella bulk is stored frozen until it is needed in the final preparation phase of each varicella-containing vaccine. Thus, the lower virus yield in the production of bulk varicella zoster virus (VZV) does not affect the quality of any of Merck’s VZV-containing vaccines currently on the market, nor does it affect any lots of vaccine manufactured and ready for release to the market. Production of VZV bulk will remain suspended until Merck identifies the cause of the lower-than-expected virus yield.

  To conserve existing bulk, Merck prioritized continued production of Varivax and the newly licensed zoster vaccine (Zostavax) over ProQuad, since production of Varivax requires less bulk varicella than does production of ProQuad. Zostavax is licensed for use in adults age 60 and older, and should never be administered to children.

  Merck said it foresees no problems in meeting an increased demand for Varivax and MMR while ProQuad is unavailable. Further information is available in the CDC’s Morbidity and Mortality Weekly Report.

  Supplies of Varivax are expected to be adequate for implementation of the new recommendation from the Academy and the CDC that a second dose of varicella vaccine routinely be administered to all children and adolescents without evidence of immunity to varicella-zoster virus. Although the Academy recommends that the second dose of varicella-containing vaccine be administered routinely at 4-6 years of age, during the ProQuad shortage physicians who wish to reduce the number of injections at the 4-6 year old visit may routinely give the second dose of Varivax prior to this age, as long as the first and second doses are separated by at least 28 days (and preferably by at least three months). Full recommendations on use of varicella vaccine in pediatric patients are available online on the AAP Member Center, and will be published in the July issue of Pediatrics.

  Questions about the supply of these Merck products can be addressed by contacting Merck’s National Service Center at 1-800-637-2590. (5/15/07)

Status of Licensure and Recommendations for New Vaccines - New from AAP Red Book Online™ (Exit Site)
This table provides up-to-date information on the status of recommendations for new vaccines and is freely accessible to all visitors by clicking the link above.

Understanding Vaccine Research & Development, Licensure, and the Recommendation Process (Exit Site)
Dr Margaret Rennels, Dr John Bradley, and Dr Larry Pickering, describe the comprehensive process of adding new vaccine recommendations to the immunization schedule. Reprint permission for this article courtesy of AAP News.

Manufacturers and Distributors Phone Numbers
Link to vaccine manufacturers and distributors telephone numbers.

Resources:

• GAO Report On Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges (Exit Site)
  The report addresses three questions asked by the United States Congress: 1. To what extent have recent childhood vaccine shortages affected immunization policies and programs; 2. What factors have contributed to the recent shortages, and have they been resolved; and 3. What strategies are federal agencies considering to help mitigate disruptions in the vaccine supply?
• Article: Poland GA, Marcuse EK. Vaccine availability in the US: problems and solutions. Nature Immunology. 2004;5:1195-1198
  The shortage in US influenza vaccine supply has finally focused public attention on recurrent problems faced by public health officials in ensuring the availability of many vaccines.
• Slideset: Meeting the Challenges of Pandemic Vaccine Preparedness: FDA Perspectives
  Presented by Jesse L. Goodman, MD, MPH, Director, Center for Biologics Evaluation and Research, at the IOM Symposium on Pandemic Influenza Research on April 5, 2005. This presentation provides an overview of changes in the vaccine industry and ideas about how to meet the challenges ahead.