Dear Provider Letter on the Shortage of Hib Vaccine

February 26, 2008

Dear Vaccines for Children Provider,

The purpose of this letter is to provide you with information regarding the supply of Haemophilus influenzae type b (Hib) vaccine available through the New York State Vaccines for Children (NYS VFC) Program. There is currently a shortage of Hib vaccine due to a recall of certain lots of two of the types of Hib vaccine manufactured by Merck & Co., PedvaxHIB and COMVAX. Provider offices may still have lots of the Merck vaccines that are safe to use, but most Hib vaccine that is currently available is ActHIB which is manufactured by Sanofi Pasteur. The NYS VFC Program has predominantly ActHIB for distribution and the supply is limited. For more information on the recall and supply of Hib vaccine and interim recommendations, please see the attached Morbidity and Mortality Weekly Report (MMWR) or the advisory sent by the New York State Department of Health (NYSDOH) Immunization Program on December 26, 2007 that is posted on the Health Provider Network (HPN) at https://commerce.health.state.ny.us/hpn/ctrldocs/alrtview/postings/doc071226_0.pdf (HPN account needed) or see the"Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib)" letter. To see the specific lots that have been recalled, please visit the Merck website at http://www.merckvaccines.com/PCHRecall.pdf or the website of the Food and Drug Administration at http://www.fda.gov/consumer/updates/hib121307.html.

Because of the current shortage of Hib vaccines, the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics, and the American Academy of Family Physicians recommend that providers temporarily defer administering the routine Hib vaccine booster dose administered at age 12--15 months except to children in specific groups at high risk. Children at high risk for Hib disease include children with sickle cell anemia, asplenia, malignancy, HIV infection, or immune system disorders and children who are Native Americans; these high-risk children should still get the complete series of immunizations, including the 12-15 month booster dose. Providers should continue to give all children the primary series (i.e., give the first 2 doses if PedvaxHIB or COMVAX is used or the first 3 doses if ActHIB is used), as long as supplies are adequate.

The NYS VFC program is taking steps to help ensure that health care providers have a supply of Hib vaccine. These steps include:

  • Limiting a provider/practice's VFC order of Hib vaccine to 75% of what the practice usually orders;
  • Allowing providers to order Hib vaccine only once a month;
  • Prioritizing vaccine for practices that have no supply of Hib vaccine;
  • Allowing providers, in rare situations, to borrow from their private supply and pay back that supply with VFC vaccine when it arrives, or vice versa. No borrowing may occur before first contacting the NYS VFC Program at 518-474-4578; and
  • Informing providers about any changes in the Hib vaccine supply or recommendations.

If providers run out of Hib vaccine and are unable to provide the entire primary series to all their patients, they should track all these infants and recall them when vaccine is available. Those children unable to receive the 12-15 month dose of Hib vaccine should also be tracked. They should be recalled when the recommendation to administer this dose is resumed and supply is available.

To maximize the amount of available Hib vaccine, providers should order only the number of doses of vaccine required to meet immediate needs (i.e., a supply up to 4 weeks) and should refrain from attempting to build an inventory of Hib vaccine.

Enclosed is a flyer that can be given to the parents of your patients to help them understand the Hib supply situation. If you have any questions about vaccine ordering, please call the NYS VFC program at 518-474-4578. If you have any questions about Hib vaccine and the recommendations for administering it, please call your local health department or the NYSDOH Immunization Program at 518-473-4437.

Thank you for your patience during this shortage and your dedication to vaccinating children in New York State.

Sincerely,

Debra Blog, MD, MPH
Medical Director
Immunization Program

cc: Local Health Department Commissioners and Public Health Directors

Enclosure