Merck PedvaxHIB Shortage

Merck & Co., Inc. has reported that PedvaxHIB® is unavailable for shipment.  Based on the latest information, Merck expects PedvaxHIB® (PRP-OMP) to be available sometime in the first quarter of 2008.  Merck reports that the exact timing is dependent upon resolution of a manufacturing issue.  There are currently adequate amounts of ComVax® (PRP-OMP/Hepatitis B) to meet historical demand, but not to meet additional demand.

Limited amounts of PedvaxHIB® (PRP-OMP) will be made available from the CDC vaccine stockpile.  Doses for the private sector will be made available through Merck & Co., Inc. and to the public sector through the CDC vaccine contracts.

There will not be a sufficient quantity of stockpile vaccine to meet the historical demand for the PedvaxHIB® (PRP-OMP).  Sanofi Pasteur is working to provide additional ActHib® (PRP-T) to meet demand.  Current estimates are that providers of Haemophilus influenzae b conjugate vaccine (Hib) will need to utilize ActHib® (PRP-T) for approximately one-half of their historical PedvaxHIB® (PRP-OMP) use for the immediate future.  Orders placed beyond the available inventory of vaccine will result in backorders.

Updates of vaccine availability will be provided as more information becomes available.  If it becomes necessary to complete a series with PRP—T (ActHIB® [sanofi pasteur]) that was started with PRP-OMP (PedvaxHIB® or ComVax® (PRPOMP/Hepatitis B) [Merck]), the following guidelines may be followed:

• If the first 2 doses of PRP-OMP were administered as the primary series, any Haemophilus influenzae b conjugate vaccine including PRP-T may be administered for the dose 3 booster at age 12-15 months.

• If only one dose of PRP-OMP has been administered, the primary series may be completed with 2 additional doses of PRP-T. There should be a minimum interval of 4 weeks between all doses of the primary series followed by a 4th dose as a booster at age 12-15 months.

Please consult the Catch-Up Immunization Schedule (found on page 3 of the schedule) for the timing of doses for those who start late or are more than one month behind: http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2007/child-schedule-color-print.pdf

Pneumococcal Immunization for Entry Into Day Care or Pre-kindergarten

     New York State Public Health Law now requires pneumococcal immunization for entry into a licensed day care or pre-kindergarten program.  Children born on or after January 1, 2008, who are enrolled in a day care or pre-kindergarten program will be required to provide proof of immunization against pneumococcal disease.  
     There are two exemptions from this requirement: (1) a medical exemption consisting of a written statement from a physician licensed to practice medicine in the State of New York stating that there is a valid medical contraindication to the student receiving the booster vaccine, or (2) a statement of religious exemption written by the parent(s) or guardian(s) of the student stating that they hold genuine and sincere religious beliefs which prohibit the immunization of their child.  A religious exemption must be approved by the superintendent, principal, administrator, or person in charge of the school, and the principal may require additional documents to support the application.  Secular principles, including philosophical exemptions, are not allowed.  The New York State Education Department (SED) has provided guidance for schools regarding religious exemptions.  Information can be found at the SED website at: http://www.schoolhealthservicesny.com/laws_guidelines.cfm .