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Vaccine Price Increase

The vaccine division of Merck has announced a price increase of 4% for its MMR, varicella, HPV, and rotavirus products, effective January 31, 2008. The AAP has worked with Merck and the company will extend a price discount that allows physicians to buy these vaccines at the pre-increase price for the next 30 days. Click here for the price increase notification and more details.  Member Center access requires you to log into the AAP Member Center using your AAP member ID and password. 
 


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 .
 


 

Below is a CDC Health Advisory disseminated via the Health Alert Network (HAN) on January 14, 2006 at 3:25 p.m. EST. 

This is an official
CDC Health Advisory

 Distributed via Health Alert Network, January 14, 2006, 15:25 EST (03:25 PM EST)

CDC Recommends against the Use of Amantadine and Rimandatine for the Treatment or Prophylaxis of Influenza in the United States during the 2005–06 Influenza Season

Recent evidence indicates that a high proportion of currently circulating Influenza A viruses in this country are resistant to these medications

 While the primary strategy for preventing complications of influenza infections is annual vaccination, antiviral medications with activity against influenza viruses can be effective for the prophylaxis and treatment of influenza. Two classes of antivirals are currently available—the M2 ion channel inhibitors (i.e., the two adamantanes amantadine and rimantadine) and the neuraminidase inhibitors (i.e., oseltamivir and zanamivir). The neuraminidase inhibitors are effective for the treatment and prophylaxis of influenza A and B, while the adamantanes are only active against influenza A viruses. This alert provides new information about the resistance of influenza viruses currently circulating in the United States to the adamantanes, and it makes an interim recommendation that these drugs not be used during the 2005–06 influenza season. Amantadine is also used to treat the symptoms of Parkinson’s disease, and should continue to be used for this indication.

 Viral resistance to adamantanes can emerge rapidly during treatment because a single point mutation at amino acid positions 26, 27, 30, 31, or 34 of the M2 protein can confer cross-resistance to both amantadine and rimantadine. The transmissibility of adamantane-resistant viruses is not impaired by any of these amino acid changes. A recent report on the global prevalence of adamantane-resistant influenza viruses showed a significant increase (from 1.9% to 12.3%) in drug resistance over the past 3 years. In the United States, the frequency of drug resistance increased from 1.9% in 2004 to 14.5% during the first 6 months of the 2004–05 influenza season.

 For the 2005–06 season, 120 influenza A (H3N2) viruses isolated from patients in 23 states have been tested at CDC through January 12, 2006; 109 of the isolates (91%) contain an amino acid change at position 31 of the M2 protein, which confers resistance to amantadine and rimantadine. Three influenza A(H1N1) viruses have been tested and demonstrated susceptibility to these drugs. All influenza viruses from the United States that have been screened for antiviral resistance at CDC have demonstrated susceptibility to the neuraminidase inhibitors.

 On the basis of available antiviral testing results, CDC is providing an interim recommendation that neither amantadine nor rimandatine be used for the treatment or prophylaxis of influenza A in the United States for the remainder of the 2005–06 influenza season. During this period, oseltamivir or zanamivir should be selected if an antiviral medication is used for the treatment and prophylaxis of influenza. Testing of influenza isolates for resistance to antivirals will continue throughout the 2005–06 influenza season, and recommendations will be updated as needed. Annual influenza vaccination remains the primary means of preventing morbidity and mortality associated with influenza.

 Additional information about the prevention and control of influenza is available at http://www.cdc.gov/flu/. Specific information regarding the use of the neuraminidase inhibitors is available at http://www.cdc.gov/flu/protect/antiviral/index.htm. These websites will be updated as new information becomes available.


 

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