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Vaccine Supply Update

Vaccine Supply Update. Jeanne M. Santoli (jsantoli@cdc.gov) Vaccine Supply and Assurance Branch January 22, 2010. Outline. Hib vaccine Hepatitis B vaccine Hepatitis A vaccine Rotavirus Vaccine MMRV PCV 13. Hib Vaccine.

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Vaccine Supply Update

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  1. Vaccine Supply Update Jeanne M. Santoli (jsantoli@cdc.gov) Vaccine Supply and Assurance Branch January 22, 2010

  2. Outline • Hib vaccine • Hepatitis B vaccine • Hepatitis A vaccine • Rotavirus Vaccine • MMRV • PCV 13

  3. Hib Vaccine • Merck received FDA approval for distribution of monovalent Hib vaccine on January 14, 2010 • Product will become available for order in late Jan; doses to reach CDC depots in early February • Grantees will receive allocations next week and will need to update VOFAs to reflect planned orders • Other products available for Hib include • Monovalant Hib from sanofi, GSK (booster dose only for GSK) • Combination vaccine from sanofi (Pentacel) • Combination vaccine from Merck (Comvax) is not currently available • CDC will continue allocations for 1-2 months to assess how product demand matches availability, ensure initial equitable access to vaccine

  4. Hepatitis B Vaccine--Pediatric • Both manufacturers are back to full supply of monovalent pediatric hepatitis B vaccine • Doses borrowed from the stockpiles in 2009 are being repaid • CDC discontinued allocations January 1, 2010 • GSK’s syringe product is changing from a 5-pack to a 10-pack; no change in price per dose; will ask that grantees order the 5-pack until it is no longer available in their depots; need for VOFA updates being assessed.

  5. Hepatitis B Vaccine--Adult • Merck is not currently distributing its adult/dialysis hepatitis B vaccines • Dialysis formulation will return in 3Q10  • Adult formulation will not be available in the first half of 2010 • Following backorders (> 1 month) in the late fall for both formulations, GSK now has product available and has cleared backorders. • GSK expects to have at least one presentation of monovalent product continually available. • The combination product, Hep A-Hep B vaccine, is available as an alternative

  6. Hepatitis A Vaccines Pediatric • There have been fluctuations of product/brand availability over the past six months • Both manufacturers are currently making vaccine available to the market and utilizing doses from the pediatric stockpiles to fill in gaps as needed Adult • Merck will not be distributing vaccine for the rest of 2010 • GSK's production and supply of their monovalent and combination adult vaccines are in adequate supply to meet demand for the first half of 2010; currently assessing ability to support the full market for the remainder of 2010

  7. Rotavirus vaccines • Intermittent product outages in November and December for GSK’s rotavirus vaccine • Supply arrived in late December, early January, addressing backorders • May be some intermittent backorders for GSK during March timeframe, but both manufacturers anticipate being able to meet demand

  8. MMRV • Merck expects to begin taking orders for MMRV on February 15th, 2010 • Shipping will begin before the end of February. • Grantees will need to update their VOFAs to reflect planned purchases

  9. PCV 13 • Anticipated licensure prior to Feb ACIP meeting • Following ACIP, likely available for provider orders by mid to end March • Manufacturer swaps will include: • CDC stockpiles • McKesson depots • Private stock in provider offices • Since VFC stock in provider offices will not be swapped, CDC has encouraged smaller, more frequent provider orders to bring inventory levels down in provider offices and minimize vaccine waste • Specific guidance is being developed about use of PCV7 after PCV13 is licensed

  10. CDC’s Vaccine Supply/Shortage Webpage • Available at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

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