Vaccine Supply Update Jeanne M. Santoli Vaccine Supply and Assurance Branch January 22, 2010

Outline  Hib vaccine  Hepatitis B vaccine  Hepatitis A vaccine  Rotavirus Vaccine  MMRV  PCV 13

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

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.

Hepatitis B Vaccine--Adult  Merck is not currently distributing its  Merck is not currently distributing its adult/dialysis hepatitis B vaccines – Dialysis formulation will return in 3Q10 – 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

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

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

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

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

CDC’s Vaccine Supply/Shortage Webpage  Available at: gen/shortages/default.htm gen/shortages/default.htm gen/shortages/default.htm