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Red Book® Online Table –
Status of Licensure and Recommendations for New Vaccines*

Due to the complexity of the vaccine licensure process and the large number of vaccines on the horizon, the American Academy of Pediatrics (AAP) has developed this information page on Red Book Online to provide current information about the licensure process and AAP recommendations about vaccines listed in the table. This table will be updated when changes occur.

Printer-Friendly Table (PDF)

Vaccine Manufacturer BLA submitted to FDA BLA age indications** FDA licensure Status of AAP/CDC recommendations***
DTaP-IPV (KINRIX) GlaxoSmithKline (GSK) Jun-2007 4 through 6 years of age Licensed 24-Jun-08 AAP: aapnews.aappublications.org/cgi/content/full/29/8/20
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5739a4.htm
DTaP-IPV/Hib (PENTACEL™) sanofi pasteur Jul-2005 2, 4, 6, and 15 through 18 months of age Licensed 20-Jun-08 AAP: aapnews.aappublications.org/cgi/content/full/29/8/1-b
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm
Hib(Hiberix) GlaxoSmithKline (GSK) Mar-2009 Booster dose in children 15 months through 4 years of age Licensed 19-Aug-09 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5836a5.htm
Hepatitis A (VAQTA®) Merck Supplement to original BLA Greater than or equal to 12 months of age Licensed 11-Aug-05 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/1/189
CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5507a1.htm
CDC for post-exposure and for international travelers cdc.gov/mmwr/preview/mmwrhtml/mm5641a3.htm
Hepatitis A (HAVRIX®) GlaxoSmithKline (GSK) Supplement to original BLA Greater than or equal to 12 months of age Licensed 17-Oct-05
Hepatitis A and Hepatitis B (TWINRIX®) GlaxoSmithKline (GSK) Supplement to original BLA: accelerated dosing Greater than or equal to 18 years of age
0, 7, and 21 through 30 days and 12 month booster
Licensed 28-Mar-07 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5640a5.htm
Herpes zoster vaccine (ZOSTAVAX®) Merck Apr-2005 Greater than or equal to 60 years of age Licensed 25-May-06 ACIP: cdc.gov/mmwr/preview/mmwrhtml/rr57e0515a1.htm
HPV4 (GARDASIL®) Merck Dec-2005 Females 9 through 26 years of age (3 doses) Licensed 8-Jun-06 ACIP: cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm
AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/3/666
Supplement to original BLA Males 9 through 26 years of age Licensed 16-Oct-09 Pending publication
Supplement to original BLA 27 through 45 years of age To be reviewed Pending FDA licensure
HPV2 (Cervarix™) GlaxoSmithKline (GSK) Mar-2007 10 through 25 years of age Licensed 16-Oct-09 Pending publication
Influenza vaccines - TIV varies n/a See recommendations varies AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;124/4/1216
CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5808a1.htm
CDC Seasonal: cdc.gov/flu
CDC H1N1: cdc.gov/h1n1
Influenza - LAIV-T (FluMist®) MedImmune Supplement to original BLA 24 months to 49 years of age Licensed 19-Sep-07
Japanese Encephalitis (IXIARO) Intercell Biomedical Dec-2007 Greater than or equal to 17 years of age Licensed 30-Mar-09 ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/je-july2009-508.pdf
MCV4 (Menactra®) sanofi pasteur Dec-2003 11 through 55 years of age Licensed 14-Jan-05 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;116/2/496
CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm
Supplement to original BLA March 2005 2 through 10 years of age only for children at high risk Licensed 18-Oct-07 ACIP: cdc.gov/mmwr/preview/mmwrhtml/mm5717a4.htm
MCV4 (Menveo™) Novartis Aug-2008 11 through 55 years of age To be reviewed Pending FDA licensure
MenCY-Hib (MenHibrix™) GlaxoSmithKline (GSK) 2009 2, 4, 6 and 12 months of age To be reviewed Pending FDA licensure
MMRV (ProQuad®) Merck Aug-2004 Same as for MMR dose 1 or dose 2; 12 months through 12 years of age Licensed 6-Sep-05 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5447a4.htm
CDC Update: cdc.gov/vaccines/recs/provisional/downloads/mmrv-oct2009-508.pdf
PCV13 (Prevnar 13®) Wyeth Mar-2009 2 months through 5 years of age To be reviewed Pending FDA licensure
Rotavirus (ROTATEQ®) Merck Apr-2005 2, 4, and 6 months of age Licensed 3-Feb-06 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;123/5/1412
ACIP: cdc.gov/mmwr/PDF/rr/rr5802.pdf
Rotavirus (ROTARIX®) GlaxoSmithKline (GSK) Jun-2007 2 and 4 months of age Licensed 3-Apr-08
Tdap (BOOSTRIX®) GlaxoSmithKline (GSK) Jul-2004 10 through 18 years of age Licensed 3-May-05 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;117/3/965
CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm
Supplement to original BLA 19 through 64 years of age Licensed 4-Dec-08 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5814a5.htm
Tdap (ADACEL™) sanofi pasteur Aug-2004 11 through 64 years of age Licensed 10-Jun-05 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;117/3/965
CDC Adolescent: cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm
CDC Adult: cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm
ACIP in Pregnancy: cdc.gov/mmwr/preview/mmwrhtml/rr5704a1.htm
Varicella virus second dose (Varivax®) Merck Supplement to original BLA: second dose 12 months to 12 years of age (3 month minimum interval) Licensed 5-Apr-05 AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;120/1/221
CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm

Table updated 11/4/09
Vaccine supply shortages may result in changes to recommendations. Please consult cdc.gov/vaccines/vac-gen/shortages/default.htm


BLA = biologics license application, VRBPAC = Vaccines and Related Biological Products Advisory Committee, FDA = Food and Drug Administration
AAP = American Academy of Pediatrics, ACIP = Advisory Committee on Immunization Practices, MCV4 = Meningococcal conjugate vaccine
DTaP = Diphtheria, Tetanus and Pertussis, Hib = Haemophilus influenzae b, HPV = human papillomavirus vaccine, IPV = Inactivated Poliovirus Vaccine, LAIV-T = Live attenuated influenza vaccine-trivalent, MMRV = measles, mumps, rubella, varicella, PCV7 = Pnemococcal 7-valent conjugate, Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, adsorbed

* Information from vaccine manufacturers, from ACIP meetings and from AAP
** Age licensure can change following FDA review; not final until package insert approved
*** ACIP recommendations do not become official until approved by the CDC Director and Department of HHS and publication in MMWR