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1.5 months |
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2.5 months |
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3.5 months |
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6 months |
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9 months |
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15 months |
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1 year |
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1.5 years |
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2 years |
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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 |
Hib/DTaP/IPV (PENTACEL™) | sanofi pasteur | Jul-2005 | 2, 4, 6, and 15 to 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 |
HPV (GARDASIL®) | Merck | Dec-2005 | 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 | 27 through 45 years of age | To be reviewed | Pending FDA licensure | ||
HPV (Cervarix™) | GlaxoSmithKline (GSK) | Mar-2007 | Data not available | To be reviewed | Pending FDA licensure |
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 H1N1: cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm |
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 |
MMRV (ProQuad®) | Merck | Aug-2004 | Same as for MMR dose 1 or dose 2; 12 months to 12 years of age | Licensed 6-Sep-05 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5447a4.htm
CDC Update: cdc.gov/mmwr/preview/mmwrhtml/mm5710a3.htm |
PCV13 (Prevnar 13®) | Wyeth | Mar-2009 | 2 months to 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 |