| 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 |
