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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.
| 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
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