Red Book® Online Table – NEW
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 |
| 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 |
| 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 21-30 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 | 9-26 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 | 27-45 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 | varies | n/a | See recommendations | varies | AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;122/5/1135 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr57e717a1.htm |
| Influenza - LAIV-T (FluMist®) | MedImmune | Supplement to original BLA | 24 months to 49 years of age | Licensed 19-Sep-07 | AAP recommendations to be published in Pediatrics in October CDC: cdc.gov/mmwr/preview/mmwrhtml/rr57e717a1.htm |
| Japanese Encephalitis | Intercell AG | Dec-2007 | Greater than or equal to 17 years of age | To be reviewed | Pending FDA licensure |
| MCV4 (Menactra®) | sanofi pasteur | Dec-2003 | 11-55 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 | 2-10 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 | 11-55 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 |
| Rotavirus (ROTATEQ®) | Merck | Apr-2005 | 2, 4, and 6 months of age | Licensed 3-Feb-06 | AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;119/1/171 AAP 2nd Dose: aapnews.aappublications.org/cgi/content/full/29/8/19 CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5512a1.htm ACIP: cdc.gov/vaccines/recs/provisional/downloads/roto-7-1-08-508.pdf |
| Rotavirus (ROTARIX®) | GlaxoSmithKline (GSK) | Jun-2007 | 2 and 4 months of age | Licensed 3-Apr-08 | AAP: aapnews.aappublications.org/cgi/content/full/29/8/19 ACIP: cdc.gov/vaccines/recs/provisional/downloads/roto-7-1-08-508.pdf |
| Varicella virus second dose (Varivax®) | Merck | Supplement to original BLA: second dose | children 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 |
| Tdap (BOOSTRIX®) | GlaxoSmithKline (GSK) | Jul-2004 | 10-18 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 | 19-64 years of age | Licensed 4-Dec-08 | CDC: To be reviewed | ||
| Tdap (ADACEL™) | sanofi pasteur | Aug-2004 | 11-64 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 |
Table updated 1/6/09
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
MMRV = measles, mumps, rubella, varicella, Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, adsorbed
HPV = human papillomavirus vaccine, Hib = Haemophilus influenzae b, DTaP = Diphtheria, Tetanus and Pertussis, IPV = Inactivated Poliovirus Vaccine, LAIV-T = Live attenuated influenza vaccine-trivalent
* 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
         |
| Site Requirements | Privacy Policy | Core Values, Vision, and Mission Statement | ||
| The recommendations in this online publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. | ||
| Copyright © 2008 American Academy of Pediatrics |  |
|