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Vaccine Status Table
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. Click on disease names for current Red BookŪ recommendations.
Jump to: PDF Version | Status of Recently Submitted, Licensed, and Recommended Vaccines | Status of Older Vaccine Licensure and Recommendations | Status of Recommendations for Vaccine Use in Special Circumstances or in Adults, or Changes in Recommended Vaccine Use
Table 1: Status of Recently Submitted, Licensed, and Recommended VaccinesGeneral Recommendations on Immunization from ACIP - cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm |
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Vaccine |
Manufacturer |
BLA submitted to FDA |
BLA age indications** |
FDA licensure |
Table 1: Status of AAP/CDC recommendations*** |
| 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 |
| HPV4 (GARDASIL®] | Merck | Dec-2005 | Females 9 through 26 years of age | Licensed 8-Jun-06 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr56e312a1.htm CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5920a5.htm |
| sBLA | Males 9 through 26 years of age | Licensed 16-Oct-09 | |||
| sBLA | Prevention of anal cancer in males and females nine through 26 years of age | Licensed 22-Dec-10 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm6050a3.htm | ||
| HPV2 (Cervarix™) | GlaxoSmithKline (GSK) | Mar-2007 | Females 10 through 25 years of age | Licensed 16-Oct-09 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5920a4.htm |
| Influenza vaccines - TIV | varies | n/a | See recommendations | varies | AAP: pediatrics.org/cgi/doi/10.1542/peds.2011-2295 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm60e0818a1.htm CDC Seasonal: cdc.gov/flu Red Book Online Influenza Resource Page: aapredbook.org/flu |
| Influenza -LAIV-T (FluMist®) | MedImmune | sBLA | 24 months through 49 years of age | Licensed 19-Sep-07 | |
| sBLA | Quadrivalent vaccine including 2 B strains | To be reviewed | Pending review | ||
| Influenza -Intradermal (Fluzone®) | sanofi pasteur | New administration route | 18 through 64 years of age | Licensed 9-May-11 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm60e0818a1.htm |
| 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 Menactra: cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm CDC Menveo: cdc.gov/mmwr/preview/mmwrhtml/mm5909a5.htm CDC Update: cdc.gov/mmwr/preview/mmwrhtml/mm6030a3.htm Recommendations for children at prolonged risk: see Table 3. CDC Menactra Recommendations for children under 2 years of age: cdc.gov/mmwr/preview/mmwrhtml/mm6040a4.htm |
| 2 through 10 years of age | Licensed 17-Oct-07 | ||||
| 9 through 23 months of age | Licensed 22-Apr-11 | ||||
| MCV4 (Menveo™) | Novartis | Apr-2010 | 11 through 55 years of age | Licensed 19-Feb-10 | |
| 2 through 10 years of age | Licensed 28-Jan-11 | ||||
| 2, 4, 6, 12 through 16 months 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 for dose 1 or dose 2: 12 months through 12 years of age | Licensed 6-Sep-05 | AAP: Pending publication CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5447a4.htm CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5903a1.htm |
| PCV13 (Prevnar 13®) | Wyeth | Mar-2009 | 2 months through 71 months of age | Licensed 25-Feb-10 | AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;126/1/186 CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5909a2.htm CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm Recommendations for adults: see Table 3 |
| 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 CDC: cdc.gov/mmwr/PDF/rr/rr5802.pdf Recommendations for contraindication for SCID: see Table 3 |
| Rotavirus (ROTARIX®) | GlaxoSmithKline (GSK) | Jun-2007 | 2 and 4 months of age | Licensed 3-Apr-08 | |
| 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 AAP Update: aappolicy.aappublications.org/cgi/content/full/pediatrics;128/4/809 CDC Adolescent: cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm CDC Update: cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm CDC Pregnancy: cdc.gov/mmwr/preview/mmwrhtml/rr5704a1.htm ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/pregnant-Tdap-use.pdf CDC Adacel for health care personnel: cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm |
| Tdap (BOOSTRIX®) | GlaxoSmithKline (GSK) | Jul-2004 | 10 through 18 years of age | Licensed 3-May-05 | |
| Supplement to original BLA | 19 through 64 years of age | Licensed 4-Dec-08 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5814a5.htm | ||
| Supplement to original BLA | Greater than or equal to 65 years of age | Licensed 8-Jul-11 | Pending review | ||
Table Updated: 2/27/12
Current Recommended Immunization Schedules: 0-6 Years | 7-18 Years | Catch-up Schedule | AdultVaccine 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, DTaP = Diphtheria, Tetanus and Pertussis, Hib = Haemophilus influenzae b, HPV = human papillomavirus vaccine, IPV = Inactivated Poliovirus Vaccine, LAIV-T = Live attenuated influenza vaccine-trivalent, MCV4 = Meningococcal conjugate vaccine, MMRV = measles, mumps, rubella, varicella, PCV13 = Pnemococcal 13-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
Table 2: Status of Older Vaccine Licensure and Recommendations |
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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: aappolicy.aappublications.org/cgi/content/full/pediatrics;128/4/805
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: aappolicy.aappublications.org/cgi/content/full/pediatrics;128/4/805
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5739a5.htm |
| Hepatitis A (VAQTA®) | Merck | sBLA | 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) | sBLA | Greater than or equal to 12 months of age | Licensed 17-Oct-05 | |
| Varicella virus second dose (Varivax®) | Merck | sBLA: 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: 2/27/12
Table 3: Status of Recommendations for Vaccine Use in Special Circumstances or in Adults, or Changes in Recommended Vaccine Use |
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Vaccine |
Indications** |
Date of Recommendation |
Web site |
| Anthrax AVA | People at risk of or already exposed to Bacillus anthracis spores | July 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5906a1.htm |
| Hepatitis A and Hepatitis B (TWINRIX®) | Greater than or equal to 18 years of age: 0, 7, and 21 through 30 days; 12 month booster | Mar 2007 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5640a5.htm |
| Hepatitis A | International adoptees | Sep 2009 | AAP: aappolicy.aappublications.org/cgi/content/abstract/pediatrics;128/4/803
CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5836a4.htm |
| Herpes zoster vaccine (ZOSTAVAX®) | Greater than or equal to 60 years of age | May 2006 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr57e0515a1.htm |
| 50 through 59 years of age | Mar 2011 | Pending review | |
| Influenza | All health care personnel | Oct 2010 | AAP: aappolicy.aappublications.org/cgi/content/full/pediatrics;126/4/809 |
| Influenza (Afluria) | Greater than or equal to 9 years of age | Aug 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5931a4.htm |
| Influenza, high dose | 65 years of age and older | Apr 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5916a2.htm |
| Japanese Encephalitis (IXIARO) | Greater than or equal to 17 years of age | Mar 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5901a1.htm May 2011 Update: cdc.gov/mmwr/preview/mmwrhtml/mm6020a6.htm |
| Booster dose | Feb 2011 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm6020a5.htm | |
| MCV4 (Menactra) | 2 through 55 years of age, reimmunize people at prolonged risk of meningococcal disease | Sep 2009 | AAP: aapnews.aappublications.org/cgi/reprint/28/12/14-a.pdf CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5648a4.htm CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5717a4.htm CDC Update: cdc.gov/mmwr/preview/mmwrhtml/mm5837a4.htm CDC Update: cdc.gov/mmwr/preview/mmwrhtml/mm6003a3.htm |
| Jan 2011 | |||
| MCV4 (Menveo) | 2 through 55 years of age, reimmunize people at prolonged risk of meningococcal disease | Jan 2011 | |
| MMR | Evidence of immunity requirement for healthcare personnel | Jun 2009 | ACIP Provisional: cdc.gov/vaccines/recs/provisional/downloads/mmr-evidence-immunity-Aug2009-508.pdf |
| PPSV23 | All adults aged 65 years and older and those adults aged 19--64 years with underlying medical conditions that put them at greater risk for serious pneumococcal infection. | Sep 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5934a3.htm |
| PCV13 | Greater than or equal to 50 years of age | To be reviewed | Pending FDA licensure |
| Polio | Final dose administered on or after 4th birthday and at least 6 months following previous dose | Aug 2009 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5830a3.htm |
| Rabies HDCV or PCECV | 4-dose vaccination regimen for postexposure prophylaxis | Mar 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5902a1.htm |
| RV5 and RV1 | Addition of severe combined immune deficiency as a contraindication for administration of rotavirus vaccine | Feb 2010 | CDC: cdc.gov/mmwr/preview/mmwrhtml/mm5922a3.htm |
| Tdap | All healthcare personnel | Apr 2011 | CDC: cdc.gov/vaccines/recs/provisional/downloads/use-of-Tdap-in-hcp.pdf |
| Yellow Fever | Persons greater than or equal to 9 months of age traveling to or living in areas at risk for yellow fever transmission in South America and Africa. | Oct 2009 | CDC: cdc.gov/mmwr/preview/mmwrhtml/rr5907a1.htm |
Table Updated: 2/27/12
