Publications:

News about Vaccine Information Statements

IMPORTANT: By Federal law, all vaccine providers must give patients, or their parents or legal representatives, the appropriate Vaccine Information Statement (VIS) whenever a vaccination is given.

All VISs

• More audio files updated. On October 9, seven more audio VIS files were updated to be consistent with the current print versions: hepatitis A, mengocococcal, pneumococcal conjugate, varicella, rabies, Japanese encephalitis, and yellow fever. (10/9/07)

• Audio file update. As of September 5, the audio files for DTaP, hepatitis B, LAIV, and TIV have been updated, and new files have been added for HPV, rotavirus, shingles, and Tdap. (9/5/07).

• Audio files being updated. We are in the process of re-recording the audio files of all VISs to bring them up to date with the current print versions. New files will be posted as they are completed. (8/17/07)

• Updating CDC web addresses. The addresses for some CDC web pages have recently changed (e.g., URLs that began "www.cdc.gov/nip" now begin "www.cdc.gov/vaccines"). We are in the process of updating the VISs to make sure CDC web addresses listed on them reflect these changes. It is not necessary to discard current stocks of VISs, as people entering old URLs are being automatically rerouted to the new ones. The edition dates of the updated VISs will not change. (8/16/07)

  

 

Influenza

• LAIV update posted. The updated VIS for LAIV, incorporating new licensure information, has been posted. (10/4/07)

• LAIV VIS update on the way. FDA has approved changes in the licensure of LAIV – mainly to allow vaccination of children 2-4 years of age. An updated VIS is undergoing approval and should be posted before October. (9/25/07)

• Important Notice about the 2007-2008 LAIV VIS. It is very possible that FDA will approve updated licensing for FluMist during this flu season – possibly before any vaccine has shipped. If this happens, a new, interim VIS for LAIV will be published. The available 2007-08 VIS reflects the current licensing. It might be prudent for providers to delay printing large quantities of the LAIV VIS until it is known whether this version will be used. (7/27/07)

• 2007-08 editions. VISs for both TIV and LAIV have been posted for the 2007-2008 flu season. NOTE: The licensing for LAIV might change this year to include younger children. If this happens, an interim VIS for LAIV will be posted to reflect the change. (7/19/07)

• Translations. Translations of the 2005-2006 influenza VIS are available in several languages, including Spanish, Vietnamese, Chinese, Korean and Tagalog. They can be found on the Immunization Action Coalition's VIS webpage (exit). Translations of the 2006-2007 influenza VIS are underway. (6/30/06)

Tdap

Updated interim VIS available. A new interim Tdap VIS, including information about adult, as well as adolescent, use of the vaccine, is now available. NOTE: A second update was posted on 7/12/06. This update reflects the ACIP's evolving recommendations regarding Tdap and pregnancy. Pregnancy is not considered a contraindication for Tdap (as was implied in the previous edition), but Td is usually preferred for pregnant women who need diphtheria and tetanus protection. Other than this change to Section 3, the current Tdap VIS is identical to the 5/31/06 edition. Providers may use up existing stocks of that edition, but should be sure pregnant vaccinees are aware of the current recommendation.

A final version of the Tdap VIS will be developed after ACIP has published its recommendations. Until then, the interim version may be used. (7/12/06)

Hepatitis A

• Final VIS approved. The final hepatitis A VIS has been approved and posted. This version includes the 1-year minimum age, routine childhood recommendation, and a section on the Vaccine Injury Compensation Program. It is dated 3/21/06, and its use is required under the National Childhood Vaccine Injury Act. (3/22/06)

• Spanish translation. A Spanish translation of the current (3/21/06) hepatitis A VIS was completed on June 14, 2006. It will be posted on the Immunization Action Coalition website soon. (6/15/06)

Hepatitis B

• Updated VIS published. An interim VIS for hepatitis B has been posted with an edition date of 7/18/07. The main reason for this update is to stress that the birth dose of hepatitis B vaccine is now recommended for all children, but there are other updates as well. This replaces the 7/11/01 version of the hepatitis B VIS. A “final” version will be published in several months. Existing stocks of the 2001 edition may be used, but use of the updated version is encouraged. (7/19/07)

Meningococcal

• VIS revision. The interim meningococcal VIS has been updated again, this time to make it consistent with MCV4's recent licensure for children 2-10 years of age and ACIP's recommendations for this age group (see December 7, 2007 MMWR Notice to Readers).

• VIS revised yet again. The interim meningococcal VIS has been updated slightly to make it consistent with the ACIP's recent vote to recommend MCV4 for all children and adolescents 11-18 years of age, as published in an August 10, 2007 MMWR Notice to Readers. The change affects only the first two paragraphs of Section 3 of the VIS; providers may use up stocks of the previous version, but should be prepared to explain the updated indication to patients. (8/17/07)

• VIS revised again. Because several additional cases of GBS have been associated with meningococcal conjugate vaccine (see MMWR Update from October 2006), it was decided to slightly change the VIS to state that "some" cases have been reported, rather than "a few" cases. The VIS has a new date (11/16/06), but existing stocks of the 10/7/05 edition may be used up. No other changes were made. (11/17/06)

• VIS revised to reflect GBS risk. In light of reports of several cases of Guillain-Barré Syndrome following vaccination with meningococcal conjugate vaccine (Menactra), the VIS has been revised to include information about the potential association between the vaccine and the disease. (See MMWR Dispatch) This revised VIS is available now and should be used. (10/7/05)

• New VIS coming. The current (4/4/05) VIS for meningococcal vaccines is an "interim" version because it was released before the ACIP recommendations were published. Meningococcal will soon be added to the Vaccine Injury Compensation Program, and a new VIS will be developed at that time. We do not know when this will happen. NOTE: The 10/7/05 version of this VIS is a revision of the 4/4/05 edition, and is still an interim document. (10/7/05)

MMRV

• Updated MMR and varicella VISs. Both MMR and varicella VISs have been updated to include information about MMRV, including information about the increased rates of certain adverse events such as febrile seizures after MMRV, compared with MMR and varicella vaccines given separately. When giving MMRV, the new VISs should be used. When giving MMR or varicella vaccine separately, the previously-published VISs may be used until stocks are depleted. (3/13/08)

• No new VIS planned at this time. We don't know yet whether a VIS for the newly-licensed MMRV (measles, mumps, rubella, varicella) vaccine will be developed. Our policy is that separate VISs are not developed for most combination vaccines. Once the ACIP has published recommendations regarding MMRV, we will decide whether a VIS will be produced. If indications, contraindications, adverse events, etc. are similar to those of the separate MMR and varicella vaccines, a new VIS will probably not be developed. (9/15/05)

Rabies

• VIS updated. A small change has been made in the rabies VIS. In Section 4 ("Tell your doctor if . . .") a statement regarding anti-malarial drugs has been removed. This is because intradermal rabies vaccine is no longer available in the U.S., and this precaution applied only to the intradermal formulation. The revised VIS is dated 1/12/06. Stocks of the earlier version of the VIS may be used up, but patients should be made aware that use of anti-malarial drugs is no longer a precaution for rabies vaccination. (1/12/06)

• Spanish translation of update is available from the Immunization Coalition as of Monday, January 30, 2006. (1/25/06)

New Multi-vaccine VIS

• Multi-vaccine VIS posted. This VIS may be used in place of individual VISs whenever routine birth through 6-month vaccines (DTaP, IPV, Hib, Hepatitis B, PCV, and Rotavirus) are administered at the same visit – including combination vaccines (e.g., Pediarix or Comvax) containing those components. When using this VIS, please check the boxes on the first page indicating which antigens are being administered.
  
  Note that this VIS is 4 pages (2 pages front & back), instead of the usual 2.
  
  Use of the Multi-vaccine VIS is optional. The individual VISs for these vaccines may still be used. (1/31/08)

• Multi-vaccine VIS one step closer to publication. A draft of this VIS has been submitted to the Federal Register for a 60-day public comment period, completing the federally mandated development process. Afterward, only internal CDC clearance will be needed before it can be published. (10/4/07)

• A new VIS that can be used for all the routine 2, 4, 6 month vaccines (i.e., DTaP, hepatitis B, Hib, IPV, and pneumococcal) is being developed, and should be available in 2007. It will be offered as an alternative to the 5 individual VISs, which will also remain available. It will be 4 pages long (2 pages, front and back). NOTE: It was hoped that this VIS would be available in 2006. The addition of rotavirus vaccine is delaying its release until 2007. (1/10/07)

Rotavirus

• Interim VIS available now. A new rotavirus vaccine (RotaTeq®) from Merck was approved by the FDA on February 3, 2006. An interim VIS, dated 4/12/06, is now available on the NIP website. A final VIS will be available after ACIP recommendtions have been published and the new VIS has been developed according to legally-mandated procedures, probably later in 2007. (1/10/07)

HPV (Human Papillomavirus)

• VIS updated. Section 3 of the HPV VIS has been revised to make it more clear. We had received reports from providers and patients who found the catch-up recommendations confusing. Specifically, it wasn't clear that the routine 3-dose schedule also applied to catch-up. The updated VIS is now available. Existing stocks of the previous (9/5/06) version may still be used. (2/2/07)

• Interim VIS available. A VIS for the newly-licensed HPV vaccine (Gardasil®) is now available. A final edition will be developed after ACIP recommendations are published and the vaccine is covered by the Vaccine Injury Compensation Program. (9/5/06)

Zoster

• Minor changes to zoster VIS. On October 13, several minor changes were made to the zoster VIS. These involve changes in numbers (number of annual cases, age over which the disease is more common, and duration of rash) to make the VIS more consistent with other materials published on our website. The edition date has not changed. There is no need to discard existing stocks of the VIS. (10/13/06)

• Interim VIS available. An interim VIS for the newly-licensed zoster (shingles) vaccine (Zostavax®) has been posted. NOTE: The ACIP has not yet voted on recommendations for zoster vaccine. This VIS is based primarily on information from the manufacturer's package insert. The final VIS will be produced after the ACIP's recommendations have been published, and could differ from this edition. (9/11/06)

Varicella

• Updated MMR and varicella VISs. Both MMR and varicella VISs have been updated to include information about MMRV, including information about the increased rates of certain adverse events such as febrile seizures after MMRV, compared with MMR and varicella vaccines given separately. When giving MMRV, the new VISs should be used. When giving MMR or varicella vaccine separately, the previously-published VISs may be used until stocks are depleted. (3/13/08)

• Updated VIS available. The VIS for varicella vaccine is being updated to reflect the two-dose schedule for children. An interim edition is available now, and a final edition will be issued after the ACIP publishes its updated varicella recommendations. The interim VIS also mentions the availability of MMRV. (1/10/07)

DTaP

• Updated VIS available. Minor updates were made to the DTaP VIS on May 17, 2007. Section 4 ("Older children and adults") now contains a reference to Tdap vaccine. In Sections 6 and 7 the web addresses for VAERS and the Vaccine Injury Compensation Program have been updated, and in Section 1 the case-fatality rate for tetanus was changed from 1/10 to 2/10 to reflect current data. Existing stocks of the previous (7/30/01) edition of the VIS may still be used. (5/17/07)

MMR

• Updated MMR and varicella VISs. Both MMR and varicella VISs have been updated to include information about MMRV, including information about the increased rates of certain adverse events such as febrile seizures after MMRV, compared with MMR and varicella vaccines given separately. When giving MMRV, the new VISs should be used. When giving MMR or varicella vaccine separately, the previously-published VISs may be used until stocks are depleted. (3/13/08)

 Return to main VIS page

• Email this page
• Printer-friendly version

• Help
• Glossary / Acronyms
• Site Map