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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

• "Text" file format updated. All VIS "text-only" files, which previously have been either individual "txt" or "rtf" files, have been updated and collected on one web page in html format. These files can still be accessed through links from the VIS homepage. These files are screen-reader accessible and are meant to be used with patients who are vision-impaired. (9/18/08)

• Minor updates on several VISs. Several VISs have received minor updates. Changes could include correcting the web addresses of VAERS or the Vaccine Injury Compensation Program on some of the older VISs, adding the new statement about the availability of translations, cleaning up fonts that don't print properly, etc. None of these changes affect the mandated purpose of VISs (i.e., to inform parents or patients about the benefits and risks of vaccines). Edition dates on these VISs have not changed, and it is not necessary to replace existing stocks. (Affected VISs are anthrax, DTaP, hepatitis A, hepatitis B, Hib, HPV, Japanese encephalitis, pneumococcal conjugate, pneumococcal polysaccharide, polio, rabies, rotavirus, shingles, Tdap, typhoid, and yellow fever.) (9/10/08)

• 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)

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Influenza

• 2008-09 Influenza VISs posted. Updates for both TIV and LAIV VISs for the 2008-2009 flu season have been posted. (7/25/08)

Tdap/Td

• Combined Tdap/Td VIS now available. A new interim VIS that can be used for both Tdap and Td vaccines is now available, and was posted on 11/18/08. It replaces the Tdap VIS dated 7/12/06 and the Td VIS dated 6/10/94. These older VISs may still be used until stocks are depleted. (11/18/08)

• 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). (1/28/08)

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)

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 update. An updated interim edition of the pediatric multi-vaccine VIS, dated September 18, 2008, has been posted. It has been made consistent with the recently updated rotavirus VIS by noting the availability of two rotavirus vaccines in the "Routine Childhood Vaccines" section and adding "irritability" to the mild problems listed for rotavirus in the "Vaccine Risks" section. Otherwise, the VIS is identical to the 1/30/08 edition. Providers using the multi-vaccine VIS when administering Rotarix should begin using the new edition now. When Rotarix is not administered, the older edition may be used until stocks are used up. (9/18/08)

• 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)

Rotavirus

• New interim rotavirus VIS available. An interim rotavirus VIS, incorporating information about the recently licensed Rotarix®, is now available. (8/29/08)

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)

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)

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)

Pneumococcal

• Updated PCV7 VIS. The PCV VIS has been updated to reflect recent changes in recommendations for vaccinating children 2 through 4 years of age. (12/9/08)

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