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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

• All VISs are now available in RTF format. Some providers have requested that VISs be made available in a text-based format for integration into electronic systems. VISs for all vaccines have been converted into rtf (rich text format) files, and are accessible from the main VIS webpage along with the traditional pdf files. (The only exception is Adenovirus, which is used only by the military.)
  Some electronic systems favor other text-based formats, such as xml or html. RTF files can be converted to these formats using Microsoft Word.
  (7/23/12)
• More barcodes. Barcodes have been added to 7 more VISs (in addition MMR, the first VIS to feature a barcode). These are hepatitis A, hepatitis B, HPV (Gardasil), polio, Japanese encephalitis, meningococcal, and Td/Tdap. Other than the addition of barcodes, these VISs are identical to the ones they replace. The edition dates have not changed, and existing (non-barcode) versions may still be used. For more information, see our VIS Barcode webpage. (5/21/12)
• Barcodes are here! The first VIS featuring a 2D barcode (the updated MMR VIS) is now available. Barcodes will be added to existing and updated VISs begining today. They will be located on the back of the VIS near the edition date, in a box labeled "Office Use Only." These barcodes will allow providers with the necessary hardware and software to scan the VIS name and edition date into patients' electronic medical records. Use of these barcodes is not required; it is simply an alternative to entering the information manually. For more information, see our VIS Barcode webpage. (4/24/12)
• Upcoming updates. Several VISs are in clearance and will soon be updated. Most of these are minor updates. As part of our drive to convert all "interim" VISs to final VISs, the first step is to update the interim. Soon we will be posting new versions of the MMR, rotavirus, hepatitis A, Td/Tdap, and polio VISs. (10/14/11)
• New VIS format. As a result of some recent focus-group studies, the format of VISs is evolving. The new format will not be dramatically different from the current one. VISs will be converted to the new format as they are updated; there are no plans at this time to change over all VISs at once. The new meningococcal VIS (dated 10/14/11) is the first VIS to convert to the new format. (10/14/11)
• Provider responsibilities. Given wider availability of VISs in electronic form for patients (see below) and other options that allow patients to get VISs without actually receiving individual paper copies, we have updated instructions regarding provider responsibilities accordingly. See VIS Facts. (6/16/09)
• Patients may now download VISs onto their mobile device. Law requires that patients be offered a copy of the appropriate VIS to take home with them after each vaccination. Patients who want to save paper, and who have a mobile device (e.g., iPhone, Palm Pre, some BlackBerries) that can display a pdf file, may now download VISs onto these devices to take home, rather than taking paper copies. Patients can go to www.cdc.gov/vaccines/pubs/vis/vis-downloads.htm on their mobile device and click on the appropriate link to download that VIS. Providers should make their patients aware of this option, as there is no practical way to make the information universally available to potential vaccine recipients. (6/10/09)

Influenza

• 2012-2013 Influenza VISs are available. Both the live, intranasal and inactivated influenza VISs (including the large type version of the inactivated influenza VIS) are available for downloading as both pdf and rtf files. They are dated 7/2/2012. While they have been updated into the newer VIS format, the content is identical to last year's flu VISs. [Please note that there are minor changes in the ACIP influenza recommendations this season; however, these do not affect the VISs.] (7/3/12)
• Febrile seizures update. CDC has posted a more detailed explanation of the potential risk of febrile seizures when TIV and PCV13 are administered simultaneously at http://www.cdc.gov/vaccinesafety/Concerns/FebrileSeizures.html. (9/9/11)
• TIV & PCV13 and febrile seizures. The 2011-12 inactivated influenza vaccine VIS contains a note about increased risk of febrile seizures when TIV and PCV13 are given simultaneously. Until a more detailed explanation is published on CDC's website, a brief note accessible from the VIS homepage (with the influenza vaccine download) or from here gives some information that providers can share with their patients about this issue. (8/26/11)
• 2011-12 Influenza VISs are here. The only major change from last year (on the TIV VIS only) is the addition of a note in the "risks" section about concurrent administration of TIV and PCV13 and febrile seizures. References to H1N1 were removed from both VISs. The TIV "Large Print" edition is also available for 2011-12. (7/26/11)
• 2011-2012 influenza VISs coming soon. After some unavoidable delays, the updated VISs should be available the week of July 25. (But no promises.) (7/21/11)
• 2010-2011 inactivated influenza vaccine VIS LARGE TYPE version available. In response to a request from a thoughtul provider of flu vaccine to elderly patients, we have posted a large print version of the inactivated flu vaccine VIS. It occupies 4 pages, instead of the usual 2, but is otherwise identical to the standard edition. (10/29/10)
• 2009 H1N1 VISs no longer available. All monovalent 2009 H1N1 vaccines have expired and should no longer be used. The VISs for these vaccines have been removed from the website. (9/30/10)
• Translations. The 2010-11 influenza VISs are in the process of being translated into more than 20 languages. They will be posted on the IAC website (www.immunize.org) as soon as they are completed. As of now, these languages will include Arabic, Armenian, Bengali, Cambodian, Chinese, Farsi, French, Haitian Creole, Hmong, Indonesian, Karen, Korean, Mandarin, Portuguese, Romanian, Russian, Somali, Spanish, Tagalog, Thai, Turkish, Urdu, and Vietnamese (8/26/10)
• Influenza VISs are posted. At long last, the 2010-11 seasonal influenza VISs are available. AND . . . one day earlier than last year! We will keep the H1N1 VISs available as long as the vaccine is being used. (8/10/11)

Tdap/Td

• Another uppdated Td/Tdap VIS coming. On February 22, 2012 ACIP voted to make a dose of Tdap routine for all adults 65 years of age and older. This will require an VIS update to reflect the change. Since the change is relatively minor, we anticipate that the updated VIS will be available soon. (2/22/12)
• New interim Td/Tdap VIS posted. There are minor wording changes throughout, and a conversion to the new VIS format. The main reason for the change is to incorporate updated ACIP recommendations regarding children 7 through 9 years of age, adults 65 and older, and pregnant women; and to add a paragraph about the risk of syncope. Because of this addition to the "risks" section, we encourage providers to begin using the updted edition as soon as possible. (1/24/12)
• Updated Tdap/Td VIS is on the way. It is in clearance and depending on how quickly clearance can be obtained, could be posted as early as late January. (1/13/12)
• 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)

Hepatitis A

• VIS update published. An updated (interim) hepatitis A VIS was posted today, mainly to include indications for families with newly arriving adopted children and post-exposure prophylaxis. As always, we prefer that providers begin using an updated VIS soon after publication; however, because this update doesn't affect contraindications or adverse events, providers may choose to use existing stores of the existing VIS. (10/25/11)

Hepatitis B

• An updated hepatitis B VIS is coming. There will not be any dramatic changes. The routine schedule will be included again, as we have had several requests for it. (1/13/12)
• 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

• Minor change. Eagle-eyed readers might notice that the a slightly updated meningococcal VIS has been posted in which the box in Section 5 dealing with syncope was moved. This was done to make it clear that this is an independent statement and not associated with the "Severe problems" portion of this section. The date of the VIS has not changed, and copies printed before this change was made may still be used. (10/25/11)
• Updated VIS available. An updated meningococcal interim VIS is being posted today (October 14, 2011). It incorporates changes in the routine schedule and indications, as well as in the precautions and adverse events sections. Mainly because of these latter changes, providers should begin using the new VIS as soon as possible. (10/14/11)

MMRV

• MMRV VIS is now available. It is the preferred VIS for children getting MMRV vaccine, as it contains more detailed information about the risk of febrile seizures. (5/25/10)
• 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 again. The rabies VIS has been updated, mainly to incorporate the new 4-dose post exposure regimen, but also to make minor updates throughout. (10/6/09)
• 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)

New Multi-vaccine VIS

• Multi-vaccine VIS is being updated; current edition may still be used. Following publication of the updated rotavirus VIS, we've received many inquiries about whether the multi-vaccine VIS can still be used. This VIS is being updated to reflect, among other things, the addition of intussusception as a rare adverse event for rotavirus. Until this updateis available, remember that the law encourages providers to supplement VISs either verbally or with written materials when appropriate.  This is a situation in which a practice should consider providing a brief printed supplement (using the same wording as on the rotavirus VIS) or make sure whoever administers the vaccinations discusses this issue with parents. An alternative, of course, is to give the rotavirus VIS separately. (12/14/10)
• 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 rotavirus VIS coming. An updated rotavirus VIS has cleared, and should be posted by mid-January. The main change is the addition of a history of intussusception as a contraindication. (1/13/12)
• Yet another update. A new rotavirus VIS is being published. This edition includes several minor changes from recent reviews and is being used as a draft to move from an "interim" to an upcoming "final" version. It is not significantly different from the previous edition, and exisiting stores of that edition needn't be discarded. (11/3/11)
• Another update. An updated (interim) rotavirus VIS was posted on December 7, 2010. This edition includes information about a possible increased risk of intussusception among vaccine recipients and revised wording on porcine circovirus, along with several minor changes. (12/7/10)
• Update. A statement was added to the rotavirus VIS noting the presence of porcine circovirus (PCV) in both formulations. Stocks of the previous edition may be used up; providers using the previous edition may inform parents about PCV either verbally or using supplemental written materials.
  NOTE: The Multi-vaccine VIS may still be used; the same comment regarding supplements applies. (5/19/10)

HPV (Human Papillomavirus)

• Gardasil VIS updated. An updated VIS for Gardasil (Cervarix VIS is unchanged) has been posted. The main change is to incorporate ACIP's decision to recommend the vaccine routinely for adolescent males. Because using the previous VIS could cause confusion about this recommendation, we recommend beginning to use the new VIS as soon as possible. (2/22/12)
• New Gardasil VIS coming. An updated VIS for Gardasil is in the works and should be approved by February. It will contain updated information about use of Gardasil in males. The Cervarix VIS will probably remain unchanged. (1/13/12)
• Minor updates to HPV VISs. Both VISs for human papillomavirus vaccines (Cervarix and Gardasil) have received minor updates to incorporate Gardasil's approval for prevention of anal cancer. ACIP recommendations have not changed. Stocks of the existing HPV VISs may be used up. (5/4/11)
• Updated VISs are here. VISs for Gardasil and Cervarix, dated 3/30/2010, were posted on March 31. These are interim VISs, and replace the single HPV VIS dated 2/2/07. Stocks of this older VIS may be used up, although the updated editions are preferred; it may be supplemented verbally or with written materials as appropriate to inform patients of changes (e.g., use of Gardasil in males). (3/31/10)

Zoster

• Another zoster VIS update. On October 6, 2009 the zoster VIS was changed slightly. The main reason was to remove active, untreated tuberculosis as a contraindication – which had been erroneously included in the previous editions. Several other minor updates were also made. Existing stocks may be used up, but ensure that patients know about this change when appropriate. (10/6/09)

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 VIS posted. This update is the first step of the process to convert the MMR VIS to a final (rather than interim) version.
  Summary of changes:
  There are minor wording changes throughout. A sentence in Section 2 has been added noting that children younger than 12 months who are traveling overseas should get a dose of MMR. In Section 3, a note has been added asking the patient to tell their provider if they received another vaccine within the past 4 weeks (to alert the provider of the possibility of administering two live vaccines too close together). In Section 4, the statement that minor problems usually occur 7-12 days after the shot was changed to the more accurate 6-14 days, and the box noting the risk of adverse events following MMRV was removed, as it is not relevant for patients receiving MMR.
  This VIS is the first to feature a 2D barcode, which will allow providers to scan selected information into the patient's record or into an immunization information system. See the All VISs news for more information.
  As always, it is preferable to begin using the new VIS immediately, but because there are no major changes involving contraindications or risks in this update, the previous edition may be used until stocks are depleted. (4/24/12)

Pneumococcal

• PCV7 VIS available temporarily. Due to a groundswell of popular demand, we have re-posted the PCV7 VIS for use by those providers who have not completed the transition to PCV13. It will be available as long as PCV7 supplies are being used. Please use the VIS appropriate to the formulation being administered. Both VISs can be downloaded from the Pneumococcal Conjugate section of CDC's VIS webpage. (5/5/10)
• PCV13 VIS posted. It may be used immediately, and is preferred over the previous PCV VIS. (4/16/10)
• PPSV23 minor change. The paragraph on pregnancy under Section 5 of the PPSV VIS has received a minor update. In the previous edition the term "is not recommended" was used in a way that could be misinterpreted to mean "should never be given." In fact, while PPSV is not routinely recommended for pregnant women it may be given under some circumstances. The previous edition may be used until stocks are depleted. (10/6/09)

Japanese Encephalitis

• New JE VIS released. The updated VIS reflects the fact that Ixiaro is now the only available vaccine for Japanese encephalitis. Minor changes concern patients younger than 17 (who can no longer be advised to get JE-VAX) and recommendations for booster doses. See the Note to Providers (also accessible from the main VIS page) for more information on these topics. Existing stocks of the previous (3/1/10) Ixiaro VIS may still be used, although it refers to JE-VAX as still being available. (12/7/11)
• New VIS for Ixiaro. The Japanese encephalitis VIS for Ixiaro is being updated to remove most references to JE-VAX (which is no longer available), and to make minor updates, including updated recommendations for booster doses. (11/3/11)
• New JE VISs. Two new VISs have been published for Japanese encephalitis vaccines, one for each licensed vaccine (JE-VAX and Ixiaro). (3/1/10)

Anthrax

• Minor update to new Anthrax VIS. In Section 2, we a phrase stating that the vaccine was relicensed in 2008. This was misleading . . . the vaccine was approved for a different route and scuedule, but not actually relicensed. The edition date of the VIS hasn't been changed, and copies of the unmodified version already printed may still be used. (3/19/10)
• New Anthrax VIS posted. (3/10/10)
• Updated Anthrax VIS. At long last a new anthrax VIS, incorporating the 5-dose routine schedule, should be out of clearance and posted soon. (3/3/10)

Yellow Fever

• New YF VIS is available. A new Yellow Fever VIS, updated to correspond with the recently published ACIP Yellow Fever recommendations, has been posted. Because this new edition contains updated information on rates of adverse events, among other changes, we suggest using it immediately. (4/6/11)

Adenovirus

• Adenovirus VIS added. Recently a new adenovirus vaccine was licensed and a VIS created for it. NOTE that while this VIS is available on CDC's VIS webpage, adenovirus vaccine is approved only for military recruits, who are at increased risk for outbreaks of respiratory illness caused by adenovirus. (7/21/11)

Polio

• Polio VIS update. The polio VIS was recently updated, and an interim edition was posted on 11/8/2011. The only significant changes are 1) elimination of the box containing information about OPV, and 2) addition of a statement noting that children receiving combination vaccines may get an additional (5th) dose of IPV. Existing stocks of the previous edition may still be used. (12/1/11)

Typhoid

• Minor change. The 5/29/12 typhoid VIS stated that oral typhoid vaccine should be delayed until at least 3 days after "certain" antibiotics. This wording was inadvertently held over from the previous VIS. The VIS has been changed to remove the word "certain." The edition date has not changed. Copies of the VIS already printed needn't be replaced, but be aware that the precaution applies to all antibiotics. (6/18/12)
• Typhoid VIS update. The typhoid VIS got its first update since 2004. The main reason for the update was to clarify the dosing schedule for the oral typhoid vaccine, which some readers of the previous VIS found confusing. There are other, mostly minor, changes, the most significant of which is a waiting period of 3 days (rather than 24 hours) after certain antibiotics before receiving the oral vaccine. (5/29/12)

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