What's New with VISs
This page offers the latest information about vaccine information statements currently under development or newly released.
April 16, 2015
A new rotavirus Vaccine Information Statement has been published on April 15, 2015. It does not differ significantly from the edition it replaces, but it is a "final" (as opposed to "interim") edition. Ideally the new version should begin to be used now, but existing copies of the 8/26/13 edition may continue to be used until stocks are depleted.
April 15, 2015
A VIS for Gardasil 9 has just been released, and may be used immediately. The VIS for standard Gardasil should not be used for Gardasil 9
April 1, 2015
A "final" edition of the Hib Vaccine Information Statement has been posted and is now available. It is not significantly different from the current “interim” edition dated 2/4/14. Existing stocks of that edition may be used up – but once they are depleted, switch to the new edition.
March 27, 2015
Both the Td and Tdap Vaccine Information Statements have been updated, and are now available. They have been updated to make them “final,” as opposed to “interim” editions. They are not significantly different than the previous editions, which may be used while existing stocks last.
March 19, 2015
The VIS for Gardasil 9 is being prepared and should be available in early April.
Pediatric Multi-Vaccine VIS Available
The pediatric multi-vaccine Vaccine Information Statement has been updated, and is now available. This VIS may be used in place of the individual VISs for DTaP, Hib, Hepatitis B, Polio, and PCV13 when two or more of these vaccines are administered during the same visit. It may be used for infants through children receiving their routine 4-6 year vaccines.
Note that this VIS no longer includes rotavirus vaccine, because its unique recommendations aren’t easily harmonized with those for other infant vaccines. The individual rotavirus VIS should be used.
Remaining stocks of the previous (11/16/12) edition of the multi-vaccine VIS should be discarded, and this edition used, beginning now.
Provider Information: Influenza VISs
A ‘Provider Information’ document has been posted to accompany the 2014-15 influenza Vaccine Information Statements. It can be linked to from both the Live, Intranasal Influenza VIS and the Inactivated Influenza VIS. It summarizes selected information and recommendations for this season’s influenza vaccines, and may be used to answer patients’ questions and clarify information that is dealt with more superficially on the VIS.
2014-2015 influenza VISs
The 2014-2015 influenza VISs are available and may be used immediately. The accompanying Provider Information document is being updated for the 2014-15 season and will be available soon.
The updated multi-vaccine VIS has been reviewed by all the necessary subject-matter experts, FDA, and the Advisory Commission on Childhood Vaccines, and is beginning the final clearance process. The updated VIS could be available as early as September, but the actual release date will depend on whether additional revisions are required before it can be cleared.
Influenza VISs Coming Soon
The two VISs (IIV and LAIV) for the 2014-15 influenza season are undergoing final approval, and we anticipate they will be available in early August.
In the meantime, continue to use the 2013-14 VISs. Supplementing them with additional information as you feel is appropriate is acceptable, but not necessary. Do not defer flu vaccination because you don't have this season's VIS.
When the new VISs are posted, we will expect providers to begin using them immediately, so we would not recommend printing large quantities of last year's editions.
Providers who have registered to receive VIS email updates will be notified the day the new editions are posted.
June 11, 2014
The adenovirus VIS has been updated to remove references to the Adenovirus Vaccine Pregnancy Registry, which has been discontinued. The VIS also has a new edition date, but otherwise it is unchanged from the previous edition.
March 5, 2014
Multi-Vaccine Vaccine Information Statement
The Multi-Vaccine Vaccine Information Statement is being temporarily removed from circulation while it is being updated. In the meantime, please use the individual VISs when vaccinating children with DTaP, Hib, Hepatitis B, PCV13, Polio, and Rotavirus vaccines. We hope to have an updated edition available by mid-2014.
February 4, 2014
Updated VISs for Td and Hib are now available. The Td VIS replaces the older Td/Tdap VIS, which had been pressed into temporarily service for Td alone; and the new Hib edition allows us to finally retire the elder statesman of VISs (Hib was last published in 1998). Because both VISs contain a change in the adverse events section (“problems that can happen after any vaccine”), it is advisable to begin using the updated VISs immediately.
Provider Guidelines for both vaccines will be available soon.
January 24, 2014
Updated VIS for Japanese Encephalitis is available. The major change from the previous edition concerns the reduction in the minimum approved age from 17 years to 2 months. There are also changes in the "risks" section. An accompanying "Provider Information" document will be available soon.
Updated Rotavirus VIS
The most significant change in the August 26, 2013 updated rotavirus VIS is in the estimated rates of intussusception following vaccination. Because this change concerns a potential adverse event, the new VIS should be used beginning immediately. The accompanying Provider Information Sheet gives more detailed information for discussing the vaccine with parents. When using the multi-vaccine VIS for patients receiving rotavirus vaccine, give the new rotavirus VIS in addition to the multi-VIS. The multi-VIs is being updated to reflect these changes.
August 7, 2013
A change has been made to Section 3 of the Inactivated Influenza vaccine VIS, to the bullet regarding allergies, noting the availability of an egg-free formulation. The original language was not incorrect, and providers who have already printed copies of that VIS do NOT need to discard them. The edition date of the VIS (July 26, 2013) has not changed. Providers should make severely egg-allergic patients aware that an egg-free influenza vaccine is available.
July 26, 2013
The 2013-14 influenza VISs have been posted, and are dated July 26, 2013. There are separate VISs for the inactivated and the live, attenuated intranasal vaccines. The “inactivated” vaccine influenza VIS may be used for all non-live virus formulations (e.g., trivalent, quadrivalent, cell-culture, recombinant, intradermal, high-dose). Provider Guidelines for influenza vaccine VISs will be available soon.
June 18, 2013
2D barcodes, which can be used to scan the VIS name and edition date into an electronic medical record, have been added to all VISs. VISs printed before these barcodes were added may still be used. See Barcodes on Vaccine Information Statements for more information.
Soon, all VISs will be re-released in a slightly modified format. They will have a consistent look, and consistent language for the sections common to all VISs. These will not be new VISs, but redesigned versions of existing VISs, with the same edition dates. Existing stocks needn’t be discarded.
May 17, 2013
The pregnancy registry for Gardasil has been terminated by the manufacturer. Consequently, the reference to the registry has been removed from Section 4 of the Gardasil VIS. This is the only change. Stocks of the previous VIS may still be used as long as patients are made aware that the registry no longer exists. The updated Gardasil VIS has an edition date of 5/17/13.
May 9, 2013
A new VIS for Tdap, incorporating updated recommendations for pregnant women, is now available. The existing Td/Tdap VIS should continue to be used for patients receiving Td, until an updated Td VIS is available.
April 11, 2013
Work on an updated Hib VIS is also beginning. It will probably contain information about MenHibrix, regardless of whether a separate MenHibrix VIS is developed.
Work is beginning on a new meningococcal VIS, to incorporate recommendations from the recently published ACIP statement. We expect it will take at least several months to accomplish the necessary reviews and clearance. Discussions are ongoing regarding whether a separate VIS for MenHibrix will be produced.
An updated rotavirus VIS is temporarily on hold while some new safety data are being reviewed.
An updated YF VIS should be out of clearance after several minor comments from subject-matter experts are addressed.
March 1, 2013
CDC released an updated Pneumococcal Conjugate (PCV13) VIS with an edition date of 2/27/13. The update primarily added information for adults receiving the vaccine. (3/1/13)
February 27, 2013
Beginning in 2013, each new or updated VIS will be accompanied with a "Provider Information" document, which will
- Summarize relevant ACIP recommendations
- Include more detailed information about indications, schedules, and precautions
- Contain other information that gives providers a quick reference to help address common patients' questions. An example of this is the Provider Information: PCV13 VIS.
- Page last reviewed: June 14, 2014
- Page last updated: April 16, 2015
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