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Vaccine Information Statements News
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At
a Glance: This page offers the latest information about
vaccine information statements currently under development. |
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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.
News about (contents
of this page):
Influenza
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2006-07
editions. VISs for both TIV and LAIV have been posted
for the 2006-2007 flu season. NOTE:
When the LAIV VIS was posted, Section 3 erroneously identified
contacts and caretakers of "infants from 0-23
months of age" as candidates for LAIV. This was corrected
to "infants from 0-59 months of age"
on July 5, 2006. Existing copies needn't be discarded. (7/5/06)
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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.
Translations of the 2006-2007 influenza VIS are underway. (6/30/06)
Top
Tdap
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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
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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)
Top
Meningococcal
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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)
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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)
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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)
Top
MMRV
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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)
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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)
Top
New
Multi-Vaccine VIS
-
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)
Top
Rotavirus
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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)
Top
HPV
(Human Papillomavirus)
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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)
Top
Zoster
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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
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)
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