# Presentation: 508796

## Immunization Update 2008
Webcast
August 28, 2008

Influenza Vaccine Segment

**Webcast**
**August 28, 2008**
**Influenza Vaccine Segment**

**Graphics subject to change.**
**This material is in the public domain.**

## ACIP Statements Published Since August 2007

**Human Rabies (5/23/2008)**
**Herpes Zoster (6/6/2008) **
**Influenza (8/8/2008)**
**Pertussis vaccine and pregnancy (5/30/2008)**
**MMWR Notice To Readers**
**MCV, hepatitis A, HPV, MMRV, PCV**

**All ACIP statements available at www.cdc.gov/vaccines/pubs/ACIP-list.htm**

## All children 6 months through 18 years of age receive influenza vaccine annually, beginning in the 2008-2009 influenza season if possible 

**2008-2009 Influenza Vaccine Recommendations**

***MMWR***** 2008;57 (RR-7)**

## 2008-2009 Influenza Vaccine Recommendations

**Annual vaccination of all children 6 months through 59 months of age**
**Annual vaccination of older children with conditions that place them at increased risk for complications from influenza**
**Healthy children as young as 2 years of age may now receive live attenuated influenza vaccine (LAIV) **

***MMWR***** 2008;57 (RR-7)**

## Impact of Influenza, 1990-1999

**Approximately 36,000 influenza-associated deaths during each influenza season**
**Persons 65 years of age and older accounted for more than 90% of deaths**
**Deaths of 85 children 0-18 years provisionally reported for 2007-2008**
**Average of 226,000 hospitalizations during each influenza season**

***MMWR***** 2008;57 (RR-7) and CDC unpublished data**

## Influenza Vaccines

**Inactivated subunit (TIV)**
**intramuscular**
**trivalent**
**contains egg protein**
**Live attenuated vaccine (LAIV)**
**intranasal**
**trivalent**
**contains egg protein****	**

## Trivalent Inactivated Influenza Vaccine (TIV) Schedule

**Age Group**
**6-35 mos**
**3-8 yrs**
**9 years or older**

**Dose**
**0.25 mL**
**0.50 mL**
**0.50 mL**

**# Doses**
**1 or 2***
**1 or 2***
**1**

** ****TIV should only be administered by the intramuscular route.**
***Doses should be separated by at least 4 weeks.**
*** ******MMWR***** 2008;57 (RR-7)**

## ACIP does NOT recommend a second dose of influenza vaccine in the same season except for children 6 months through 8 years of age being vaccinated for the first time

**Trivalent Inactivated Influenza Vaccine (TIV) Schedule**

## Influenza Vaccination of Children

**Children 6 months through 8 years of age who did not receive the recommended second dose of influenza vaccine in the initial year that they received influenza vaccine should receive 2 doses during the next influenza season**
**Children 6 months through 8 years of age who are being vaccinated two or more seasons after receiving an influenza vaccine for the first time should receive a single annual dose, regardless of the number of doses administered previously **

***MMWR***** 2008;57 (RR-7)**

## Inactivated Influenza Vaccines Available in 2008-2009

| Vaccine | Package | Dose | Age | Thimerosal |
| --- | --- | --- | --- | --- |
| Fluzone
(sanofi | Multidose vial* | Age-dependent | >6 mos | Yes |
| pasteur) | Single dose syringe* | 0.25 mL | 6-35 mos | No |
|    | Single dose syringe and vial* | 0.5 mL | >36 mos | No |
| Fluvirin
(Novartis) | Multidose vial | 0.5 mL | >4 yrs | Yes |
| Fluarix
(GSK)
Flulaval
(GSK) | Single dose syringe
Multidose vial | 0.5 mL

0.5 mL | >18 yrs

>18 yrs | Trace

Yes |
| Afluria
(CSL) | Single dose syringe
Multidose vial | 0.5 mL

0.5 mL | >18 yrs

>18 yrs | No

Yes |

*****_**inactivated**_** vaccines approved for children younger than 4 years **

## Live Attenuated Influenza Vaccine (LAIV)

**Approved only for healthy persons 2 years through 49 years of age who are not pregnant**
**healthcare personnel**
**persons in close contact with high-risk groups**
**persons who want to reduce their risk of influenza **

***MMWR***** 2008;57 (RR-7)**

##    LAIV Schedule

**   ****LAIV Schedule**

_**Age Group**_
**2 through 8 years**
**     ****-no previous**
**      ****influenza vaccine**
**     ****-previous influenza**
**      ****vaccine **
**9 through 49 years**

_**Number of Doses**_
**2 **
**(separated by 4 weeks)**
**1 or 2**
**1**

***MMWR***** 2008;57 (RR-7)**

## Timing of Influenza Vaccination

**Influenza activity can occur as early as October**
**In more than 80% of influenza seasons peak activity has not occurred until January or later**
**In more than 60% of seasons the peak was in February or later**

***MMWR***** 2008;57 (RR-7)**

## Timing of Influenza Vaccination

**Immunization providers should begin offering vaccine soon after it becomes available and if possible by October**
**Providers should offer vaccine during routine healthcare visits or during hospitalizations whenever vaccine is available**

***MMWR***** 2008;57 (RR-7)**

## Timing of Influenza Vaccination

**Consider scheduling organized vaccination campaigns after at least mid-October**
**Scheduling campaigns after mid-October will minimize the need for cancellations because vaccine is unavailable **

***MMWR***** 2008;57 (RR-7)**

## Continue to offer influenza vaccine in December, especially to healthcare personnel and those at high risk of complications
Continue to vaccinate throughout influenza season (December-March)

**Continue to vaccinate throughout influenza season (December-March)**

**Timing of Influenza Vaccination**

***MMWR***** 2008;57 (RR-7)**

## Evolution of Influenza Vaccination Recommendations

**2004 - routine vaccination of healthy children 6 months through 23 months of age**
**evidence of increased rates of complications and hospitalizations**
**2006 - routine vaccination to children 24 through 59 months of age**
**increased risk for influenza-associated clinic, ED, and hospital visits **

***MMWR***** 2008;57 (RR-7)**

## Evolution of Influenza Vaccination Recommendations

**Beginning with the 2008–2009 influenza season, all children 6 months through 18 years of age should be vaccinated against influenza annually**
**Begin in 2008 if feasible, but no later than the 2009–2010 influenza season **

***MMWR***** 2008;57 (RR-7)**

## Impact of Influenza on Children

**Children typically have the highest attack rates during community outbreaks of influenza**
**Children serve as a major source of transmission within communities **

***MMWR***** 2008;57 (RR-7)**

## Average Influenza-Associated Illness Rates by Age Group*

**Sources: Monto J Infect Dis**
** ****Glezen N Engl J Med**

## Impact of Influenza on Children

**School absenteeism**
**Medical care visits**
**5 to 7 influenza-related outpatient visits per 100 children**
**children frequently receive antibiotics**
**Parental work loss**

***MMWR***** 2008;57 (RR-7)**

## Benefits of Influenza Vaccination of Children

**Reductions in influenza-like symptoms and medical visits among household contacts in communities where vaccination programs among school-aged children were established**
**Improve vaccine coverage levels among the 50% of school-aged children who already have a risk- or contact-based indication for annual influenza vaccination **

***MMWR***** 2008;57 (RR-7)**

## Efficacy of Influenza Vaccine in Children

**Age Group (yrs)**
**1-15**
**3-9**
**10-18**

**Reduction**
**91%**
**56%**
**100%**

***MMWR***** 2008;57 (RR-7)**

## Inactivated Influenza Vaccine Recommendations, 2007-2008

**Conditions that increase the risk of influenza infection or complications:**
**Age**
**65 years and older**
**50 through 64 years**
**59 months and younger**
**Pulmonary (emphysema, asthma)**
**Cardiovascular**
**Metabolic (diabetes)**
**Renal dysfunction **
**Hemoglobinopathy**
**Immunosuppression, including HIV infection**
**Conditions that compromise respiratory function or increase the risk of aspiration**

***MMWR***** 2008;57 (RR-7)**

## Inactivated Influenza Vaccine Recommendations, 2008-2009

**Persons at increased risk of influenza complications**
**Residents of long term care facilities**
**Persons 6 months to 18 years of age receiving chronic aspirin  therapy**
**Pregnant women**

***MMWR***** 2008;57 (RR-7)**

## Pregnancy and Influenza Vaccine

**Risk of hospitalization more than 4 times higher than among nonpregnant women**
**Risk of complications comparable to nonpregnant women with high risk medical conditions**
**ACIP recommends vaccination with inactivated influenza vaccine for ALL women who will be pregnant during influenza season**

***MMWR***** 2008;57 (RR-7)**

## Influenza Vaccine Recommendations, 2008-2009

**Immunization providers should administer influenza vaccine to  any person who wishes to reduce the likelihood of becoming ill with influenza or transmitting influenza to others**

***MMWR***** 2008;57 (RR-7)**

## Household members of high-risk persons
Healthcare personnel, including home care
Employees of long-term care facilities

**Healthcare personnel, including home care**
**Employees of long-term care facilities**

**Influenza Vaccine ****Recommendations, 2008-2009**

***MMWR***** 2008;57 (RR-7)**

## Use of LAIV Among CloseContacts of High Risk Persons

**Inactivated influenza vaccine is preferred for close contacts of severely immunosuppressed persons who require care in a protective environment**
**Persons who receive LAIV should refrain from contact with severely immunosuppressed persons for 7 days after vaccination**
**Persons who receive LAIV do not need to be excluded from visitation of patients who are not severely immunosuppressed**

***MMWR***** 2008;57 (RR-7)**

## Inactivated Influenza VaccineContraindications and Precautions

**Severe allergic reaction to a vaccine component (e.g., egg) or following a prior dose of vaccine**
**Moderate or severe acute illness**
**History of Guillian Barre’ syndrome within 6 weeks following a previous dose of TIV (precaution) **

***MMWR***** 2008;57 (RR-7)**

## Live Attenuated Influenza VaccineContraindications and Precautions

**Children younger than 2 years of age***
**Persons 50 years of age or older***
**Persons with underlying medical conditions***
**Immunosuppression from any cause***
**Children younger than 18 years receiving long-term aspirin therapy***
**Pregnant women***

***These persons should receive inactivated influenza vaccine**

## Live Attenuated Influenza VaccineContraindications and Precautions

**History of Guillian-Barré syndrome**
**Children younger than 5 years with recurrent wheezing***
**Severe (anaphylactic) allergy to egg or other vaccine components**
**Moderate or severe acute illness  **

***These persons should receive inactivated influenza vaccine**

## Live Attenuated Influenza Vaccination of Children 2-4 Years of Age

**Clinicians and immunization programs should avoid use of LAIV in children with asthma or a recent wheezing episode**
**Consult the medical record, when available, to identify children 2 through 4 years of age with asthma or recurrent wheezing that might indicate asthma **

***MMWR***** 2008;57 (RR-7)**

## Live Attenuated Influenza Vaccination of Children 2-4 Years of Age

**Parents or caregivers of children 2-4 years should be asked:**
** “****In the past 12 months, has a healthcare provider ever told you that your child had wheezing or asthma?” **
**Children whose parents or caregivers answer "yes" to this question, or whose medical record notes asthma or a wheezing episode within the past 12 months, should not receive LAIV**
**Inactivated influenza vaccine should be administered to children with asthma or possible reactive airways diseases **

***MMWR***** 2008;57 (RR-7)**

## Influenza VaccineStorage and Handling

**Both TIV and LAIV should be stored at refrigerator temperature (35****o****- 46****o**** F) at all times**
**Neither vaccine should be exposed to freezing temperature**

***MMWR***** 2008;57 (RR-7)**

## Administration of LAIV

**Severely immunosuppressed persons should not administer LAIV**
**Other persons at increased risk for influenza complications* may administer LAIV**
**Gloves and masks are not required**

***e.g., pregnant women, persons with asthma and persons 50 years of age or older**

## Immunization Update 2008
Webcast
August 28, 2008

Zoster Vaccine Segment

**Webcast**
**August 28, 2008**
**Zoster Vaccine Segment**

**Graphics subject to change.**
**This material in the public domain.**

## Herpes Zoster Vaccine (Zostavax®)

**Contains live attenuated varicella virus in an amount that is approximately 14 times greater than that in regular varicella vaccine**
**Approved for persons 60 years and older**
**Administered by the subcutaneous route**

***MMWR***** 2008;57 (RR-5)**

## Herpes Zoster Vaccine Trial

**Compared with the placebo group the vaccinated group had**
**51% fewer episodes of zoster**
**Less severe disease **
**66% less postherpetic neuralgia**
**No significant safety issues identified**

***NEJM***** 2005;352(22):2271-84.**

## ACIP Recommendations for Zoster Vaccine

**Single dose of zoster vaccine for adults 60 years of age and older whether or not they report a prior episode of shingles**
**Persons with a chronic medical condition may be vaccinated unless a contraindication or precaution exists for their condition**

***MMWR***** 2008;57 (RR-5)**

## Screening for Zoster Vaccine Eligibility

**Screening for a history of varicella disease is NOT necessary or recommended to administer zoster vaccine to a person 60 years of age or older**
**Persons born in the U.S. before 1980 can be assumed to be immune regardless of their recollection of chickenpox**

***MMWR***** 2008;57 (RR-5)**

## Screening for Zoster Vaccine Eligibility

**Do NOT test the person for varicella antibody**
**A negative test is more likely to indicate waning antibody level rather  than true susceptibility**
**Seronegative persons should receive 2 doses of single antigen varicella vaccine**

***MMWR***** 2008;57 (RR-5)**

## Zoster VaccineContraindications and Precautions

**Severe allergic reaction to a vaccine component or following a prior dose**
**Immunosuppression from any cause **
**Pregnancy or planned pregnancy within 4 weeks**
**Moderate or severe acute illness**

***MMWR***** 2008;57(RR-5)**

## Zoster VaccineContraindications and Precautions

**Current treatment with an antiviral drug active against herpesviruses***
**discontinue at least 24 hours before administration of zoster vaccine**
**should not be taken for at least 14 days after being vaccinated**
**Recent blood product is NOT a precaution**

***e.g., acyclovir, famciclovir, valcyclovir**
***  ******MMWR***** 2008;57(RR-5)**

## Zoster Vaccine Storage and Handing

**Must be stored at 5****o**** F (-15****o**** C) or colder AT ALL TIMES**
**Protect from light**
**Administer within 30 minutes of reconstitution**

***MMWR***** 2008;57 (RR-5)**

## Immunization Update 2008
Webcast
August 28, 2008

New Vaccine Segment

**Webcast**
**August 28, 2008**
**New Vaccine Segment**

**Graphics subject to change.**
**This material in the public domain.**

## Rotarix® Rotavirus Vaccine (RV1)

**Contains one strain of live attenuated human rotavirus (G1P[8])**
**Provided as a lyophilized powder that is reconstituted with 1 mL of a citrate bicarbonate buffer**

**Source: Rotarix package insert**

## Rotarix® Rotavirus Vaccine (RV1)

**Schedule**
**Two oral doses at 2 and 4 months of age**
**Minimum interval 4 weeks**
**Minimum age is 6 weeks**
**Labeled maximum age for any dose is 24 weeks**

**Source: Rotarix package insert**

## Provisional ACIP Rotavirus Vaccine Recommendations

**For BOTH vaccines**
**Maximum age for first dose is 14 weeks 6 days**
**Minimum interval between doses is 4 weeks**
**All doses should be administered by age 8 months 0 days**

**www.cdc.gov/vaccines/recs/provisional/default.htm#acip**

## Provisional ACIP Rotavirus Vaccine Recommendations

**ACIP recommends that the rotavirus vaccine series be completed with the same product whenever possible**
**Vaccination should not be deferred if the product used for previous doses is not available or is unknown**
**The provider should continue or complete the series with the product available **

**www.cdc.gov/vaccines/recs/provisional/default.htm#acip**

## Provisional ACIP Rotavirus Vaccine Recommendations

**If any dose in the series was RV5 (RotaTeq) or the vaccine brand used for any previous dose in the series is unknown, a total of three doses of rotavirus vaccine should be administered**

**www.cdc.gov/vaccines/recs/provisional/default.htm#acip**

## KINRIXTM Vaccine

**Approved for**
**5th dose in the DTaP series, and**
**4th dose in the IPV series**
**children 4 through 6 years of age**
**previous DTaP vaccine doses were Infanrix and/or Pediarix for the first three doses and Infanrix for the fourth dose**

**Source: Kinrix package insert**

## KINRIXTM Vaccine

**ACIP recommends that whenever feasible the same manufacturer’s DTaP vaccine should be used for the all doses of the series**
**Vaccination should not be deferred if the specific DTaP brand previously administered is unavailable or unknown **

***MMWR***** 1997;46(RR-7):19**

## KINRIXTM Vaccine

**Approved by the FDA ONLY for the 5th dose of the DTaP series, and as the 4th dose of the IPV series**
**Off-label use is not recommended**
**Use of Kinrix for any dose EXCEPT the 5th dose of DTaP and 4****th**** dose of IPV should be considered a vaccine administration error **

## KINRIXTM Vaccine

**If Kinrix is inadvertently administered as an earlier dose in the series the dose may be counted as valid and does not need to be repeated if the minimum age and minimum interval since the prior dose are met **

## Pentacel® Vaccine

**Licensed by FDA for doses 1 through 4 of the DTaP series among children 6 weeks through 4 years of age**
**Should NOT be used for the fifth dose of the DTAP series, or for children 5 years or older **

**Source: Pentacel package insert**

## Pentacel® Vaccine

**Schedule**
**4 doses at ages 2, 4, 6, 15 through 18 months**
**Each of the first 3 doses should be separated by a minimum of 4 weeks **
**Fourth dose may be administered as early as 12 months of age if at least 6 months have elapsed since the 3****rd**** dose of DTaP **

**Source: Pentacel package insert**

## Pentacel® Vaccine

**The availability of Pentacel is not sufficient to reinstate the last (booster) dose of the Hib vaccine series**

## Pentacel® Vaccine

**Until the Hib supply improves Pentacel should be used ONLY for the first three doses of the DTaP, IPV, and Hib vaccination series, except for children at increased risk of Hib disease or who have not completed a primary Hib schedule**** **

## Immunization Update 2008
Webcast
August 28, 2008

Vaccine Safety Segment

**Webcast**
**August 28, 2008**
**Vaccine Safety Segment**

**Graphics subject to change.**
**This material in the public domain.**

## Syncope

**463 syncope (fainting) reports to the Vaccine Adverse Event Reporting System (VAERS) between 2005 and 2007**
**Rate almost doubled since 2004**

***MMWR***** 2008;57(No. 17):457-60**

## Syncope

**Adolescents and young adults are vulnerable to syncope**
**Since February 2005 three vaccines targeted to adolescents have been licensed**
**Meningococcal conjugate (MCV)**
**Tdap**
**Human papillomavirus (HPV)**
**Vaso-vagal response **

***MMWR***** 2008;57(No. 17):457-60**

## Syncope - Injury

**Injury following syncope a public health concern**
**76% of serious syncope VAERS reports occurred among adolescents**
**Life-threatening injuries, head trauma, and one fatality**

***MMWR***** 2008;57(No. 17):457-60**

## Preventing Syncope and Injury

**Consider observing patients for 15 minutes after they are vaccinated**
**Prevent injury if weakness, dizziness or loss of consciousness occurs**
**Adolescents and adults should be seated during the vaccination and observation period **

***MMWR***** 2008;57(No. 17):457-60**

## HPV Vaccine Safety Monitoring 

**FDA and CDC analyze adverse events reported from individual vaccine lots**
**No unusual patterns of adverse events have been observed in HPV vaccine lots since the vaccine was licensed **

**www.fda.gov/cber/safety/gardasil071408.htm**

## HPV Vaccine VAERS Reports*

**9,749 reports**
**94% classified as non-serious**
**6% classified as serious**
**20 deaths reported**
**no common pattern to the deaths **
**the cause of death was explained by factors other than the vaccine **

- *as of June 30, 2008

***As of June 30, 2008**
** ****www.cdc.gov/vaccinesafety/vaers/gardasil.htm**

## HPV Vaccine VAERS Reports

**Guillain-Barré Syndrome (GBS)**
**no evidence that HPV vaccine has increased the rate above that expected in the population**
**Thromboembolic disorders (blood clots)**
**Most had known risk factors**
**Additional studies are being conducted**

- *as of June 30, 2008

***As of June 30, 2008**
** ****www.cdc.gov/vaccinesafety/vaers/gardasil.htm**

## Immunization Update 2008
Webcast
August 28, 2008

Vaccine Briefs Segment

**Webcast**
**August 28, 2008**
**Vaccine Briefs Segment**

**Graphics subject to change.**
**This material in the public domain.**

## HPV Vaccine 

**HPV vaccine is approved by FDA only for females 9 through 26 years**
**not approved for males of any age at this time**
**should not be administered to females younger than 9 years or older than 26 years **

## HPV Vaccination Schedule 

**Routine schedule is 0, 2, 6 months**
**Minimum intervals**
**4 weeks between doses 1 and 2 **
**12 weeks between doses 2 and 3**
**24 weeks between doses 1 and 3**

## HPV Minimum Intervals 

**Minimum intervals between doses should not be used for routine vaccination**
**On March 5, 2008 CDC published a revised “catch-up” schedule indicating a 24 week interval between HPV doses 1 and 3**

## HPV Interval Violations

**If the 3-dose series was administered in less than 24 weeks but at least 16 weeks**
**do not repeat***
**If the 3-dose series was administered in less than 16 weeks**
**repeat 3****rd**** dose at least 12 weeks after the invalid dose**

***if minimum intervals between doses were observed**

## HPV Vaccine Intervals

**ACIP has not defined a maximum interval between HPV vaccine doses **
**If the interval between doses is longer than recommended**
**continue the series where it was interrupted**

## Vaccine Administration Errors

**Wrong vaccine or wrong diluent**
**Wrong vaccine dosage**
**Expired vaccine**
**Timing and spacing mistakes**
**Wrong site, route, or needle length **

## Preventive Strategies

**Involve staff in selection of vaccine products**
**Orient new staff to vaccines and validate their knowledge and skills about vaccine administration**
**Train all staff on use and administration of new vaccines**

## Preventive Strategies

**Keep current reference materials available on each vaccine**
**Rotate vaccines with the shortest expiration dates in the front and remove and discard any expired vaccines**

## Preventive Strategies

**Label storage containers or baskets with the age indications for each vaccine**
**Keep reference sheets for timing and spacing, as well as recommended sites, routes, and needle lengths posted for easy reference in your medication preparation area**

## Preventive Strategies

**Administer only vaccines that you have prepared for administration**
**Triple check your work BEFORE you administer a vaccine and ask other staff to do the same**
**Counsel parents and patients on vaccines to be administered and the importance of maintaining immunization records on all family members**

## Report Vaccine Administration Errorsto theInstitute for Safe Medication Practiceswww.ismp.org/

## Vaccine Supply - Influenza

**A shortage or delay in the influenza vaccine supply for the 2008-2009 season is not expected**
**As many as 146 million doses will be available **
**Distribution began for several manufacturers in early August, with other anticipated to begin no later than early September **

## Vaccine Supply - Hib

**The booster dose of Hib vaccine usually administered at 12 through 15 months of age should be deferred except for children who have not completed a complete primary Hib schedule or who are at increased risk of Hib disease***
**Merck’s Hib-containing vaccines are expected to be available again in fourth quarter of 2008**

****MMWR***** 2008;56(No. 50):1318-20**

## Vaccine Supply - Varicella

**In July 2008 Merck obtained FDA approval for resumption of manufacturing of their varicella vaccine virus bulk**
**MMRV remains unavailable but may become available in 2009 **

## Vaccine Information Statements

**Every healthcare provider, public or private, who administers a vaccine covered by the National Childhood Vaccine Injury Act is required by law to provide a copy of the most current VIS with EACH DOSE of vaccine**

## Vaccine Information Statements

**Not required by Federal law to obtain a signature**
**Must note in each patient’s permanent medical record or permanent office file:**
**date printed on the VIS**
**date the VIS is given to the vaccine  recipient, or their legal representative **

## Vaccine Information StatementsNew or Revised Since August 2007

**New**
**Multi-vaccine**
**Revised**
**MMR (include MMRV)**
**Varicella (include MMRV)**
**Meningococcal (include children 2-10 years)**
**Rotavirus (include Rotarix)**
**Influenza (TIV and LAIV)**

## CDC Vaccines and ImmunizationContact Information

**Telephone    (800) CDC-INFO**
**Email             nipinfo@cdc.gov**
**Website         www.cdc.gov/nip**
**Updates and Resources Web Page**
**	****www.cdc.gov/vaccines/ed/webcasts.htm**