© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 1

APhA Immunization Update from the October 2013 ACIP Meeting 

Stephan L. Foster, Pharm.D.

CAPT (Ret) U.S.P.H.S.

Professor and Vice Chair

University of Tennessee College of Pharmacy

Liaison Member

CDC Advisory Committee on Immunization Practices (ACIP)

Accreditation

The American Pharmacists Association is accredited by theAccreditation Council for Pharmacy Education as a provider of continuing 

pharmacy education. This activity, APhA Immunization Update from the October 2013 ACIP Meeting, is approved for 1.0 hours of continuing pharmacy education credit (0.10 CEUs). The ACPE Universal Activity Number assigned by the accredited provider is: 0202‐0000‐13‐106‐L04‐P. 

To obtain continuing pharmacy education credit for this activity, participants will be required to actively participate in the entire webinar and complete an online evaluation and CPE recording form located at www.pharmacist.com/education by November 20, 2013.

Initial Release Date: November 6,2013

Target Audience: Pharmacists

ACPE Activity Type: Knowledge‐Based

Learning Level: 1

Free CPE credit is brought to you by your APhA membership. Non‐members will be assessed a $25 CPE activity fee for this webinar.

Learning Objectives

Identify changes to vaccine recommendations necessary for compliance with standards of practice

Apply recent changes to guidelines to their vaccination program

Evaluate information on new or future vaccines for potential use in their practice

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 2

Disclosures

Stephan L. Foster, PharmD, FAPhA, serves on the speaker bureau for Merck, and  on an Advisory Committee for Pfizer.

APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures visit www.pharmacist.com/education

Disclaimer

• This contains data presented at the ACIP meeting

• Some of this data is unpublished

• If there is a slide without a reference, then it contains such data

• Do not quote this specific data until it is published

• ACIP meeting minutes will be on the ACIP website in the near future, along with the meeting slides– www.cdc.gov/vaccines/recs/acip/default.htm

Advisory Committee on Immunization Practices

• Members

– 15 Experts in the field of Immunization

• Voting Members

– Ex‐officio Members (9)

– Liaison Members (33)

• Mission

– Provide advice and Guidance to CDC

– Develop written recommendations

– Reduce the incidence of vaccine‐preventable disease

• Meets 3 times a year

– More often in subcommittees

6

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 3

Dr. Thomas Frieden, Director CDC

Meningococcal Vaccine

• MenACWY‐135‐CRM (Menveo‐Novartis)– FDA approved for 2 months – 55 years

• Infant dose series  2,4,6,12 months• First licensed at this age

• Menactra – sanofi pasteur( MenACWY135‐D) 9 months – 55 years• MenHibrix – GSK (HibMenCY‐TT) 6 weeks – 18 months• CDC recommended for high‐risk only

– Complement Deficiencies– Asplenia– Community Outbreaks– Travel to Epidemic Countries– HIV– Microbiologist

MenACYW‐135‐CRM

• Immunogenicity

– Studies presented that were used for 2 month FDA approval

– Phase 2/3 studies were described

– Titers were adequate for protection

– Did not interfere with other vaccines in ped series

• Safety

– Similar to other vaccines in pediatric series

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 4

Menveo

• GRADE Evaluation Process presented– Analysis demonstrated that this vaccine was similar to other meningococcal vaccines

– Recommended for high‐risk children 

• Working Group Recommendation– Add Menveo as an option along with other meningococcal vaccines for use in high‐risk infants

– Only vaccine for ages 2‐8 months

• Vote:  Passed

Child and Adolescent Schedule

• ACIP approval for publication in Jan‐Feb 2014– AAP and AAFP must also approve

• Footnote changes– Clarify RV1 (Rotarix) and RV5 (RotaTeq)– Tdap – lower age to 7 years, no repeat doses except pregnancy

– Hib – add MenHibrix, and clarify catch up– PCV – clarify it means PCV13 and who receives PPSV– DTaP, Hep B, Hep A, IPV, Flu, MMR, varicella, HPV, Meningococcal (Add Men‐CRM)

• minor wording changes

Adult Immunization Schedule

• Recommendation based upon:– Age, prior vaccinations, health status, lifestyle, occupations, travel

• Current low rates– Limited awareness of public– Lack of provider recommendation– Lack of assessment of vaccination status at healthcare visits

• NVAC – New Standards approved Sept 2013– Final publication in March 2014– www.publichealthreports.org

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 5

NVAC Standards for Adult Immunization Practices

• All Providers– Needs assessment for every patient encounter

– Strongly recommend needed vaccines

– Stay up‐to‐date on recommendations

– Understand how to access IIS

• Non‐immunizing Providers– Routinely assess patients for needed vaccines

– Establish referral relationships

– Follow‐up to confirm patient receipt

NVAC Standards for Adult Immunization Practices

• Immunizing Providers

– Ensure professional competencies

– Assess status in every patient encounter

– Strongly recommend needed vaccines

– Document in IIS

• Public Health Departments

– See document

NVAC Standards for Adult Immunization Practices

• Professional healthcare related organizations/ associations/ healthcare systems– Provide education and training– Provide resources– Encourage members to stay up‐to‐date– Partner with other organizations– Collaborate with other stakeholders– Collect and share best practices.– Advocate policies to support standards– Work with insurers/payers/entities that cover vaccine services 

to assure network is adequate so patients are not missing opportunities.

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 6

Adult Schedule Changes

• New Flu Vaccines– Including egg allergy recommendations

• PCV13 vaccine to high‐risk individuals– Clarify by moving bar before PPSV

• Footnote changes– Hib

– Tdap and then Td every 10 years

– Varicella

– HPV

Not To be Published in MMWR in Future

• Published in Annals of Internal Medicine

• Link to CDC website

– Can be updated more frequently

• Approved by:

– American Academy of Family Physicians

– American College of Physicians

– American College of Obstetrics and Gynecology

– American College of Nurse Midwives 

Pneumococcal Conjugate Vaccine

• PCV13 Licensed in 2010– 2,4,6,12‐15 months doses

• PCV7 greatly reduced disease in children and adults– Practically eliminated IPD in children

• Early evidence of PCV13 direct and indirect effect

• Vaccine effectiveness in children– 65% all IPD

– 89% PCV13 serotype IPD

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 7

Dosage Schedule

• Evidence from around world supports 3 dose schedule– Vaccine Effectiveness 70% ‐ 100% against vaccine‐type IPD

• PCV7, PCV9, and PCV13

– 4 dose vaccine effectiveness 81% ‐ 100% 

– No head‐to‐head studies comparing 3 to 4 dose schedules

– Many difference types of studies• RCT vs Observational 

• IPD vs pneumonia

Conclusion

• Three dose PCV studies shown effective against IPD, pneumonia, and otitis media

• Immunogenicity studies demonstrate after the primary series, the 3 dose is more effective than the 2 dose– This difference does not continue after the second year of life. – Little difference after the booster dose for the 2+1 vs 3+1 series.– Same pattern for nasopharyngeal carriage

• Differences may not be meaningful– PCV7 serotypes rarely cause disease– PVC13 serotype disease is disappearing– Herd effects are similar so may not expect changes at the 

population level.

Working Group Conclusion

• More data needed

• Need to evaluate which dose if one is eliminated

• Identifying high‐risk groups if necessary

• Not FDA approved

• Public/parent opinions

• Practice issues

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 8

Herpes Zoster

• Current recommendations– Routine 60 years and older

– FDA approved for 50 and older• June 2011, ACIP reaffirmed original recommendation

• ACIP to monitor supply and revisit

• ACIP working group– Supply and uptake

– Long term persistence studies

– Reconsider recommendations 

Supply and Uptake

• No supply issues since 2012– Supply expected to be stable

– Over 6 million doses shipped

– Reintroduced ProQuad (MMRV)

– Zostavax available in over 12 countries with more launches planned.

– New manufacturing capabilities

• Uptake– 20.1% in 2012

– Increasing but slowly

Shingles Prevention Studies

• Oxman, et al. NEJM 2005;352(22):2271‐84

– 38,000 patients

– Followed for 3.1 years

– 51% reduction in cases

• Effectiveness reduced with age

– Less likely to progress to PHN is you get shingles

– Biggest effect seen in those >70 years

• Tseng, et al. JAMA 2011;305(2):160‐6– 75,000 vaccinees vs. 227,300 non‐vaccinees

– Effectiveness 55%

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 9

ZEST Trial 50‐59 year olds

• Zostavax Efficacy and Safety Trial

– 2007‐2011

– 22,439 patients

• Cases of Zoster– 30/11211 in vaccine group

– 99/11228 in placebo group

– Efficacy 69.8%

• Generally well tolerated– More ADEs in vaccine groups

• Mostly local reactions and headache

– Similar serious ADEs to placebo

Shingles Prevention Study

• SPS– Follow‐up time after 3.1 years

– Decreased HZ by 51%

– Decreased PHN and BOI

• Short‐term Persistence Study was continued to 8 years– No placebo arm

– VE was 40% for HZD and PHN 60%

– Numbers too small to continue the study

HZV Duration of Protection

• Schmader, IDSA 2008

SPS – Shingles Prevention Study     STPS – Short Term Persistence Study

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 10

Long Term Protection Study

• Extends follow‐up to 12 years– Difficult to perform since small number of cases– No placebo control

• Study Subjects– 6,867 Enrolled.– Age of enrollment 74 years– 263 evaluable cases of HZ

• Estimates duration of VE– Disease, PHN, BOI– Lower than SPS 

Burden of Disease

• Acute pain that can be disabling

• Complications

– PHN

– Secondary bacterial infections

– Ocular involvement

– Neurological complications

• Disease and complications increase with age

– Risk doubles between 60 to 80 years

Zoster Disease and Age

Insinga, et al. The incidence of Herpes Zoster in a United States administrative database. J Gen Intern Med. 2005;20:748‐753 

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 11

Long‐term Protection

• Vaccine needs to protect throughout the later years.

• Uptake low ‐ ~20%

• Cost Effectiveness

– Immunization age 70 years – reduce PHN the most

– Immunization at 60 years – Reduce HZ cases the most

– Immunization at age 50 years least cost‐effective 

WG Conclusion

• Burden of disease rapidly increases with age• Increases with age

– Incidence of HZ – Proportion of HZ progression to PHN– More complications– More interference of daily living– More hospitalizations

• Long‐term protection wanes over 11 years• Duration unable to be determined since no control group• Limited impact on prevention at age 50 years• Very difficult to do vaccine efficacy trials in elderly• No change to existing recommendation

Yellow Fever Vaccine

• New recommendations of WHO against booster doses of Yellow Fever Vaccine– Strategic Advisory Group of Experts

• Single dose of YF vaccine sufficient to protect for lifetime

• US recommendations– YF‐Vax licensed in U.S.– Used for travel to endemic areas– ACIP recommends a booster every 10 years

• Working Group– Will evaluate data and develop recommendations.– Anticipate if changes to be made, ACIP vote in 2014

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 12

Global Immunization Update

• SAGE ‐ Strategic Advisory Group of Experts

– 15 experts from around the world

– Collaborates with WHO

• Global health measures

– 17,000 fewer children die every day in 2012 vs 1990

– Still 18,000 children die daily 

• Many are vaccine‐preventable

– 90 million lives saved since 1990

• 216 million children have died

Global Vaccine Action Plan

• SAGE and Decade of the Vaccine Collaboration• Goal to extend full benefits of vaccination to all people by 2020

• Six Guiding Principles– Country ownership– Shared responsibility and partnership– Equity– Integration– Sustainability– Innovation

Successes

• MenAfricaVac Program – 95% reduction in six countries• Removed age restriction on rotavirus vaccine• Single dose Yellow Fever Vaccine• Influenza recommendation worldwide• Other Programs underway

– Hepatitis E– Japanese Encephalitis– Malaria Vaccine– Pertussis Vaccine (global switch to aP on hold)– Polio – Pregnancy and lactation –expanding vaccination– Varicella‐Zoster– Vaccine hesitancy

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 13

HPV Vaccine

• Low Update – no increase in 2012

– 13‐17 y/o

• Girls– 1 dose coverage 53.8%

– 3 dose coverage 33.4%

• Boys

– 1 dose 21%

– 3 doses 7%

• Unvaccinated with missed opportunity 84%

Low Vaccination Rates

• Top 5 reasons– Belief it is not needed

– Not recommended by Provider

– Safety concerns/ side effects

– Lack of Knowledge

– Not sexually active

• Critical Needs– Provider recommendations

– Eliminate missed opportunities

New HPV Vaccine

• Merck – 9 valent– Serotypes 6, 11, 16, 18, 31, 33, 45, 52, 58

– Virus Like Particle (VLP)

– Alum Adjuvanted

– 3 dose series

– Same target age group

– Comparable safety 

• Increases coverage rates for cervical cancer serotypes to 90%– Precancers to 85%

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 14

Updated HPV Published Recommendations

• Last published 2007

– Did not include boys

– Only quadrivalent available at the time

• Clear up the inconsistencies

• Reflect new recommendations

• Provide additional data

Revision

• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 15

October Topics

• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources

Remaining Topics

• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources

Tentative Vote June 2014

Vaccine Administration

• Changes to Infection Control

– Vaccine Administration, Preparation, Timely Disposal

– Make OSHA language stronger

• New information on ID route of administration

• Intradermal versus Subcutaneous

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 16

Vaccine Administration: Preparation and Timely Disposal

• Syringes drawn up in a clean medication area 

• Multi‐dose vials should not be kept or accessed in the immediate patient treatment area

• If single vaccine type is being, filling a small number (10 or less) of  syringes may be considered.• Labeled with the type of vaccine, lot number, and date of filling

• Administered as soon as possible after filling, by the same person who filled the syringes

• Unused syringes that are prefilled by the manufacturer and activated (i.e. syringe cap  removed or needle attached) should be discarded at the end of the clinic day.

Based on CDC guidance already on web site by CDC working group (distinct from GRWG)

OSHA Regulations

2011 General Recommendation are both strong and weak with respect to use of needle‐shielding syringes or needle‐free injectors

STRONG 

• “These federal regulations require that safety‐engineered injection devices (e.g. needle‐shielding syringes or needle‐free injectors) be used for injectable vaccination in all clinic settings. 

WEAK

• “Safety‐engineered needles and syringes or needle‐free injection devices are preferred and should be encouraged to reduce risk for injury.”

Will remove weak statements

Vaccine Route: Revision to Needle Length Table

TABLE 10. Needle length and injection site of IM injections for children aged ≤18 years (by age) and adults aged ≥19 years (by sex and weight)

Age group Needle length Injection site

Children (birth--18 yrs)

Neonates* 5/8 inch (16 mm)† Anterolateral thigh

Infants, 1--12 mos 1 inch (25 mm) Anterolateral thigh

Toddlers, 1--2 yrs 1--1.25 inch (25--32 mm) Anterolateral thigh§

5/8†--1 inch (16--25 mm) Deltoid muscle of arm

Children, 3--10 yrs 5/8†--1 inch (16--25 mm) Deltoid muscle of arm§

1--1.25 inches (25--32 mm) Anterolateral thigh

Children, 11-18 yrs5/8ϯ – 1inch(16—25mm) Deltoid muscle of arm§

1—1.5 inches (25—32 mm) Anterolateral thigh

Jackson LA, Yu O, Nelson JC, et. Al. The 15 fifth dose of Diphtheria, Tetanus and Acellular Pertussis Vaccine. Pediatrics 16 2011:127(3), p. e580‐e588 

Middleman, 1 A, Anding R, Tung C, Pediatrics 2010: 125(3), p. e1‐e5 

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 17

Vaccination Route: Intramuscular vs. Subcutaneous

• Background• Hepatitis B only IM

• Repeat if given by other route

• Patients with bleeding disorders• Permissive language on routes of other vaccines• Hepatitis B in Bleeding Disorder – Give IM

o Only if physician familiar with patient’s bleeding risko Can it be given SubQ?

• Other Sub Q is OKo MCV4o Hep A 

• If not mentioned that it should not be Sub Q does that imply it is OK?

• Working Group to Discuss

Provider Records

• Clarification of which vaccines are covered by the National Vaccine Injury Compensation Program – Reminder of documentation requirements

• Immunization Information Systems (IIS)– Maintain interoperability with other electronic health record 

tools– Reduce health disparities– Engage patients and families in their health– Improve the coordination of care– Improve population health– Ensure adequate privacy and security protection for personal 

health information.– www.cdc.gov/ehrmeaningfuluse/introduction.html

Advantages of IIS

• Prevent duplicate vaccinations

• Forecast when the next dose is due

• Limit missed appointments

– Allow recall for those who missed appointments, 

• Determine when vaccines need to be repeated 

• Reduce vaccine waste 

• Reduce staff time required to produce or locate vaccination records or certificates. 

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 18

CDSI

• Clinical Decision Support for Immunizations 

– Project to aid computer systems

• Aid in delivering current ACIP recommendations and schedules to Health Information Systems

– Provide clarity and consistency

Pharmacist 89.1%Hospital Pharmacist 97.7%

• New– New Vaccine Strains

– Licensure of 6 new influenza vaccines

– Clarification of Egg Allergy recommendations

• Since Publication– FluLaval Quadrivalent

– FluLaval age changed to 3 years and older

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 19

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2012 – 2013 Season

• 134.9 Million Doses distributed

• Coverage

– Children – 57%

– Adults over 18 years – 41.5%

– Adults over 65 years – 66%

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 22

High‐dose Efficacy Trial

• Trivalent Fluzone HD– Pre‐licensure

• Statistically significant higher antibody response

– 13 million doses distributed

• Comparison of HD to regular Fluzone against laboratory‐confirmed influenza associated with – 32,000 participants

• 15,892 High‐dose• 15,911 Regular dose

– 2 influenza seasons– Relative Efficacy 24.2% (95% CI 9.7:36.5)

• Lower‐limit set by FDA of CI >9.1 is met• 227 (1.43%)  vs 300 (1.89% )• 0.46% difference = 4.6 cases / 1000 injections

Quadrivalent Influenza Vaccine (QIV)

• Influenza B viruses

• Circulates globally each year

• Two lineages– B/Yamagata

– B/Victoria

– Cross protection unclear

• Vaccine Match– 5/10 years

– 2012‐13 (Both Strains Circulated)

2013‐2014 Vaccine Strains

• A/California/7/2009 (H1N1)‐like• A/Victoria/361/2011 (H3N2)‐Like• *B/Massachusetts/2/2012‐like virus.• ****B/Brisbane/60/2008‐like virus

– * Yamagata Lineage– **** (Quadrivalent) Victoria Lineage– Note:  B Strain differs from 2012‐2013

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 23

FluMist® (MedImmune)

• Currently transitioning to Q/LAIV

• Approved by FDA 2/29/12

• Same formula as TIV with additional B strain

– Immunogenicity non‐inferior to T/LAIV

– High immune response to additional B strain

– Same safety profile

• Same dose and delivery

• Will not affect supply

GlaxoSmithKline ‐ GSK• Current TIV

– Fluarix D‐TIV

• Manufactured in Dresden, Germany

– FluLaval Q‐TIV

• Manufactured in Quebec, Canada

• FDA Approved – D‐QIV

• Safe and immunogenic

• Approval December 4, 2012 (Fluarix Quadrivalent)

• Age 3 years and older

– Q‐QIV• FDA approval August 16, 2013

– Q‐TIV available for 2013‐14 season• Limited Supplies of Q‐TIV

Sanofi‐Pasteur

• Fluzone Quadrivalent

– Immunogenic and safe

– Ages 6 months and older

– FDA approval June 7, 2013

– Supply

• TIV orders will be completed

• Could not discuss with providers until FDA approved

• May not be used much this next season

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 24

Flucelvax (Novartis)

• Cell Cultured IIV– ≥ 18 years– Trivalent for 2013-14 season

• Alternative to eggs– Production by potentially vulnerable avian species

• Subunit virus vaccine propagated in canine kidney cells

• Immunogenic and safe compared to other TIV

• Plans– Produce in Holly Springs, NC 

Flublok (Protein Sciences Corp)

• FDA approved 1/16/2013• Trivalent inactivated for 18‐49 year olds• This is where it gets different!

– Insect virus (baculovirus) expression system and recombinant DNA technology

• Produces hemagglutinin (HA)

– No eggs and No flu virus used– 44.6% effective against all circulating strains

• Even those not in the vaccine!

• Shelf Life = 16 weeks• Expect 3‐5 million doses next season

2013‐14 Flu Vaccine Supply

• Fluzone (sanofi) – 50 Million– Fluzone HD– Fluzone ID– Fluzone QIV– Fluzone TIV

• Flublok (Protein Sciences) – 250,000• Fluvirin (Novartis‐TIV) 30 million• Afluria (Merck/CSL‐TIV) – 11 million • FluMist (MedImmune – QIV) – 13‐15 million• Fluarix (GSK – QIV) – 10 million• FluLaval (GSK – TIV) 12‐14 Million

© 2013 by the American Pharmacists Association. All rights reserved. Printed in the U.S.A. 25

Summary and Conclusions

• Next ACIP Meeting February 26‐27, 2014 in Atlanta

• If questions, please contact:– Stephan L. Foster, Pharm.D.E‐mail: sfoster@uthsc.edu

• Questions/comments

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Record Attendance Code: Provided During Webinar Please visit: http://www.pharmacist.com/live‐activitiesand select the Claim Credit link for this activity

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You must claim credit by November 20, 2013. No credit will be awarded after that date.