Immunization Update: 2016 · Pharmacist Learning Objectives • Discuss the new 2016 Advisory...

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Immunization Update: 2016

Golden Peters, PharmD, BCPS

Associate Professor, Pharmacy Practice Department

St. Louis College of Pharmacy

Faculty Disclosure

• Golden Peters declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, and stock holdings

Pharmacist Learning Objectives

• Discuss the new 2016 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations

• Review influenza vaccine considerations in preparation for the 2016-2017 season

• Apply immunization recommendations to specific patient scenarios

Technician Learning Objectives

• Discuss the new 2016 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations

• Review influenza vaccine considerations in preparation for the 2016-2017 season

• Evaluate specific patient scenarios to screen for vaccine candidates

My Story…

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Agenda

• Summarize ACIP recommendations since September 2015 to August 2016

• Discuss adult immunization changes

• Discuss childhood immunization changes

• Highlight influenza treatment changes

Dear Pharmacist Letter…• Anne Schuchat, MD, Assistant Surgeon General and Principal Deputy Director, CDC

• CDC applauded the accomplishment of the pharmacy profession• 20 years of service

• Improved health in our communities

• Reduced risk of vaccine-preventable disease

• Expanded immunization authority

• Improved vaccinations rates

• Commitment to “walking the walk”

• Collaborating with other providers

• Recognized APhA’s Pharmacy-Based Immunization Delivery Certification Training Program

• Upcoming 20th anniversary

• Trained more than 260,000 pharmacistsPharmacist.com CDC Letter. 2015.

Advisory Committee on Immunization Practices (ACIP)• Members

• 15 experts in the field of immunization

• Ex-officio Members (9)

• Liaison Members (33)

• Mission• Advice and guidance to the CDC

• Develop recommendations

• Reduce vaccine-preventable deaths

• Meet 3 times/year• Subcommittees meet more often

• Open to the public and available on live webcastSource: http://www.medscape.org/viewarticle/767661_transcript

Childhood Immunization Updates

Source: http://www.keyshealthystart.org/general/newborn-and-toddler

Immunization Schedule

• Reconfigured schedule to list vaccination by age of administration

• Earliest to latest age of first recommended administration

• Goal:

• Improve readability

•Allow for gold bars to align under age when first recommended

MMWR. February 2, 2016.65.

CDC.gov. Vaccine Schedules 2015.

Human Papillomavirus Vaccine

• HPV vaccination recommendations:

• Routine administration at 11 or 12 years of age

• Catch-up vaccination can occur up to 26 years old

• Administer beginning at 9 years old for any history of sexual assault

• No need for revaccination once completing a full series

MMWR. February 2, 2016.65.Source: http://www.medicalnewstoday.com/articles/246670.php

Meningococcal Vaccine• Meningococcal B (MenB) vaccination recommendations:

• Routine vaccination for people >10 years at high risk for MenB disease

• Asplenia

• Microbiologist routinely exposed to Neisseria Meningitidis

• Two-dose or three-dose series of either Meningococcal B (MenB) vaccine

• Bexsero (MenB-4c) (2 doses)

• Trumenba (MenB-FHbp) (3 doses)

• Short-term protection against MenB strains for persons 16 to 23 years old

• There is no preference for MenB vaccines

• They are NOT interchangeableMMWR. February 2, 2016.65.Source: http://www.multivu.com/Source: http://www.mainstreetvacs.com/partners/

Meningococcal Vaccine

• Meningococcal vaccination recommendations:

• Routine vaccination at 11 or 12 years old with a quadrivalent meningococcal vaccine remains unchanged

• Booster dose at age 16

• (Menactra [MenACWY-D])

• Both meningococcal vaccines can be administered at the same office visit

• Different injection sites

Diphtheria, Tetanus and Pertussis (DTaP) Vaccine

• DTaP vaccination recommendations:

• Fourth dose of DTaP usually given at 15 months of age

• Can be given at 12 months old IF separated from third dose by at least six months

Case 1• A 1 year old patient is presenting to their pediatrician for a routine visit. The

pediatrician would like to administer all age appropriate vaccines.• PMH: not remarkable

• Which vaccines are recommended for this patient?

• Immunizations are currently up to date

• Time of last vaccination:

• HepB – 2 months old

• RSV – 4 months old

• DTaP – 6 months old

• Hib – 4 months old

• PCV13 – 6 months old

• IPV – 4 months old

• Never received influenza vaccine

Time of last vaccination:

• HepB – 2 months old• RSV – 4 months old• DTaP – 6 months old• Hib – 4 months old• PCV13 – 6 months old• IPV – 4 months old

• Which vaccines are recommended for this patient?

• HepB (3rd dose)

• DTaP (4th dose)

• Hib (3rd or 4th booster dose)

• PCV13 (4th dose)

• IPV (3rd dose)

• Influenza (IIV, 2 doses, 4 weeks apart)

• MMR (1st dose)

• VAR (1st dose)

• HepA (1st dose)

Adult Immunization Updates

Source: http://tetonfamilymagazine.com/ourfrontporch/childhood-vaccines-whos-calling-the-shots

Human Papillomavirus Vaccine

• HPV vaccination recommendations:

• Added nonavalent HPV vaccine (Gardasil) as one of three formulations approved for routine vaccination

• Routine vaccination for persons 11 or 12 years old

• Women: administer through 26 years old

• Men: administer through 21 years old

• Men at high risk: administer through 26 years old

• No revaccination recommendation for those previously completing a full series

Meningococcal Vaccine

• Meningococcal vaccination recommendations:

• Persons at increased risk should be routinely vaccinated with quadrivalent meningococcal vaccine (Menactra [MenACWY-D])

• HIV is NOT an indication for routine vaccination with MenACWY-D or Men B vaccine (MMWR. Feb. 2, 2016)

• June 2016, ACIP recommends MenACWY-D vaccine to HIV infected patients ages 2 months and older

• 2 dose series, 2 months apart

MMWR. February 2, 2016.65.MMWR. October 23, 2015. 64(41).

Pneumococcal Vaccine• Pneumococcal vaccination recommendations:

• 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13])

• 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax])

• Immunocompetent adults 65 years and older, separate PCV13 and PPSV23 vaccines by 1 years

• 2015 recommendation: 6 – 12 months

• Immunocompromised adults > 19 years old, separate PCV13 and PPSV23 by eight weeks

• Asplenia, CSF leak, cochlear implant, HIV

• PCV13 and PPSV23 should NOT be co-administered

• PPSV23 inadvertently given early, do not repeatMMWR. February 2, 2016.65.MMWR. September 4, 2015. 64(34).

Pneumococcal Vaccine in

Patients > 65 Years Old

MMWR. September 4, 2015. 64(34).

Source: http://eziz.org/assets/docs/IMM-1152.pdf

Smallpox Vaccine

• Smallpox vaccination recommendation:

• Live smallpox (vaccinia) vaccine (ACAM2000)

• FDA approval in 2007, replacing Dryvax

• Routine vaccination with ACAM2000 for:

• Laboratory personnel directly handling:

• Cultures or contaminated/infected animals with vaccinia virus

• Health care personnel ( e.g. physicians and nurses)

• Currently treat or anticipate treating patients with vaccinia virus infection

• Persons administering ACAM2000 smallpox vaccine

MMWR. March 18, 2016. 65(10).Source: http://www.historyofvaccines.org/content/acam2000-vaccine

http://www.vaccinationinformationnetwork.com/revolts-and-opposition-against-compulsory-smallpox-vaccination/

Cholera Vaccine

• Cholera vaccination recommendation:• Cholera vaccine (Vaxchora)

• FDA approval June 10, 2016

• Only vaccine available to prevent cholera at this time

• Indicated for cholera prevention for travelers ages 18 – 64 to areas of active cholera transmission

• Single dose, live attenuated oral vaccine

• Administered 10 days or more before travel

• Duration of coverage is unknown

• (3 – 6 months)

AAFP. News. ACIP Recommendation June 2016.Source: http://www.vaxchora.com/

Source: http://www.who.int/gho/epidemic_diseases/cholera/epidemics/en/

Case 2• A 45 year old patient is presenting to their PCP for a routing check-up. The

patient was recently started on dialysis. The PCP calls your pharmacy asking for recommendations regarding this patient’s pneumococcal vaccine requirements.

• What recommendation would you provide to the PCP?

A. Administer PCV13

B. Administer PPSV23

C. Administer both PCV13 and PPSV23

D. Pneumococcal vaccine is not needed at this time

Case 2• A 45 year old patient is presenting to their PCP for a routing check-up. The

patient was recently started on dialysis. The PCP calls your pharmacy asking for recommendations regarding this patient’s pneumococcal vaccine requirements.

• When should the patient return for their next pneumococcal vaccination?

A. 1 month

B. 2 months

C. 5 years

D. No need to return until 65 years old

Case 3

• A 63 year old patient was recently diagnosed with type 2 diabetes mellitus. What pneumococcal vaccine should this patient receive?

A. PCV13

B. PPSV23

C. Both PCV13 and PPSV23

D. None, wait until 65 year old

Case 3

• The same patient is now presenting to their PCP 2 years later. (65 years old)• PMH: no changes

• Vaccinations: no changes

• What pneumococcal vaccine should this patient receive?A. PCV13

B. PPSV23

D. None at this time

Case 3

• The same patient is now presenting to their PCP 2 years later. (67 years old)• PMH: no changes

• Vaccinations: no changes

• What pneumococcal vaccine should this patient receive?A. PCV13

B. PPSV23

D. None at this time

Influenza Vaccine

Source: http://www.davegranlund.com/cartoons/2009/10/06/flu-vaccine-categories/

Influenza Season 2015 – 2016

• October 4th, 2015 – May 21st, 2016 in the US

• Influenza activity was lower and peaked later compared to past 3 seasons

• Peaked in mid-March 2016

• Overall influenza activity was moderate, compared to last 3 seasons:• Lower percentage of outpatient visits

• Lower hospitalizations rates

• Lower percentage of deaths attributed to pneumonia and influenza

MMWR. June 10, 2016. 65(22).Source: https://blog.pkids.org/tag/flu/

MMWR. June 10, 2016. 65(22).

2015-2016 Peak

2010-2011 Peak

2014-2015 Peak

2009-2010 Peak

2013-2014 Peak

Influenza Season 2015 – 2016• Predominant strains:

• Influenza A: H1N1pdm09

• Vaccine effectiveness (VE)

• Overall: 47%

• A strain: 41%

• Children age 2 – 17 years old

• Inactivated influenza vaccine (IIV): 63%

• Live attenuated influenza vaccine (LAIV): 3%

CDC. ACIP June Meeting 2016.

• Vaccine Adverse Event Reporting System (VEARS)

• No found safety concerns for any influenza vaccine

CDC. ACIP June Meeting 2016.Source: https://www.focusforhealth.org/ethics-and-finance-flu-shot-studies/

Influenza Vaccine

• LAIV (FluMist) offered no protection against influenza in children last season

• Poor or lower than expected VE for LAIV for the past 3 seasons

• ACIP recommends against using LAIV for the 2016 – 2017 influenza season

• Approved for use in people 2– 49 year old

• FDA has not acted against LAIV

• Waiting for more information

CDC. ACIP June Meeting 2016.Source: https://www.flumistquadrivalent.com/

Influenza Vaccine• Possible causes for LAIV’s lack of effectiveness:

• Poor performance of the A vaccine stain as a nasal formulation

• Interference by the additional B strain in the quadrivalent formulation

• AstraZeneca manufacture of FluMist:

• Projected to make 14 million doses of FluMist

• Unsure if pre-ordered supplies will be refundable

• Needle phobias or vaccine-hesitant patients should NOT use LAIV

• Proposed language to the CDC Director for final approval

• “LAIV should not be used in any setting”

CDC. ACIP June Meeting 2016.

ACIP Recommendation for 2016 – 2017 Influenza Season

• Available vaccines for 2016 - 2017

• Inactivated influenza vaccine (IIV)

• Trivalent and quadrivalent formulations

• Recombinant influenza vaccine (RIV)

• Trivalent formulation

• Interim recommendation by ACIP

• Live attenuated influenza vaccine (LAIV4)

• Should NOT be used

MMWR. August, 26 2016. 65(5):1-54.

Influenza Vaccine

• Clarification for egg allergies:• Patients with known allergies to eggs, regardless of severity can receive any influenza

vaccine:

• Inactivated influenza vaccine (IIV)

• Recombinant influenza vaccine (RIV)

• Live attenuated influenza vaccine (LAIV)

• Post-vaccination observation should be 15 minutes for all patients receiving vaccines

• Why the change?

• Most reactions to vaccines are after the 30 minute observation period (old recommendation)

• Reactions are very rare (1 in a million)

• Note: patients with severe egg allergies à vaccinate in medical setting equipped to manage severe reaction

MMWR. February 2, 2016.65.Source: http://kidshealth.org/en/kids/egg-allergy.html

Influenza Season 2016 – 2017• Influenza season is October to May

• Commonly peaks in January to February

• Annual influenza vaccination is recommended for all persons 6 months of age and older

Source: http://www.pikecountyhealth.com/v3/

• Annually the WHO researches which influenza strains will likely be the most common

• The FDA then considers these suggestions• Recommended influenza vaccines composition (2016 - 2017)

• Trivalent vaccine:

• A/California/7/2009 (H1N1)pdm09-like virus

• A/Hong Kong/4801/2014 (H3N2)-like virus

• B/Brisbane/60/2008-like virus

• Quadrivalent vaccine:

• B/Phuket/3073/2013-like virus

MMWR. June 10, 2016. 65(22).

• Total amount of influenza vaccines predicted to be produced:

• 175 million doses

• Remember this will be reduced by 14 million FluMist Vaccines

• Shortage???

• Similar to last year, 171 – 179 million predicted

MMWR. June 10, 2016. 65(22).

Vaccines in the Pipeline

• Ebola

• 100% efficacy (Guinea trial)

• Single dose, stored at -80°C

• Dengue

• Dengvaxia (Sanofi)

• Approved in Mexico

• 79% pooled efficacy against severe dengue

• WHO recommends use in endemic dengue areas

• Zika

• ~21 vaccine candidates

• NIH has begun testing in humans

Source: http://www.cdc.gov/travel/yellowbook/2016/infectious-diseases-related-to-travel/dengue

Case 4

• A patient (38 years old) has received FluMist (LAIV) nasal spray for the past 10 years without acquiring the flu. They possess a severe fear of needles (trypanophobia) and refuses any injectable medication. They are inquiring about all the ‘fuss’ on the news regarding FluMist.

• How would you approach this patient scenario?

Case 5

• A patient is inquiring about receiving the flu vaccine for the first time. In 6th

grade they had an allergic reaction to eggs (rash/hives). They have never received the flu vaccine due to this reaction. They saw on the nightly news that people with egg allergies can get the flu vaccine this year.

• How would you respond to this patient’s question?

Source: http://aboutdavidgeier.com/

Immunization Update: 2016

Golden Peters, PharmD, BCPS

Associate Professor, Pharmacy Practice Department

St. Louis College of Pharmacy

Immunization Update: 2016 · Pharmacist Learning Objectives • Discuss the new 2016 Advisory...

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