Needle Facts: Immunization

Update 2017

Miranda Wilhelm, Pharm.D.

Clinical Associate Professor

Southern Illinois University Edwardsville (SIUE)

School of Pharmacy

Disclosure and Conflict of Interest

• Miranda Wilhelm reports she is a Speaker’s

Bureau Member for Merck Vaccines

Pharmacist Objectives

At the conclusion of this program, the pharmacist will be able to:

1. Discuss the new 2017 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations

2. Review influenza vaccine considerations in preparation for the 2017-2018 season

3. Evaluate a patient’s immunization history to determine vaccine recommendations based on the appropriate immunization schedule

At the conclusion of this program, the technician will be able to:

1. Discuss the new 2017 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations

2. Review influenza vaccine considerations in preparation for the 2017-2018 season

3. Evaluate a patient’s immunization history to determine vaccine recommendations based on the appropriate immunization schedule

Technician Objectives

Pre-Test Question #1

• Which of the following patients is a candidate for a 2-

dose series of HPV vaccine?

a. 11 year old male who already received the first dose

b. 16 year old female who has not received any doses

c. 20 year old male receiving chemotherapy/radiation

d. 28 year old female who is not sexually active

Pre-Test Question #2

• Which of the following vaccines is currently available?

a. Cervarix

b. Gardasil 9

c. Menhibrix

d. Menomune

Pre-Test Question #3

• Which of the following patients is considered

immunocompromised and is contraindicated to

receive live vaccines?

a. 5 year old female with otitis media taking amoxicillin BID x

10 days

b. 19 year old male with cochlear implants attending college

for the first time this fall

c. 30 year old male taking prednisone 10 mg PO daily x 10

days

d. 45 year old female with psoriasis using Enbrel® 50 mg SQ

weekly

Pre-Test Question #4

• Which influenza vaccine contains an adjuvant and is

indicated for patients ≥ 65 years of age?

a. Fluzone Intradermal

b. Fluad

c. Flucelvax

d. Flublok

Summary ACIP Recommendations2016

• Recommendations for Use of Meningococcal

Conjugate Vaccines in HIV-Infected Persons –

Advisory Committee on Immunization

Practices (ACIP), 2016

• Use of a 2-Dose Schedule for Human

Papillomavirus Vaccination – Updated

Recommendations of the Advisory Committee

on Immunization Practices

Summary ACIP Recommendations2017

• General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices

• Recommendations of the Advisory Committee on Immunization Practices for Use of Cholera Vaccine

• Updated Recommendations for Use of MenB-FHbp Serogroup B (Trumenba) Meningococcal Vaccine

Meningococcal Conjugate in HIV-Infected Persons

• MMWR, November 4, 2016;65(43);1189-1194

• What is currently recommended?

• Why are the recommendations being modified now?

• What are the new recommendations?

Recommendation

• All HIV-infected persons aged ≥ 2 months should routinely receive age appropriate meningococcal conjugate vaccine

• Age appropriate booster doses should also be administered

Recommended Schedule and

Interval

MMWR, November 4, 2016, 65(43); 1189-1194.

Update on Vaccine Availability

• MenHibrix (Hib-MenCY)

– October 2016, GSK announced discontinuation

• Menomune (MPSV4)

– February 2017, Sanofi Pasteur announced

discontinuation

– Current lots will expire in June or September 2017

– No meningococcal polysaccharide vaccines will be

licensed for patients 56 years of age or older

– Travelers will need to use Menactra or Menveo

insteadHPV Vaccine Availability, United States. CDC Website. Available at: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2016-06/hpv-vaccine-availability-

united-states.pdf. Accessed 6/28/17.

Sanofi Pasteur Statement on the Discontinuation of Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined. Sanofi Pasteur Website. Available at:

http://sanofipasteurus.mediaroom.com/press-statements?item=34577. Accessed 6/28/17.

Clinical Update Menomune discontinuation. CDC Website. Available at: https://wwwnc.cdc.gov/travel/news-announcements/menomune-discontinuation. Accessed

6/28/17.

2-Dose HPV vaccine

• MMWR, December 16, 2016;65(49);1405-1408

• What is currently recommended?

• Why are the recommendations being modified now?

• What are the new recommendations?

Recommendation

• Persons initiating HPV vaccination at ages 9 through 14 years, except immunocompromised persons, receive 2 doses

• Persons initiating HPV vaccination at ages 15 through 26 years, and immunocompromised persons ages 9 to 26 years receive 3 doses

Recommended Schedule and Doses

MMWR, December 16, 2016, 65(49); 1405-1408.

GRADE Evidence for 2-Dose HPV

Outcome Number of

Subjects

(number of

studies)

Comparison groups Results

Immunogenicity

(seroconversions

to 9vHPV types)

1102 (1) Girls and boys 2 doses

and Girls and boys 3

doses and Women 3

doses

≥ 97.9% seropositive at 1

month post last dose in all

groups in the per-protocol

population

Immunogenicity

(GMTs for 9vHPV

types)

560 (1) Girls 2 doses versus

Women 3 doses

Non-inferiority criteria met for

all 9vHPV types at 1 month

post last dose

559 (1) Boys 2 doses versus

Women 3 doses

Non-inferiority criteria for all

9vHPV types at 1 month post

last dose

555 (1) Girls and boys 2 doses

versus Women 3 doses

Non-inferiority criteria met for

all 9vHPV types at 1 month

post last dose

Grading of Recommendations Assessment, Development and Evaluation (GRADE) of a 2-dose schedule for human papillomavirus (HPV) vaccination. CDC website.

Available at: https://www.cdc.gov/vaccines/acip/recs/grade/hpv-2-dose.html#modalIdString_CDCTable_2. Last updated December 15, 2016. Accessed April 24, 2017.

Best Practice Guidance

• CDC Website 4/20/17

• What is currently recommended?

• Why are the recommendations being modified now?

• What are the new recommendations?

Recommendation

• 13 updates are included in this document

Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices.

CDC website. Available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed June 1, 2017.

Best Practice Guidance

• New information on simultaneous vaccination and febrile seizures

• Enhancement of definition of a “precaution” to include any condition that might confuse diagnostic accuracy

• Confirmation that if a patient is not acutely moderately or severely ill, vaccination during hospitalization is best practice

• More descriptive characterization of anaphylactic allergy

• Incorporation of protocols for management of anaphylactic allergy

• Allowances for alternate route (SQ) for hepatitis A vaccination

Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization

Practices. CDC website. Available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed June 1, 2017.

Best Practice Guidance

• An age cutoff of 12 years through 17 years of age for validating a dose of intradermal influenza vaccine

• Deletion of much of the content from storage and handling

• Incorporation of Infectious Diseases Society of America guidance on vaccination of persons with altered immunocompetence

• Timing of intramuscular administration in patients with bleeding disorders

• Updated data on vaccination record policy

• Additional impacts of the Affordable Care Act on adult vaccination

• Updated programmatic contact information on source material for vaccine information

Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization

Practices. CDC website. Available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed June 1, 2017.

Definition of High- and Low-Level

Immunosuppression

• High-Level– Receiving cancer

chemotherapy

– Within 2 months after solid organ transplantation

– HIV infection with CD4 count < 200 cells/mm3 for adults

– Receiving daily corticosteroid therapy with a dose of ≥ 20 mg of prednisone for ≥ 14 days

– Receiving certain biologic immune modulators (TNF-α tumor necrosis factor-alpha blocker)

• Low-Level– Asymptomatic HIV-

infected patients with a CD4 count 200-499 cells/mm3 for adults

– Receiving a lower daily dose of corticosteroid therapy for ≥ 14 days or alternate-day therapy

– Receiving methotrexate (MTX) ≤ 0.4 mg/kg/week, azathioprine ≤ 3 mg/kg/day or 6-mercaptopurine ≤ 1.5 mg/kg/day

Clin Infect Dis 2014 Feb; 58(3):e44-100.

Recommendations for Timing of

Vaccination

• Before Immunosuppression– Vaccines should be

administered prior to planned immunosuppression if feasible

– Live vaccines should be administered ≥ 4 weeks prior to immunosuppression and should be avoided within 2 weeks of initiation of immunosuppression

– Inactivated vaccines should be administered ≥ 2 weeks prior to immunosuppression

Clin Infect Dis 2014 Feb; 58(3):e44-100.

• After Immunosuppression– Low-Level – 1 month

– High-Level – 3 months unless otherwise stated

– Live vaccines – follow before immunosuppression recommendations

– Inactivated vaccines –may consider administration as recommended by CDC depending on type of immunosuppression

Cholera Vaccine

• MMWR, May 12, 2017;66(18);482-485

• What is currently recommended?

• Why are the recommendations being modified now?

• What are the new recommendations?

Recommendation

• Safe food and water precautions, proper sanitation and personal hygiene measures should be followed

• Vaxchora (Cholera, Vaccine, Live, Oral) is recommended for adult travelers (18-64 years) from the US to an area with endemic or epidemic cholera

• Booster doses are not recommended at this time

Meningococcal Vaccine (Trumenba)

• MMWR, May 19, 2017;66(19);509-513

• What is currently recommended?

• Why are the recommendations being modified now?

• What are the new recommendations?

Recommendation

• Persons at increased risk for meningococcal disease or during a serogroup B outbreak, should receive 3 doses of Trumenba(MenB-FHbp)

• Healthy adolescents, should receive 2 doses of Trumenba (MenB-FHbp)

• Recommendations regarding Bexsero (MenB-4C) are unchanged

MenB Antibody Titers

MMWR, May 19, 2017, 66(19); 509-513.

Persistence of Antibody Response

MMWR, May 19, 2017, 66(19); 509-513.

Schedule for Birth to 18 Yearsby Age

Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. CDC website. Available at

https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed June 1, 2017.

Schedule for Birth to 18 Yearsby Medical or Other Indication

Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. CDC website. Available at

https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed June 1, 2017.

Schedule for Adults (19 Years +)by Age

Recommended Immunization Schedule for Adults Aged 19 Years or Older. CDC website. Available at https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-

combined-schedule.pdf. Accessed June 1, 2017.

Schedule for Adults (19 Years +)by Medical or Other Indication

Recommended Immunization Schedule for Adults Aged 19 Years or Older. CDC website. Available at https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-

combined-schedule.pdf. Accessed June 1, 2017.

Vaccine News

New Zoster Vaccine

New Bandage

Old vs New (Phase 3) Herpes

Zoster Vaccine

• Zostavax• 51% effective against

herpes zoster disease

• 67% effective against postherpetic neuralgia

• Shingrix• 97.2% effective against

herpes zoster disease in patients 50 years and older

• 89.9% effective against herpes zoster disease in patients 70 years and older

• 88.8% effective against postherpetic neuralgia

• Adjuvanted, inactivated two-dose series vaccine

Inject-SafeTM Barrier Bandage

Inject-SafeTM barrier Bandage Web site. Available at: http://injectsafebandages.com/. Accessed 8/10/17.

Influenza

• Influenza season is October to May and

commonly peaks in January to February

• Annual influenza vaccination is recommended

for all persons 6 months of age and older

Influenza Algorithm for Children6 months through 8 years

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

Inactivated Influenza Vaccine (IIV)

• Quadrivalent inactivated influenza vaccine (IIV4)

• Trivalent inactivated influenza vaccine (IIV3)

• Cell cultured inactivated influenza vaccine (ccIIV4)

• Adjuvanted inactivated influenza vaccine (aIIV3)

Recombinant hemagglutinin Influenza Vaccine (RIV)

Live-attenuated Influenza Vaccine (LAIV)

• Quadrivalent live-attenuated influenza vaccine (LAIV4)

ACIP Votes Down Use of LAIV

• June 21, 2017 ACIP Meeting

• Awaiting further data (anticipated October 2017)

• Poor or lower efficacy of LAIV4 for children 2 to 17 years from 2013-2016– 2015-2016 – vaccine effectiveness (VE) for LAIV4

was 3%• For H1N1 vaccine effectiveness (VE) for LAIV was -21%

– 2015-2016 – vaccine effectiveness (VE) for IIV was 63%

ACIP Says No to LAIV for 2017-2018 Flu Season. AAFP Web site. Available at: http://www.aafp.org/news/health-of-the-public/20170630acipjunemtg.html. Accessed

7/26/17. . ACIP votes down use of LAIV for 2016-2017 flu season. CDC Website. Available at: http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html. Accessed

June 1, 2017

Recommended Influenza Vaccine

Composition 2017-2018

• A/Michigan/45/2015 (H1N1)pdm09-like virus

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

• B/Brisbane/60/2008-like virus

• Additional strain for quadrivalent vaccines

– B/Phuket/3073/2013-like virus

Recommended composition of influenza virus vaccines for use in the 2017-2018 northern hemisphere influenza season. World Health Organization Website. Available at:.

http://www.who.int/influenza/vaccines/virus/recommendations/2017_18_north/en/. Accessed 4/19/17.

Seasonal Influenza Vaccines

Vaccine Approved Age Indication

Inactivated Influenza Vaccine (IIV3)

Afluria ≥ 9 years needle/syringe

18-64 years jet injector

Fluvirin ≥ 4 years

Fluzone High-Dose ≥ 65 years

Inactivated Influenza Vaccine IIV4)

Fluarix Quadrivalent ≥ 3 years

Flulaval Quadrivalent ≥ 3 years

Fluzone Quadrivalent ≥ 6 months

Fluzone Intradermal Quadrivalent 18 to 64 years

Inactivated Influenza Vaccine Cell-Cultured (ccIIV4)

Flucelvax Quadrivalent ≥ 4 years

Adjuvanted Inactivated Influenza Vaccine (aIIV3)

Fluad ≥ 65 years

Recombinant Influenza Vaccine (RIV3)

Flublok ≥ 18 years

Live Attenuated Influenza Vaccine (LAIV4)

FluMist Quadrivalent 2 to 49 years (healthy, not pregnant)

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

https://www.cdc.gov/flu/weekly/fluviewinteractive.htm

http://www.cdc.gov/flu/weekly/#S1

http://www.cdc.gov/flu/weekly/#S1

http://www.cdc.gov/flu/weekly/#S1

http://www.cdc.gov/flu/weekly/#S1

Case 1

• NS is a 15 year old male presenting to the community pharmacy. His mom recently saw something on the HPV vaccine on a morning talk show and realized they missed his appointment.

• What is the first question that you should ask NS about immunizations?

NS’s Profile and Immunization Record

• Immunization Record

– Up-to-date at 5 year

old well child visit

• Profile

– Multiple vitamin 1 PO

daily

– Amoxicillin 500 mg 1

PO BID x 10 days

(August 2017)

• What vaccinations are recommended for NS?

Screening Question Response

1. Is the child sick today? No

2. Does the child have allergies to medications, foods, a vaccine component, or latex? No

3. Has the child had a serious reaction to a vaccine in the past? No

4. Has the child had a health problem with lung, heart, kidney or metabolic disease (e.g.,

diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy?

No

5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told

you that the child had wheezing or asthma in the past 12 months?

N/A

6. If your child is a baby, have you ever been told he or she has had intussusception? N/A

7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other

nervous system problems?

No

8. Does the child or family member have cancer, leukemia, HIV/AIDS, or any other

immune system problems?

No

9. In the past 3 months, has the child taken medications that affect the immune system

such as prednisone, other steroids, or anticancer drugs; drugs for the treatment or

rheumatoid arthritis, Crohn’s disease, or psoriasis; or had radiation treatments?

No

10. In the past year, has the child received a transfusion of blood or blood products, or

been given immune (gamma) globulin or a antiviral drug?

No

11. Is the child/teen pregnant or is there a chance she could become pregnant during the

next month?

N/A

12. Has the child received vaccinations in the past 4 weeks? No

Schedule for Persons Aged 0

Through 18 Years

How Many Doses of HPV?

• Administer a 3-dose series of HPV vaccine on a schedule of 0, 6-12 months to all adolescents aged 11 or 12 years. The vaccination series can start at age 9 years.

• Administer HPV vaccine to all adolescents through age 18 years who were not previously adequately vaccinated. The number of recommended doses is based on age at administration of the first dose.

• For persons initiating vaccination before age 15, the recommended immunization schedule is 2 doses of HPV vaccine at 0, 6-12 months.

• For persons initiating vaccination at age 15 years or older, the recommended immunization schedule is 3 doses of HPV vaccine at 0, 1-2, 6 months.

• A vaccine dose administered at a shorter interval should be readministered at the recommended interval.

Case 1 Summary

• Inactivated influenza vaccine (IIV3/IIV4)

• Meningococcal conjugate vaccine (MCV4)

• Tetanus-diphtheria-acellular pertussis vaccine

(Tdap)

• Human papillomavirus vaccine (9vHPV)

Case 2

• AW, a 65 year old female, presents to the community pharmacy for an annual influenza vaccine.

• What is the first question that you should ask AW about immunizations?

AW’s Profile and Immunization Record

• Profile

– Humira (adalimumab)

40 mg SQ QOW

– Alendronate 70 mg 1

PO weekly

– Levothyroxine 100 mcg

1 PO daily

– Multiple vitamin 1 PO

daily

• Immunization Record

– Influenza – yearly x 20

years

– Unsure of childhood

immunizations

• What vaccinations are recommended for AW?

Screening Question Response

1. Are you sick today? No

2. Do you have allergies to medications, foods, a vaccine component, or latex? No

3. Have you ever had a serious reaction after receiving a vaccination? No

4. Do you have a long-term health problem with heart disease, lung disease,

asthma, kidney disease, metabolic disease (e.g., diabetes), anemia or other

blood disorder?

No

5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? No

6. In the past 3 months, have you taken medications that affect the immune system

such as prednisone, other steroids, or anticancer drugs; drugs for the treatment

or rheumatoid arthritis, Crohn’s disease, or psoriasis; or have you had radiation

treatments?

Yes

7. Have you had a seizure or a brain or other nervous system problem? No

8. In the past year, have you received a transfusion of blood or blood products, or

been given immune (gamma) globulin or a antiviral drug?

No

9. For women: Are you pregnant or is there a chance she could become pregnant

during the next month?

No

10. Have you received any vaccinations in the past 4 weeks? No

Schedule for Adultsby Age and Medical / Other Indications

Case 2 Summary

• Inactivated influenza vaccine (IIV3/IIV4)

• Tetanus-diphtheria-acellular pertussis vaccine

(Tdap)

• Pneumococcal 13-valent conjugate vaccine

(PCV13)

• 8 weeks later

– Pneumococcal 23-valent polysaccharide vaccine

(PPSV23)

Post Test Question #1

• Which of the following patients is a candidate for a 2-

dose series of HPV?

a. 11 year old male who already received the first dose

b. 16 year old female who has not received any doses

c. 20 year old male receiving chemotherapy/radiation

d. 28 year old female who is not sexually active

Post Test Question #2

• Which of the following vaccines is currently available?

a. Cervarix

b. Gardasil 9

c. Menhibrix

d. Menomune

Post Test Question #3

• Which of the following patients is considered

immunocompromised and is contraindicated to

receive live vaccines?

a. 5 year old female with otitis media taking Amoxicillin BID x

10 days

b. 19 year old male with cochlear implants attending college

for the first time this fall

c. 30 year old male taking Prednisone 10 mg PO daily x 10

days

d. 45 year old female with psoriasis using Enbrel® 50 mg SQ

weekly

Post Test Question #4

• Which influenza vaccine contains an adjuvant and is

indicated for patients ≥ 65 years of age?

a. Fluzone Intradermal

b. Fluad

c. Flucelvax

d. Flublok

Summary

• All HIV-infected persons aged ≥ 2 months should routinely receive age appropriate meningococcal conjugate vaccine and booster doses

• Persons initiating HPV vaccination at ages 9 through 14 years, except immunocompromised persons, should receive 2 doses at 0 and 6-12 months

• The CDC recently updated and published the “General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices.”

• Influenza vaccine should be administered before the onset of influenza activity in the community and by October, if possible. Balance vaccine protection with avoiding missed opportunities

• Fluad is a new adjuvanted influenza vaccine

Resources & References

• Immunization Action Coalition

– www.immunize.org

• Advisory Committee on Immunization Practices

– www.cdc.gov/vaccines/acip/index.html

• Centers for Disease Control and Prevention Vaccines and Immunizations

– https://www.cdc.gov/vaccines/index.html

• General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices

– https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf

Needle Facts: Immunization

Update 2017

Miranda Wilhelm, Pharm.D.

Clinical Associate Professor

Southern Illinois University Edwardsville (SIUE)

School of Pharmacy