An Integrated Approach to Vaccine Education for the College Campus

Stephanie James, PhD; Christine Feltman, PharmD; Robert C. Haight, PhD; LaToya Jones Braun, PhD Conflict of Interest Statements

▸ Dr. Stephanie James is a paid speaker for Merck Pharmaceuticals. ▸ Dr. Christine Feltman has no conflicts of interest to disclose. ▸ Dr. Robert Haight has no conflicts of interest to disclose. ▸ Dr. LaToya Jones Braun’s spouse owns shares (<1%) in Array BioPharma. Array Biopharma is pharmaceutical company that does not produce vaccines and has never funded Dr. L. Braun’s research. VACCINE IMMUNOLOGY

Stephanie James, PhD Learning Objective

▸ Describe how altering the immunization schedule may adversely affect a vaccine’s efficacy in a population ▸ Immune response to vaccination ▸ Development of immunological memory after vaccination ▸ Herd Immunity ▸ Disease transmission ▸ Vaccine preventable diseases on college campuses ▸ Immunization schedules Immune response to vaccination

Antigenic epitopes Attenuated pathogen Development of immunological memory after vaccination

Abbas et. al: Cellular and Molecular Immunology Herd Immunity

https://medium.com/@gidmk/herd-immunity-is-pretty-cool-adbc52630f9f Herd Immunity Disease transmission

https://www.webmd.com/children/vaccines/news/20190207/we-are-going-to-have-more-measles-threat-grows Disease transmission

https://www.webmd.com/children/vaccines/news/20190207/we-are-going-to-have-more-measles-threat-grows Vaccine preventable diseases on college campuses ▸ Measles ▸ Mumps ▸ Meningitis ▸ Influenza ▸ HPV ▸ Chickenpox Immunization schedules Immunization schedules VACCINE HESITANCY

Christine Feltman, PharmD You are now ready to vaccinate everyone! But…

Picture accessed at https://everydayfeminism.com/2014/02/5-reasons-no-children/ November 2017 Learning Objective

▸ Identify strategies to improve immunization rates of the vaccine hesitant student(s). Vaccine Hesitancy

▸ Refers to delay in acceptance or refusal of vaccines despite availability of vaccine services ▸ Vaccine “hesitancy” is an emerging term in the literature on vaccine decision-making and determinants of vaccine acceptance

1. MacDonald NE and SAGE Working Group on Vaccine Safety. Vaccine 2015; 33(34):4161-4 2. Larson, HJ Understanding vaccine hesitancy around vaccines and vaccination from a global perspective: a systematic review of published literature, 2007-2012. 2014 Apr 17;32(19):2150-9. doi: 10.1016/j.vaccine.2014.01.081. Epub 2014 Mar 2. The Social Media Influence

The List of No’s Include:

▸ Vaccines cause autism (even though this has been disproven) ▸ Vaccines are a product of “evil” pharma companies ▸ There are too many vaccines, given too soon ▸ Vaccines are full of toxins ▸ Causing individuals to have seizures, ADHD, allergies and asthma, etc. ▸ There is no need to vaccinate because infection rates are already so low in the United States ▸ I, or a friend got sick... HIGHLIGHTS -- Vaccination Perceptions of College Students: With and without vaccination waiver. (Jadhav, E.D., et al.)

Who: 964 students (waivers: yes = 79) from a student population of 14900 rural, university in the Midwest ▸ ~ ⅓ w/ waivers were not up to date and did not plan to catch up (~ 65% w/ waivers up to date!) ▸ Primary barrier: Fears of adverse events ▸ Vaccine cost is an influencer. Jadhav ED, Winkler DL, and Anderson BS (2018) Vaccination Perceptions of College Students: With and Without Vaccination Waiver. Front. Public HEalth 6:36 doi: 10.3389/fpubh.2018.00036 Thinks vaccines can cause autism

Waiver = yes Waiver = no/unsure

Created from data from: Jadhav ED, Winkler DL, and Anderson BS (2018) Vaccination Perceptions of College Students: With and Without Vaccination Waive Front. Public Health 6:36 doi: 10.3389/fpubh.2018.00036 Thinks resurgence in VPD related to declining vaccination rates Waiver = yes Waiver = no/unsure

Created from data from: Jadhav ED, Winkler DL, and Anderson BS (2018) Vaccination Perceptions of College Students: With and Without Vaccination Waiver. Front. Public HEalth 6:36 doi: 10.3389/fpubh.2018.00036 Snapshot of HPV vaccination and attitudes of college students

▸ Who: 383 undergraduates (mean age 21.01 yrs. ) ▸ Female: 70.2% ▸ White: 76.8%; Black: 13.1%; Asian: 8.9%; Other: 2.2%

▸ Vaccinated? ▸ Females:47.3% ▸ Males: 15.8%

Barnard M, George P, Perryman ML, Wolff LA (2017) Human papillomavirus (HPV) vaccine knowledge, attitudes, and uptake in college students: Implications from the Precaution Adoption Process Model. PLoS ONE 12(8):e0182266. https://doi.org/10.1371/journal.pone.0182266 Snapshot of HPV vaccination and attitudes of unvaccinated college students Our students are …

▸ from households that do (not) vaccinate ▸ are parents themselves ▸ homeless/hungry (36% housing/food insecure*) ▸ LGBTQAI ▸ of varying religious traditions/beliefs ▸ of different races/traditions ▸ have a variety of health concerns DIVERSE *https://hope4college.com/wp-content/uploads/2018/09/Wisconsin-HOPE-Lab-Still-Hungry-and-Homeless.pdf Approach ≠ One- size-fits-all The Approach

▸ Listen to concerns and acknowledge them in a non- confrontational manner ▸ Clarify and reaffirm correct beliefs about immunization, and modify misconceptions ▸ Discuss the benefits of vaccines, and provide valid educational resources and reliable websites ▸ Recognize that the majority of people believe that immunizations are important, but are unsure how to assess available information for accuracy Utilizing Motivational Interviewing

▸ Motivational interviewing is what a clinician uses to help understand the concerns and empower personal change ▸ The idea is to empower students to engage in behaviors that are good for them (e.g., immunizations) and help prevent engaging in behaviors that are harmful (e.g., smoking, marijuana, etc.) ▸ Spend the time to ask open-ended questions and understand where the concerns stem from. https://www.accp.com/docs/bookstore/psapwhe/p7b08.sample01.pdf How to Provide Resources

▸Tailor and provide proper resources that unique to the individual ▸Educate them about how to properly research what is available ▸Offer insight for proper social media resources and options Easy Resources to Share

▸ The CDC Website: https://www.cdc.gov/vaccines/index.html ▸ National Vaccine Information Center- Your Health. Your Family. Your Choice. http://www.nvic.org/resource-center.aspx ▸ Vaccines: Your best shot at good health. https://www.vaccines.gov/ ▸ We can review these resources ourselves, and provide handouts: ▸ Vaccine Information Statements (VIS) ▸ Resource available for teens: http://www.vaccineinformation.org/teens/ ▸ Check out this YouTube Video: https://www.youtube.com/watch?v=b03U6BYF9L0 REGIONAL AND LOCAL HESITANCY & POLICIES TO IMPROVE PUBLIC HEALTH ON COLLEGE CAMPUSES

Robert C. Haight, PhD Objectives

▸ Be able to describe how regional and local vaccine hesitancy might inform policies for improving the public health of a college campus. The state of Measles in 2019

▸ From January 1 to May 24, 2019, 940 individual cases of measles have been confirmed in 26 states. ▸ This is the greatest number of cases reported in the U.S. since 1994.

https://www.cdc.gov/measles/cases-outbreaks.html States reporting measles to CDC

https://www.cdc.gov/measles/cases-outbreaks.html Increasing cases of Measles

https://www.cdc.gov/measles/cases-outbreaks.html Recent Outbreaks at Universities

▸ Indiana University – Bloomington ▸ Measles - 20 confirmed cases (as of April 22, 2019) ▸ California Universities ▸ UCLA - Potential exposure of over 500 students and staff

▸ Cal State - Los Angeles - Potential exposure of over 500 students and staff ▸ Temple University ▸ Mumps – 116 reported cases (as of April 1, 2019)

https://www.cnn.com/2019/04/18/health/indiana-university-mumps-outbreak-fraternity-trnd/index.html https://www.insidehighered.com/news/2019/04/02/temple-sees-mumps-outbreak-more-100-cases https://6abc.com/health/116-cases-now-reported-in-mumps-outbreak-at-temple-university/5229206/ https://www.washingtonpost.com/health/2019/04/26/two-la-universities-quarantine-more-than-students-staff-measles-outbreak/?utm_term=.1a5b183204a0 https://www.washingtonpost.com/health/2019/04/26/two-la-universities-quarantine-more-than-students-staff-measles-outbreak/?utm_term=.dd355f9f5fac Identification of Risk

▸ What can we do about vaccine-preventable diseases at out universities and colleges? Colorado’s Immunization Data

▸ School and Child Care Immunization Data 2017-2018 Information for Partners ▸ https://www.cohealthdata.dphe.state.co.us/Data/Details/22 Total MMR Immunization Rate School MMR Total Exemptions County Map

https://www.cohealthdata.dphe.state.co.us/Data/Details/22 School MMR Total Exemptions County Map - Denver

https://www.cohealthdata.dphe.state.co.us/Data/Details/22 School MMR Total Exemptions County Map – La Plata

Taking Fort Lewis College in Durango, CO

https://www.cohealthdata.dphe.state.co.us/Data/Details/2 Considerations

▸ Universities do not receive all of our students from immediately around them. ▸ Important to identify areas where majority of your students come from. Across the United States. Across the World. Potential Policies and Procedures

▸ Does your health professionals work with your admissions professionals? ▸ Are students required to be vaccinated? Do you check records? ▸ What if there is an outbreak on campus? Do you have a plan? ▸ On -campus students ▸ Commuter students ▸ Faculty/Staff ▸ Do you provide education on vaccinations? Childhood? Adolescent? Adult? ▸ Do you provide vaccine clinics? During orientation? Strategies

▸ Work with your local health departments to understand if outbreaks are occurring. ▸ Utilize data from your State’s Health Department ▸ Utilize data from Health Departments in States that your institution heavily recruits from ▸ Discuss current health related issues with other institutions in your region. VACCINE STABILITY

LaToya Jones Braun, PhD Learning Objective

▸ Discuss the importance of handling vaccines properly WHO: Stability of a vaccine

“The ability of a vaccine to retain its chemical, physical, microbiological and biological properties within specified limits throughout its shelf-life.” Direct quote from: Knezevic I. Biologicals (2009) 37: 357-359. What could go wrong? ▸ Chemical: hydrolysis, oxidation, etc. ▸ Physical: aggregation, crystallization, etc. ▸ Microbiological: contamination ▸ Biological: loses effectiveness According to WHO …

The ONLY environmental factor that affects the stability of ALL vaccines is ______.

From: WHO. Biologicals (2009) Guidelines on stability evaluation of vaccines37: 424-434. According to WHO …

The ONLY environmental factor that affects the stability of ALL vaccines is temperature.

From: WHO. Biologicals (2009) Guidelines on stability evaluation of vaccines37: 424-434. Cold chain

A system of storing and transporting vaccines at recommended temperatures from the point of manufacture to the point of use. Direct quote from: https://www.who.int/countries/eth/areas/immunization/epi_logistics/en/index1.html

https://www.sanofipasteur.com/en/production/vaccine-manufacturing-process (images 1 & 3) http://www.usamma.army.mil/PublishingImages/Pages/Forms/AllItems/DHA%20Vaccine%20Storage%20and%20Handling%20Guidelines.pdf (Image 2) https://www.aafp.org/news/practice-professional-issues/20121105refrig-guidance.html (image 4) https://www.washingtonpost.com/outlook/2018/11/29/why-small-groups-vaccine-refusers-can-make-large-groups-people-sick/?noredirect=on&utm_term=.0829e80ed5f8 (image 5) Temp. sensitivity of marketed vaccines: 2013

https://www.technet-21.org/en/topics/temperature-monitoring/training/refresher-training Vaccines possessed by many of the 45 providers audited by DHHS for vaccine management practices were at risk

A. Adherence to the CDC’s Temperature B. Extent of vaccine freezing danger Monitoring Requirement Providers who had refrigerators with Providers who did temperatures < 2°C for NOT meet the 5+ cumulative hours over requirement = 40 a 2-week period = 19 (89%) (42%)

Figure prepared using data from a report published by DHHS in June 2012 http://oig.hhs.gov/oei/reports/oei-04-10-00430.asp (last accessed 9/16/12) Frozen vaccines linked to public health concerns Improper storage puts babies at risk

▸ Santa Ana Medical Center – 2009 ▸ Freeze-sensitive vaccines at freezing temps. 7 months!

1641 hepatitis B vaccines! 5 moms w/ hep B

Tetanus re-vaccination clinic set up in ER.

Info: https://www.ocregister.com/2010/11/12/3-oc-hospitals-fined-for-patient-errors/ Image: https://parenting.firstcry.com/articles/immunizing-your-newborn-vaccination-in-first-24-hours/ Faulty refrigerator and lack of monitoring puts kids at risk

Timeline • Jan. 14, 2015 – 2 refrigerators installed. • Sept. 21, 2015 –freezing temperatures noted. • Refrigerator temperatures not monitored consistently since installation!

https://www.mercurynews.com/2015/10/02/bad-refrigerator-at-stanford-childrens-health-medical-office-means-1551- kids-need-re-vaccination/ accessed 2/15/19 Vaccines possibly affected

1. Dtap 2. Tdap 3. IPV (Polio) 4. Pentacel (Diphtheria,Tetanus, Pertussis, Haemophilus influenzae type b, and Polio) 5. Menactra (meningococcus (meningitis)) 6. Hepatitis A 7. Hepatitis B 8. HPV – except doses given 9/10/15 – 9/21/15 9. PCV (pneumococcal) 10. Influenza https://www.stanfordchildrens.org/en/about/news/releases/2015/information-and-frequently-asked-questions-about- a-recent-vaccine-refrigeration-issue accessed 2/15/19 Tools for monitoring: Freezing indicators

https://lgpharma.com/cold-indicators/freezewatch/ Tools for monitoring: Thermal indicators on vials

1 2

https://www.dcvmn.org/IMG/pdf/vvm3 -en-2017_0305taipei.pdf4 Formulating to enhance vaccine stability: PG preserved in vitro potency & in vivo anti-HBsAg titers

Adapted from Braun LJ, et al., Vaccine. 2009 Jan 1;27(1):72-9. Epub 2008 Oct 28. Formulations improve stability?: Microneedle devices of the future

Metal Dissolvable

(Credit: Jeong-Woo Lee, Georgia Tech)

(Credit: Georgia Tech) T = 0 1 min 5 min All images from: http://drugdelivery.chbe.gatech.edu/gallery_microneedles.html (Credit: Sean Sullivan, Georgia Tech) Handling – Best Practices

▸ Unpack vaccines immediately ▸ Store vaccines at proper temperatures ▸ All components not necessarily at same temp. ▸ Use proper storage equipment ▸ Monitor temperatures daily ▸ Take action if necessary ▸ Follow instructions for handling ▸ e.g., how long can it be stored under present conditions, when to discard, etc. https://www.cdc.gov/vaccines/hcp/admin/storage/ downloads/A-vax-temp-best-practices-fridge-C.pdf https://www.cdc.gov/vaccines/hcp/admin/stora ge/downloads/C-vax-temp-best-practices- fridge-C.pdf Role of the Pharmacist References

Daniel R. Levinson, Inspector General Vaccines for children program: vulnerabilities in vaccine management. Department of Health and Human Services: Office of Inspector General (2012) https://oig.hhs.gov/oei/reports/oei-04-10- 00430.pdf

Hanson CM, George AM, Sawadogo A, Schreiber B. Is freezing in the vaccine cold chain an ongoing issue? A literature review. Vaccine (2017) 35(17): 2127-2133. https://doi.org/10.1016/j.vaccine.2016.09.070

Jadhav ED, Winkler DL, Anderson BS. Vaccination Perceptions of College Students: With and without Vaccination Waiver. Frontiers in Public Health 2018; 6: Article 36. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5826364/

Braun LJ, Jezek J, Peterson S, Tyagi A, Perkins S, Sylvester D, Guy M, Lal M, Priddy S, Plzak H, Kristensen D, and Chen D. Characterization of a thermostable hepatitis B vaccine formulation. Vaccine (2009) 27: 4609- 4614. https://doi.org/10.1016/j.vaccine.2009.05.069

Centers for Disease Control and Prevention https://www.cdc.gov/vaccines/hcp/admin/storage/