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IMMUNIZATIONS: AN OVERVIEW OF SELECT VACCINES Jacqueise Unonu, PharmD, AAHIVP Clinical Assistant Professor Integrated Therapeutics Lab 2 March 2023 Learning Objectives 1...

IMMUNIZATIONS: AN OVERVIEW OF SELECT VACCINES Jacqueise Unonu, PharmD, AAHIVP Clinical Assistant Professor Integrated Therapeutics Lab 2 March 2023 Learning Objectives 1 2 3 4 Understand the Discuss important Understand how to Discuss proper relationship between implications for apply vaccination injections the human immune special populations schedules to patient administration response and cases technique vaccinations 2 Background Every year in the United States, many people get diseases that vaccines can prevent. Healthy People 2030 focuses on preventing infectious diseases by increasing vaccination rates. 3 Pharmacy-Based Immunization Delivery Background: Common Reasons for Low Vaccination Rates Patient factors No regular health care provider Inconvenient access Many underinsured Distrust of the healthcare system and/or government Misinformation spread via social and traditional media Provider factors Poor preventive services Lack of provider recommendation Lack of effective reminders System factors Fewer requirements for vaccination (e.g., by employers) State regulations vary Complex adult vaccine schedule 3 How Can It Be Addressed? Opportunities for Collaboration Collaborate with state and local efforts State and local health departments organize, administer, and maintain vaccine campaigns and registries and educational activities Emergency Preparedness Natural disasters, pandemics, bioterrorism Join immunization coalitions Organizations that foster collaboration among stakeholders to increase immunization rates Directory of immunization coalitions at www.izcoalitions.org Refer pediatric patients for well–child visits COVID PREP Act authorities and some state laws mandate this for pharmacists administering vaccines to children. It’s good practice to collaborate with pediatricians 5 Pharmacy-Based Immunization Delivery What About US Healthcare Professionals? % Vaccinated 100 91.3 88.9 90.3 90.3 83.0 80 75.9 60 40 20 0 Overall HCP Physicians NPs/PAs Nurses Pharmacists Other clinical personnel Percentage of U.S. Health Care Personnel Who Received Influenza Vaccination 2020-2021 6 https://www.cdc.gov/flu/fluvaxview/hcp-coverage_1920-21-estimates.htm 6 Pharmacy-Based Immunization Delivery The Immune Response: An Overview Immune Response Acquired (Adaptive) Innate Immunity Immunity—Active or Passive Cell-Mediated Physiologic Cells of the Humoral Immune Physical Barriers Processes Immune Features Immune System Response Response T-Cell T-Cell Dependent Independent Immune Immune Response Response 7 Pharmacy-Based Immunization Delivery Acquired (Adaptive Immunity) 8 Pharmacy-Based Immunization Delivery Vaccines and the Immune Response Overview Vaccines (contain antigens) Antigens are recognized by immune system and evoke an immune response B cells activated T cells activated Results in production of antibodies Antibodies attack and destroy the antigen Antigen is eliminated Memory B cells and T cells are formed 9 9 Pharmacy-Based Immunization Delivery Vaccine Types Made from viruses or bacteria Must replicate to work Live Attenuated Replication mimics natural infection to stimulate immune Vaccines response Made from viruses or bacteria, or virus-like particles Do not replicate because they are not live Inactivated May contain adjuvants to enhance immune response Vaccines 10 Pharmacy-Based Immunization Delivery Differences to Consider for Live and Inactivated Vaccines Storage Timing of doses Duration of protection Adverse effects Contraindications and precautions Route of administration 11 Pharmacy-Based Immunization Delivery Polysaccharide vs. Conjugate Polysaccharide Vaccines (Inactivated) Polysaccharide Conjugate Polysaccharide Stimulate T-cell independent Protein carrier immunity Stimulate T-cell dependent Stimulate B cells without immunity assistance of helper T Helper T cells involved cells Produce immunologic Short-lived immunity memory No booster effect Result in booster effect Not consistently upon subsequent exposure immunogenic in children Increased immunogenicity younger than 2 years in children younger than 2 years 12 12 Pharmacy-Based Immunization Delivery Think About It... Why are pure polysaccharide vaccines not recommended in children less than 2 years of age? 13 13 Pharmacy-Based Immunization Delivery Think About It.... Why are adjuvants added to vaccines? 14 14 Pharmacy-Based Immunization Delivery Minimum Intervals Between Vaccines and Other Products if not Administered Simultaneously Vaccines Minimum Interval Two inactivated vaccines No minimum Inactivated and live vaccines No minimum PPD = purified protein derivative (skin Two live vaccines, if not 28-day minimum interval test for tuberculosis) simultaneous When PPD follows a vaccine, it leads Inactivated vaccines and No minimum to a false negative antibodies Live vaccines followed by blood 2 weeks products Blood product given before live Minimum interval varies (look up) vaccine Live vaccine followed by PPD 28-day minimum interval skin test PPD skin test followed by live Administer vaccine after PPD skin vaccine test has been read 15 Pharmacy-Based Immunization Delivery Think About It.... What happens if the interval between vaccine doses in a series is decreased? What happens if the interval between vaccine doses in a series is increased? 16 16 Pharmacy-Based Immunization Delivery General Rule on Contraindications A condition that greatly increases the risk of an adverse reaction Do not vaccinate if vaccine likely to injure patient Universal contraindication for all vaccines: Severe allergy (immediate and life- threatening anaphylaxis) to a vaccine component following a previous dose 17 Pharmacy-Based Immunization Delivery False Contraindications Minor illness (mild fever, upper respiratory infection, otitis media, mild diarrhea) Vaccine should not be given if the patient is ill enough to refer to physician or hospital Allergies to products not in the vaccine (e.g., penicillin, bird feathers) Allergies that are not immediate and life-threatening (e.g., other than anaphylaxis or laryngeal edema) Pregnancy in the household (even varicella) Breastfeeding (even rubella) Premature birth (do not adjust for gestation) 18 18 Pharmacy-Based Immunization Delivery Vaccines in Special Populations 19 Pharmacy-Based Immunization Delivery Vaccines and Pregnancy Encourage vaccination prior to pregnancy Inactivated seasonal influenza vaccine if pregnant during influenza season Tdap for every pregnancy, ideally during early part of gestational weeks 27 to 36 mRNA COVID-19 vaccine – ensure patient is fully vaccinated Avoid giving vaccines to women who are or might become pregnant (especially live vaccines); risks are theoretical Pregnant providers may administer live vaccines Discuss with the patient’s physician or refer the patient to her physician for vaccine decisions After pregnancy, administer any deferred vaccines 20 Pharmacy-Based Immunization Delivery Vaccines and Immunosuppression (Altered Immunocompetence) Very complicated issues Timing of vaccination Type of immunosuppression Duration and level of immunosuppression Individual vaccine issues Affects live and inactivated vaccines Live vaccines pose an increased risk for an adverse effect due to uninhibited replication Inactivated vaccines concerned with decreased effectiveness References Advisory Committee on Immunization Practices (ACIP) General Best Practice Guidelines on Immunizations Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for Vaccination of the Immunocompromised Host https://www.cdc.gov/vaccines/hcp/acip-recs/index.html 21 21 Pharmacy-Based Immunization Delivery Types of Immunosuppression Congenital Hematopoietic stem cell Solid organ transplant Cancer immunodeficiency transplant patients recipients HIV infection Immunosuppressive Vaccination depends upon degree medications Asplenia or sickle cell of immunosuppression Radiation therapy or Systemic corticosteroid therapy diseases chemotherapy Monoclonal antibodies, TNF/IL inhibitors, interferon ACIP. MMWR. 2017:60:119-40. Rubin LG. Clin Infect Dis. 2014;58:e44-e100. 22 Pharmacy-Based Immunization Delivery Immunosuppression Recommendation Low-level immunosuppression High-level immunosuppression Prednisone dose of 1 year following a single PCV15 dose for adults aged > 65 years or > 18 years with certain underlying conditions. (Another option is PCV20 alone) Dose and route: 0.5 mL IM (or SC) 57 Pharmacy-Based Immunization Delivery Prevnar 13 (Pfizer) 12 serotypes same as PPSV23 Pneumococcal 1 serotype not in PPSV23 (6A) Conjugate FDA approved for age 6 weeks and older Routine schedule: 2, 4, 6, 12 to 15 months Vaccine 13- Dose and route: 0.5 mL IM (all ages) valent (PCV13) Note: The recommendations for pediatric PCV13 use have not changed. PCV13 is no longer used for adults > 18 years of age (even though there is FDA approval). 58 Pharmacy-Based Immunization Delivery VAXNEUVANCE (Merck) 15 serotypes, 14 contained in PPSV23 1 serotype not contained in PPSV23 (6A) Pneumococcal FDA approved in adults 18 years of age or older CDC recommended in persons age > 65 years and Conjugate persons 19-64 years with certain underlying Vaccine 15- conditions. Single dose of PCV15 followed by a dose of valent (PCV15) PPSV23 > 1 year later can be given. Alternatively, these individuals may receive a single dose of PCV20 alone. CDC recommended as an alternative option to PCV13 for routine pediatric immunization at 2, 4, 6, 12 to 15 months of age and for children with high risk medical conditions per the existing pneumococcal guidelines. Dose and route: 0.5 mL IM 59 Pharmacy-Based Immunization Delivery Prevnar 20 (Pfizer) Pneumococcal Builds upon the13 serotypes of Prevnar 13. FDA approved for ages > 18 years. Conjugate CDC recommended in persons age > 65 years and persons 19-64 years with certain underlying Vaccine 20- conditions. valent (PCV20) Single dose of PCV20. Alternatively, these individuals can receive PCV15 followed by a dose of PPSV23 > 1 year later. Dose and route: 0.5 mL IM 60 Pharmacy-Based Immunization Delivery Hepatitis A and B Vaccines 61 Pharmacy-Based Immunization Delivery Hepatitis A Vaccination Routine vaccination For all children 1 to 2 years old Catch-up by age 18 Unvaccinated persons through 18 years should complete a 2-dose series (minimum interval: 6 months) Adults if risk factors are present or for any person for whom immunity against hepatitis A is desired 62 Pharmacy-Based Immunization Delivery Hepatitis A Vaccination Routine vaccination For all children 1 to 2 years old Catch-up by age 18 Unvaccinated persons through 18 years should complete a 2-dose series (minimum interval: 6 months) Adults if risk factors are present or for any person for whom immunity against hepatitis A is desired 63 Pharmacy-Based Immunization Delivery Hepatitis A Vaccines Vaccines 95%–100% effective Havrix (GSK) and Vaqta (Merck) Brands interchangeable Give 2-dose series at least 6 months apart Dosing 18 years and younger: 0.5 mL IM 19 years and older: 1.0 mL IM Twinrix (GSK) Hepatitis A (Pediatric dose) + Hepatitis B (Adult dose) – 3 dose series 64 Pharmacy-Based Immunization Delivery Hepatitis B Vaccination 65 Pharmacy-Based Immunization Delivery Target Groups for Hepatitis B Vaccination All infants All adolescents who have not been previously vaccinated All adults 19 to 59 years All adults > 60 years of age with risk factors Any adult over age 60 who wishes to protect themselves against Hepatitis B Photograph courtesy of Patricia Walker, MD Ramsey Clinic 66 Associates, St. Paul, MN Pharmacy-Based Immunization Delivery Hepatitis B Vaccine Recombivax HB (Merck) and Engerix-B (GSK) Infants 3 doses Birth, 1-2 months, 6 months (no earlier than 24 weeks) 0.5 mL IM Adolescents and adults 3 doses 0, 1, 6 months (0.5 mL IM) The adult formulation of Recombivax is licensed for a 2-dose schedule for adolescents 11 to 15 y/o (1 mL IM) HEPLISAV-B (Dynavax) 2 doses 1 month apart 2018 ACIP Recommendations for the use of Heplisav B. Adults >18 years 2018 ACIP Recommendations for Prevention of Hepatitis B. 67 Pharmacy-Based Immunization Delivery Hepatitis B Titers Duration​ After seroconversion, protection appears to persist indefinitely​ Memory cells present, despite undetectable circulating antibody​ No booster dose needed​ What if a heath care provider’s titer is zero?​ Give one dose, wait 1 month and repeat titer​ If high, no more doses needed​ http://www.immunize.org/catg.d/p2110.pdf If low or none, complete series, then repeat 68 titer. Pharmacy-Based Immunization Delivery Rotavirus Vaccines Live attenuated vaccines RotaTeq (Merck) Oral solution in ready-to-use dosing tubes Rotarix (GSK) Oral vaccine requires reconstitution before administration Contraindicated in children with moderate-severe gastrointestinal problems, severe combined immunodeficiency (SCID) and history of intussusception 69 Pharmacy-Based Immunization Delivery Rotavirus Vaccines Recommended schedule RotaTeq: 3-dose series (2, 4, 6 months of age) Dose: 1.0 mL oral Rotarix: 2-dose series (2, 4 months of age) Dose 2.0 mL oral Ages for administration Minimum age for first dose: 6 weeks Maximum age for first dose: 14 weeks 6 days Maximum age for final dose: 8 months 0 days 70 Pharmacy-Based Immunization Delivery COVID-19 Vaccines https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 71 Pharmacy-Based Immunization Delivery COVID-19 Vaccines https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 72 Pharmacy-Based Immunization Delivery Primary Series Vaccination Pfizer-BioNTech 2 doses 3 to 8 weeks apart for healthy individuals 3 weeks apart for high risk/immunocompromised persons 2 doses 4 to 8 weeks apart for healthy individuals Moderna 3 doses, with 2nd dose 4 weeks after first dose; then 3rd dose 4 weeks after for immunocompromised persons Novavax 2 doses 3 to 8 weeks apart for healthy individuals 2 doses 3 weeks apart for immunocompromised individuals 1 dose represents a primary series J&J 1 dose of J&J followed > 4 weeks with an mRNA vaccine as the additional dose for immunocompromised persons https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html 73 Pharmacy-Based Immunization Delivery COVID-19 Boosters Persons Age > 18 years 1st Booster: CDC recommends a booster of either Pfizer-BioNTech or Moderna COVID-19 vaccine for: o Most people, at least 5 months after the final dose in the primary series o People who are moderately or severely immunocompromised, at least 3 months after the final dose in the primary series 2nd Booster: CDC recommends a 2nd booster of either Pfizer-BioNTech or Moderna COVID-19 vaccine at least 4 months after the 1st booster for: o Adults ages 50 years and older o People who are moderately or severely immunocompromised https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html 74 Pharmacy-Based Immunization Delivery Monovalent Versus Bivalent: What's the Deal? Monovalent Contains one strain of the virus Original COVID-19 SARS-CoV-2 Bivalent Contains original plus newer omicron variant strains, BA.4 and BA.5. Recommendation- get an updated bivalent booster if one is eligible despite previously contracting COVID-19 or prior monovalent booster-COVIDvariantprogression 75 Pharmacy-Based Immunization Delivery Vaccine Combinations DTaP Tdap Infanrix (GSK) Adacel (Sanofi Kinrix (GSK) — Td (various) Daptacel (Sanofi Pasteur) DTaP + IPV Pasteur) Boostrix (GSK) Pentacel (Sanofi Pediarix (GSK) — Twinrix (GSK) — ProQuad (Merck) Pasteur) — DTaP + DTaP + Hep B + IPV Hep A + Hep B — MMR + Varicella Hib + IPV Vaxelis (Merck and Sanofi Pasteur) — DTaP + Hib + IPV + Hep B 76 Pharmacy-Based Immunization Delivery Injection Administration Review 77 Pharmacy-Based Immunization Delivery Intramuscular Injections Site Infants Anterolateral thigh Not taught in this course Children 3 years and older and adults Deltoid muscle https://together.stjude.org/en-us/patient-education-resources/tests-procedures/give-intramuscular-injections.html 78 Pharmacy-Based Immunization Delivery Intramuscular 22–25 gauge Insert at 90° angle Injection Weight Needle Size Men and women less than 60 kg (less 1 inch than 130 lb) Women 60–90 kg (130–200 lb) 1–1½ inches Men 60–118 kg (130–260 lb) Women more than 90 kg (more than 1½ inches 200 lb) Men more than 118 kg (more than 260 lb) Children (deltoid) ⅝–1¼ inches 79 Pharmacy-Based Immunization Delivery Subcutaneous Injection Site Children 3 years and older and adults Outer aspect of upper arm (posterolateral) 80 Pharmacy-Based Immunization Delivery Subcutaneous Injection ⅝ inch 23–25 gauge Insert at 45° angle 81 Pharmacy-Based Immunization Delivery Preventing Shoulder Injury Related to Vaccine Administration (SIRVA) Know the anatomy of the upper arm Injector should be at the same level as the patient Injector should target the lower two- thirds of the deltoid muscle Assess history of previous injuries Pay attention to proper technique https://www.ramoslaw.com/navigating-the-legal-and-medical-landscape-of-sirva-what-you-need-to-know-about-shoulder-injury-related-to-vaccine- administration/ 82 Pharmacy-Based Immunization Delivery Intranasal Vaccine** **For the 2021-2022 season, immunization providers may choose to administer any licensed, age-appropriate influenza vaccine (LAIV, IIV and RIV). LAIV is an option for influenza vaccination for persons for whom it is otherwise appropriate. FluMist [package insert] July 2013. 83 Pharmacy-Based Immunization Delivery Jet Injector Technology Needle-free​ Eliminates needlesticks​ For patients with fears of needles​ Approved in 2014 only for use with Afluria​ aged 18 through 64 Pharmajet Needle-Free System​ https://injectneedlefree.com/ 84 Pharmacy-Based Immunization Delivery Vaccine Injury Table (VIT)—Condensed (VAERS Reports Required) Anaphylaxis Encephalopathy or encephalitis Brachial neuritis after tetanus toxoid (any form) Chronic arthritis after rubella vaccine (any form) Thrombocytopenic purpura after measles vaccine Vaccine-strain measles infection in immunodeficient person after any form of measles vaccine Paralytic polio or poliovirus infection after Oral polio virus (OPV) Intussusception after rotavirus vaccine Any acute sequelae of these events (including death) Shoulder injury related to vaccine administration www.vaers.hhs.gov/reportable.htm 85 Pharmacy-Based Immunization Delivery Immunization Read the literature; keep current references Resources: APhA Immunization Center Staying Up-to- www.pharmacist.com/immunization- center Date Immunization Action Coalition https://www.immunize.org/ APhA-APPM Immunization SIG and e- community (Engage) Electronic mailing lists IAC Express: [email protected] APhA Immunizing Pharmacists News MMWR: subscribe at www.cdc.gov/mmwr 86 Pharmacy-Based Immunization Delivery Must-Have General Best Practice Guideline for Immunization References https://www.cdc.gov/vaccines/hcp/acip- recs/general-recs/index.html 2013 IDSA Clinical Practice Guideline for Vaccination of Immunocompromised Host https://academic.oup.com/cid/article/58/ 3/e44/336537 87 Pharmacy-Based Immunization Delivery Conclusion There are vaccine schedules There are common reasons for based on age and health There are two types of for low immunization rates condition vaccines: live attenuated which need to be Selection of appropriate vaccines and inactivated addressed is based on the individual profile of the patient The timing of vaccine Proper immunization Utilize resources to stay up administration is important technique is imperative for to date with immunization and can affect the timing of safety and effectiveness information protection Pharmacy-Based Immunization Delivery

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