Immunizations- NAPLEX

Meningococcal Vaccines- Administration Recommendations for MenB

*Age 10+ with High Risk* - Asplenia/Sickle Cell Disease, Compliment Component Deficiencies, or Eculizumab (Soliris) use. - Lab workers with N. Meningitidus exposure. - During an outbreak - Optional for patients 16-23 years who are not a high risk but want the vaccine (if given, the preferred age is 16-18 years) Bexsero: 2 doses, given 1 month apart Trumenba: 2 doses, given 6 months apart. If high risk of meningococcal disease or during an outbreak, give 3 doses at months 0, 1-2, and 6.

Vaccine Adverse Reactions- Management of Severe Allergic Reactions

*All providers* who administer vaccines must have *emergency protocols and supplies to treat anaphylaxis*. If symptoms are severe, a second person should activate the Emergency Medical System (EMS) by calling 911. The primary healthcare provider should remain with the patient, assessing the airway, breathing, circulation, and level of consciousness. Care should be provided until EMS arrives: - For adults, administer aqueous Epinephrine 1 mg/mL (1:1,000) dilution intramuscularly, 0.01 mg/kg, up to a maximum 0.5 mg maximum dose. Most pharmacies used *prefilled Epinephrine auto-injectors*. At least *three adult (0.3 mg)* auto-injectors should be available. Most adults will require 1 to 3 doses administered every 5 to 15 minutes. - Diphenhydramine can be given to reduce swelling and pruritus. Drugs cannot be given orally if airway swelling is present, due to the risk of choking. - The patient should be placed in a supine position (flat on the back), unless there is breathing difficulty. Elevating the head will help with breathing, but caution must be taken to keep the blood pressure adequate. If the BP is low, elevate the legs only. Monitor BP and pulse every 5 minutes. - Provide CPR, if necessary. Immunizing pharmacists need a current Basic Life Support (BLS or CPR) certification. - Record all vital signs and administered medications. The reaction should be reported to the patient's PCP and to the FDA VAERS.

Timing and Spacing of Vaccines- Live Vaccines and Antibodies

*Antibodies*, whether in blood or IV Immunoglobulin, can *interfere with live vaccine replication* and a separation period may be required. This is a concern with live vaccines because replication is required to produce an immune response. The *interval* between an *antibody-containing product* and a *Measles, Mumps, and Rubella*-containing vaccine (*MMR*), or a *Varicella-containing vaccine* (Varivax or MMRV) is a *minimum of 3 months* and can be *up to 11 months*. The specific product and dose determines the separation time. Consult the *Pink Book* for recommendations. Maternal antibodies are passed from the mother to the baby before birth, and will reduce the baby's response to live vaccines. Most live vaccines are withheld until the child is 12 months of age, because by this time, the mother's antibodies will be depleted. An exception is Rotavirus, which is a live virus given to infants. It has shown to be effective at preventing rotavirus-induced gastroenteritis despite the presence of maternal antibodies. *Inactivated vaccines* can be given *at any time*. Inactivated vaccines are started when the baby is two months old, except for the *Hepatitis B vaccine* series, which is *started at birth*.

Inactivated Vaccines- Overview and Types

*Inactivated vaccines* used the *killed* version of a wild virus or bacteria that causes the disease. Inactivated vaccines *cannot replicate* and cannot cause disease. There are less affected by circulating antibodies than live vaccines. Because they are not alive, inactivated vaccines *have limitations*. Immunity is not as strong as with live vaccines, and *booster doses* may be required for ongoing immunity. Types of Inactivated Vaccines - Polysaccharide - Conjugate - Recombinant - Toxoid

Timing and Spacing of Vaccines- Vaccines Given in a Series

*Increasing the interval* between doses of vaccine given in a series does not diminish the effectiveness of the vaccine after completion of the series. It may, however, *delay more complete protection. Decreasing the interval* between doses of vaccine can *interfere with the antibody response* and protection. In a few cases, the interval can be shortened for high-risk patients (e.g., between doses of the two pneumococcal vaccines in an immunocompromised patient).

Influenza Vaccines- Overview

*Influenza (the flu)* is the *most common vaccine preventable illness in the U.S.* Influenza A and B are the two types of influenza viruses that cause epidemic human disease. Influenza A virus has subtypes based on the two surface antigens, *Hemagglutinin and Neuraminidase*. Immunity to the surface antigens reduces the likelihood of infection, and severity of disease if infection occurs. The influenza vaccine is given *annually*. The vaccine changes every year to account for antigenic drift, which causes variations in the virus. More dramatic antigenic changes, or "shifts," occur about every 30 years and can result in the emergence of a novel influenza virus, with the potential to cause a pandemic. *The virus spreads* from person to person, primarily through *respiratory droplet transmission*. This can happen when an infected person coughs or sneezes in close proximity to an uninfected person. Influenza illness has an *abrupt onset of symptoms* (fever, myalgia, headache, malaise, nonproductive cough, sore throat, rhinitis). In children, otitis media, nausea, and vomiting are commonly reported. Uncomplicated influenza illness typically resolves after 3 to 7 days, though cough and malaise can persist for more than 2 weeks. In some people, influenza can exacerbate underlying medical conditions (e.g., pulmonary or cardiac disease) and lead to secondary bacterial pneumonia or primary influenza viral pneumonia (as with elderly or immunocompromised patients). Hospitalization and death are more common in people aged <5 years, 65+ years or those with comorbid conditions.

Measles, Mumps, Rubella-Containing Vaccines- Formulations, Storage/Administration

*Live Attenuated* - *MMR: M-M-R II* - *MMRV* (MMR + Varicella): *Proquad* Storage/Administration - *MMR*: Store in the *refrigerator or freezer*. - *MMRV*: Store *vaccine in the freezer only* due to the varicella component. - Store *diluents at room temperature or in the refrigerator*. - *Give SC*

Live Vaccines- Overview and Types

*Live vaccines* are most *similar* to the *actual disease* and provide a *strong, long-lasting* immune response. However, patients who are *immunocompromised* may *not be able to halt replication* and the vaccination could cause the disease. *Pregnant women* are considered immunocompromised and are *contraindicated* from receiving live vaccines. The live vaccine may also be interfered with my *circulating antibodies*. Common Live Vaccines: (remember *COZY IV RM*, "cozy IV room") - Cholera - Oral Typhoid - Zostavax - Yellow Fever - Intranasal Influenza - Varicella - Rotavirus - MMR Other Live Vaccines - Tuberculosis (BCG Vaccine) - Dengue - Smallpox - Ebola

Timing and Spacing of Vaccines- Simultaneous Administration

*Most* live or attenuated vaccines can be *administered simultaneously* (or on the same day or at the same visit) without decreasing the antibody response or increasing the risk of adverse reactions. Simultaneous administration of all vaccines for which a child is eligible is very important in childhood vaccination. Every effort should be made to provide all necessary vaccinations at one visit, to improve compliance and increase the probability that a child will be fully immunized at the appropriate age. Combination vaccines help accomplish this will less injections.

Influenza Vaccines- Administration Recommendations

*Trivalent vs. Quadrivalent* - Trivalent flu vaccines protect against 3 influenza viruses: two influenza A's (H1N1 and H3N2) and one influenza B. The quadrivalent protects against the two influenza A's and two influenza B's. *Vaccine Timing* - *Give the vaccine as soon as available*, even if it arrives in late summer. It is preferable to administer the vaccine before October, but individuals should still be vaccinated later in the season. Outbreaks usually peak by February. *Live Attenuated Vaccine* - LAIV4 is indicated for healthy patients age 2-49 years. *Do not use in pregnancy* or if *immunocompromised*.

Varicella-Containing Vaccines- Formulations, Storage/Administration

*Varicella* virus-containing vaccines and the *Zostavax* brand of Zoster vaccine are *live attenuated* vaccines. The *Shingrix* brand of Zoster vaccine is a *recombinant (non-live)* vaccine. Formulations 1. *Varicella Virus Vaccine (for Chickenpox)*: - *Varivax* - *MMRV: ProQuad* 2. *Zoster Virus Vaccines (for herpes zoster / Shingles)*: - *Shingrix* - *Zostavax* Storage/Administration 1. *Varivax and Zostavax* - Store vaccine *in the freezer*. Store the diluent in the refrigerator or at room temperature. - *Reconstitute immediately* upon removal from the freezer *and inject*. Both have a short stability (about 30 minutes). - Do *not* give if there is a hypersensitivity to *gelatin or neomycin*. - *Give SC* 2. *Shingrix* - Store vaccine and adjuvant liquid in the refrigerator. *Do not freeze*. - *Give IM*

Vaccine Storage Requirements

- *Most* vaccines are stored in the *refrigerator* (between 36F and 46F, or 2C and 8C) - Vaccines that should be stored in the freezer (between -58F and 5F, or -50C and -15C) include: *Varicella vaccine, Zostavax, MMRV*, oral *Cholera* vaccine, Ebola, Smallpox and Monkeypox vaccine. - *MMR* is stored either in the *refrigerator or freezer* Diluents - Some vaccines require reconstitution with a diluent before use. The diluents that come with varicella, Zostavax, MMR, and MMRV can be stored in the *refrigerator* or at *room temperature*. - Vaccines that are reconstituted should be used shortly after preparation.

Vaccinations for Adults

- Influenza - Tdap, Td - Shingles - HPV - Pneumococcal - Meningococcal - Hepatitis B - Hepatitis A

Timing and Spacing of Vaccines- General Rules

- Vaccines can usually be given at the same time (same visit or the same day). The only exception to this is patients with Asplenia that need both the Prevnar and Menactra vaccine. These two should be separated by 4 weeks. - Multiple live vaccines can be given on the same day or (if not given on the same day) *spaces 4 weeks apart*. The only exception is the oral rotavirus vaccine. There is no separation needed for the oral rotavirus vaccines. - If a vaccine series requires >1 dose, the intervals between the doses can be extended without restarting the series, but they *cannot be shortened* in most cases. - MMR and Varicella-containing vaccines (not Zoster) require separation from antibody-containing products (e.g., blood transfusions, IVIG). The recommended spacing is: --- Vaccine --> 2 weeks --> Antibody-containing product --- Antibody-containing product --> 3 months or longer ---> Vaccine - Simultaneous administration of vaccine and antibody (in the form of Immunoglobulin) is recommended for post-exposure prophylaxis of certain diseases (e.g., Hepatitis A and B, Rabies, Tetanus)

Types of Vaccines

1. *Live Attenuated* - These are live vaccines that have been "weakened." They are produced by modifying a disease-producing virus or bacterium in a laboratory that has the ability to *replicate* (i.e., grow) and produce immunity, but usually does not cause illness. - Live Attenuated vaccines are most similar to the actual disease and produce a strong immune response to the vaccine. They are, however, *contraindicated* in *immunocompromised* and/or *pregnant* patients since uncontrolled replication of the pathogen can occur. 2. *Inactivated* - These are vaccines that can be composed on either a whole virus or bacterium, or fractions of either, but are not alive and cannot replicate. Immunity resulting from an inactivated vaccine can diminish with time and *supplemental doses* may be required to increase, or "boost," immunity.

Non-Routine Vaccines

1. *Rabies Vaccine*: - *RabAvert* - Imovax 2. Typhoid Vaccine - Vivotif - Typhim Vi 3. Japanese Encephalitis Virus Vaccine - Ixiaro 4. Tuberculosis Bacille Calmette-Guerin (BCG) Vaccine 5. Yellow Fever Vaccine - YF-VAX 6. Cholera Vaccine - Vaxchora 7. Dengue Vaccine - Dengvaxia 8. Smallpox and Monkeypox Vaccine - Jynneos 9. Ebola Vaccine - Ervebo

Vaccine Administration- Administration Technique

1. *SC*: - Use a 23 to 25 gauge, *5/8th inch needle at a 45 degree angle*. - Inject adults into the *fatty tissue over the triceps*. - Inject infants into the anterolateral mid-thigh muscle. 2. *IM* - Use a 22 to 25 gauge needle. Inject at a *90-degree angle*. Inject adults in the *deltoid muscle* above the level of the armpit and below the shoulder joint. Inject infants into the anterolateral mid-thigh muscle. *IM needle length: 1 inch* in adults. - *Exceptions to 1 inch needle length*: if patient weighs <130 pounds, use a 5/8 to 1 inch needle. If patient weighs >260 lbs. (male) or >200 lbs. (female), use a 1.5 inch needle. 3. Never mix vaccines in the same syringe. 4. Use of Acetaminophen before vaccine administration, to prevent ADEs, is not recommended. It can be given if symptoms occur.

Varicella-Containing Vaccines- Administration Recommendations

1. *Varicella Virus Vaccines* - Varivax: A routine childhood vaccine series; 2 doses given at age 12-15 months and 4-6 years. - Anyone without evidence of immunity to varicella should receive *2 doses* of Varivax - *Do not use in pregnancy or if immunocompromised* 2. *Zoster Virus Vaccines* - *Shingrix is preferred*. ACIP recommends routine vaccination (*2 doses* given at month 0 and month 2-6) in patients *age 50+ years*, including those who previously received varicella virus vaccine or Zostavax (wait at least 8 weeks after Zostavax before starting the 2-dose series of Shingrix) - *Vaccinate even if the patient has a history of zoster infection*, since recurrence is possible. - If Zostavax is used, it is recommended in patients aged 60+ years (1-dose) - Zoster vaccine are indicated for the prevention of shingles (not for treatment of an active case). They can reduce complications, such as the severity of PHN following infections. - *Some antivirals* (e.g., Acyclovir, Valacyclovir, Famciclovir) can *interfere with the live vaccines* (Varivax and Zostavax). *Stop 24 hours before* vaccine administration and do not take for 14 days after vaccination.

Pneumococcal Vaccines- Administration Recommendations

1. 13-Valent Conjugate Vaccine (PCV13): Prevnar 13 - *Children <5*: 4-dose series given at age 2, 4, 6, and 12-15 months. After the initial pediatric series is complete, a patient should not get it again. Otherwise, it is given as a one-time dose. - Immunocompromised patients age 6-64 years: 1 dose if never received before. - *Adults 65+ years old: Optional* to give 1 dose if never received before. 2. 23-Valent Polysaccharide Vaccine (PPSV23): Pneumovax 23 - Patient age 2 to 64 years with select risk factors: 1 or 2 doses. - *All adults 65+ years old*: 1 dose.

Vaccinations for Specific Conditions/Populations- Infants and Children

1. 3-dose Hepatitis B Vaccine started at birth 2. Other vaccine series start at age 2 months, including *Prevnar 13, DTaP, Hib, Polio, Rotavirus* 3. Live vaccine series generally start at age 12+ months, including *MMR, Varicella*. 4. An annual influenza vaccine is recommended for everyone 6+ months or older *No polysaccharide vaccines before age 2 years*

Vaccinations for Specific Conditions/Populations- Healthcare Professionals

1. Annual influenza vaccine is usually required (with proof/documentation of vaccination) 2. Hepatitis B: If there is no evidence of HBV vaccine series completion or a blood test showing immunity 3. Tdap: 1 dose, if not up-to-date, then Td or Tdap every 10 years. 4. Varicella: If there is no history of vaccination or chickenpox infection 5. MMR: If there is no history of vaccination or a blood test showing immunity

Diphtheria Toxoid-, Tetanus Toxoid-, and Acellular Pertussis-Containing Vaccines- Administration Recommendations

1. DTaP - A routine childhood vaccine series; 5 doses given at ages 2, 4, 6, 12 to 18 months, and at 4 to 6 years. - DTaP is for *children younger than 7 years of age* 2. DT - Used for routine vaccine series in infants and children <7 years old who have a contraindication to the acellular pertussis antigen in DTaP 3. Td or Tdap - Tdap booster typically given at 11+ years old (if not previously received) - Routine booster (Td) given every 10 years in patients 7+ years old - *Wound prophylaxis*: For *deep or dirty wounds*, revaccinate with Td or Tdap if it has been *more than 5 years* since the last dose. Tetanus Immunoglobulin (TIG) may be required if no previously tetanus vaccines have been given. - Recommended in: - 1) Pregnant women or postpartum women, with *each pregnancy* - 2) *Close contacts of infants* younger than age 12 months (e.g., father, grandparents, and child-care providers), if not up to date. - 3) Healthcare personnel with direct patient contact, if not up to date. - 4) Children aged 7 to 10 years who did not get fully vaccinated with the DTaP series; give a single dose of Tdap instead of DTaP.

Hepatitis-Containing Vaccines- Administration Recommendations

1. Hepatitis A - Children: A routine childhood vaccination series; 2 doses given at age 12 months and then 6 to 18 months later. - Adults: Men who have sex with men, illicit drug users, *chronic liver disease*, homeless individuals, HIV, travelers to countries with high Hepatitis A incidence, or anyone else who wants it. 2. Hepatitis B: - Children: A routine childhood vaccination series started *within 24 hours after birth*; 3 doses given at age 0, 1 to 2 months, and 6 - 18 months. - Adults: *Healthcare workers*, patients with ESRD (on dialysis), *chronic liver disease* (including HCV), *HIV, diabetes* (age 19-59 years, or 60+ at HCP discretion), IVDA, men who have sex with men, anyone with multiple sexual partners, incarcerated people, some travelers. - Engerix-B and Recombivax HB: 3-dose series given at month 0, 1, and 6 (can be completed in 4 months if necessary, but requires a booster at 1 year if the series is accelerated) - Heplisav-B (*age 18+*): 2-dose series given at month 0 and 1. Do not use in pregnant women. 3. Hepatitis A and B (Twinrix) - 3-dose series given at months 0, 1, and 6.

Vaccinations for Specific Conditions/Populations- Older Adults

1. Herpes Zoster Vaccine - *Shingrix* (preferred): Two dose series at age 50+ years old, 2 to 6 months apart. - Zostavax: age 60+ years old (not recommended anymore due to Shingrix availability; patients who got Zostavax should get Shingrix. Patients who get Shingrix should not get Zostavax) 2. Pneumococcal Vaccine(s) - Age 65+: Pneumovax 23 x 1 dose (wait at least 1 year after Prevnar 13, if given, and at least 5 year after any prior dose of Pneumovax 23) - Age 65+: Prevnar 13 x 1 dose (if immunocompromised and *not received previously*; optional for all other adults). Prevnar 13 should be administered *first* if patient needs or wants Prevnar 13.

Vaccine Administration- Routes of Administration

1. IM only: - *Most* vaccines are given IM. The following vaccines in the next sections are exceptions. 2. SC only: - *MMR, MMRV, Varicella, Zostavax, Yellow Fever*, Dengue, Smallpox and Monkeypox 3. IM or SC - *PPSV23*, IPV (IPOL) Intranasal - *FluMist* Quadrivalent (Live attenuated vaccine) 5. PO - *Typhoid (Vivotif)* capsules - Oral solutions: Cholera (Vaxchora), and Rotavirus (Rotarix, RotaTeq)

Vaccinations for Adults- Influenza, Tdap/Td, Shingles

1. Influenza - Annually for all patients 6+ months old 2. Tdap, Td - Tdap x 1 if not received previously - Td or Tdap every 10 years thereafter 3. Shingles - Shingrix is preferred. Vaccinate all adults 50+ years old, even if they have had chickenpox or shingles or previously received Zostavax. - Shingrix is a 2-dose series, with the second dose given 2 to 6 months after the first dose. Do not give Shingrix until at least 8+ weeks after Zostavax. - Alternative: Zostavax x 1 at age 60+ years old

Vaccinations for Specific Conditions/Populations- Adolescents and Young Adults

1. Meningococcal vaccine (MCV4; Menactra or Menveo) - 2 doses: 1 dose at age 11 to 12 and 1 dose at age 16 - First-year college students in residential housing (if not previously vaccinated): 1 dose 2. HPV vaccine - Recommended at age 11 to 12 and 2 to 3 doses depending on age at start of series. 3. Tdap: First dose at age >11 years

Vaccinations for Specific Conditions/Populations- Diabetes

1. Pneumococcal vaccine - Before age 65: 1 dose of Pneumovax 23 2. Hepatitis B: - Age 19 to 59 years (or at age 60+ years old per HCP discretion)

Pneumococcal Vaccines- Indications, Sequence, Intervals

1. Prevnar 13: - NOTE: Patients should only receive PCV13 once in their lifetime (either as the childhood series or one dose if 6+ years old) - Give 1 dose if never received to the following patient populations: --- Immunocompromised patients age 6-64 (e.g., Sickle Cell Disease, Asplenia, HIV, CKD, Malignancy, Transplant, Immunosuppressive drug use, including Steroids) --- Adults 65+ can be considered based on a patient and healthcare provider discussion of the benefits (again, if never received before). 2. Pneumovax 23: - NOTE: Patients may receive 1, 2, or 3 doses in their lifetime. - Give 1 dose before age 65 years (age 2 to 64) if immunocompetent but has diabetes, heart, lung, or liver disease, alcoholism, or a smoker) - Give 2 doses before age 65 years old if immunocompromised (age 2-64) (e.g., Sickle Cell Disease, Asplenia, HIV, CKD, Malignancy, Transplant, Immunosuppressive drug use, including Steroids) - Give 1 dose at age 65+ to ALL patients (whether 0, 1, or 2 doses were received before age 65) Sequence and Interval - If both PCV13 and PPSV23 are indicated, PCV13 should be administered first (remember 13 comes before 23). - Immunocompromised patients who get PCV13 then PPSV23 must wait 8 weeks in between the shots. - Immunocompetent patients who get PCV13 then PPSV23 must wait *1 year* in between the shots. - Doses of PPSV23 must be spaced out by at least 5 years.

Meningococcal Vaccines- Administration Recommendations for MCV4

1. Routine Vaccination - *Adolescents*: 2-dose series given at age 11 - 12 years and at age 16 years (booster dose) 2. Special Populations at Risk - Travel to certain countries, such as the *Meningitis Belt* in *Sub-Saharan Africa*. - Age 2 months and older with *HIV, Asplenia/Sickle Cell Disease*, Compliment Component Deficiencies, or Eculizumab (Soliris) use. - Lab workers with N. Meningitidis exposure. - 1st year college students (age 21 or younger) living in residential housing, if not up to date. - Military recruits. - The number of doses and timing will depend on age and the specific risk. People with ongoing risk of meningococcal disease should be revaccinated every 5 years.

Influenza Vaccines- Storage/Administration

1. Store in the refrigerator. Do not freeze. 2. *Administer IM except*: - FluMist Quadrivalent is given as a 0.2mL, divided between the *two nostrils*. Product Notes: - Fluzone HD formulations contain 4x the antigen dose of standard dose IM vaccines to increase antibody production. - Fluad contains an oil-in-water emulsion of MF59 (an adjuvant) to increase antibody production. - Flucelvax Quadrivalent is grown in a cell culture, but could still contain miniscule amounts of egg protein. - Afluria Quadrivalent can be given with a needle-free jet injector.

Active vs. Passive Immunity

Active Immunity: - From the person's own immune system, either from vaccines or from fighting off the infection. Active immunity lasts a long time, often a lifetime. Passive Immunity: - Received from someone else, such as receiving Immunoglobulins (Ig) that are pooled from other people, or through transfer from a mother to her baby. - Mom gives baby a copy of her antibodies shortly before birth. These decrease over time as the child's own antibody production increases. - IV Immunoglobulin (IVIG) provides already made antibodies, and can be used for quick immunity after exposure to an antigen. For example, a person who is bitten by a rapid animal will quickly receive the Rabies Vaccine (which will take time to work), but also get Rabies IVIG to help the patient fight the rabies virus right away as the active immunity builds up.

Vaccine Safety Concerns

Autism: - Some people believe that vaccines cause autism. The causes of autism are not fully understood, but there is *no evidence* that autism is caused by vaccines. Parents often first notice the behaviors of autism around the time when most childhood vaccines series are near completion (18 to 24 months). Abnormal brain structure that is present in children with autism can be ID'd in the Prefrontal and Temporal Cortical tissue before a child is born, prior to receiving vaccines. Genetic studies have confirmed that genes play an important role. For example, if one twin has autism, the other twin is highly likely to have autism as well. Thimerosal - Thimerosal, a mercury-containing preservative used in some vaccines, was alleged to be contributing to the increase in autism, since mercury has been linked to some brain disorders. There is *no evidence* that Thimerosal poses a risk for autism. Thimerosal was removed from childhood vaccines in 2001, and the rates of autism have continued to increase. Thimerosal is contained in some multi-dose flu vaccines. If that is a concern, parents may require a single-dose flu vaccine which does not contain the preservative, or a multi-dose vaccine without Thimerosal. Gelatin - Gelatin is used in some vaccines as a stabilizer. It is porcine- (pig-) derived. For observant Muslims, Jews, and Seventh-Day Adventists who follow the dietary rules that prohibit pork products, most religious leaders permit the use of gelatin-containing vaccines because the gelatin is injected, not ingested, and the end-product has been rendered pure.

Measles, Mumps, Rubella-Containing Vaccines- Administration Recommendations

Children - A routine vaccination series; 2 doses given at age 12-15 months and age 4-6 years. ProQuad - Indicated for patients age 12 months to 12 years Adults 1. 1 to 2 doses if no evidence of immunity. 2. Give 2 doses, 4 weeks apart, if no evidence of immunity: - *Healthcare workers* - HIV patients with CD4 count 200+ for at least 6 months - Nonpregnant women of childbearing age (with no evidence of immunity to rubella) - International travelers - Household contacts of immunocompromised people - Students in post-secondary educational institutions 3. *Do not use in pregnancy or if immunocompromised* 4. Adults born before 1957 are generally considered immune to measles and mumps

Vaccine Contraindications and Precautions- Diphtheria, Tetanus, and Pertussis Vaccines

Contraindications - For pertussis-containing vaccines: Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) that is not attributable to another cause within 7 days after receiving the vaccine. Precautions - Guillian-Barre Syndrome (GBS) within 6 weeks of a previous Diphtheria, Tetanus, and/or Pertussis vaccine. - For DTaP and Tdap only: Infantile spasms, uncontrolled seizures.

Vaccine Contraindications and Precautions- Rotavirus Vaccines

Contraindications - History of Intussusception (part of the intestine slides into an adjacent part of the intestine, blocking food/fluids) Precautions - Chronic gastrointestinal disease

Vaccine Contraindications and Precautions- Varicella Vaccines

Contraindications - History of severe allergic reactions (e.g., anaphylaxis) to gelatin or neomycin Precautions - Use of Acyclovir, Valacyclovir, or Famciclovir in the 24 hours before vaccination. Avoid these antivirals for 14 days after vaccination.

Vaccine Contraindications and Precautions- All Vaccines

Contraindications - Severe allergic reaction (e.g., anaphylaxis) to a vaccine or vaccine component after a previous dose. Precautions - *Minor Illness*: If a child or adult has a *mild illness* (such as a cold), vaccines should be given. Treatment with antibiotics is *not* a valid reason to delay vaccines. - *Moderate-to-severe illness*: If the person has a *moderate-to-severe* acute *illness* (regardless of antibiotic use) it is *reasonable to delay* vaccines until the condition has improved.

Vaccine Contraindications and Precautions- Live Vaccines

Contraindications 1. *Pregnancy* - Do not attempt pregnancy until 4 weeks after receiving a live vaccine. 2. *Immunosuppression* Precautions - Recent administration of an antibody-containing blood product

Vaccine Contraindications and Precautions- Zoster Vaccines

Contraindications 1. Both Vaccines - Pregnancy 2. Recombinant Zoster Vaccine (RZV) only: - Lactation 3. Zoster Vaccine Live (ZVL): - History of severe allergic reactions (e.g., anaphylaxis) to gelatin or neomycin. Precautions 1. ZVL only: - Use of Acyclovir, Valacyclovir, or Famciclovir in the 24 hours before vaccination. Avoid these antiviral drugs for 14 days after vaccination.

Vaccine Contraindications and Precautions- Influenza Vaccines

Contraindications 1. Live, attenuated influenza vaccine (LAIV): - Severe egg allergy (e.g., anaphylaxis) - Use of Aspirin-containing products (children and adolescents) - Use of Influenza Antiviral medications in the past 48 hours - Children aged 2 to 4 with asthma or a wheezing episode in the past 12 months - Close contact with an immunosuppressed person. Precautions: 1. ALL Influenza Vaccines: - History of BGS within 6 weeks of a previous Influenza vaccination 2. LAIV: - Asthma in any patient aged 5+ - Underlying conditions that predispose to Influenza complications (e.g., chronic lung, heart, renal, hepatic, neurologic, hematologic, and metabolic disorders, including diabetes) 3. Inactivated Influenza Vaccines (IIV): - Egg allergy other than hives (e.g., angioedema, respiratory distress, recurrent emesis or required emergency medical intervention). Give IIV injection only under the supervision of a HCP who can manage severe allergic reactions.

BCG Vaccine

For protection against Tuberculosis (TB). BCG is *Bacille Calmette-Guerin*. This is a *live vaccine*. Administration Recommendations - Not often used in the U.S. Given to infants and small children in countries with a higher TB incidence. Provides weak protection for pulmonary TB. - Can cause a *positive reaction* to the *TB skin test*.

Japanese Encephalitis Vaccine

Formulation - Ixiaro Storage - Store in the refrigerator. Do not freeze. - Give IM Administration Recommendations - Give if spending 1+ month in endemic areas during transmission season, especially if the travel will include rural areas. - Give 2 doses, 28 days apart. Complete at least 1 week prior to potential exposure.

Pneumococcal Vaccines- Formulations, Storage/Administration

Formulations - *13-valent Conjugate Vaccine (PCV13): Prevnar 13* - *23-valent Polysaccharide Vaccine (PPSV23): Pneumovax 23* Storage/Administration - Store in refrigerator. Do not freeze. - Shake the vial or prefilled syringe prior to use. - *PCV13*: Give IM. - *PPSV23*: Give *IM or SC*

Human Papillomavirus Vaccine- Formulations, Storage/Administration and Administration Recommendations

Formulations - *HPV9 (9-Valent): Gardasil 9, prevents* about *90% of cervical cancers*, as well as vulvar, vaginal, oropharyngeal, penile, and anal cancers, and *genital warts*. Storage/Administration - Store in the refrigerator. Do not freeze. - Shake the prefilled syringe or vial before use. - Give IM - Caution for fainting (incidence is similar to other vaccines). Administer to seated patient and monitor after vaccination. Administration Recommendations 1. *Age 9 to 26* (FDA-approved up to age 45 years, ACIP recommendations have not changed, clinical decision-making for anyone 27-45). - *Recommended age: 11-12 years* (may be started at age 9, and recommended if history of sexual abuse) 2. Regimens: - If started *before age 15*, give *2 doses* (at month 0 and 6-12 months later) - If started at *age 15 or older*, or if immunocompromised, give *3 doses* (at months 0, 1 to 2, and 6)

Hepatitis-Containing Vaccines- Formulations, Storage/Administration

Formulations - *Hepatitis A: Havrix, VAQTA* - *Hepatitis B: Engerix-B, Heplisav-B, Recombivax HB* (high-dose Recombivax HB [40 mcg/mL] is indicated for dialysis patients) - Hepatitis A and B: Twinrix - *DTaP-HepB-IPV: Pediarix* - DTaP-IPV / Hib / HepB: Vaxelis Storage/Administration - Store in the refrigerator. Do not freeze. - Shake the vial or prefilled syringe before use. - Give IM.

Rabies Vaccine

Formulations - *RabAvert* - Imovax Storage/Administration - Store in refrigerator. - Reconstitute with the provided diluent. - Give IM. Administration Recommendations - Given preventatively for high-risk exposure (e.g., animal handlers, traveling to a high-risk area); 3 doses. - Given after possible rabies exposure: --- With previous vaccination: 2 doses --- Without previous vaccination: 4 doses; *1 dose of rabies immunoglobulin (RIG)* should be given *with the first vaccine dose*

Dengue Vaccine

Formulations - Dengvaxia: *Live vaccine* Storage - Store in the refrigerator. Reconstitute with the provided diluent; swirl, do not shake. - Give SC Administration Recommendations - Given to people age 9-16 years who have previously tested positive for dengue infection and live in endemic areas. - NOT indicated for primary prevention. - Give 3 doses at months 0, 6, and 12

Ebola Vaccine

Formulations - Ervebo: *Live vaccine* Storage - Keep frozen. Allow vaccine to thaw at room temperature (do not thaw in the refrigerator) until no visible ice is present before use. - Give IM Administration Recommendations - Give to adults 18+ years old for the prevention of disease caused by the Zaire Ebolavirus. - Does not offer protection against other species of Ebolavirus or Marburgvirus. - Give 1 dose IM.

Haemophilus Influenzae Type B (Hib)-Containing Vaccines- Formulations, Names, Storage/Administration, Administration Recommendations

Formulations - Hib: ActHIB, Hiberix, Pedvax HIB - DTaP-IPV / Hib: Pentacel - DTaP-IPV / Hib / HepB: Vaxelis Storage/Administration - Store in the refrigerator. Do not freeze. - Shake the prefilled syringe or vial before use. - Give IM Administration Recommendations - Hib: a routine childhood vaccine series given between ages 2 to 15 months - ActHIB and Hiberix are 4-dose series, PedvaxHIB is a 3-dose series. - Given to *adults with asplenia*.

Cholera Vaccine

Formulations - Vaxchora: *Live vaccine* Storage - *Store* the packet for reconstitution *in the freezer*. Remove no more than 15 minutes prior to reconstitution. - Dissolve the buffer packet in 100 mL of cold or room temperature water, then add the active component packet, stir for 30 seconds, and drink within 15 minutes. Administration Recommendations - Given to people age 18-64 years who are traveling to an area of active toxigenic *Vibrio cholerae* transmission. - Give 1 oral dose 10+ days prior to exposure.

Typhoid Vaccine

Formulations - Vivotif (*live vaccine, oral*) - Typhim Vi (inactivated polysaccharide vaccine, *IM injection*) Storage - *Oral* capsules: *store in the refrigerator*. Take on an *empty stomach* (1 hour before a meal) *with cold or lukewarm water*. - Injection: store in the refrigerator. Do not freeze. Given IM. Administration Recommendations - To prevent Typhoid Fever caused by *Salmonella Typhi*. - ORAL: Take 1 capsule PO on alternate days (days 0, 2, 4, and 6). *Complete at least 1 week prior to possible exposure*. Give every 5 years if continued risk or exposure. - Injection: Give 1 dose *at least 2 weeks prior to possible exposure*. Give every 2 years if continued risk or exposure.

Yellow Fever Vaccine

Formulations - YF-VAX: *Live vaccine* Storage - Store in the refrigerator. - *Reconstitute with the provided diluent*; swirl, do not shake. - *Given SC* Administration Recommendations - Given to those who travel to, or live in areas of risk, and to travelers to countries that require vaccinations. - Contraindicated with a *severe (life-threatening) allergy to eggs or gelatin*, immunosuppression, age <6 months, or breastfeeding. - Avoid donating blood for 2 weeks after receiving the vaccine. - The *International Certificate of Vaccination (yellow card)* is provided and is valid for 10 years, starting 10 days after vaccination. It may be required to enter endemic areas.

Smallpox and Monkeypox Vaccine

Formulations: - Jynneos: *Live vaccine* Storage - Keep frozen. Allow vaccine to thaw and reach room temperature before use. Swirl for at least 30 seconds. - Give SC Administration Recommendations - Give to adults 18+ years old who are at high-risk for infection. - Give 2 doses, four weeks apart.

Influenza Vaccines- General Recommendations and Patient Considerations

General Recommendations - *Recommended annually* in *all patients aged 6+ months*, unless contraindicated. If there is a vaccine shortage, the highest risk patients will be vaccinated first. - Any vaccine can be used within the FDA indications (ACIP does not give preference to any one type of influenza vaccine) - All brand names have *FLU* in the name (e.g., Afluria, Fluzone, FluMist) Special Patient Considerations 1. *Age 6 months to 8 years* (and not previously vaccinated: - Give *2 doses*, 4 weeks apart 2. *Patients with an egg allergy* - Can receive any age-appropriate inactivated influenza vaccine, even if severe allergy symptoms (e.g., wheezing, requiring epinephrine, hypotension, or cardiovascular changes). Administration in those with severe allergy symptoms should be supervised by a HCP who is able to recognize and treat severe allergic reactions. No additional observation period is recommended (beyond the required 15 minutes). - *Flublok* is an *egg-free product* and is approved for ages 18 and older only. - *Do not administer the live influenza vaccine (FluMist)* 3. *Pregnant patients* - Can receive any age-appropriate inactivated influenza vaccine. *Do not administer the live influenza vaccine (FluMist)* 4. *Indicated only for patients aged 65+ years* - Fluzone HD, Fluzone HD Quadrivalent, and Fluad (adjuvanted influenza vaccine)

Vaccinations for Adults- HPV, Pneumococcal, Meningococcal

HPV - Adults 26 years old or younger who did not complete the HPV series. - HPV Vaccine is indicated for up to age 45 years old Pneumococcal 1. Pneumovax 23: - All adults 65+ years old x 1 dose. - Patients 2 to 64 years old: 1 dose if Heart, Lung, Liver Disease, Diabetes, Alcohol abuse, smokers - Patients 2 to 64 years old: 2 doses if immunocompromised 2. Prevnar 13 (if not received before) - Any patient 6+ years old who are immunocompromised. - Optional for adults 65+ years old Meningococcal 1. Serogroup B Vaccines (Trumenba, Bexsero) - Complement Component Deficiency - Taking Eculizumab (Soliris) - Asplenia - Microbiologist with exposure to Neisseria Meningititis - Serogroup B Meningococcal disease outbreak exposure 2. Conjugate Vaccines (Menactra, Menveo) - Give to same groups above plus give to the following groups: - HIV - Are travelers/residents to countries in which the disease is common - Military recruits - First-year college students living in dorms, if not up to date (e.g., did not receive a dose when 16+ years old)

Vaccinations for Adults- Hepatitis A and B

Hepatitis A (give alone [Havrix, VAQTA] or with Hepatitis B [Twinrix]) - Adults traveling to undeveloped countries outside of the US - Household members and other close contacts of adopted children newly arriving from countries with moderate-high infection risk - Liver disease - Hemophilia - Men who have sex with men - IV drug users - Homeless individuals - HIV Hepatitis B (give alone [Engerix-B, Recombivax HB, Heplisav-B] or with Hepatitis A [Twinrix]) - Sexually active adults who are not in a long-term monogamous relationship - Patients with diabetes aged 19-59 (or 60+ per HCP discretion) - Household contact with an infected person - IV drug users - Patients with HIV - Liver disease

Immunization Registries

Immunization registries are computerized information systems that collect vaccination histories and help ensure correct and timely immunizations, especially for children. They are useful for HCPs, who can use the registry to obtain the patient's history, produce vaccine records, and manage vaccine inventories, among other benefits. Registries also helps the community at-large to identify groups who are not receiving vaccines in order to target outreach efforts. Some systems are able to notify patients if vaccines are needed. Where allowed, pharmacists should strive to report all vaccines administered to their state or local registry.

Vaccinations for Specific Conditions/Populations- Immunodeficiency

Immunodeficiency, or Altered Immunocompetence, Immunosuppression, or Immunocompromised; caused by drugs or conditions: - Chemotherapy/bone marrow transplant drugs. These cause myelosuppression (*decreased WBCs*, RBCs, and platelets) - Strong immunosuppressant drugs used for autoimmune diseases (e.g., Etanercept, Infliximab) or transplants (e.g., Cyclosporine, Tacrolimus) - HIV with a CD4 count <200 (AIDS) - Systemic steroids for 14+ days (does not include inhaled, topical, or intraarticular) at 20+ mg/day or 2 mg/kg Prednisone daily or equivalent steroid dose. - Chronic renal failure 1. Live vaccines are *contraindicated* 2. Pneumococcal vaccines (Prevnar 13 and Pneumovax 23) - Before age 65: 1 dose Prevnar 13 (if not received previously) followed by 2 doses of Pneumovax 23. Give Prevnar 13 first, then the first Pneumovax 23 dose 8+ weeks later. Give 2nd Pneumovax 23 5+ years after the first Pneumovax dose. 3. *AIDS only*: - Meningococcal conjugate vaccine (Menactra or Menveo) - Hepatitis A vaccine - Hepatitis B Vaccine

Vaccinations for Specific Conditions/Populations- Pregnancy

Live vaccines are contraindicated. 1. Influenza vaccine, inactivated (not live) can be given in any trimester. 2. Tdap x 1 with *each pregnancy* (weeks 27-36, optimally). It is not just Mom that needs a Tdap x1 to protect the baby from Pertussis. Vaccinate others in close contact with the infant (e.g., father, grandparents, child-care providers) *if they are not up-to-date*.

Vaccine Adverse Reactions- Local and Systemic Reactions

Local reactions occur at or near the injection site. This are *common*, more so with inactivated vaccines, and include *pain, swelling, and redness*. Rarely, local reactions may be very exaggerated or severe. Systemic reactions are less common than local reactions. They include fever, malaise, myalgias, headache, loss of appetite, or a mild illness that has similarities to the disease being prevented, such as a few chickenpox vesicles after receiving the varicella vaccine. Patients who have experienced systemic reactions after a flu shot might think (incorrectly) that the vaccine caused the flu. The flu shot is an *inactivated vaccine* and *cannot* cause the flu. With *live vaccines*, mild *systemic* reactions can occur *3 to 21 days* after the vaccine is given (i.e., after an incubation period). *Intranasal flu vaccine* can replicate in the upper airways (nose and throat) and can cause mild *cold-like* symptoms, such as a runny nose.

Poliovirus-Containing Vaccines- Formulations, Storage/Administration, Administration Recommendations

Only inactivated poliovirus vaccine (IPV) is available in the US. Oral polio vaccine (live attenuated) may be administered in other countries. Formulations - IPV: IPOL - DTaP-IPV: Kinrix, Quadracel - *DTaP-HepB-IPV: Pediarix* - DTaP-IPV / Hib: Pentacel - DTaP-IPV / Hib / HepB: Vaxelis Storage/Administration - Store in the refrigerator. Do not freeze. - Shake the prefilled syringe or vial before use. - IPV (IPOL): Give IM or SC. Administration Recommendations - A routine childhood vaccine series; 4 doses given at age 2, 4, 6-18 months, and 4-6 years.

Reliable Vaccine Information for Patients

Pharmacists can provide patients with credible sources of information to counter erroneous information found on the internet and in the media. *Vaccine Information Statements (VISs)* are *prepared by the CDC* for each vaccine to explain the benefits and risks. Federal law requires that the *VIS be handed to the patient* (or parent) *before* the vaccination is given.

Polysaccharide, Conjugate Inactivated Vaccines

Polysaccharide Inactivated Vaccines: - Polysaccharide (sugar) molecules are taken from the outside layer of encapsulated bacteria (such as pneumococcal serotypes; each serotype matches to a circulating strain of the organism). Polysaccharide vaccines do *not* produce a good immune response in *children <2 years of age*. - Example: Pneumococcal Polysaccharide Vaccine (Pneumovax 23) Conjugate Inactivated Vaccines - Conjugate vaccines use polysaccharide (sugar) molecules from the outside layer of encapsulated bacteria and *join the molecules to carrier proteins*. Conjugation *increases the immune response in infants*, and the antibody booster response to multiple doses of vaccine. - Examples: Pneumococcal Conjugate Vaccine (Prevnar 13), Meningococcal Conjugate Vaccine (Menactra, Menveo)

Rotavirus-Containing Vaccines

Rotavirus vaccines are live attenuated and given *orally*. Formulations - RV1: *Rotarix* - RV5: *RotaTeq* Storage/Administration - Store in the refrigerator. Do not freeze. - *Given orally* Administration Recommendations - Given to all infants. Do not initiate the series after age 15 weeks. - Rotarix: 2 doses at age 2 and 4 months. - RotaTeq: 3 doses at age 2, 4, and 6 months.

Timing and Spacing of Vaccines- Live Vaccines and the TB Skin Test

The *Tuberculin Skin Test (TST)*, also called a Purified Protein Derivative (*PPD*) test, is used to determine if a person has latent Tuberculosis. Live vaccines can cause a false-negative result. Options to reduce the risk of a false-negative TST result include: 1. Give the *live vaccine on the same day* as the skin test. 2. Wait *4 weeks after a live vaccine* to perform the skin test. 3. Administer the skin test first, wait 48 to 72 hours to get the result, then give the live vaccine.

Diphtheria Toxoid-, Tetanus Toxoid-, and Acellular Pertussis-Containing Vaccines- Formulations, Names, Storage/Administration

The *pediatric formulations* (with the *upper-case D*, as in DTaP) have 3 to 5 times as much Diphtheria component than the adult formulations. The *adult formulations* have a *lower-case d* (Tdap or Td). Formulations - DTaP: Daptacel, Infanrix - DTaP-IPV: Kinrix, Quadracel - *DTaP-HepB-IPV: Pediarix* - DTaP-IPV / Hib: Pentacel - DTaP-IPV / Hib / HepB: Vaxelis - DT - Td: Tenivac - *Tdap: Adacel, Boostrix* Storage and Administration - Store in the refrigerator; do not freeze - Shake the prefilled syringe or vial before use - Give IM

Pneumococcal Vaccines- Overview

The bacteria *S. Pneumoniae*, called Pneumococcus, is the most common cause of Otitis Media, Pneumonia, Meningitis, and bloodstream infections in *children*. Adults *age 65 years and older* and those with certain *chronic conditions* or *altered immunocompetence* are at increased risk of pneumococcal disease. There are two pneumococcal vaccines: a conjugate vaccine, PCV13 (Prevnar 13); and a polysaccharide vaccine, PPSV23 (Pneumovax 23). Children *<5 years receive PCV13 (Prevnar 13)* as part of *routine childhood vaccinations*. This is because young children (<2 years old) do not produce an *adequate antibody response* to polysaccharide vaccines. The following patients are candidates for *one dose of PCV13, if not received previously* as part of routine childhood vaccinations: - *Immunocompromised* patients aged 6+ - *Adults 65+*, but *optional* based on a discussion between the patient and healthcare provider. PCV13 is *not routinely recommended* anymore in adults 65+ unless they are immunocompromised. PPSV23 is recommended in *all adults aged 65+* and in select patients between the ages of 2 and 64. The pneumococcal vaccine recommendations and spacing varies based on patient risks. The usual *interval between PCV13 and PPSV23* when both are indicated is *12 months*. A shorter interval of *8 weeks* is used in *immunocompromised patients*, to provide protection more quickly. Multiple *doses of PPSV23* are *separated by at least 5 years*.

Immunity- Overview

The purpose of the immune system is to identify self substances (e.g., normal body parts/components) and non-self (foreign) substances, which are called *antigens. Antibodies* are produced naturally to *provide immunity* against *antigens*. When an *antigen* is detected, the body produces *antibodies* and destroys the antigen. *Immunoglobulin* is the medical term for antibody. The antibody marks the antigen for detection and destruction by the immune system. *Immunity* is acquired *actively* or *passively*. Active immunity develops when the person's own immune system produces antibodies to fight an infection or in response to vaccine administration. Passive immunity is acquired when antibodies are provided from someone else. The CDC's *Pink Book* is a useful resource for details regarding *immunology and immunizations*.

Vaccinations for Specific Conditions/Populations- Sickle Cell Disease and Other Causes of Asplenia

The spleen contains T-cells and B-cells. A damaged or missing spleen (e.g., splenectomy) causes a type of immunodeficiency. 1. H. Influenzae Type B Vaccine (Hib) 2. Pneumococcal vaccines (Prevnar 13 and Pneumovax 23) - Before age 65: 1 dose of Prevnar 13 (if not received previously) and 2 doses of Pneumovax 23. Give Prevnar 13 first, then the first Pneumovax 23 8+ weeks later, then give the 2nd Pneumovax 23 5+ years after the first dose. 3. Meningococcal vaccines - Meningococcal conjugate vaccine (Menactra or Menveo) - Serogroup B Meningococcal vaccine (Bexsero or Trumenba)

Vaccine Contraindications and Precautions- Invalid Contraindications to Vaccination

The vaccination may be given, if indicated, in the following situations: 1. Mild acute illness (slight fever, mild diarrhea) 2. Current antimicrobial treatment (with some exceptions: Varicella, Zoster, and Oral Typhoid Vaccines) 3. Previous local skin reaction (mild/moderate) from a vaccine 4. Allergies: Bird feathers, penicillin, allergies to products not in the vaccine 5. Pregnancy (except live vaccines), breastfeeding, preterm birth 6. Recent TST (but follow appropriate timing with consideration to live vaccines) 7. Immunosuppressed person in the household, recent exposure to the disease or convalescence 8. Family history of adverse events to the vaccine

Influenza Vaccines- Formulations

There are many formulations of the influenza vaccine. Key differences between them include the number of strains (3-trivalent or 4-quadrivalent), whether the virus is *inactivated* (IIV) or *live attenuated* (LAIV), the route (IM, intranasal), the antigen dose, or the presence of an adjuvant. Inactivated Influenza Vaccines are produced using eggs unless otherwise noted (*Flublok*). Formulations 1. *Trivalent Inactivated Influenza Vaccines* (IIV3) - *Fluzone High-Dose*: approved for *age 65+ years* - *Fluad* (adjuvanted): approved *for age 65+ years* 2. *Quadrivalent Inactivated Influenza Vaccines* (IIV4) - *Afluria* Quadrivalent, *Fluarix* Quadrivalent, *Flulaval* Quadrivalent, *Fluzone* Quadrivalent: approved for various ages - *Flucelvax Quadrivalent* (grown in cell culture): approved for ages 4+ years - Flublok Quadrivalent (recombinant inactivated vaccine, RIV, *egg-free*): approved for ages 18+ years - *Fluzone High-Dose Quadrivalent*: approved for *ages 65+ years* 3. *Quadrivalent Live Attenuated Influenza Vaccine (LAIV4)* - *FluMist* Quadrivalent: approved for *healthy people age 2 to 49 years*

Vaccine Contraindications and Precautions- Overview

There are specific circumstances when vaccines should not be given. Most precautions are temporary, and the vaccine can be given at a later time. For example, if the patient has a moderate-to-severe acute illness, vaccine administration should be delayed until it resolves. Mild acute illness is not a precaution and the vaccine can be administered. A *Contraindication* is a condition that significantly increases the potential for a *serious adverse reaction. Pregnancy and immunosuppression* are two very important contraindications to the use of *live vaccines*. Live vaccine administration must be timed carefully in patients who have recently received an antibody-containing blood product. A *severe or anaphylactic reaction* following a dose of vaccine is a *contraindication to any subsequent doses of that vaccine*.

Vaccine Adverse Reactions- True Allergic Reactions

These are very uncommon, and can be caused by the vaccine or a component of the vaccine, such as the stabilizer, preservative, or antibiotic present in the vaccine (used to inhibit bacterial growth). Minor allergic reactions will resolve quickly and can be treated with *Diphenhydramine* (OTC) or *Hydroxyzine* (Prescription). A minor reaction is not a contraindication to future vaccination. *Severe* allergic reactions are very rare (<1 in 500,000 doses). A severe reaction with *anaphylaxis* can be *life-threatening* if not managed correctly. Anaphylactic reactions are IgE-mediated and occur within minutes of receiving the vaccine. Symptoms include urticaria (hives), swelling of the mouth and throat, difficulty breathing, wheezing, abdominal pain, cramping, and hypotension or shock. The protocol for emergency management will include the use of *Epinephrine*, which must be available to quickly reverse breathing difficulty.

Vaccine Contraindications and Precautions- Screening Prior to Vaccine Administration

Use a screening form to rule out specific contraindications and precautions to the vaccine in adults. Note that a "yes" response to some of these questions will indicate a type of vaccine to use, rather than a contraindication to all formulations (e.g., someone with an allergy to Thimerosal can use a single-dose vial vaccine or prefilled syringe to avoid the preservative). The screening form should include: - Are you sick today? - Do you have allergies to medications, food, a vaccine component, or latex? - Have you ever had a serious reaction after receiving a vaccine? - 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? - Do you have cancer, leukemia, AIDS, or other immune system problem? - Do you take Cortisone, Prednisone, other Steroids, Anticancer drugs, or have you had radiation treatments? - Have you ever had a seizure or nervous system problem? - During the past year, have you received a transfusion of blood or blood products, or been given immune globulin or an antiviral drug? - For women: are you pregnant or do you plan to become pregnant during the next month? - Have you received any vaccinations in the past 4 weeks?

Immunizations- Background

Vaccines prevent patients from acquiring serious or potentially fatal diseases. Childhood diseases that used to be common (e.g., Diphtheria, Meningitis, Polio, Tetanus) are not rare because children are vaccinated to prevent the illness, or are prevented by herd immunity (where vaccinated people protect the unvaccinated and make them less likely to be infected). However, if vaccination rates drop below 85-95%, vaccine-preventable diseases can become a threat, as demonstrated by the U.S. pertussis and measles outbreak seen in recent years. The *FDA approves* vaccinations based on the *safety and efficacy* for the *indication*. The FDA then has a committee, the *Advisory Committee on Immunization Practices (ACIP)* provide *recommendations for vaccine administration* in children and adults (i.e., who gets what vaccine and when). Based on these recommendations, the *Centers for Disease Control and Prevention (CDC)* approves the ACIP recommendations and publishes them in the CDC's *Morbidity and Mortality Weekly Report (MMWR)* and *The Pink Book* (AKA Epidemiology and Prevention of Vaccine-Preventable Diseases book). Other helpful resources for pharmacists related to immunizations are available on the following websites: - American Pharmacists Association (APhA): pharmacist/com/immunization-center - Immunization Action Coalition, immunize.org

Vaccine Storage- Overview

Vaccines should be properly stored and *kept in the original packaging* (box) until use. Some vaccines require protection from light. Vaccines should be stored in the refrigerator or freezer units designed for storing biologics (including vaccines) or in separate, free-standing freezer and refrigerator units. Household freezer units or dormitory-style refrigerators should not be used for vaccine storage. Vaccines should be stored on the shelves away from the walls. *Never* place vaccines *in the doors* of the freezer or the refrigerator as the temperature there is unstable. *Rotate stock* so vaccines and diluents *with the earliest expiration date are used first*. The CDC recommends a calibrated thermometer or a digital data logger be connected to a *buffered temperature probe* in the refrigerator and freezer. An example of a buffered probe is one immersed in a vial of liquid (e.g., glycol). This prevents false readings due to the rapid changes in air temperature that occur when refrigerator doors are opened. Read and *document* refrigerator and freezer *temperatures* at least *twice each workday* (in the AM and PM before the end of the workday). Maintain a consistent power source. *Keep temperature logs for 3 years (or longer*, as required by individual states).

Vaccine Contraindications and Precautions- Yellow Fever Vaccine, Latex Allergies

Yellow Fever Vaccine 1. Contraindications - Severe allergic reaction (e.g., anaphylaxis) to eggs Latex Allergies 1. Contraindications - Most latex sensitivities are a contact-type allergy, which does not prohibit vaccine administration. If the reaction to latex is severe (e.g., anaphylaxis), avoid vaccines with latex.

Vaccine Adverse Reactions- Overview

All vaccines have the potential to cause an adverse reaction. Reactions can range from local (e.g., soreness, redness, itching) to severe and life-threatening (e.g., anaphylaxis). Patients are *screened* for precautions and contraindications before vaccine administration to reduce the risk of severe reactions. The patient should be monitored for *at least 15 minutes after vaccination* to watch for an allergic reaction, syncope, dizziness, or falls. Pharmacists who administer vaccines need a plan (*protocol*) that covers *emergency management* of severe reactions until emergency medical help arrives. Adverse reactions that require some type of assistance should be reported to the *FDA's Vaccine Adverse Event Reporting System (VAERS)*

Vaccine Contraindications and Precautions- Hepatitis B Vaccines and HPV Vaccine

Contraindications - Hypersensitivity to yeast No Precautions

Meningococcal Vaccines- Formulations, Storage/Administration

Quadrivalent meningococcal conjugate vaccines (MC4) include serogroups A, C, W, and Y. Serogroup B (MenB) is available in a separate vaccine. Formulations 1. *MCV4* (Conjugate Vaccines) - *Menactra*: for age 9 months to 55 years - *Menveo*: for age 2 months to 55 years - Both may be used in adults 56+, if needed 2. MenB - Bexsero, Trumenba: for age 10 to 25 years Storage/Administration 1. MCV4 - Store in the refrigerator. Do not freeze. - Give IM - *Menveo: both vials contain vaccine* (the powder and the liquid). Use only the supplied liquid for reconstitution. - MCV4 vaccine is required by Saudi Arabia for travel to the Hajj and Umrah pilgrimages; proof of vaccination is required. 2. MenB: - Store in the refrigerator. Do not freeze. - Give IM. - Bexsero and Trumenba cover the serogroup B strain and are used in addition to the quadrivalent meningococcal conjugate vaccines.

Recombinant, Toxoid Inactivated Vaccines

Recombinant Inactivated Vaccines - A gene segment of a protein from the organism is inserted into the gene of another cell, such as a yeast cell, where it replicates. - Examples: Human Papillomavirus Vaccine (Gardasil 9), Recombinant Influenza Vaccine (FluBlok Quadrivalent) Toxoid Inactivated Vaccines - The vaccine targets a toxin produced by the disease. - Example: Diphtheria Toxoid Vaccine, Tetanus Toxoid Vaccine.