Appropriate Utilization of Vaccinationsin Adults

25th Annual Emerald Coast ConferenceAlabama Osteopathic Medical Association

Destin, FloridaJuly 23, 2015

Kenneth Greenberg D.O., Pharm.D.Assistant Professor of Medicine University of Colorado

Denver Infectious Disease

Disclosure Information

Kenneth Greenberg D.O., Pharm.D.Grants/Research Support:

CDCConsultant:

CDC (HOPS), Prescribers Letter, Hepatitis C Connection, Gilead, Merck, ViiVChairman P&T Committee Rose Medical CenterMedical Director Rocky Mountain CARES

Speaker’s Bureau: Gilead, Merck, ViiV, Simply Speaking

Honoraria: ALOMA

Stock Shareholder: none

Other Financial or Material Support: none

Objectives The role of the Advisory Committee on Immunization Practices

(ACIP) and the Center for Disease Control (CDC) is to provide advice that will lead to a reduction in the incidence of vaccine preventable diseases in the United States, and an increase in the safe use of vaccines and related biological products.

The purpose of today’s lecture is to review the current data for the

routine administration of vaccines to adults recommendations include age for vaccine administration number of doses and dosing interval precautions and contraindications

This discussion will review, define and appraise adult vaccinations as determined by the ACIP and CDC.

With this knowledge base the primary care physician, specialist and heath care providers will be able to identify and formulate appropriate vaccinations for their adult patients

Frequently Asked Vaccination Questions by Healthcare Providers

We have some adults who are in need of multiple vaccines

ACIP recommends giving all indicated vaccines simultaneously (i.e., at the same visit, NOT in the same syringe).

Giving vaccines together produces seroconversion rates and occurrences of adverse reactions similar to those observed when the vaccines are administered separately.

When giving 2 IM injections in the same limb, the vaccines should be separated by 1 inch or more if possible in the muscle so that any local reactions are unlikely to overlap.

If two live virus vaccines are inadvertently given less than 4 weeks apart, what should be done?

If two live virus vaccines are administered less than 4 weeks apart and not on the same day, the vaccine given second should be considered invalid and repeated.

The repeat dose should be administered at least 4 weeks after the invalid dose.

Alternatively, one can perform serologic testing to check for immunity, but this option may be more costly.

Should vaccines be withheld for patients on steroids?

Steroid therapies that are short term (less than 2 weeks) alternate-day physiologic replacement topical (skin or eyes) aerosol given by intra-articular, bursal, or tendon injection

Are not considered contraindications to the use of live virus vaccines. The immunosuppressive effects of corticosteroid treatment vary, but many clinicians

consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg per day of prednisone for 2 or more weeks as sufficiently immunosuppressive to raise concern about the safety of vaccination with live virus vaccines (e.g., MMR, varicella, zoster, LAIV, yellow fever).

Providers should: wait at least 1 month after discontinuation of therapy or reduction of dose before administering a live virus vaccine to patients who have

received high systemically absorbed doses of corticosteroids for 2 weeks or more. Inactivated vaccines and toxoids can be administered to all immunocompromised

patients in usual doses and schedules, although the response to these vaccines may be suboptimal.

What vaccines are indicated for someone who has had a splenectomy, and is there concern that they may have a less than optimum response to

vaccines?

Patients who do not have a functioning spleen or who have had a splenectomy do not handle encapsulated bacteria well and are at increased risk for infection with encapsulated bacteria, especially N. meningitidis, S. pneumoniae, and H. influenzae type b.

Vaccinate with age-appropriate: pneumococcal meningococcal Haemophilus influenzae type b (Hib) vaccine generally is not recommended

for people age 5 years and older, studies suggest good immunogenicity in patients who have had a splenectomy. Giving 1 pediatric dose of Hib vaccine to these patients who have not previously received Hib vaccine is not contraindicated.

Vaccines should be administered at least 2 weeks before a scheduled splenectomy, if possible.

If vaccines are not administered before surgery, administer as soon as the person’s condition stabilizes post-operatively.

A 60-year-old patient was given varicella vaccine instead of zoster vaccine. What should be done?

If a provider mistakenly administers varicella vaccine to a patient for whom zoster vaccine is indicated, no specific safety concerns exist, but the dose should not be considered valid; administer a dose of zoster vaccine during that same visit.

If the error is not immediately detected, a dose of zoster vaccine should be administered as soon as possible but not within 28 days of the varicella vaccine dose to prevent potential interference of 2 doses of live attenuated virus.

Note to remember that the zoster vaccine is 14 times more potent than the varicella vaccine

How soon after experiencing a case of shingles can a patient age 50 years or older receive zoster vaccine?

The general guideline for any vaccine is to wait until the acute stage of the illness is over and symptoms abate.

We accidentally gave a 47-year-old healthcare worker zoster vaccine instead of varicella vaccine for work. Does this count?

This is UNCOOL Yes, but this is a serious vaccine administration error because

Zostavax vaccine contains about 14 times as much varicella vaccine virus as Varivax.

The dose of zoster vaccine can be counted as the first of two doses of varicella vaccine for an adult who is not immune to varicella.

The second dose of varicella vaccine should be given 4 to 8 weeks after the first dose.

Which vaccines are contraindicated if a child is breast-feeding?

Breast-feeding is not a contraindication to the administration of any routinely recommended vaccine, either to the mother or to the child.

Which vaccines are contraindicated if a child's mother or other household member is pregnant?

Having a pregnant woman in a household, including the child's mother, is not a contraindication to administration of any routinely recommended vaccine.

For how long should a woman of child-bearing age avoid pregnancy after receiving a live attenuated vaccine?

Due to theoretical risks to the developing fetus, ACIP recommends that women avoid pregnancy for four weeks after receiving a live attenuated vaccine (e.g., MMR, varicella, LAIV). This interval may be shorter than that recommended by the manufacturer.

Is there a risk for a pregnant staff person administering live-virus vaccines?

A pregnant woman may administer any vaccine except smallpox vaccine.

For which vaccines is an egg allergy a contraindication? What about MMR vaccine?

Vaccines that are contraindicated for people who have a history of a severe (anaphylactic) allergy to eggs.

Influenza H1N1 Yellow fever vaccines

Due to denaturation of some egg proteins through heating, tolerance of ‘baked egg’ products may not predict tolerance of ‘native eggs’ proteins present in the influenza vaccine

Allergy to eggs is no longer considered a contraindication for giving MMR vaccine. Though measles and mumps vaccines are grown in chick embryo tissue culture, several studies have documented the safety of these vaccines in children with severe egg allergy.

Neither AAP's Committee on Infectious Diseases ("Red Book Committee") nor ACIP consider egg allergy a contraindication to MMR vaccine.

1.Settipane RA, Allergy and Asthma Proceedings Vol 30 No 6 Dec 2009 p660-665

ACIP recommended routine use of PCV13 for adults aged ≥19 years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implants The ACIP decision to recommend PCV13 use among adults aged ≥65 years was deferred until data became available on:1) impact of PCV13 use in children on disease in adults (i.e., indirect effects) a2) efficacy of PCV13 against noninvasive pneumococcal pneumonia among adults. IIn accordance with accelerated approval requirements, a randomized placebo-controlled trial (CAPiTA trial) was conducted in the Netherlands among approximately 85,000 adults aged ≥65 years during 2008–2013 to verify and describe further the clinical benefit of PCV13 in the prevention of pneumococcal pneumonia The results of the CAPiTA trial demonstrated 45.6% (95% confidence interval [CI] = 21.8%–62.5%) efficacy of PCV13 against vaccine-type pneumococcal pneumonia, 45.0% (CI = 14.2%–65.3%) efficacy against vaccine-type nonbacteremic pneumococcal pneumonia, 75.0% (CI = 41.4%–90.8%) efficacy against vaccine-type IPD among adults aged ≥65 years

Sequential administration and recommended intervals for PCV13 and PPSV23 for adults aged ≥65 years — ACIP

Bonten N et al Abstract no. 0541. Pneumonia 2014;3:95.

Use of 9-Valent Human Papillomavirus (HPV) Vaccine

(ACIP) recommended 9-valent human papillomavirus (HPV) vaccine (9vHPV) as one of three HPV vaccines that can be used for routine vaccination

HPV vaccine is recommended for routine vaccination at age 11 or 12 years ACIP also recommends vaccination for females aged 13 through 26 years and males aged 13 through 21 years not vaccinated previously.

Vaccination is also recommended through age 26 years for men who have sex with men and for immunocompromised persons (including those with HIV infection) if not vaccinated previously

9vHPV is a noninfectious, virus-like particle (VLP) vaccine. Similar to quadrivalent HPV vaccine (4vHPV), 9vHPV contains HPV 6, 11, 16, and 18 VLPs. In addition, 9vHPV contains HPV 31, 33, 45, 52, and 58 VLPs

9vHPV was approved by the FDA on December 2014, for use in females aged 9 through 26 years and males aged 9 through 15 years for these recommendations,. ACIP reviewed additional data on 9vHPV in males aged 16 through 26 years. 9vHPV and 4vHPV are licensed for use in females and males.

MMWR Recomm Rep 2014;63(No. RR-05):1–30

Meningococcal B Vaccine In October 2014 FDA approved Trumenba (MenB-FHbp); January 2015 Bexsero

(MenB-4C) Approved for use in patients 10-25 years old Recommended for patients:

With persistent deficiencies in the complement pathway Utilization of eculizumab in Tx of atypical HUS or paroxysmal nocturnal

hemoglobinuria Functional or anatomical asplenia Microbiologists/lab technicians with exposure to N meningitides Patients identified at increased risk because of serogroup B

meningococcal disease outbreak Trumenba MenB-FHbp (factor H binding protein) is a 3 dose series given at

baseline then 2 months and 6 months after first dose can be administered at the same time as HPV, Menactra, Tdap, dTap 50 to 84% patients in clinical trials had appropriate Ab response Side effects: pain at injection site, fatigue, ha, myalgias, chills

MMWR Recomm Rep June 12, 2015/ 64 (22); 608-12

Meningococcal B Vaccine Bexsero (MenB-4C (consists of three recombinant proteins and outer

membrane vesicles) is a 2 dose series given at baseline then at least one month after first dose

data for co-administration with vaccines routinely administered to adolescents are not available (except MenACWY vaccine)

63 to 88% patients in clinical trial had appropriate Ab response Side effects: pain at injection site, induration, fatigue, ha, myalgias,

chills

Other groups of patients that receive MenACWY due to increased risk are not included in this recommendation:

MenB vaccines are not licensed for children <10y/o Not recommended for patients who travel to or reside in countries

where meningococcal disease is hyperendemic or epidemic (usually this not associated with serogroup B)

Not currently recommended for routine use in first-year college students living in residence halls, military recruits or all adolescents

MMWR Recomm Rep June 12, 2015/ 64 (22); 608-12