immunizing your adult patients

Immunizing Your Adult Patients

1© Primary Care Network


Linda Davis, MDDirector and Founder

Kolvita Family Medical GroupMission Viejo, CA

Learning Objectives

▪ Review the different types of immunizations

▪ Explain the concept of “shared clinical decision-

making” with regards to immunization

recommendations

▪ Discuss the current Advisory Committee on

Immunization Practices (ACIP) recommendations

for adult immunizations

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Definitions

▪ Immunization – the process by which a person

becomes immune to an infectious etiology as a result

of receiving a vaccination

▪ Vaccine – a product that stimulates a person’s immune

system to create an antibody response against an

infectious agent that will prevent (reduce risk) of

contracting that disease

https://www.cdc.gov/vaccines/vac-gen/imz-basics.htm

Why Do We Care?

▪ Mortality

▪ In 1900, life expectancy in U.S. was 47.3 years.

Communicable diseases (i.e.: pneumonia, influenza, TB,

diphtheria, smallpox, pertussis, measles, and typhoid fever

were the leading causes of mortality)1

▪ In 2019, life expectancy was 78.8 years.

Non-communicable diseases (i.e.: ischemic heart disease,

stroke, and cancer are the leading cause of death)2

1Rappuoli R, Pizza M, Del Giudice G, De Gregorio E. Vaccines, new opportunities for a new society. Proc Natl Acad Sci U S A. 2014;111(34):12288-12293.

doi:10.1073/pnas.14029811112 Kochanek KD, Xu JQ, Arias E. Mortality in the United States, 2019. NCHS Data Brief, no 395. Hyattsville, MD: National Center for Health Statistics. 2020.

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COVID-19 Impact on US Life Expectancy

▪ Projected impact – average decline of 1.13 years (77.48)

▪ Largest single year decline in over 40 years

▪ Lowest life expectancy since 2003

▪ Worse for Latinos and Blacks

▪ Latinos: - 3.05 years to 78.77 years

▪ Blacks: - 2.10 years to 72.78 years

▪ Whites: - 0.68 years to 77.84 years

University of Southern California. "COVID-19 reduced U.S. life expectancy, especially among Black and Latino populations: Life expectancy at birth will

shorten by more than one year." ScienceDaily. ScienceDaily, 14 January 2021.

COST $$$

▪ Flu costs the U.S. approximately $10.4 billion in direct

costs for hospitalizations and outpatient visits for adults

(2007 data)1

▪ COVID-19 estimated costs ???

▪ Direct healthcare costs?

▪ Economic impact beyond healthcare?

1Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs.

Vaccine. 2007; 25(27):5086-96.

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History

▪ 430 BC Thucydides observed

that those that survived a deadly

disease did not get it again

▪ Middle Ages – China – “variolation”

(SQ inoculation) – exposing healthy

people to air-dried pustules of

smallpox

Rappuoli R, Pizza M, Del Giudice G, De Gregorio E. Vaccines, new opportunities for a new society. Proc Natl Acad Sci USA. 2014;111(34):12288-12293.

doi:10.1073/pnas.1402981111

By user:shakko - Own work, CC BY-SA 3.0,

https://commons.wikimedia.org/w/index.php?curid=55

73987

Vaccine Pioneers

▪ Edward Jenner 1796 – transitioned to exposure to an agent that mimicked smallpox (pustule derived from cowpox)1,2

▪ Latin word for cow: vacca

▪ Latin word for cowpox: vaccinia

▪ Jenner coined this new procedure “vaccination”

▪ Louis Pasteur 1870s – pioneer of vaccinations/immunology – dead or attenuated microorganisms that mimicked but did not cause disease1

▪ 1940s – in vitro culture growth of viruses

▪ Jonas Salk 1953 – polio vaccine (dead vaccine), Sabin 1955 –attenuated polio vaccine

1Rappuoli R, Pizza M, Del Giudice G, De Gregorio E. Vaccines, new opportunities for a new society. Proc Natl Acad Sci USA. 2014;111(34):12288-12293.

doi:10.1073/pnas.14029811112Proc (Bayl Univ Med Cent). 2005 Jan;18(1): 21-25.

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Vaccination Types

Live Attenuated VaccineUtilizes a weakened (or attenuated) form of the infectious agent

Pros

▪ Very similar to the actual virus

▪ Can produce a robust, lasting

immune response

▪ Prolonged immunity often

achieved with one or two doses

▪ Examples:

▪ Historical: Smallpox (1798)

▪ Measles, Mumps, Rubella

▪ Chickenpox

Cons

▪ Those with weakened immune

system may not be able to receive

the vaccine

▪ May cause a mild illness

▪ Must be kept cold (fragile) hard to

deliver to vulnerable populations

(i.e., developing countries, remote

villages)

https://www.vaccines.gov/basics/types

Plotkin S (2014) History of vaccination PNAS 111(34); 12283-12287.

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Inactivated/Killed Whole OrganismUtilizes a killed version of the infectious agent

▪ Effective for stimulating immune

response – short term

▪ Examples:

▪ Historical: Typhoid (1896),

Cholera (1896), Plague (1897)

▪ Hepatitis A

▪ Polio shot (i.e., IPV vs OPV)

▪ Influenza shot

▪ Rabies

▪ Immunity not typically long lasting

▪ Typically, will require a booster



Pros Cons

Subunit, Recombinant, Polysaccharide, and Conjugate Vaccines

▪ Utilize specific pieces of the infectious microorganism

i.e.: protein, sugar, or capsid

▪ Produces a very specific immune response to that

organism

▪ Safe for immunocompromised patients

▪ May require booster

▪ Examples: Hib, Hep B, HPV, Pertussis, Pneumococcal,

Meningococcal, Zoster


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Toxoid (Purified Protein)

▪ Targets the toxin that is produced by the infectious

organism

▪ Requires boosters to maintain immune response

▪ Examples:

▪ Diptheria Toxoid (1923)

▪ Tetanus Toxoid (1926)



New(er) Technology

▪ Viral Vector – utilizes a different virus as a means to introduce

the targeted “agent” to the immune system1

▪ Example: J&J’s COVID-19 vaccine

▪ mRNA – delivers the genetic code “blueprint” on a specific

protein/antigen for cellular production – for which the body will

recognize as “foreign” and stimulate an immune response2

▪ Example: Pfizer and Moderna COVID-19 vaccine

1 https://www.vaccines.gov/basics/types2 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

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Adjuvant

▪ A substance “added” to a vaccine to stimulate a more potent/robust immune response

▪ Original adjuvant: aluminum salts since the 1930s

▪ Newer adjuvants target specific components of the immune response resulting in stronger immunity (may see more side effects)

▪ MF59 (influenza >65 “Fluad”)

▪ AS01B (zoster “Shingrix”)

https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html

Our Role

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“Shared Clinical Decision Making”

▪ Paternalistic, Autonomy, vs Shared Decision

▪ Definition: model allowing patient involvement in their

healthcare planning/decisions

▪ Discussing Pros/Cons (i.e., efficacy, side effects, cost)

▪ Recognizing Limitations (Medicine is NOT an exact

science. It’s an “Art”. We are “practicing”.)

▪ Dispelling misinformation: Key role for providers

ACIPAdvisory Committee on Immunization Practices

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ACIP

▪ Updated Yearly

▪ Pediatric and Adult Recommendations

▪ Adult Schedule Ages 19 and older

▪ Endorsed by CDC, ACP, AAFP, ACOG, American College of Nurse-Midwives, and American Academy of PAs

▪ Available at: www.cdc.gov/vaccines/acip

https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf

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http://www.cdc.gov/vaccines/acip





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”Cade”

▪ 19-year-old male

▪ Freshman in college

▪ Lives in the dormitory

▪ No significant PMHx

▪ Allergic to eggs (trouble swallowing)

▪ Sexually active (3 lifetime partners)

▪ Routine Pex

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Immunization Record

▪ Childhood Vaccinations “Up to Date”

▪ Adolescent Vaccinations:

▪ Completed series for meningitis A,C,Y,

W-135 and Men B

▪ Had Tdap boosted 3 years ago, due to

surfing injury

▪ Flu shot – doesn’t get due to egg allergy

HPV VaccineHuman Papillomavirus

▪ First FDA approved in 2006 – quadrivalent formulation (strains 6, 11, 16, 18)

▪ Females ages 9-26

▪ Prevention of cervical cancer from strains 16, 18

▪ Prevention of genital warts from strains 6, 11

▪ Expanded in 2009 to males ages 9-26

▪ Prevention of genital warts from strains 6, 11

▪ Transitioned to 9-valent vaccine formulation (approved in 2014)

▪ Additional oncogenic types 31, 33, 45, 52, 58

https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil

https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9

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▪ Expanded coverage for ages 27-45 in October 2018

▪ June 2020 approved for the prevention of HPV-related oropharyngeal and other head and neck cancers

▪ Females age 9-45 for the prevention of:

▪ Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58

▪ Cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

▪ Genital warts caused by HPV Types 6 and 11



▪ Males age 9-45 for the prevention of:

▪ Anal, oropharyngeal and other head and neck cancers

caused by HPV Types 16, 18, 31, 33, 45, 52, and 58

▪ Anal precancerous or dysplastic lesions caused by HPV

Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

▪ Genital warts caused by HPV Types 6 and 11


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Interesting Facts About HPV

▪ Over 100 different subtypes have been identified with

varying genetic sequences and oncogenic potential

▪ HPV 16 and 18 are the primary contributors to

cervical cancer

▪ Younger age, use of oral contraceptives, smoking and

number of sexual partners increases risk

Faridi R, Zahra A, Khan K, Idrees M. Oncogenic potential of Human Papillomavirus (HPV) and its relation with cervical cancer. Virol J.

2011;8:269. Published 2011 Jun 3. doi:10.1186/1743-422X-8-269

▪ The majority of patients with HPV will clear the virus on

their own . . . but can be reinfected

▪ HPV-attributable oropharyngeal cancer has surpassed

cervical cancer as the most prevalent type of HPV-

related cancer in the U.S.1

▪ Oropharyngeal cancer affects men five times more than

women1

1Senkomago V, Henley SJ, Thomas CC, Mix JM, Markowitz LE, Saraiya M. Human Papillomavirus–Attributable Cancers — United States, 2012–2016.

MMWR Morb Mortal Wkly Rep 2019;68:724–728.

Interesting Facts About HPV

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Administering HPV 9 Vaccine

▪ Ages 9-14 years:

▪ 2-dose schedule: 2nd dose 6-12 months after the first dose.

If the 2nd dose is <5 months after the 1st dose, a 3rd dose

should be given at least 4 months after the 2nd dose

▪ 3-dose schedule: 0, 2 months, and 6 months

▪ Ages 15-45 years:

▪ 3-dose schedule: 0, 2 months, and 6 months

https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf

ACIP HPV Guidelines


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ACIP HPV Notes


Other Vaccines?

▪ COVID vaccine – but I’m low risk . . .

▪ Carrier

▪ Herd immunity

▪ Flu shot – annually . . . Egg allergy?

▪ Allergist consult?

▪ Non egg-based option (Flucelvax or Flublok)

▪ Flumist

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“Barb”

▪ 65-year-old female

▪ Recently retired

▪ Wants to travel

▪ History of “minor” heart attack

2 years ago

▪ Remembers having chickenpox

and mumps as a child

▪ Last tetanus booster was over

10 years ago after she was bit

by a dog

Barb’s Vaccine History

▪ Td (?) >10 years ago

▪ Flu shot annually through

her work

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Facts about Pneumonia

▪ Streptococcus pneumoniae - leading cause of

pneumonia, sepsis, and meningitis in adults

▪ Depending on site of infection, age, and comorbidities

mortality ranges from 5-35%

Martens P, Worm SW, Lundgren B, Konradsen HB, Benfield T. Serotype-specific mortality from invasive Streptococcus pneumoniae disease

revisited. BMC Infect Dis. 2004;4:21. Published 2004 Jun 30. doi:10.1186/1471-2334-4-21

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PPSV23(Pneumococcal 23-valent polysaccharide vaccine)

▪ Contains 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A,

11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F

▪ Contains a mixture of purified capsular polysaccharide antigen

from the above Streptococcus pneumoniae serotypes

▪ Stimulates a T-cell independent immunity – may result in

waning immunity over time

Full Prescribing information – Pneumovax 23 (pneumococcal vaccine polyvalent) https://www.fda.gov/media/80547/download

PCV13(Pneumococcal 13-valent conjugate vaccine)

▪ Contains 13 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,

19A, 19F, 23F

▪ 12 of the serotypes are the same as those in PPSV23 with

serotype 6A found in PCV13 but not in PPSV23

▪ Conjugate vaccine - combines capsular polysaccharides with

a protein carrier

▪ T-cell dependent immune response with antibody production

and the potential for immune memory

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PCV13 + PPSV23

▪ Based on persistent high burden of pneumococcal disease in the elderly

even with high PPSV23 vaccination rates

▪ 2014 ACIP recommended sequential immunization with PCV13 followed by

PPSV23 in all adults over 65

▪ Guidelines for the dual vaccination was based on a study looking at PCV13

vs PPSV23 (not assessed for superiority)

▪ Also did not look at the combination of PCV13 + PPSV23 vs PPSV23 alone

▪ Have not been able to establish meaningful impact in reduction of invasive

disease using combination vs PPSV23 alone so now “shared clinical

decision-making” recommendation

Hayward S, Thompson LA, McEachern A. Is 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Combined With 23-Valent Pneumococcal Polysaccharide

Vaccine (PPSV23) Superior to PPSV23 Alone for Reducing Incidence or Severity of Pneumonia in Older Adults? A Clin-IQ. J Patient Cent Res Rev. 2016;3(2):

111-115. doi:10.17294/2330-0698.1214

Order Matters

▪ If giving both – PCV13 should be administered prior

to PPSV23

▪ No significant immune boost if PPSV23 precedes

PCV13

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent

pneumococcal polysaccharide vaccine.Jackson LA, Gurtman A, Rice K, Pauksens K, Greenberg RN, Jones TR, Scott DA, Emini EA, Gruber WC,

Schmoele-Thoma B Vaccine. 2013 Aug 2; 31(35):3585-93.

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Newly Approved Pneumococcal Vaccines - 2021

▪ 20-Valent pneumococcal conjugate vaccine1

▪ Manufactured by Wyeth Pharmaceuticals, Marketed by Pfizer Inc - “Prevnar20” for adults

▪ Serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F

▪ October 2021 – CDC ACIP committee provisional recommendation all adults receive a conjugated pneumococcal vaccine either PCV20 OR PCV15 (if PCV15 should be followed sequentially by PPSV23)

▪ 15-Valent pneumococcal conjugate vaccine2

▪ Manufactured by Merck – “Vaxneuvance” for adults (pediatric trials underway)

▪ Serotypes: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F

▪ Noninferior to PCV13 overall, superior for 3 and unique serotypes 22F and 33F

▪ October 2021 – CDC ACIP committee provisional recommendation for sequential immunization PCV15 followed by PPSV23 (all adults 65+; certain adults 19-64 with underlying high risk medical conditions)

1Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2021.2Vaxneuvance Prescribing Information, Merck Sharp & Dohme Corp., 2021.

Other Vaccines for Barb?

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Shingles (Herpes Zoster Virus)


RZV(Recombinant Zoster Virus)

▪ Combination of lyophilized varicella zoster virus glycoprotein E antigen with AS01B adjuvant

▪ The gE antigen – genetically engineered from Chinese hamster ovary cells

▪ Works by boosting VZV-specific immune response (VZV-specific immunity declines with age)

▪ Reduces risk of developing Herpes Zoster by 97.2% in patients over 50 years old, and 89.8% overall in patients over 70 years old

▪ Reduction in incidence of PHN 88.8% in those over age 70

https://www.fda.gov/media/108597/download

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ZLV(Zoster Live Vaccine)

▪ No longer available – pulled from US market in

November 2020

▪ Studies showed 51% reduction in risk of developing

Herpes Zoster and 67% reduction against developing

PHN

▪ Immunity waned over time – protection lasted

approximately 5 years

https://www.cdc.gov/vaccines/vpd/shingles/public/zostavax/index.html

Influenza


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“Senior” Flu ShotsImmune response decreases with age

▪ Options:

▪ Quadrivalent high dose influenza vaccine (4x the antigen concentration)

▪ Adjuvant MF59

▪ No head-to-head trials

▪ CDC lists either as option for seniors

▪ Cost considerations $$$ some retrospective data suggest benefit1

1Wells C, Grobelna A. High Dose Influenza Vaccine for Adults: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa

(ON): Canadian Agency for Drugs and Technologies in Health; 2019 Jan 8. Available from: https://www.ncbi.nlm.nih.gov/books/NBK541617/

Travel Immunizations

▪ Not directly included in the ACIP recommendations

▪ Some are similar – i.e., Hepatitis A, B, Td booster

▪ Some considerations based on destination, activities

planned and personal health history

▪ CDC website:

https://wwwnc.cdc.gov/travel/destinations/list

▪ For travelers

▪ For clinicians

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https://wwwnc.cdc.gov/travel/destinations/list



COVID-19

▪ Constantly evolving

▪ HCPs play critical role

▪ Lots of resources


COVID-19 Vaccination

ACIP recommends use of COVID-19

vaccines within the scope of the Emergency

Use Authorization or Biologics License

Application for the particular vaccine. Interim

ACIP recommendations for the use of

COVID-19 vaccines can be found at

www.cdc.gov/vaccines/hcp/acip-recs/vacc-

specific/covid-19.html

mRNA VaccinesInitial Trial Data

▪ BNT162b21

▪ Pfizer-BioNTech

▪ 2 doses, 21 days apart

▪ FDA approved 16+ (8/2021)

▪ EUA for 12 – 15

▪ Believed to be safe in pregnancy

▪ 95% effective in preventing laboratory confirmed COVID-19 infection in trials (alpha variant)

▪ Most side effects mild-mod

▪ Contraindicated if h/o anaphylaxis or immediate allergic reaction

▪ Polyethylene glycol

▪ After first dose of vaccine

▪ mRNA-12732

▪ ModernaTX, Inc

▪ 2 doses, 28 days apart

▪ EUA for 18 and older (data submitted for EUA for ages:12-17 May 2021)

▪ Believed to be safe in pregnancy

▪ 94.1% effective in preventing laboratory confirmed COVID-19 infection in trials (alpha variant)

▪ Most side effects mild-mod


▪ Polyethylene glycol

▪ After first dose of vaccine

1. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Pfizer-BioNTech.html

2. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/Moderna.html

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http://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html



Viral Vector

▪ JNJ-78436735

▪ Janssen Pharmaceuticals Companies of Johnson & Johnson

▪ Single dose

▪ EUA 18 and older; Believed to be safe in pregnancy

▪ 66.3% effective in preventing laboratory confirmed COVID-19 infection/illness (highly effective in preventing hospitalization/death)

▪ Most side effects mild-moderate


▪ Polysorbate

▪ JNJ-78436735 in past

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html

Clotting issue . . . next slide

Blood Clot Concern

▪ JNJ-78436735 administration temporarily paused after reports of 6 cases of rare/serious blood clots combined with thrombocytopenia (aka thrombosis-thrombocytopenia syndrome “TTS”)

▪ Cerebral venous sinus thrombosis (CVT)

▪ Other large vessel sites

▪ Lifted April 23, 2021 – committees ruled benefits outweigh risks

▪ New verbiage – women ages 18-50 should be “aware” of risk

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html

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Additional Side Effects

▪ Myocarditis/Pericarditis

▪ mRNA vaccines

▪ Typically within 10-14 days

▪ Primarily young adult males (higher risk with COVID-19?)

▪ Guillain-Barre Syndrome

▪ J&J increase risk (4-10x higher than expected baseline frequency)

▪ Begins typically within 6 weeks of vaccine

▪ Immune system targets nerve cells

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

Vaccine Fact Sheets

▪ Janssen fact sheet:

▪ https://www.fda.gov/media/146305/download

▪ Moderna fact sheet:


▪ Pfizer fact sheet:


https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

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Breakthrough Infections . . .

▪ Likely multiple reasons:

▪ Waning immunity

▪ Viral mutations (i.e., delta variant and others)

▪ Viral transmissibility/virulence

▪ Lack of herd immunity? (Even in states/countries that achieved % vaccinations nearing herd immunity surges occurring)

BoostersAs of 10/25/2021

▪ 9/23/21 Boosters recommended for Pfizer vaccine – 6 months after 2nd dose:

▪ 65 years and older & residents of long-term care facilities

▪ 50-64 years at high risk for severe COVID

▪ 18-49 years at high risk if the person feels they need one (risk vs benefit)

▪ 18-64 years with frequent exposure (i.e., essential workers)

▪ 10/22/21 Boosters recommended for Moderna vaccine – 6 months after 2nd dose (same criteria for Pfizer booster):

▪ ½ dose (2.5ml) for routine booster

▪ Full dose for immune compromised (0.5ml)

▪ 10/22/21 2nd dose recommended for ALL J&J vaccine recipients – 2 months after initial dose

▪ 10/22/21 Ok to mix and match . . . .

https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines

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Summary

▪ The development of vaccines have significantly impacted our life expectancy

▪ Shifted primary cause of mortality from communicable disease to non-communicable diseases

▪ Technology continues to evolve allowing for more targeted and better immune stimulating options

▪ ACIP valuable resource – updated yearly

▪ Shared Clinical Decision-Making – engages patients in their healthcare decision/choices

A vaccine is useless if it doesn’t become a vaccination!

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immunizing your adult patients

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