From Immunization Action Coalition <[email protected]>
Subject IAC Express #1487 - Ask The Experts
Date March 30, 2020 12:07 PM
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Issue 1487: March 30, 2020

Ask the Experts: IAC Experts Answer Your Questions

As a thank-you to our loyal IAC Express readers, we periodically publish extra editions such as this one, with new and updated "Ask the Experts" Q&As answered by experts from the Immunization Action Coalition (IAC). The Q&As in this issue all relate to pneumococcal vaccination in light of the recent Advisory Committee on Immunization Practices (ACIP) pneumococcal vaccine recommendations for adults age 65 years and older ([link removed]) published November 22, 2019.

IAC wishes to recognize its team of experts: Kelly L. Moore, MD, MPH (team lead); Carolyn Bridges, MD, FACP; William Atkinson, MD, MPH; and Deborah Wexler, MD.

To access answers to many more questions on the use of pneumococcal vaccines, visit IAC's Ask the Experts: Pneumococcal Vaccines (PCV13 and PPSV23) web page ([link removed]) on immunize.org.

PCV13 Vaccination of Adults
* Q: What changed in November 2019 regarding ACIP pneumococcal conjugate vaccine (PCV13, Prevnar, Pfizer) recommendations for adults age 65 years and older?
* Q: What is CDC’s guidance for shared clinical decision-making for PCV13 vaccination of adults age 65 years and older?
* Q: If PCV13 is given based on shared clinical decision-making, when should PCV13 be given?
* Q: Did the recommendation change for PPSV23 vaccination of adults age 65 years and older?
* Q: Which high-risk adults are recommended to receive a dose of PCV13?
* Q: How effective is PCV13 vaccine in adults 65 years and older?
* Q: I have a patient who takes adalimumab (Humira) for rheumatoid arthritis. Does a person who takes adalimumab meet the definition of immunosuppression for the purposes of PCV13 vaccination?

PPSV23 Vaccination of Children and Adults
* Q: Who is recommended to receive pneumococcal polysaccharide vaccine (PPSV23)?
* Q: Could you briefly summarize the revaccination recommendations for PPSV23?
* Q: How effective is PPSV23 vaccine for adults 65 years and older?
* Q: I have patients who are in their 70s and 80s and remember getting a pneumococcal vaccine a few years ago. Should we assume that this was PPSV23? Should I assume that it was given before the 65th birthday?
* Q: Since PPSV23 is recommended for all adults who smoke, should adults who use smokeless tobacco products (e.g., chewing tobacco, e-cigarettes) be vaccinated too?
* Q: ACIP recommends vaccinating adults with asthma with PPSV23. Should I give PPSV23 to people with mild, intermittent asthma or exercise-induced asthma? Why isn't PPSV23 recommended for children with asthma?
* Q: Should a healthy 75-year-old patient who was given PPSV23 at age 65 years be revaccinated?

PCV13 Vaccination of Children
* Q: What are the recommendations for routine vaccination of children with PCV13?
* Q: Which underlying medical conditions indicate that a child age 6 through 18 years should receive PCV13?

Vaccination Intervals for PPSV23 and PCV13
* Q: What dosing intervals should be used when giving PCV13 and PPSV23 to patients (children and adults) who are recommended to receive both vaccines?
* Q: A 2-month-old was mistakenly given PPSV23 instead of PCV13. What should be done?
* Q: Rather than giving PCV13 first and waiting 8 weeks to give PPSV23 as recommended for an immunocompromised child (2 years or older) or adult patient, we inadvertently gave both vaccines at the same visit. We are looking for guidance.
* Q: Can I give other vaccines at the same time I give either PCV13 or PPSV23 to a patient?

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PCV13 Vaccination of Adults
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Q: WHAT CHANGED IN NOVEMBER 2019 REGARDING ACIP PNEUMOCOCCAL CONJUGATE VACCINE (PCV13, PREVNAR, PFIZER) RECOMMENDATIONS FOR ADULTS AGE 65 YEARS AND OLDER?

A: According to the updated Advisory Committee on Immunization Practices (ACIP) recommendations published November 22, 2019, PCV13 vaccination is no longer routinely recommended for all adults 65 years and older. Instead, shared clinical decision-making for PCV13 use is recommended for adults age 65 years and older who do not have an immunocompromising condition, cerebrospinal fluid (CSF) leak, or cochlear implant. PCV13 continues to be recommended for all adults with immunocompromising conditions, cerebrospinal fluid (CSF) leak, or cochlear implant.

Immunocompromising conditions include chronic renal failure, nephrotic syndrome, congenital or acquired immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies.

The 2019 PCV13 recommendations update ACIP's 2014 statement which recommended routine use of pneumococcal conjugate vaccine (PCV13) in series with pneumococcal polysaccharide vaccine (PPSV23) for all adults 65 years and older. The incidence of PCV13-type disease has been reduced to historically low levels among adults age 65 years and older through indirect effects from pediatric PCV13 use. Because of this changing epidemiology, ACIP updated its recommendations on PCV13 vaccine scheduling in older adults and incorporated the concept of shared clinical decision-making, as summarized in the question and answer below.

Pneumococcal polysaccharide vaccine (PPSV23, Pneumovax, Merck) continues to be recommended for all adults age 65 years and older.

For more information, the most recent ACIP pneumococcal vaccine recommendations can be accessed at: [link removed].

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Q: WHAT IS CDC’S GUIDANCE FOR SHARED CLINICAL DECISION-MAKING FOR PCV13 VACCINATION OF ADULTS AGE 65 YEARS AND OLDER?

A: When patients and vaccine providers engage in shared clinical decision-making for PCV13 use to determine whether PCV13 is right for the specific individual age 65 years and older, considerations include the individual patient's risk for exposure to PCV13 serotypes and the risk for pneumococcal disease for that person as a result of underlying medical conditions. These considerations are detailed below.

* PCV13 is a safe and effective vaccine for older adults. The risk for PCV13-type disease among adults age 65 years and older is much lower than it was before the pediatric program was implemented. The remaining risk is a function of each individual patient's risk for exposure to PCV13 serotypes and the influence of underlying medical conditions on the patient's risk for developing pneumococcal disease if exposure occurs.

* The following adults age 65 years and older are potentially at increased risk for exposure to PCV13 serotypes and might attain higher than average benefit from PCV13 vaccination, and providers/practices caring for many patients in these groups may consider regularly offering PCV13 to their patients age 65 years and older who have not previously received PCV13:

+ Persons residing in nursing homes or other long-term care facilities
+ Persons residing in settings with low pediatric PCV13 uptake
+ Persons traveling to settings with no pediatric PCV13 program

* Incidence of PCV13-type invasive pneumococcal disease and pneumonia increases with increasing age and is higher among persons with chronic heart, lung, or liver disease, diabetes, or alcoholism, and those who smoke cigarettes or who have more than one chronic medical condition. Although indirect effects from pediatric PCV13 use were documented for these groups of adults and were comparable to those observed among healthy adults, the residual PCV13-type disease burden remains higher in these groups. Providers and practices caring for patients with these medical conditions may consider offering PCV13 to such patients who are age 65 years and older and who have not previously received PCV13.

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Q: IF PCV13 IS GIVEN BASED ON SHARED CLINICAL DECISION-MAKING, WHEN SHOULD PCV13 BE GIVEN?

A: If PCV13 is recommended for an adult age 65 years or older based on shared clinical decision-making, PCV13 should be administered first followed by PPSV23 one year later.

If PCV13 is given to adults of any age with immunocompromising conditions, CSF leaks, or cochlear implants, then PCV13 should be given first followed by PPSV23 at least 8 weeks later.

If PPSV23 has already been given, the PCV13 should be given at least 1 year later.

PCV13 and PPSV23 should not be given at the same time.

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Q: DID THE RECOMMENDATION CHANGE FOR PPSV23 VACCINATION OF ADULTS AGE 65 YEARS AND OLDER?

A: No. ACIP continues to recommend that all adults age 65 years and older routinely receive 1 dose of PPSV23. PPSV23 contains 12 serotypes in common with PCV13 and an additional 11 serotypes for which there are no indirect effects from PCV13 use in children. The additional 11 serotypes account for 32%–37% of invasive pneumococcal disease among adults age 65 years and older. Adults age 65 years and older who received one or more doses of PPSV23 before age 65 years should receive one additional dose of PPSV23 at age 65 years or older, at least 5 years after the previous PPSV23 dose.

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Q: WHICH HIGH-RISK ADULTS ARE RECOMMENDED TO RECEIVE A DOSE OF PCV13?

A: Pneumococcal conjugate vaccine (PCV13, Prevnar 13, Pfizer) is recommended for all adults without a prior PCV13 vaccination who have a high-risk condition, including immunocompromising conditions, cerebrospinal fluid (CSF) leak, and cochlear implant.

Immunocompromising conditions include chronic renal failure, nephrotic syndrome, congenital or acquired immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies.

PCV13 can be given to adults age 65 years and older without these high-risk conditions based on shared clinical decision-making. Considerations for PCV13 vaccination of adults age 65 years and older without these high-risk conditions include any potential increased risk for exposure to PCV13 serotypes, such as residing in a nursing home or other long-term care facility, residing in settings with low PCV13 vaccination rates among children, or traveling to areas with no PCV13 vaccination coverage, and their risk of getting pneumococcal disease as a result of underlying medical conditions, such as chronic heart, lung or renal disease, diabetes, alcoholism, or smoking cigarettes.

For complete information on CDC’s recommendations for the use of pneumococcal vaccines, go to [link removed].

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Q: HOW EFFECTIVE IS PCV13 VACCINE IN ADULTS 65 YEARS AND OLDER?

A: The CAPiTA PCV13 vaccine 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, and 75.0% (CI = 41.4%–90.8%) efficacy against vaccine-type invasive pneumococcal disease (IPD) among adults age 65 years and older. PCV13 is licensed for use among adults 50 years of age and older.

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Q: I HAVE A PATIENT WHO TAKES ADALIMUMAB (HUMIRA) FOR RHEUMATOID ARTHRITIS. DOES A PERSON WHO TAKES ADALIMUMAB MEET THE DEFINITION OF IMMUNOSUPPRESSION FOR THE PURPOSES OF PCV13 VACCINATION?

A: Adalimumab is a potent anti-inflammatory drug that blocks the activity of tumor necrosis factor (TNF). Adalimumab is considered immunosuppressive because serious infections have been reported in people taking the drug, including tuberculosis and infections caused by viruses, fungi, or bacteria. Consequently, a person taking adalimumab or other drugs that affect TNF activity (such as infliximab [Remicade], certolizumab pegol [Cimzia], golimumab [Simponi], or etanercept [Enbrel]) should be considered to have immunosuppression and receive PCV13 followed by PPSV23 at least 8 weeks later.

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PPSV23 Vaccination of Children and Adults
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Q: WHO IS RECOMMENDED TO RECEIVE PNEUMOCOCCAL POLYSACCHARIDE VACCINE (PPSV23)?

A: PPSV23 (Pneumovax, Merck) is recommended for anyone who meets any of the criteria below:
* Age 65 years and older
* Age 2 through 64 years with any of the following conditions
1. tobacco smokers age 19 years and older
2. alcoholism
3. chronic liver disease, including cirrhosis
4. chronic heart disease (e.g., congestive heart failure, cardiomyopathies), excluding hypertension
5. chronic lung disease (including COPD and emphysema, and for adults age 19 years and older, asthma)
6. diabetes mellitus
7. candidate for or recipient of cochlear implant
8. cerebrospinal fluid (CSF) leak
9. functional or anatomic asplenia (e.g., splenectomy or congenital asplenia)
10. sickle cell disease and other hemoglobinopathies
11. congenital or acquired immunodeficiencies (e.g., B- (humoral) or T-lymphocyte deficiency, complement deficiencies (particularly C1, C2, C3, and C4), and phagocytic disorders (excluding chronic granulomatous disease)
12. generalized malignancy
13. HIV infection
14. Hodgkin disease, leukemia, lymphoma, and multiple myeloma
15. immunosuppression due to treatment with medication, including long-term systemic corticosteroids, and radiation therapy
16. solid organ transplantation; for bone marrow transplantation, see [link removed]
17. chronic renal failure or nephrotic syndrome

Public health authorities may also consider recommending PPSV23 for Alaska Natives and American Indians age 50 through 64 years who are living in areas in which the risk of invasive pneumococcal disease is increased.

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=Q: COULD YOU BRIEFLY SUMMARIZE THE REVACCINATION RECOMMENDATIONS FOR PPSV23? =

A: Children and adults younger than age 65 years who are at highest risk for serious pneumococcal infection (see categories 9 through 17 in previous answer) should get 2 doses of PPSV23 five years apart, with a third dose after they turn age 65 (if at least 5 years have passed since the last dose).

Patients with risk factors 1 through 8 above should get one dose of PPSV23 before age 65 and then a second dose after they turn 65 years (if at least 5 years have passed since the last dose).

Patients with no risk factors should get one dose at age 65. Thus, depending on risk and age at vaccination, an adult may have received 1, 2, or 3 doses of PPSV23.

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Q: HOW EFFECTIVE IS PPSV23 VACCINE FOR ADULTS 65 YEARS AND OLDER?

A: PPSV23 vaccine is 60%–80% effective against invasive pneumococcal disease when it is given to immunocompetent people age 65 years and older or people with chronic illnesses. The vaccine is less effective in immunocompromised people. Studies of the effectiveness of this vaccine in preventing noninvasive pneumococcal pneumonia among adults age 65 years and older have been inconsistent.

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Q: I HAVE PATIENTS WHO ARE IN THEIR 70S AND 80S AND REMEMBER GETTING A PNEUMOCOCCAL VACCINE A FEW YEARS AGO. SHOULD WE ASSUME THAT THIS WAS PPSV23? SHOULD I ASSUME THAT IT WAS GIVEN BEFORE THE 65TH BIRTHDAY?

A: Because PPSV23 and PCV13 were both routinely recommended for all adults 65 years of age and older from 2014-2019, it cannot be assumed which pneumococcal vaccine they received. Ideally, providers and patients should work to verify which vaccines were received, including by querying the jurisdiction’s immunization information system where the patient was likely vaccinated.

If vaccination records cannot be obtained, then the patient should be vaccinated.

All patients should receive PPSV23 at age 65 years or older. If a patient has a high-risk indication for PCV13 or PCV13 is recommended based on shared clinical decision-making, then PCV13 should be given first followed by PPSV23.

*Note: Per the CDC General Best Practices for Immunization Guidelines, self-reported doses of influenza and PPSV23 are acceptable. All other vaccines must be documented with a written, dated record.

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Q: SINCE PPSV23 IS RECOMMENDED FOR ALL ADULTS WHO SMOKE, SHOULD ADULTS WHO USE SMOKELESS TOBACCO PRODUCTS (E.G., CHEWING TOBACCO, E-CIGARETTES) BE VACCINATED TOO?

A: No. ACIP does not identify people who use smokeless tobacco products as being at increased risk for pneumococcal disease or as being in a risk group recommended for vaccination.

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Q: ACIP RECOMMENDS VACCINATING ADULTS WITH ASTHMA WITH PPSV23. SHOULD I GIVE PPSV23 TO PEOPLE WITH MILD, INTERMITTENT ASTHMA OR EXERCISE-INDUCED ASTHMA? WHY ISN'T PPSV23 RECOMMENDED FOR CHILDREN WITH ASTHMA?

A: PPSV23 (but not PCV13) is recommended for adults age 19 through 64 years with all types of asthma. Available data do not indicate that asthma alone increases the risk of invasive pneumococcal disease among people younger than age 19 years, so PPSV23 is not currently recommended for people younger than age 19 years with asthma. For more information, go to www.cdc.gov/mmwr/preview/mmwrhtml/mm5934a3.htm.

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Q: SHOULD A HEALTHY 75-YEAR-OLD PATIENT WHO WAS GIVEN PPSV23 AT AGE 65 YEARS BE REVACCINATED?

A: No. Adults vaccinated at age 65 years or older do not require any more doses of PPSV23.

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PCV13 Vaccination of Children
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Q: WHAT ARE THE RECOMMENDATIONS FOR ROUTINE VACCINATION OF CHILDREN WITH PCV13?

A: All infants should be given a primary series of PCV13 at ages 2, 4, and 6 months, with a booster at age 12 to 15 months. Children who fall behind should be given catch-up vaccination through age 59 months, if otherwise healthy or, through age 71 months if they have certain underlying medical conditions.

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Q: WHICH UNDERLYING MEDICAL CONDITIONS INDICATE THAT A CHILD AGE 6 THROUGH 18 YEARS SHOULD RECEIVE PCV13?

A: A single dose of PCV13 should be given to children 6–18 years old who have not received PCV13 before and have anatomic or functional asplenia (including sickle cell disease), immunocompromising conditions, such as HIV-infection, cochlear implant, or CSF leaks. Routine use of PCV13 is not recommended for healthy children age 5 years or older.

When elective splenectomy, immunocompromising therapy, or cochlear implant placement is being planned, PCV13 and PPSV23 vaccination, given in series, should be completed at least 2 weeks before surgery or initiation of therapy in children not up to date on these vaccines. For people not vaccinated 2 weeks prior, vaccinate as soon as possible.

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Vaccination Intervals for PPSV23 and PCV13
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Q: WHAT DOSING INTERVALS SHOULD BE USED WHEN GIVING PCV13 AND PPSV23 TO PATIENTS (CHILDREN AND ADULTS) WHO ARE RECOMMENDED TO RECEIVE BOTH VACCINES?

A: Give PCV13 before PPSV23 if possible. PCV13 and PPSV23 should not be given at the same visit. For children, if the child has already received PPSV23, wait at least 8 weeks before giving PCV13.

For adults at highest risk of pneumococcal disease (immunocompromised, asplenia, CSF leak, or cochlear implant), give PCV13 followed by PPSV23 at least 8 weeks later.

For adults age 19 through 64 years with other high-risk conditions (e.g., chronic heart, lung, or liver disease, diabetes, smoking, or alcoholism), give PPSV23 followed by an additional PPSV23 dose at age 65 years (at least 5 years after the first PPSV23 dose).

For people age 65 years and older with no prior pneumococcal vaccination who do not have a high-risk condition, but a decision is made, based on shared clinical decision-making, to give PCV13, give PCV13 followed by PPSV23 one year later.

For adults who have already received PPSV23 and for whom PCV13 is recommended, wait one year before giving PCV13.

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Q: A 2-MONTH-OLD WAS MISTAKENLY GIVEN PPSV23 INSTEAD OF PCV13. WHAT SHOULD BE DONE?

A: PPSV23 is not effective in children less than 24 months of age. PPSV23 given at this age should not be considered to be part of the pneumococcal vaccination series. PCV13 should be administered as soon as the error is discovered. Any time the wrong vaccine is given, the parent/patient should be notified.

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Q: RATHER THAN GIVING PCV13 FIRST AND WAITING 8 WEEKS TO GIVE PPSV23 AS RECOMMENDED FOR AN IMMUNOCOMPROMISED CHILD (2 YEARS OR OLDER) OR ADULT PATIENT, WE INADVERTENTLY GAVE BOTH VACCINES AT THE SAME VISIT. WE ARE LOOKING FOR GUIDANCE.

A: PCV13 and PPSV23 should not be administered at the same visit or at an interval less than 8 weeks. However, in adults, if PCV13 and PPSV23 are administered at the same visit or at an interval less than 8 weeks, neither dose needs to be repeated. In children, if PCV13 and PPSV23 are administered at the same visit, the PCV13 dose should be repeated, and should be administered no earlier than 8 weeks after doses that were administered on the same day.

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Q: CAN I GIVE OTHER VACCINES AT THE SAME TIME I GIVE EITHER PCV13 OR PPSV23 TO A PATIENT?

A: Yes, with several exceptions. PPSV23 and PCV13 are both inactivated vaccines, which means you can give all other recommended vaccines at the same visit (using separate syringes) or at any later time with no waiting period following the vaccination. Here are the exceptions:
1. You cannot give both PCV13 and PPSV23 at the same time.
2. If the person has functional or anatomic asplenia or HIV infection, observe these rules:
+ If using Menactra brand MenACWY vaccine, you should give PCV13 first with a 4-week separation between the final dose of PCV13 and Menactra.
+ If using Menveo brand MenACWY, give PCV13 at the same visit or at any interval before or after each other.

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Editorial Information

Editor
Deborah L. Wexler, MD ([email protected])

Associate Editors
Carolyn Bridges, MD, MPH ([email protected])
John D. Grabenstein, RPh, PhD ([email protected])
Sharon Humiston, MD, MPH ([email protected])

Consulting Editors
Taryn Chapman, MS ([email protected])
Marian Deegan, JD ([email protected])
Courtnay Londo, MA ([email protected])
Jane Myers, MA, EdM ([email protected])

Technical Editor
Liv Augusta Anderson, MPP ([email protected])

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About IAC Express
We encourage you to reprint any of these Q&As in your own newsletters. When you do so, please add a note that the Immunization Action Coalition is the source of the material and provide a link to this issue ([link removed]).

IAC Express is supported in part by Grant No. 6NH23IP922550 from the National Center for Immunization and Respiratory Diseases, CDC. Its contents are solely the responsibility of IAC and do not necessarily represent the official views of CDC.

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