CDC Current Pneumococcal Vaccination Recommendations
On October 20, 2022, the ACIP voted to provide updated recommendations for the administration of Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine). These recommendations have been adopted by the CDC Director and are now official. They are now published in the MMWR as of September 8, 2023.2
Click here for the full recommendation
*Alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus, chronic renal failure, nephrotic syndrome, 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, CSF leak, or cochlear implant.1
ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention; MMWR=Morbidity and Mortality Weekly Report.
Pneumococcal Pneumonia
Risk of Hospitalization
Pneumococcal pneumonia is a potentially serious disease with no seasonality that can lead to hospitalization at any time of year.3,4 Furthermore, age and certain medical conditions increase the risk of pneumococcal pneumonia.4Pneumococcal bacteria are responsible for 10% to 30% of community-acquired pneumonia (CAP) for adults3
>10x
more hospitalizations
Adults age 65 or older are >10x more likely to be hospitalized with pneumococcal pneumonia than adults younger than 505,6*
~2 in 5
patients are hospitalized
~2 in 5 adult patients age 65 or older with all-cause CAP are hospitalized7
~5
days in the hospital
The mean length of hospital stays due to pneumococcal pneumonia is ~5 days for adults age 18 or older who require hospitalization8†
Health Conditions & Age Risks
Even younger adult patients with certain chronic health conditions have a greater risk of getting pneumococcal pneumonia.9Elevated risk for pneumococcal pneumonia in those aged 18-64 with preexisting condition vs healthy‡ adults aged 18-64 (2013-2015)9
Chronic Condition | Times Greater Risk |
---|---|
Asthma | 5.7x |
Chronic Lung Disease | 22.6x |
Chronic Heart Disease | 7.9x |
Diabetes | 5.3x |
On immunosuppressants | 17.3x |
Chronic renal failure | 29.9x |
Nonfunctioning spleen (asplenia) | 48.9x |
HIV | 15.2x |
Elevated risk in healthy‡ older adults vs healthy adults aged 18 to 49 (2013-2015)10§
Treatment Challenges
Treatment after infection can be challenging. Therefore, helping to protect through immunization is key.
- The emergence of drug-resistant S. pneumoniae has made treatment of pneumococcal disease more difficult11
- In 2021, as many as 29% of pneumococcal isolates had some degree of antibiotic resistance12
Clinical and Economic Burden
The clinical and economic burden of pneumococcal disease affects every community because it can lead to significant morbidity and mortality in adults. Consider these numbers:
>180,000
adult hospital admissions
and
>150,000
adult outpatient visits
in the US yearly for pneumococcal disease13‖
5%-7%
case-fatality rate
for pneumococcal pneumonia (may be even higher in the elderly)14
~10%
of all patients with IPD die from their illness
according to the CDC (even higher for the elderly and those with certain underlying illnesses)11
Economic BurdenPneumococcal disease may result in costly hospital stays. The data below were observed among adults admitted for an episode of pneumococcal disease in 20178¶:
Pneumococcal Pneumonia All adults |
|
---|---|
5.1 days | Mean length of stay |
$11,549 | Mean inpatient cost |
IPD All adults |
|
---|---|
7.2 days | Mean length of stay |
$17,966 | Mean inpatient cost |
*Calculation of relative incidence (not included in publication). The average incidences reported in Ramirez et al for adults under age 50 and those age 65 or older were weighted to the estimated 2015 US population using data from the US Census.5,6
†Based on Agency for Healthcare Research and Quality reported outcomes by patient and hospital characteristics for various principal diagnoses, 2017.8
‡“Healthy” is defined as adults with none of the underlying chronic conditions in this study.4
§Retrospective, claims-based cohort study analyzed data from 2 large US databases for 56.6 million adults with commercial or Medicare coverage between 2005 and 2015. Researchers examined patients with claims indicative of a hospitalization for IPD, all-cause pneumonia, or pneumococcal pneumonia and used operational algorithms and codes to identify patients with conditions that place them at risk or high risk for pneumococcal disease. Rate ratios were calculated using rates of IPD and pneumococcal pneumonia per 100,000 person-years in healthy adults in the older age groups compared with healthy adults aged 18-49 years. Limitations include possible misclassification of patients with underlying conditions and lack of knowledge about pneumococcal vaccine uptake during the study period. Adults with public health insurance and adults without health insurance are not represented in the study databases; caution should be used when generalizing study results to other populations and settings.4,10
‖Extrapolated to year-2019 US population estimates.
¶Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project data for discharges with ICD-10 codes for pneumococcal pneumonia (J13) and IPD (A40.3, sepsis due to S. pneumoniae; B95.3, S. pneumoniae as cause of other diseases; G00.1, pneumococcal meningitis; M00.1, pneumococcal arthritis and polyarthritis; M00.2, other streptococcal arthritis; R78.81, bacteremia, combined).8
CDC=Centers for Disease Control and Prevention; IPD=invasive pneumococcal disease.
About Prevnar 20®
20 Serotype Coverage
Help protect patients against pneumococcal pneumonia with the broadest serotype coverage available in a conjugate vaccine15-17
Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) helps protect against the 20 Streptococcus pneumoniae serotypes in the vaccine15
Pneumococcal disease can place a burden on patients and the healthcare system
- Advancing age and chronic conditions such as diabetes, asthma, and heart and pulmonary diseases heighten pneumococcal risk4,9
- Pneumococcal pneumonia results in more than 180,000 adult hospitalizations annually13
A next-generation pneumococcal conjugate vaccine
- Delivers the most serotypes in a pneumococcal conjugate vaccine by adding 7 serotypes to Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])15-17
- Provides coverage for some of the most prevalent serotypes that can threaten your patients' or members' health15,18-20
Just 1 dose of Prevnar 20 delivers the most serotypes in a pneumococcal conjugate vaccine, by adding 7 serotypes15-17
Prevnar 13 | PCV15* | Prevnar 20 | |
---|---|---|---|
1 | |||
3 | |||
4 | |||
5 | |||
6A | |||
6B | |||
7F | |||
8 | |||
9V | |||
10A | |||
11A | |||
12F | |||
14 | |||
15B | |||
18C | |||
19A | |||
19F | |||
22F | |||
23F | |||
33F |
*There are currently no studies comparing the efficacy of Prevnar 20 to a pneumococcal 15-valent conjugate vaccine. PCV15 is manufactured by Merck & Co.
More serotypes may help protect against more cases of IPD
Proportion of IPD cases from 2018-2019 caused by serotypes in pneumococcal conjugate vaccines18†
Age | Prevnar 13 | PCV15‡ | Prevnar 20 |
---|---|---|---|
19-49 | 32% | 44% | 62% |
50-64 | 29% | 42% | 59% |
65+ | 27% | 42% | 56% |
Prevnar 20 contains serotypes that account for the majority of IPD in adults in the US15,21
Percentage of potential IPD cases covered by vaccine serotypes21§‖¶
Age | Prevnar 13 | PCV15‡ | Prevnar 20 |
---|---|---|---|
19-64 CMC | 32% | 44% | 61% |
19-64 IC | 25% | 39% | 53% |
65+ | 27% | 42% | 56% |
§The 13 serotypes include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, and 6C (highly related to 6A22). The 15 serotypes include all 13 serotypes and the additional serotypes 22F and 33F. 20 serotypes include all 15 serotypes and the additional serotypes 8, 10A, 11A, 12F, and 15B.21
‖Percentages for adults age 19-64 with chronic medical conditions and 19-64 with immunocompromising conditions based on Active Bacterial Core surveillance data collected by the Centers for Disease Control and Prevention in 2017-2018.21
¶Percentages for adults age 65 or older based on Active Bacterial Core surveillance data collected by the Centers for Disease Control and Prevention in 2018-2019.21
CMC=chronic medical conditions; IC=immunocompromising conditions; IPD=invasive pneumococcal disease; PCV15=pneumococcal 15-valent conjugate vaccine.
One and Done15
A patient's age and/or chronic condition can increase the risk of pneumococcal disease4,9
Vaccine
Dose
Visit
Vaccine
Dose
Visit
Complete the CDC-recommended pneumococcal vaccination schedule with one dose of Prevnar 20 for ALL adult patients23
On October 20, 2022, the ACIP voted to provide updated recommendations. These recommendations have been adopted by the CDC Director and are now official. They are now published in the Morbidity and Mortality Weekly Report (MMWR) as of September 8, 2023.2
*Also applies to people who received PCV7 at any age and have received no other pneumococcal vaccines.
†If PCV13 was administered at any age and PPSV23 was administered before age 65, with the last pneumococcal vaccine being at least 5 years prior, then the patient is eligible for Prevnar 20 as part of routine vaccination. Based on shared decision-making, a patient is eligible to receive Prevnar 20 if PCV13 was administered at any age and PPSV23 was administered at or after the age of 65, and the last pneumococcal vaccine was at least 5 years prior.
‡Adults with chronic medical conditions were previously not recommended to receive PCV13, and there is no current CDC recommendation for those who have received both PCV13 and PPSV23.
§Also applies to those with an immunocompromising condition (listed below) who have received PCV13 plus 2 doses of PPSV23.
Underlying medical conditions or other risk factors
Alcoholism; chronic heart disease (including CHF and cardiomyopathies); chronic liver disease; chronic lung disease (including COPD, emphysema, and asthma); chronic renal failureǁ; cigarette smoking; cochlear implant; congenital or acquired aspleniaǁ; cerebrospinal fluid leak; diabetes; generalized malignancyǁ; HIV infectionǁ; Hodgkin diseaseǁ; congenital or acquired immunodeficiency (includes B- [humoral] or T-lymphocyte deficiency, complement deficiencies [particularly C1, C2, C3, and C4 deficiencies], and phagocytic disorders [excluding chronic granulomatous disease])ǁ; iatrogenic immunosuppression (diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids and radiation therapy)ǁ; leukemiaǁ; lymphomaǁ; multiple myelomaǁ; nephrotic syndromeǁ; solid organ transplantǁ; or sickle cell disease or other hemoglobinopathies.23ǁ
ǁImmunocompromising conditions.23Is Your Patient Eligible But Hesitant?
Overcoming barriers to immunization
There are many reasons for vaccine hesitancy. Discuss the facts with adult patients who are eligible for a vaccination:
No need for vaccination when diseases have been eliminated24
Outbreaks of previously eradicated infectious diseases have been attributed to vaccine refusal25
Mistrust of science24
Misinformation results from a lack of information about vaccines
Concerns about safety25
Components of H. influenzae type B, pneumococcal, and other vaccines are extensively tested for safety
Belief that vaccines are not effective24
Those who are vaccinated may still get sick, but may experience mild symptoms
Belief that vaccines will make you sick15, 24, 26
Side effects are generally mild to moderate
You can delay routine vaccinations until the pandemic is over26,27
The CDC recommends staying up to date on routine vaccinations
Here's a Resource You Can Download and Review With Patients Who Are Still Vaccine Hesitant and Say Things Like:
- Am I at risk because of my age or health conditions?4
- How does my age put me at risk for pneumococcal pneumonia?28
- How do my health conditions put me at risk for pneumococcal pneumonia?4,9
- How could pneumococcal pneumonia make my health condition worse?4,9
Alcoholism; chronic heart disease (including CHF and cardiomyopathies); chronic liver disease; chronic lung disease (including COPD, emphysema, and asthma); chronic renal failureǁ; cigarette smoking; cochlear implant; congenital or acquired asplenia; cerebrospinal fluid leak; diabetes; generalized malignancy; HIV infection; Hodgkin disease; congenital or acquired immunodeficiency (includes B- [humoral] or T-lymphocyte deficiency, complement deficiencies [particularly C1, C2, C3, and C4 deficiencies], and phagocytic disorders [excluding chronic granulomatous disease])ǁ; iatrogenic immunosuppression (diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids and radiation therapy)ǁ; leukemiaǁ; lymphomaǁ; multiple myelomaǁ; nephrotic syndromeǁ; solid organ transplantǁ; or sickle cell disease or other hemoglobinopathies.30ǁ
Immunocompromising conditions.30
ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention; CHF=congestive heart failure; COPD=chronic obstructive pulmonary disease; CSF=cerebrospinal fluid; PCV13=13-valent pneumococcal conjugate vaccine; PPSV23=23-valent pneumococcal polysaccharide vaccine.
Clinical Study Results
Results of 3 clinical studies showing the immunogenicity of PREVNAR 20
Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) can help protect against the 20 Streptococcus pneumoniae serotypes in the vaccine15
Three phase 3 studies involving more than 6000 adult participants15:
Immunogenicity
- Demonstrated immunogenicity across serotypes in pneumococcal vaccine–naïve adults age 18 and older
- Induced immune responses in older adults previously vaccinated with Prevnar 13® or PPSV23 or both
Adverse events
- Most AEs were mild or moderate
AE=adverse event; PPSV23=23-valent pneumococcal polysaccharide vaccine.
Detailed Safety Information
The most common side effects were pain and swelling at the injection site, muscle pain, fatigue, headache, and joint pain.15 See tables below for more details.
Adverse reaction data from Study 1: Safety in pneumococcal vaccine–naïve adults15
Percentage of participants in Study 1 with solicited adverse reactions within 7 to 10 days after vaccination in pneumococcal vaccine-naïve adults*
18-49 years of age Prevnar 20 (N†=335), %
Local reaction‡ | |
Pain at injection site§|| | 81.2 |
Swelling (>2.0 cm)§¶ | 11.6 |
Redness (>2.0 cm)§¶ | 9.0 |
Any local reaction# | 81.2 |
Systemic reaction‡ | |
Muscle pain** | 66.6 |
Fatigue** | 42.7 |
Headache** | 38.8 |
Joint pain** | 13.4 |
Fever (≥38.0°C) | 1.2 |
Any systemic reaction†† | 79.4 |
Use of antipyretic or pain medication‡‡ | 25.7 |
50-59 years of age Prevnar 20 (N†=331), %
Local reaction‡ | |
Pain at injection site§|| | 72.5 |
Swelling (>2.0 cm)§¶ | 8.8 |
Redness (>2.0 cm)§¶ | 8.2 |
Any local reaction# | 72.8 |
Systemic reaction‡ | |
Muscle pain** | 49.8 |
Fatigue** | 39.3 |
Headache** | 32.3 |
Joint pain** | 15.4 |
Fever (≥38.0°C) | 1.5 |
Any systemic reaction†† | 69.5 |
Use of antipyretic or pain medication‡‡ | 24.5 |
≥60 years of age Prevnar 20/Saline (N†=1505), %
Local reaction‡ | |
Pain at injection site§|| | 55.4 |
Swelling (>2.0 cm)§¶ | 7.5 |
Redness (>2.0 cm)§¶ | 7.3 |
Any local reaction# | 57.4 |
Systemic reaction‡ | |
Muscle pain** | 39.1 |
Fatigue** | 30.2 |
Headache** | 21.5 |
Joint pain** | 12.6 |
Fever (≥38.0°C) | 0.9 |
Any systemic reaction†† | 55.2 |
Use of antipyretic or pain medication‡‡ | 18.5 |
*Study 1 was conducted in the United States and in Sweden.
†N=Number of participants with any e-diary data reported after vaccination (after Vaccination 1 [Prevnar 20 or PCV13] for Study 1 participants 60 years of age and older). This value is the denominator for the percentage calculations.
‡Local reactions measured within 10 days after vaccination. Systemic reaction measured within 7 days after vaccination.
§Includes all participants who reported a reaction as “mild,” “moderate,” or “severe” during Day 1 to Day 10 after vaccination.
||Mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity.
¶Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit=0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as follows: mild is >2.0 to 5.0 cm; moderate is >5.0 to 10.0 cm; severe is >10.0 cm.
#“Any local reaction” includes all participants who reported any injection site reaction (pain, swelling, or redness) as “mild,” “moderate,” or “severe” during Day 1 to Day 10 after vaccination.
**Includes all participants who reported a reaction as "mild," "moderate," or "severe" during Day 1 to Day 7 after vaccination. Mild=does not interfere with activity; moderate=some interference with activity; severe=prevents daily activity.
††“Any systemic reaction” includes all participants who reported any fever ≥38.0°C or any other systemic reaction (fatigue, headache, joint pain, or muscle pain) as “mild,” “moderate,” or “severe” during Day 1 to Day 7 after vaccination.
‡‡Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (ie, number of reactions reported).
PCV13=pneumococcal 13-valent conjugate vaccine.
Preparation for Administration15
Do not mix Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) with other vaccines/products in the same syringe.
1
Resuspend drug product
Hold the prefilled syringe horizontally between the thumb and the forefinger and shake vigorously until the vaccine is a homogeneous white suspension.
Do not use the vaccine if it cannot be resuspended.
2
Visual inspection
Visually inspect the vaccine for large particulate matter and discoloration prior to administration.
Do not use if large particulate matter or discoloration is found. If the vaccine is not a homogeneous suspension, repeat Steps 1 and 2.
3
Remove syringe cap
Remove the syringe cap by slowly turning the cap counterclockwise while holding the Luer lock adapter.
Avoid pressing the syringe plunger rod while removing the syringe cap.
4
Attach a sterile needle
Hold the Luer lock adapter and attach a needle appropriate for intramuscular administration to the prefilled syringe by turning clockwise.
Administration15
For intramuscular injection only
Each 0.5-mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe.
- Prevnar 20 should be administered as soon as possible after being removed from refrigeration
- Prevnar 20 can be administered provided total (cumulative multiple excursions) time out of refrigeration (at temperatures between 8ºC and 25ºC) does not exceed 96 hours. Cumulative multiple excursions between 0ºC and 2ºC are also permitted as long as the total time between 0ºC and 2ºC does not exceed 72 hours. These are not, however, recommendations for storage
The tip cap and plunger stopper of the prefilled syringe are not made with natural rubber latex.
Clinical Guidance from the CDC’s ACIP adult pneumococcal vaccination recommendations
Concomitant administration of Prevnar 20 with adjuvanted QIV (FLUAD® Quadrivalent) "has been demonstrated to be immunogenic and safe. However, slightly lower pneumococcal serotype-specific OPA GMTs or geometric mean concentrations were reported when pneumococcal vaccines were coadministered with QIV compared with when pneumococcal vaccines were given alone."29
- Coadministering Prevnar 20 with the flu vaccine is immunogenic, as established by a double-blind, randomized study in adults age 65 or older15
- The rates of local reactions at the Prevnar 20 injection site within 10 days after vaccination were similar for those who received Prevnar 20 and FLUAD® Quadrivalent (Influenza Vaccine, Adjuvanted) concomitantly or seperately15
- The rates of systemic reactions within 7 days following administration of Prevnar 20 were generally numerically higher in the concomitant-administration group compared to the separate-administration group. However, overall, fever in both groups was uncommon, and other systemic reactions (fatigue, headache, muscle, or joint pain) were primarily mild to moderate15
Bacterial coinfections associated with influenza are a leading cause of severe disease and death, especially among the elderly and other high-risk groups. Streptococcus pneumoniae is one of the most frequent causes of bacterial coinfection with influenza.30
ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention; GMT=geometric mean titer; OPA=opsonophagocytic activity; QIV=quadrivalent influenza vaccine.
FLUAD® QUADRIVALENT is a registered trademark of Seqiris UK Limited or its affiliates.
Coadministration with COVID-19 Vaccines
The safety and efficacy of concomitant administration of Prevnar 20 and COVID-19 vaccines are not included in the Full Prescribing Information for Prevnar 20 or any COVID-19 vaccines. According to the Full Prescribing Information and Emergency Use Authorization (EUA) fact sheets for the COVID-19 vaccines, there is no information on the coadministration of COVID-19 vaccines with other vaccines.
As of March 16, 2023, the CDC provides guidance for coadministration of other vaccines with a COVID-19 vaccine31*
In accordance with general best practices, routine administration of all age-appropriate doses of vaccines simultaneously is recommended for adults for whom no specific contraindications exist at the time of the healthcare visit. However, there are additional considerations if administering an orthopox vaccine. See CDC guidance for details. Extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone. Studies that compared coadministration of COVID-19 vaccines and seasonal influenza vaccines with separate administration of these vaccines found similar levels of immunogenicity and similar or slightly higher reactogenicity; no specific safety concerns were identified.
Guidance may be updated frequently; please refer to the CDC website for the most updated guidance.
Best Practices
CDC recommendations for multiple injections include32:
- Prepare each injectable vaccine using a separate syringe
- Label each syringe with the name and the dosage (amount) of the vaccine, lot number, initials of the preparer, and exact beyond-use time, if applicable
- Separate injection sites by 1 inch or more, if possible
- Administer vaccines that are known to be painful when injected (e.g., MMR, HPV) last. Because pain can increase with each injection, the order in which vaccines are injected matters. Injecting the most painful vaccine last when multiple injections are needed can decrease the pain associated with the injections
- Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction in different limbs, if possible
HPV=human papillomavirus; MMR=measles, mumps, and rubella.
Storage and Handling
The following are recommended for the storage and handling of Prevnar 2015:
- To minimize resuspension time, syringes should be stored in the refrigerator horizontally
- Packaged as a prefilled syringe
After shipping, Prevnar 20 may arrive at temperatures between 2ºC to 25ºC (36ºF to 77ºF). Upon receipt15:
- Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF)
- Syringes should be stored in the refrigerator horizontally to minimize the resuspension time
- Do not freeze. Discard if the vaccine has been frozen
Implementing Billing Codes
The following billing codes should be used for Prevnar 20:
CPT® Codes for Vaccines33 |
---|
The Prevnar 20 CPT code is 90677 |
Billing Code for Diagnosis (ICD-10)33 |
---|
Z23 (Encounter for immunization)* |
Billing Codes for Administration | |
---|---|
Medicare | G0009(Administration of pneumococcal vaccine)33 |
Commercial | 90471(Immunization administration [includes percutaneous, intradermal, subcutaneous, or intramuscular injections]; 1 vaccine [single or combination vaccine/toxoid])34 |
Addressing Insurance Concerns With Patients
Most patients have no copay for this vaccine.
Would you like me to check your insurance for you?
Insurance Coverage
The majority of patients have coverage for Prevnar 20
Prevnar 20 is covered by Medicare.
Medicare fee-for-service Pneumococcal vaccines covered under Part B are available to Medicare beneficiaries at $0 out of pocket35
Medicare Advantage (MA)
$0 cost share applies when the vaccine is administered by an in-network provider, which includes pharmacists35-37
For more information about patient eligibility:
Prevnar 20 is covered by commercial plans.
Under the Affordable Care Act, non-grandfathered commercial health plans cover Advisory Committee on Immunization Practices (ACIP)—recommended vaccines without requiring a copayment or coinsurance38,39
$0 cost share applies when the vaccine is administered by an in-network provider, which includes pharmacists35-37
*Procedure codes are required to identify the type of immunization given.40
CPT=Current Procedural Terminology; MMWR=Morbidity and Mortality Weekly Report.