This presentation has been created and paid for by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
The information in this presentation is intended for health care professionals in the United States, its territories, and Puerto Rico.
Dr. Siddiqui: You may have heard that the Centers for Disease Control and Prevention updated their pneumococcal disease recommendations for adults ages 65 years and older in November of 2019.
I’m Dr. Javeed Siddiqui, an infectious disease physician and Chief Medical Officer at TeleMed2U in Roseville, CA, and I am here today to talk to you about this update.
There are 2 kinds of pneumococcal vaccines available for use in adults in the United States: PNEUMOVAX®23, Pneumococcal Vaccine Polyvalent, and Prevnar 13. The use of both vaccines in adults ages 65 years and older is discussed in the CDC recommendations.
But first, let’s discuss Indications for PNEUMOVAX 23.
(Voiceover): PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine.
PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
Dr. Siddiqui: The CDC continues to recommend routine vaccination with PNEUMOVAX 23 for all appropriate adults ages 65 years and older.
In 2019, the CDC modified its recommendations for use of Prevnar 13 in adults ages 65 years and older. Prevnar 13 is no longer recommended for routine administration to all immunocompetent adults in this age group.
Instead, for Prevnar 13, the CDC recommends shared clinical decision-making for certain adults ages 65 years and older who have not previously received that vaccine. We’ll talk more about this change.
(Voiceover): Now, let’s discuss some Select Safety Information for PNEUMOVAX 23, which you’ll hear more of throughout this video.
Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.
Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.
Dr. Siddiqui: To understand the November 2019 updates to the CDC recommendation for pneumococcal vaccination in adults ages 65 years and older let us first look at the history of the previous recommendations for this age group.
In the 1980s, PNEUMOVAX 23 was approved by the FDA and was recommended by the CDC for adults ages 65 years and older.
Prevnar 13 was FDA approved for use in older adults in 2011, and in 2014, the CDC recommended routine vaccination with Prevnar 13 for immunocompetent adults ages 65 years and older followed by a routine dose of PNEUMOVAX 23.
The CDC stated that the dose of PNEUMOVAX 23 should be given at least one year after the dose of Prevnar 13.
The CDC made this recommendation with the commitment to reevaluate the use of Prevnar 13 in this population.
Since then, the CDC has been reevaluating direct and indirect effects of Prevnar 13 in adults ages 65 years and older, given the remaining disease burden.
In November 2019, the CDC updated its recommendations for immunocompetent adults ages 65 years and older.
Let’s discuss the CDC’s rationale for this change. The CDC observed no population level impact on Prevnar 13-type invasive pneumococcal disease incidence, as shown in this graph. As well, there was no observed reduction in incidence of non-invasive pneumococcal pneumonia during this time.
As stated in the CDC’s official publication of its updated pneumococcal recommendations, routine vaccination with a single dose of PNEUMOVAX 23 continues to be recommended for all appropriate adults ages 65 years and older.
However, the use of Prevnar 13 in certain patients ages 65 years and older– specifically, those who do not have an immunocompromising condition, cerebrospinal fluid, or CSF leak, or cochlear implant, and who have not previously received Prevnar 13 – is based on shared clinical decision making. Unlike a routine recommendation, shared clinical decision-making recommendations are individually-based and informed by a decision process between the health care provider and the patient.
When these patients and their vaccine providers engage in shared clinical decision-making about the option to use Prevnar 13, considerations may include the individual patient’s risk of exposure to Prevnar 13 serotypes and the risk for pneumococcal disease for that person as a result of underlying medical conditions.
(Voiceover): Here is some additional safety information for PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
Dr. Siddiqui: Let’s discuss intervals for sequential administration if you decide to vaccinate appropriate immunocompetent patients ages 65 and older with Prevnar 13.
For pneumococcal vaccine-naïve patients ages 65 years and older, who receive Prevnar 13 based on shared clinical decision making, it is important for the patient to also receive 1 dose of PNEUMOVAX 23 at least 1 year later because PNEUMOVAX 23 remains routinely recommended for these patients.
Importantly, for immunocompetent adults in whom the 2014 sequential regimen was initiated with Prevnar 13 but not yet completed with PNEUMOVAX 23, 1 dose of PNEUMOVAX 23 should be routinely administered at least 1 year after Prevnar 13 was given.
For those who previously received PNEUMOVAX 23 before the age of 65 years, for example, those with certain chronic conditions, such as diabetes, for whom PNEUMOVAX 23 is recommended, an additional dose of PNEUMOVAX 23 should be administered when they reach the age of 65, given at least 5 years after their first PNEUMOVAX 23 dose.
Please note these important considerations regarding sequential administration:
There are limited data on the sequential administration of PNEUMOVAX 23 with other vaccines, including Prevnar 13.
An immunogenicity study described in the Prescribing Information for Prevnar 13 evaluated the sequential administration with PNEUMOVAX 23 in adults ages 60–64 years:
- Diminished immune response with 1 dose of PNEUMOVAX 23 followed by a dose of Prevnar 13 1 year later vs Prevnar 13 alone
- Noninferior immune response with 1 dose of Prevnar 13 followed by a dose of PNEUMOVAX 23 1 year later vs PNEUMOVAX 23 alone
The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended.
For subjects ages 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination with PNEUMOVAX 23 than following initial vaccination with PNEUMOVAX 23.
PNEUMOVAX 23 contains 11 unique pneumococcal serotypes not contained in Prevnar 13and 12 shared serotypes with Prevnar 13.
(Voiceover): Let’s again discuss some safety information for PNEUMOVAX 23.
The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
Dr. Siddiqui: Despite CDC recommendations for pneumococcal vaccination for adults ages 65 years and older, pneumococcal vaccination rates in this population remains suboptimal.
Based on a CDC analysis of certain pneumococcal vaccination claims submitted for reimbursement to the Centers for Medicare and Medicaid Services, as of September 2017, approximately 57% of adults ages 65 years and older had not received PNEUMOVAX 23, as recommended by the CDC.
We can make a positive impact for our patients by doing all we can today to help protect them against pneumococcal disease.
(Voiceover): Before administering PNEUMOVAX 23, please read the accompanying Prescribing Information. The Patient Information also is available.
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Accessed March 25, 2020.