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INDICATION FOR PNEUMOVAX 23

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention
of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1,
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CDC PNEUMOCOCCAL RECOMMENDATIONS FOR ADULTS 65+



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Dr. Javeed Siddiqui shares the November 2019 CDC recommendation for pneumococcal
vaccination and how you can help protect your patients ages 65+.

Return to CDC Pneumococcal Vaccination Recommendations for Adults Ages 65+



VIDEO TRANSCRIPT | CDC 2019 RECOMMENDATIONS FOR PNEUMOCOCCAL VACCINATION

Voice-Over:

This presentation has been created and paid for by Merck Sharp & Dohme Corp, a
subsidiary of Merck & Co., Inc.

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. 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.

Voice-Over:

But first, let’s discuss Indications for PNEUMOVAX 23. 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 and older
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.

Voice-Over:

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.

Voice-Over:

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, one 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 to 64 years:

 * Diminished immune response with one dose of PNEUMOVAX 23 followed by a dose
   of Prevnar 13 one year later vs Prevnar 13 alone
 * Noninferior immune response with one dose of Prevnar 13 followed by a dose of
   PNEUMOVAX 23 one 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 13 and 12 shared serotypes with Prevnar 13.

Voice-Over:

Let’s again discuss some safety information for PNEUMOVAX 23. The most common
adverse reactions, reported in more than 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 remain
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.





ref1

Reference

 1. Centers for Disease Control and Prevention (CDC). Use of 13-valent
    pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide
    vaccine among adults aged ≥65 years: Updated recommendations of the Advisory
    Committee on Immunization Practices. MMWR. 2019;68(46):1069–1075.






INDICATION FOR PNEUMOVAX 23

PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) is a vaccine indicated for
active immunization for the prevention of pneumococcal disease caused by the 23
serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

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.

Close


SELECT SAFETY INFORMATION FOR PNEUMOVAX 23

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.


SELECT SAFETY INFORMATION FOR PNEUMOVAX 23

Do not administer PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) 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.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not
established the presence or absence of a vaccine-associated 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.

PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in
patients who have chronic cerebrospinal fluid (CSF) leakage resulting from
congenital lesions, skull fractures, or neurosurgical procedures.

The most common adverse reactions, reported in >10% of subjects vaccinated with
PNEUMOVAX 23 for the first time in a clinical trial, were: injection-site
pain/soreness/tenderness, injection-site swelling/induration, headache,
injection-site erythema, asthenia and fatigue, and myalgia.

For subjects aged 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 than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal
infection.

Before administering PNEUMOVAX 23, please read the accompanying Prescribing
Information. The Patient Information also is available.

INDICATION FOR PNEUMOVAX 23

PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) is a vaccine indicated for
active immunization for the prevention of pneumococcal disease caused by the 23
serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

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.

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