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1HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
PREVNAR 20 safely and effectively. See full prescribing information for
PREVNAR 20.
PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) , suspension
for intramuscular injection
Initial U.S. Approval: 2021
--------------------------- INDICATIONS AND USAGE ----------------------------
Prevnar 20 isa vaccine indicated for active immunization for the prevention
of pneumonia and invasive disease caused by Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A,
19F, 22F, 23F ,and 33F in adults 18 years of age and older . (1)
This indication for the prevention of pneumonia caused by S. pneumoniae
serotypes 8, 10A, 11A, 12F, 15B, 22F ,and 33F is approved under accelerated
approval based on immune responses as measured by opsonophagocytic
activity (OPA) assay . Continued approval for this indication may be
contingent upon verification and description of clinical benefit in a
confirmatory trial. (1)
----------------------- DOSAGE AND ADMINISTRATION -----------------------
Adults 18 years of age and older: a single dose ( 2.3)--------------------- DOSAGE FORMS AND STRENGTHS ----------------------
0.5 mL suspension for intramuscular injection, supplied in a single -dose
pre-filled syringe. (3)
------------------------------ CONTRAINDICATIONS ------------------------------
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or
todiphtheria toxoid. (4)
------------------------------ ADVERSE REACTIONS ------------------------------
In adults 1 8 through 59 years of age , the most commonly reported solicited
adverse reactions >10% were pain at the injection site (> 70%), muscle pain
(>50% ), fatigue (>40%), headache (>30%), and arthralgia and injection site
swelling (>10%). (6)
In adults 60 years of age and older, the most commonly reported solicited
adverse reactions >10% were pain at the injection site (>50%), muscle pain
andfatigue (>30%), headache (>20%), and arthralgia (>10%). (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfize r Inc. at
1-800-438- 1985 or VAERS at 1 -800-822- 7967 or http://vaers.hhs.gov .
See 17 for PATIENT COUNSELING INFORMATION .
Revised: 6/2021
FULL PRESCRIBING INFORMATION: CONTENTS *
1INDICATIONS AND USAGE
2DOSAGE AND ADMINISTRATION
2.1 Preparation
2.2 Administration
2.3 Vaccination Schedule
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
5.2 Altered I mmunocompetence
6ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience With Prevnar 13
7DRUG INTERACTIONS
7.1 Prior Vaccination with PNEUMOVAX 23
7.2 Immunosuppressive Therapies8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, I mpairment of Fertility
14CLINICAL STUDIES
14.1 Prevnar 13 Adult Efficacy Data
14.2 Prevnar 20 Clinical Trials
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are
not listed.
FDA-CBER-2021-5683-0951395
2FULL PRESCRIBING INFORMATION
1INDICATIONS A ND USAGE
Prevnar 20™isa vaccine indicated for active immunization for the prevention of pneumonia and invasive
disease caused b y Streptococcus pneumoniae seroty pes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B,
18C, 19A, 19F, 22F, 23F ,and 33F in adults 18 years of age and older.
This indication for the prevention of pneumonia caused b y S. pneumoniae seroty pes 8, 10A, 11A, 12F, 15B,
22F,and 33F is approved under accelerated approval based on immune responses as measured b y
opsonophagocy tic activity (OPA) assay [see Clinical Studies (14. 2)]. Continued approval for this indication
may be contingent upon verification and description of clinical benefit in a confirmatory trial.
2DOSAGE AND ADMINISTRATION
For intramuscular administration only.
2.1 Preparation
Do not mix Prevnar 20 with other vaccines/products in the same sy ringe.
Step 1 . Resuspend drug product
Hold the pre -filled s yringe horizontally between the thumb and the
forefinger and shake vigorously until the vaccine isa homogen eous
white suspension. Do not use the vaccine if it cannot be re -suspended.
Step 2 . Visual inspection
Visually inspect the vaccine for large particulate matter and discoloration
prior to administration. Donot use if large particulate matter or
discoloration is found. If the vaccine isnot a homogeneous suspension,
repeat Steps 1 and 2.
Step 3 . Remove syringe cap
Remove the sy ringe cap by slowl y turning the cap counterclockwise
while holding the Luer lock adapter.
Avoid pressing the sy ringe plunger rod while removing the s yringe cap.
Step 4 . Attach a sterile needle
Hold the L uer lock adapter and a ttach a need le appropriate for intramuscular administration to the pre -filled
syringe b y turning clockwise.
FDA-CBER-2021-5683-0951396
32.2 Administration
For intramuscular injection only .
Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied pre -filled
syringe.
2.3 Vaccination Schedule
Prevnar 20 is administered as a single dose.
3 DOSAGE FORMS AND STRENGTHS
Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single -dose pre -filled syringe.
4CONTRAINDICATIONS
Severe allergic reaction (e.g., anaph ylaxis) to any component of Prevnar 20 or todiphtheria toxoid [see
Description (11) ].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision used to manage immediate allergic reactions must be
immediately available should an acute anaphy lactic reaction occur following administration of Prevnar 20 .
5.2 Altered Immunocompetence
Safety and immunogenicity data on Prevnar 20 are not available for individuals in immunocompromised groups
and vaccination should be considered on an individual basis.
Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have
reduced immune responses to Prevnar 20 .
6ADVERSE REACTIONS
In adults 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain
at the injection site (> 70%), muscle pain (>50%), fatigue (>40%), headache (>30%), and arthralgia and
injection site swelling (>10%).
In adults 60 y ears of age and older, the most commonly reported solicited adverse reactions >10% were pain at
the injection site (>50%), muscle pain and fatigue (>30%), headache (>20%), and arthralgia (>10%).
6.1Clinical Trials Experience
Because cli nical trials are conducted under widely varying conditions, adverse reaction rates observed in the
clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may
not reflect the rates observed in practic e.
FDA-CBER-2021-5683-0951397
4The safet y of a single dose of Prevnar 20 in adults 18 y ears of age and older was evaluated in five randomized,
active -controlled, multicenter clinical trials and one open-label, multicenter clinical trial. All of the trials were
conducted in the United St ates and 2 of the trials also enrolled participants (N=172) in Sweden. Across the 6
trials, 4552 adults received Prevnar 20 and 2496 received active control vaccine.
Pneumococcal Vaccine Naïve Adults 18 Years of Age and Older
The safet y of Prevnar 20 in adults 18 y ears of age and older with no history of pneumococcal vaccination was
evaluated in five studies (Studies 1 -5).In the main cohort of Study 1 (NCT03760146) and in S tudy 2
(NCT03313037) ,participants ≥ 60 years of age and participants 60 through 64 y ears of age, respectively ,
received a single dose of Prevnar 20 followed 1 month later with administration of saline placebo or received a
single dose of Prevnar 13 followed 1 month later with a dose of PNEUMOVAX® 23 ( PPSV23 ). The 2 other
cohorts of Study 1, participants 50 through 59 years of age and participants 18 through 49 years of age ,received
a single vaccination with Prevnar 20 or Prevnar 13.In Study 3 (NCT03828617) , participants 18 through 49
years of age received a single vaccination with Prevnar 20 or Prevnar 13. In Studies 4 ( NCT 02955160) and 5
(NCT03642847) , which were smaller studies conducted early in the clinical development of Prevnar 20,
participants 18 through 49 y ears of age received a single dose of Prevnar 20 or an active control (Tdap or
Prevnar 13 ).
Adults ≥65 Years of A ge Previously Immunized with a Pneumococcal Vaccine
The safet y of Prevnar 20 in adults 65 y ears of age and older with pneumococcal vaccination given as routine
care prior to enrollment w as assessed in Study 6(NCT03835975) . Participants were enrolled into 1 of 3 cohorts
based on their prior pneumococcal vaccination history (PPSV23 only ≥1 to ≤5 y ears prior to enrollment ,
Prevnar 13 onl y ≥6 months prior to enrollment, or Prevnar 13 followed by PPSV23 [with PPSV23 given
≥1year prior to enrollment ]). Participants in 2 of the cohorts received a single vaccination with Prevnar 20 or
control pneumococcal vaccine (Prevnar 13), and the other cohort received a single vaccinat ion with Prevnar 20 .
only.
Demographics of Trial Participants
In the three main trials (Studies 1, 3,and 6) , participants were predominantly female (52.0% to 65.9%) across
groups defined b y age and prior pneumococcal vaccination status within the Prevnar 20 and control vaccine
groups. Across all 3 trials combined, 59.8% of participants were 60 years of age and older , 6.9% were
50through 59 years of age, and 33.3% were 18 through 49 years of age. In Studies 1 and 3, participants were
80.7% White , 14.2% Black, 2.1% Asian ,and 10.3% Hispanic. In Study 6, participants were predominantly
White (92.4%). Participants were primarily from the United States ;however a portion of participants 65 y ears
of age and older were enrolled from Sweden in Study 1 (5.7 % of participants 60 years of age and older in that
study ) and also in Study 6(35.5 % of participants with prior PPSV23 only).
In the three main trials, participants with pre -existing underl ying diseases were enrolled if the medical condition
was stable ( did not require a significant change in therapy in the 6 weeks before receipt of stud y vaccine or an y
hospitalization for worsening disease within 12 weeks before receipt of study vaccine) . In Study 1,
approximately one- third of all participants had risk factors that placed them at increased risk for serious
pneumococcal disease, including smoking (12. 9%), stable medical conditions of chronic cardiovascular disease
(5.5%), chronic pulmonary disease including asthma (8. 7%), chronic liver disease (0.4%), and diabetes mellitus
(13.9%).
FDA-CBER-2021-5683-0951398
5Safety Monitoring
Solicited adverse reactions for Prevnar 20 in the three main trials were monitored in participants recording daily
into an electronic diary their local adverse reactions for 10 consecutive days and sy stemic r eactions for
7consecutive day s following vaccination. Across all trials, s erious and nonserious adverse events were
collected for 1month after each vaccination. Safety follow -up of serious adverse events (SAEs) continued
through 6 months after vaccination with Prevnar 20 or Prevnar 13 (or other appropriate control vaccine), as
applicable. Newl y diagnosed chronic medical conditions occurring within 6 months after vaccination were also
collected via telephone conta ct.
Serious Adverse Events
Across all6clinical trial scombined ,performed in adults of all ages ,naïve to and with prior pneumococcal
vaccin ation, the proportion of participants reporting 1 or more SAEs within 6 months after vaccination with
Prevnar 20 was 1.5% (67 of 4552 participants) . This was similar to the proportion of participants with SAEs
after vaccination with Prevnar 13 or other applicable control vaccine (1.8% , 44 of 2496) . The proportions of
participants with SAEs occurring within 1 month after vaccination with Prevnar 20 or with Prevnar 13 or other
applicable control vaccine were both 0.4% (19 of 4552 participants and 11 of 2496 participants, respectivel y).
There were no notable patterns or imbalances between vaccine groups for specific categories of serious adverse
events that would suggest a causal relationship to Prevnar 20.
Solicited Adverse Reactions
The frequency and severity of the local adverse rea ctions (redness, swelling, and pain at the injection site)
prompted daily in the 10 day s after Prevnar 20 vaccination in adults na ïve to pneumococcal vaccination
(Study 1) and in adults with prior pneumococcal vaccination (Study 6) are shown in Table 1 and Table 2,
respectivel y. The frequency and severity of the s ystemic adverse reactions (fever , fatigue, headache, muscle
pain, and joint pain) prompted daily in the 7 day s after Prevnar 20 vaccination in adults na ïveto pneumococcal
vaccination (Study 1) and in adults with prior pneumococcal vaccination (Study 6) are shown in Table 3 and
Table 4, respectivel y.
Table 1. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity,
Within 10 Days After Vaccination in Pneumococcal Vaccine- Naïve Adults -Study 1a
18-49Years of Age 50-59 Years of Age ≥60Years of Age
Vaccine Group
Prevnar 20
(Nb=335)
%Prevnar 13
(Nb=112)
%Prevnar 20
(Nb=331)
%Prevnar 13
(Nb=111)
%Prevnar
20/Saline
(Nb=1505 )
%Prevnar 13 /
PPSV23
(Nb=1483 )
%
Local Reaction
Pain at i njection
sitee
Anyd
Mild
Moderate
Severe 81.2
42.7
38.2
0.382.1
52.7
28.6
0.972.5
53.5
17.8
1.269.4
52.3
16.2
0.955.4
45.3
9.9
0.254.1
44.6
9.2
0.3
Swellingc
Any (>2.0 cm)d
Mild
Moderate
Severe11.6
7.2
4.5
012.5
8.9
3.6
08.8
5.7
3.0
010.8
7.2
3.6
07.5
4.8
2.4
0.38.0
4.9
2.8
0.3
FDA-CBER-2021-5683-0951399
6Table 1. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity,
Within 10 Days After Vaccination in Pneumococcal Vaccine- Naïve Adults -Study 1a
18-49Years of Age 50-59 Years of Age ≥60Years of Age
Vaccine Group
Prevnar 20
(Nb=335)
%Prevnar 13
(Nb=112)
%Prevnar 20
(Nb=331)
%Prevnar 13
(Nb=111)
%Prevnar
20/Saline
(Nb=1505 )
%Prevnar 13 /
PPSV23
(Nb=1483 )
%
Rednessc
Any (>2.0 cm)d
Mild
Moderate
Severe9.0
3.0
5.4
0.69.8
5.4
4.5
08.2
5.1
2.7
0.35.4
2.7
2.7
07.3
3.7
2.8
0.86.2
3.8
2.2
0.2
Any local
reactionf81.2 82.1 72.8 70.3 57.4 56.0
a.Study 1 was conducted in the United States and in Sweden (NCT03760146 ).
b.N = number of participants with any e -diary data reported after vaccination (after Vaccination 1 [Prevnar 20 or Prevnar 13 ]for Study 1
participants 60years of age and older ). This value is the denominator for the percentage calculations.
c.Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were r ounded 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.
d.“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
e.Mild = does not interfere with activity; m oderate = interferes with activity; severe = prevents daily activity.
f. “ Any local reaction” includes all p articipants who reported any injection site reaction (pain, swelling, or redness) as “mild”, “moderate”, or
“severe” during Day 1 to Day 10 after vaccination.
Table 2. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity,
Within 10 Days After Vaccination inAdults 65 Years of Age and Older WithPrior
Pneumococcal Vaccination –Study 6a,b
Prior Pneum ococcal Vaccination Statusc
PPSV23 Prevnar 13 Prevnar 13and
PPSV23
Vaccine Group
Prevnar 20
(Nd=253)
%Prevnar 13
(Nd=121)
%Prevnar 20
(Nd=245)
%PPSV23
(Nd=126)
%Prevnar 20
(Nd=125)
%
Local Reaction
Pain at the i njection
siteg
Anyf
Mild
Moderate
Severe 50.2
45.8
4.3
043.0
38.8
3.3
0.861.2
54.7
6.1
0.456.3
40.5
14.3
1.652.8
47.2
5.6
0
Swellinge
Any (>2.0 cm)f
Mild
Moderate
Severe9.9
5.1
3.6
1.26.6
6.6
0
09.4
5.7
3.7
014.3
6.3
7.1
0.84.0
1.6
2.4
0
Rednesse
Any (>2.0 cm)f
Mild
Moderate
Severe7.9
3.6
3.2
1.22.5
1.7
0.8
08.6
2.9
5.3
0.412.7
4.8
7.1
0.84.8
1.6
3.2
0
Any local reactionh53.0 43.8 64.1 57.9 54.4
FDA-CBER-2021-5683-0951400
7Table 2. Percentage of Participants With Solicited Local Adverse Reactions, by Maximum Severity,
Within 10 Days After Vaccination inAdults 65 Years of Age and Older WithPrior
Pneumococcal Vaccination –Study 6a,b
Prior Pneum ococcal Vaccination Statusc
PPSV23 Prevnar 13 Prevnar 13and
PPSV23
Vaccine Group
Prevnar 20
(Nd=253)
%Prevnar 13
(Nd=121)
%Prevnar 20
(Nd=245)
%PPSV23
(Nd=126)
%Prevnar 20
(Nd=125)
%
a.Study 6 was conducted in the United States and in Sweden (NCT03835975 )
b.Open -label administration of Prevnar 20 .
c. Includes participants who previously received either PPSV23 ≥1 to ≤5 years before enrollment (PPSV23), Prevnar 13 ≥6 months before
enrollment (Prevnar 13), or Prevnar 13 followed by PPSV23 ≥1 year before enrollment (Prevnar 13 and PPSV23) in the study .
d.N = number of participants with any e -diary data reported after vaccination. This value is the denominator for the percentage calculations.
e.Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were r ounded 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.
f.“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 10 after vaccination.
g.Mild = does not interfere with activity; m oderate = interferes with activity; severe = prevents daily activity.
h.“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.
Table 3. Percentage of Participants With Solicited Systemic Reactions , by Maximum Severity, Within
7Days After Vaccination in Pneumococcal Vaccine -Naïve Adults –Study 1a
18 through 49 Years of Age 50through 59 Years of Age ≥60Years of Age
Vaccine Group
Prevnar 20
(Nb=335)
%Prevnar 13
(Nb=112)
%Prevnar 20
(Nb=331)
%Prevnar 13
(Nb=111)
%Prevnar
20/Saline
(Nb=1505)
%Prevnar
13/PPSV23
(Nb=1483)
%
Systemic Reaction
Muscle painc
Anyd
Mild
Moderate
Severe66.6
36.4
29.0
1.274.1
42.0
31.3
0.949.8
33.8
15.4
0.649.5
31.5
17.1
0.939.1
28.9
9.8
0.437.3
26.8
10.0
0.5
Fatiguec
Anyd
Mild
Moderate
Severe42.7
18.8
22.1
1.843.8
20.5
19.6
3.639.3
21.1
17.2
0.936.0
18.0
15.3
2.730.2
16.1
12.8
1.230.7
17.5
11.9
1.2
Headachec
Anyd
Mild
Moderate
Severe 38.8
21.5
14.6
2.733.9
16.1
17.0
0.932.3
20.5
10.9
0.936.0
21.6
13.5
0.921.5
15.5
5.4
0.723.3
17.0
5.9
0.3
Joint painc
Anyd
Mild
Moderate
Severe13.4
6.3
7.2
017.9
8.9
8.0
0.915.4
10.6
4.8
020.7
12.6
7.2
0.912.6
6.9
5.4
0.313.7
7.1
6.3
0.2
Fever
≥38.0℃
≥38.0℃ to 38.4℃
>38.4 ℃ to 38.9℃
>38.9 ℃ to 40.0℃
>40.0 ℃1.2
0.6
0.3
0.3
01.8
0
0
1.8
01.5
0.6
0.3
0.3
0.30.9
0.9
0
0
00.9
0.3
0.3
0
0.30.8
0.4
0.2
0
0.2
Any systemic reactione79.4 83.0 69.5 67.6 55.2 55.4
FDA-CBER-2021-5683-0951401
8Table 3. Percentage of Participants With Solicited Systemic Reactions , by Maximum Severity, Within
7Days After Vaccination in Pneumococcal Vaccine -Naïve Adults –Study 1a
18 through 49 Years of Age 50through 59 Years of Age ≥60Years of Age
Vaccine Group
Prevnar 20
(Nb=335)
%Prevnar 13
(Nb=112)
%Prevnar 20
(Nb=331)
%Prevnar 13
(Nb=111)
%Prevnar
20/Saline
(Nb=1505)
%Prevnar
13/PPSV23
(Nb=1483)
%
Use of antipyretic or
pain medicationf25.7 23.2 24.5 27.9 18.5 20.4
a.Study 1 wasconducted in the United States and in Sweden (NCT03760146 ).
b.N = number of participants with any e -diary data reported after vaccination (after Vaccination 1 [Prevnar 20 or Prevnar 13 ]for Study 1
participants 60years of age and older ). This value is the denominator for the percentage calculations.
c.Mild = does not interfere with activity ; moderate = some interference with activity; severe = prevents daily activity.
d.“Any” includes all participants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Day 7 after vaccination.
e.“Any systemic reaction ” includes all p articipants 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 vacc ination.
f.Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (i .e., number of reactions
reported).
Table 4. Percentage of Participants With Solicited Systemic Reactions , by Maximum Severity, Within
7 Days After Vaccination inAdults 65 Years of Age and Older WithPrior Pneumococcal
Vaccination – Study 6a,b
Prior Pneumococcal Vaccination Statusc
PPSV23 Prevnar 13Prevnar 13and
PPSV23
Vaccine Group
Prevnar 20
(Nd=253)
%Prevnar 13
(Nd=121)
%Prevnar 20
(Nd=245)
%PPSV23
(Nd=126)
%Prevnar 20
(Nd=125)
%
Systemic Reaction
Muscle paine
Anyf
Mild
Moderate
Severe32.0
26.1
5.5
0.431.4
24.0
5.0
2.533.9
25.3
8.6
046.0
31.7
11.9
2.437.6
28.0
8.8
0.8
Fatiguee
Anyf
Mild
Moderate
Severe28.9
17.8
11.1
022.3
9.9
9.9
2.531.0
19.6
10.2
1.233.3
19.8
13.5
032.8
19.2
12.0
1.6
Headachee
Anyf
Mild
Moderate
Severe 17.8
12.6
4.7
0.418.2
12.4
5.8
013.5
9.8
3.7
021.4
20.6
0.8
019.2
12.8
5.6
0.8
Joint paine
Anyf
Mild
Moderate
Severe6.7
4.7
2.0
010.7
5.0
5.0
0.811.8
7.8
4.1
015.9
10.3
5.6
016.8
12.8
4.0
0
Fever
≥38.0℃
≥38.0℃ to 38.4℃
>38.4 ℃ to 38.9℃
>38.9 ℃ to 40.0℃
>40.0 ℃0.8
0.8
0
0
00
0
0
0
00
0
0
0
01.6
0.8
0.8
0
00
0
0
0
0
Any systemic
reactiong51.8 43.8 50.2 59.5 52.8
FDA-CBER-2021-5683-0951402
9Table 4. Percentage of Participants With Solicited Systemic Reactions , by Maximum Severity, Within
7 Days After Vaccination inAdults 65 Years of Age and Older WithPrior Pneumococcal
Vaccination – Study 6a,b
Prior Pneumococcal Vaccination Statusc
PPSV23 Prevnar 13Prevnar 13and
PPSV23
Vaccine Group
Prevnar 20
(Nd=253)
%Prevnar 13
(Nd=121)
%Prevnar 20
(Nd=245)
%PPSV23
(Nd=126)
%Prevnar 20
(Nd=125)
%
Systemic Reaction
Use of antipyretic or
pain medicationh15.8 14.9 17.1 19.8 17.6
a.Study 6 was conducted in the United States and in Sweden (NCT03835975).
b.Open -label administration of Prevnar 20 .
c.Includes participants who previously received either PPSV23 ≥1 to ≤5 years before enrollment (PPSV23), Prevnar 13 ≥6 months before
enrollment (Prevnar 13), or Prevnar 13 followed by PPSV23 ≥1 year before enrollment (Prevnar 13 and PPSV23) in the study .
d.N = number of participants with any e -diary data reported after vaccination. This value is the denominator for the percentage calculations.
e. Mild = does not interfere with activity; moderate = interferes with activity; severe = prevents daily activity.
f.“Any” includes allparticipants who reported a reaction as “mild”, “moderate”, or “severe” during Day 1 to Da y 7 after vaccination.
g.“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 vaccin ation .
h.Severity was not collected for use of antipyretic or pain medication. The numbers listed reflect “yes” responses (i .e., number of reactions
reported) .
6.2 Postmarketing Experience With Prevnar 13
Thepostmarketing safety experience with Prevnar 13 is relevant to Prevnar 20 since the vaccines are
manufactured and formulated similarly and contain 13of the same pol ysaccharide conjugates . These adverse
reactions are included based on one or more of the following factors: severity , frequency of reporting, or
strength of evidence for a causal relationship to Prevnar 13 vaccine in adults. Because these reactions are
reported voluntaril y from a population of uncertain size, it is not alway s possible to reliably estima te their
frequency or establish a causal relationship to product exposure. The following adverse reactions have been
spontaneously reported during post approval use of Prevnar 13 and may also be seen in postmarketing
experience with Prevnar 20 .Reactions reported in the postmarketing experience and which pertain only to
pediatric populations are not included in this listing.
Immune S ystem Disorders : Anaph ylactic/anaph ylactoid reaction , including shock
Skin and Subcutaneous Tissue Disorders : Angioneurotic edema, E rythema multiforme
Blood and l ymphatic sy stem disorders : Lymphadenopathy localized to the region of the injection site
General Disorders and Administration Site Conditions : Vaccination- site dermatitis, vaccination- site
pruritus, vaccination -site u rticaria
7DRUG INTERACTIONS
7.1 Prior Vaccination with PNEUMOVAX 23
Receipt of PPSV23 1 to 5 y earsprior to Prevnar 20 result edin diminished OPA geometric mean titers (GMTs)
to Prevnar 20 compared to OPA GMTs in recipients who received Prevnar 13 at least 6 months previously , and
compared to OPA GMTs in recipients who received Prevnar 13 followed by PPSV23 ,with the last dose of
PPSV23 given at least 1 y ear prior to Prevnar 20 [see Clinical Studies (14.2) ].
FDA-CBER-2021-5683-0951403
107.2 Immunosuppressive Therapies
Individuals with impaired immune responsiveness due to the use of immunosuppressive therap y (including
irradiation, corticosteroids, antimetabolites, alky lating agents, and cy totoxic agents) may not respond optimally
to Prevnar 20 .
8USE IN SPECIFIC POPU LATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the
estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to
4% and 15% to 20%, respectivel y. There are no adequate and well- controlled studies of Prevnar 20 in pregnant
women. Available data on Prevnar 20 administered to pregnant women are insufficient to inform
vaccine -associated risks in pregnancy .
A developmental toxicity study wasperformed in female rabbits administered Prevnar 20 prior to mating and
during gestation. The dose was 0.5 mL at each occasion (a single human dose is 0.5 mL ). This study revealed
no evidence of harm to the fetus due to Prevnar 20 (see Data) .
Data
Animal Data
In a developmental toxicity study , female rabbits were administered Prevnar 20 by intramuscular injection twice
prior to mating (17 day s and 4 day s prior to mating) and twice during gestation ( Gestation D ays 10 and 24),
0.5mL/rabbit/occasion (a single human dose). No adverse effects on pre -weaning development were observed.
There were no vaccine -related fetal malformations or variations.
8.2 Lactation
Risk Summary
It is not known whether Prevnar 20 is excreted in human milk. Data are not available to assess the effects of
Prevnar 20 on the breastfed infant or on milk production/excretion. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical need for Prevnar 20 and an y potential
adverse effects on the breastfed child from Prevnar 20 or from the underly ing maternal condition. For
preventive vaccines, the underly ing maternal condition is susceptibility to disease prevented by the vaccine.
8.4 Pedia tric Use
The safet y and effectiveness of Prevnar 20 in individuals y ounger than 18 y ears of age have not been
established.
8.5 Geriatric Use
Of the total number of Prevnar 20 recipients 18 y ears of age and older evaluated for safet y in the 3 main clinical
trials (N=4263), 26.7% (n=1138) were 65 years of age and older and 1.7% ( n=72) were 80 years of age and
older [see Clinical Studies (14.2)] .
FDA-CBER-2021-5683-0951404
11Prevnar 20 recipients 70 through 79 years of age and ≥80 y ears of age had lower OPA GMTs for all
pneumococcal serot ypes compared to Prevnar 20 recipients 18 through 49 years, 50 through 59, and 60 through
64 years of age [see Clinical Studies (14.1) ].
11DESCRIPTION
Prevnar 20 , Pneumococcal 20-valent Conjugate Vaccine is a sterile suspension of saccharides of the capsular
antigens of S. pneumoniae serot ypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F,
23F, and 33F, individually linked to non -toxic diphtheria CRM 197protein. Each serot ype is grown in soy
peptone broth. The individual poly saccharides are purified by a series of chemical and ph ysical methods. The
polysaccharides are chemically activated and then directly conjugated to the carrier protein CRM 197, to form the
glycoconjugate. CRM 197is a non- toxic variant of diphtheria toxin isolated from cultures of Corynebacterium
diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract -based medium or in a chemically -
defined medium .CRM 197is purified by a ser ies of chemical and ph ysical methods. The individual
glycoconjugates are purified by a series of chemical and ph ysical methods and anal yzed for saccharide to
protein ratios, molecular size, free saccharide, and free protein.
The individual glycoconjugates are compounded to formulate Prevnar 20 .Potency of the formulated vaccine is
determined b y quantification of each of the saccharide antigens and b y the saccharide to protein ratios in the
individual gly coconjugates. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 μg of
each of S.pneumoniae seroty pes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F,
33Fsaccharides, 4.4 μg of 6B saccharides, 51μg CRM 197carrier protein, 100 μg polysorbate 80, 295 μg
succinate buffer , 4.4 mg sodium chloride, and 125 μg aluminum as aluminum phosphate adjuvant.
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Protection against pneumococcal disease is conferred mainly by opsonophagocy tic killing of S. pneumoniae.
Prevnar 20 generates functional antibodies as measured by opsonophagocy tic activity (OPA).
The effectiveness of Prevnar 20 was assessed b y measuring serot ype-specific serum OPA of antibodies at 1-
month post vaccination .
Anopsonic antibody titer that is predictive of protection against invasive pneumococcal disease or
pneumococcal pneumonia has not been established.
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 20 has not been evaluated for the potential to cause carcinogenicit y, genotoxicity , or impairment of
male fertility . Vaccination of female rabbits with Prevnar 20 had no effect on female fertility [see Use in
Specific Populations (8.1)] .
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1214CLINICAL STUDIES
14.1 Prevnar 13 Adult Efficacy Data
Efficacy and effectiveness of Prevnar 13 are relevant to Prevnar 20 ,since the vaccines are manufactured
similarly and contain 13 of the same pol ysaccharide conjugates .
The efficacy of Prevnar 13 against vaccine -type(VT) pneumococcal community -acquired pneumonia (CAP) and
invasive pneumococcal disease ( IPD)was assessed in a randomized, double -blind, placebo -controlled study
(Community -Acquired Pneumonia Immunization Trial in Adults [CAPiTA ])conducted over ~4 years in the
Netherlands. A total of 84,496 participants 65 years of age and older received a single dose of either Prevnar 13
or placebo in a 1:1 randomization; 42,240 participants were vaccinated with Prevnar 13 and 42,256 participants
were vaccinated with pla cebo. Chronic medical conditions (asthma, diabetes, heart, liver, and/or lung diseases)
were reported in 42.3% of study participants at baseline.
The primary objective was to demonstrate the efficacy of Prevnar 13 in the prevention of a first episode of
confirmed VT -CAP (defined as presence of ≥2specified clinical criteria, chest X -ray consistent with CAP as
determined b y a central committee of rad iologists ,and positive VT -specific urinary antigen detection assay
[UAD] or isolation of VT S.pneumoniae from blood or other sterile site) . The secondary objectives were to
demonstrate the efficacy of Prevnar 13 in the prevention of a first episode of 1 ) confirmed
nonbacteremic/noninvasive (NB/NI) VT -CAP (an episode of VT -CAP for which the blood culture result and
any other sterile site culture results were negative for S.pneumoniae ) and 2 )VT-IPD (the presence of
S.pneumoniae in a sterile site).
Surve illance for suspected pneumonia and IPD began immediately after vaccination and continued through
identification of a prespecified number of cases. Participants who had a CAP or IPD episode with symptom
onset less than 14 day s after vaccination were exclud ed from all analy ses.
The median duration of follow -up per participant was 3.93 years. Prevnar 13 demonstrated statistically
significant vaccine efficacy (VE) in preventing first episodes of VT pneumococcal CAP, NB/NI VT
pneumococcal CAP, and VT -IPD (see Table 5 ).
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13Table 5. Vaccine Efficacy for the Primary and Secondary Efficacy Endpoints – Per-Protocol
Population
Vaccine Group
Prevnar 13 Placebo
N=42 ,240 N=42 ,256
Efficacy EndpointTotal
Number of
Episodesn n VE (%) (95.2% CI)
Primary endpoint:
First case of confirmed VT
pneumococcal CAP139 49 90 45.6 (21.8, 62.5)
Secondary endpoint:
First episode of confirmed NB/NI
VT pneumococcal CAP93 33 60 45 (14.2, 65.3)
Secondary endpoint:
First episode of VT -IPD35 7 28 75 (41.1, 90.9)
Abbreviations: CAP =community -acquired pneumonia; CI =confidence interval; NB/NI =nonbacteremic/noninvasive;
IPD =invasive pneumococcal disease; VE =vaccine efficacy; VT =vaccine -type.
14.2 Prevnar 20 Clinical Trials
Immunogenicit y of Prevnar 20 in Pneumococcal Vaccine Naïve Adults
Prevnar 20 effectiveness against invasive pneumococcal disease caused b y the 20 vaccine serot ypes and against
pneumonia caused b y the 13 seroty pes in Prevnar 13 was inferred from comparative immunogenicity to
US-licensed pneumococcal vaccines (Prevnar 13 and PPSV23). Study 1, conducted in the United States and
Sweden, was designed to evaluate immunologic noninferiority of Prevnar 20 to Prevnar 13 (for the 13 original
S. pneumoniae serot ypes) and PPSV 23 (for the 7 new S. pneumoniae seroty pes) in pneumococcal vaccine naive
adults ≥60 y earsof age. Immune responses elicited by Prevnar 20 and the control pneumococcal vaccines were
measured b y an OPA assay . OPA assay s were used to measure functional antibodies to S. pneumoniae .
Study 1included healthy adults and immunocompetent adults with stable underly ing conditions, including
chronic cardiovascular disease, chronic pulmonary disease, renal disorders, diabetes mellitus, chronic liver
disease, and medical risk conditions and behaviors (e.g. , smoking) that are known to increase the risk of serious
pneumococcal pneumonia and IPD. A stable medical condition was defined as a medical condition not requiring
significant change in therapy in the previous 6 weeks (i .e., change to new therap y category due to worsening
disease) or any hospitalization for worsening disease within 12weeks before receipt of the stud y vaccine.
Comparison of I mmune Responses of Prevnar 20 to Prevnar 13 and PPSV23 in Pneumococcal Vaccine Naïve
Adults ≥60 Years of Age
In a randomized, active- controlled, double -blind noninferiority clinical trial (Study 1) of Prevnar 20 in the
United States and Sweden, pneumococcal vaccine -naïve adults 18 years of age and older were enrolled into
1of 3cohorts based on their age at enr ollment and randomized to receive either Prevnar 20 or control.
Participants 60 years of age and older were randomly assigned (1:1 ratio) to Prevnar 20 followed 1 month later
with saline placebo or to Prevnar 13 followed 1 month later with PPSV23.
Seroty pe-specific OPA GMTs were measured before the first vaccination and 1 month after each vaccination.
Noninferiorit y of immune responses ,OPA GMTs 1 month after vaccination, with Prevnar 20 to a control
FDA-CBER-2021-5683-0951407
14vaccine for a serot ype was declared if the lower bound of the 2 sided 95% CI for the GMT ratio
(Prevnar 20/Prevnar 13; Prevnar 20 /PPSV23) for that seroty pe was greater than 0.5.
In adults 60 y ears of age and older , immune responses to all 13 matched seroty pes el icited b y Prevnar 20 were
noninferior to the immune responses to the serot ypes elicited b y Prevnar 13 one month after vaccination.
Immune responses to 6 out of the 7 additional seroty pes induced by Prevnar 20 were noninferior to the immune
responses to the se same seroty pes induced by PPSV23 one month after vaccination. The response to seroty pe 8
missed the prespecified statistical noninferiority criterion by a small margin (the lower bound of the 2 -sided
95% CI for the GMT ratio being 0.49 versus >0.50) (Ta ble 6 ).
In supportive anal yses, 77.8% of participants in the Prevnar 20 group achieved a ≥4-fold rise in seroty pe 8 OPA
titers from before vaccination to 1 month post -vaccination.
Table 6. OPA GMTs 1 Month After Vaccination in Adults 60 Years of Age and Older Given
Prevnar 20Compared to Prevnar 13 for the 13 Matched Serotypes and PPSV23 for the
7 Additional Serotypes (Study 1)a,b,c,d
Prevnar 20
(N = 1157–1430)Prevnar 13
(N = 1390–1419)PPSV23
(N = 1201–1319)Vaccine
Comparison
GMTeGMTeGMTeGMT Ratioe
(95% CI)e
Serotype
1 123 1540.80
(0.71, 0.90)
3 41 480.85
(0.78, 0.93)
4 509 6270.81
(0.71, 0.93)
5 92 1100.83
(0.74, 0.94)
6A 889 11650.76
(0.66, 0.88)
6B 1115 13410.83
(0.73, 0.95)
7F 969 11290.86
(0.77, 0.96)
9V 1456 15680.93
(0.82, 1.05)
14 747 7471.00
(0.89, 1.13)
18C 1253 14820.85
(0.74, 0.97)
19A 518 6450.80
(0.71, 0.90)
19F 266 3330.80
(0.70, 0.91)
23F 277 3350.83
(0.70, 0.97)
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15Table 6. OPA GMTs 1 Month After Vaccination in Adults 60 Years of Age and Older Given
Prevnar 20Compared to Prevnar 13 for the 13 Matched Serotypes and PPSV23 for the
7 Additional Serotypes (Study 1)a,b,c,d
Prevnar 20
(N = 1157–1430)Prevnar 13
(N = 1390–1419)PPSV23
(N = 1201–1319)Vaccine
Comparison
GMTeGMTeGMTeGMT Ratioe
(95% CI)e
Additional Serotypes
8 466 8480.55
(0.49, 0.62)
10A 2008 10801.86
(1.63, 2.12)
11A 4427 25351.75
(1.52, 2.01)
12F 2539 17171.48
(1.27, 1.72)
15B 2398 7693.12
(2.62, 3.71)
22F 3666 18461.99
(1.70, 2.32)
33F 5126 37211.38
(1.21, 1.57)
Abbreviations: CI =confidence interval; GMT = geometric mean titer; LLOQ =lower limit of quantitation; N =number of
participants; OPA =opsonophagocytic activity; PPSV23 =pneumococcal polysaccharide vaccine (23 -valent) .
a.Study 1wasconducted in the United States and in Sweden (NCT03760146 ).
b.Noninferiority for a seroty pe was met if the lower bound of the 2 -sided 95% CI for the GMT ratio (ratio of
Prevnar 20/comparator) was greater than 0.5 (2 -fold criterion for noninferiority).
c.Assay results below the LLOQ w ere set to 0.5 × LLOQ in the analysis.
d.Evaluable immunogenicity population.
e.GMTs ,GMT ratios , and the associated 2 -sided CIs were based on analysis of log -transformed OPA titers using a regression
model with vaccine group, sex, smoking status, age at vaccination in years, and baseline log -transformed OPA titers.
Immuno bridging in Pneumococcal Vaccine Naïve Adults 18 T hrough 59 Years of Age
In Study 1 (described above), the effectiveness of Prevnar 20 in adults 50 through 59 years of age and in adults
18 through 49 years of age was inferred following com parison of the immune response to each of the
20vaccine serot ypes in each of these age groups to the corresponding serotype -specific immune responses in
adults 60 through 64 years of age following Prevnar 20 (immunobridging) . In Study 1,pneumococcal
vaccine-naïve participants 50 through 59 years of age and 18 through 49 years of age were randomly assigned
(3:1 ratio) to receive 1 vaccination with Prevnar 20 or Prevnar 13. Seroty pe-specific OPA GMTs were
measured before vaccination and 1 month after vaccination. A comparative analysis of Prevnar 20 in the
younger age group versus Prevnar 20 in adults 60 through 64 y ears of age for each vaccine serot ype was
performed to support the indication in adults 18 through 49 years of age and 50 through 59 years of age.
Immunobridging was to be declared successful if the lower bound of the 2 -sided 95% CI for the GMT ratio
(Prevnar 20 in participants 18 through 49 years o f age/60 through 64 years of age and in participants 50 through
59 years of age/60 through 64 y ears of age) for the 20 seroty pes was >0.5 (2-fold) . Prevnar 20 elicited
seroty pe-specific immune responses to each of the 20 vaccine serot ypes in both of the y ounger age groups that
were within 2 -fold of the corresponding serot ype-specific responses in adults 60 through 64 y ears of age , when
measured 1 month after vaccination (Table 7).
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16Table 7. Comparisons of OPA GMTs 1 Month After Prevnar 20 in Adults 18 Through 49 or 50
Through 59 Years of Age to Adults 60 Through 64 Years of Age (Study 1)a,b,c,d
18–49 Years
(N = 251–317)60–64 Years
(N = 765–941)18–49 Years
Relative to
60–64 Years50–59 Years
(N = 266–320)60–64 Years
(N = 765–941)50–59 Years
Relative to
60–64 Years
GMTeGMTeGMT Ratioe
(95% CI)eGMTeGMTeGMT Ratioe
(95% CI)e
Serotype
1 163 1321.23
(1.01, 1.50) 136 1321.03
(0.84, 1.26)
3 42 421.00
(0.87, 1.16) 43 411.06
(0.92, 1.22)
4 1967 5943.31
(2.65, 4.13) 633 5781.10
(0.87, 1.38)
5 108 971.11
(0.91, 1.36) 85 970.88
(0.72, 1.07)
6A 3931 10233.84
(3.06, 4.83) 1204 9971.21
(0.95, 1.53)
6B 4260 12503.41
(2.73, 4.26) 1503 11991.25
(1.00, 1.56)
7F 1873 11871.58
(1.30, 1.91) 1047 11730.89
(0.74, 1.07)
9V 6041 17273.50
(2.83, 4.33) 1726 16881.02
(0.83, 1.26)
14 1848 7732.39
(1.93, 2.96) 926 7421.25
(1.01, 1.54)
18C 4460 13953.20
(2.53, 4.04 ) 1805 13551.33
(1.06, 1. 68)
19A 1415 6112.31
(1.91, 2.81) 618 6001.03
(0.85, 1.25)
19F 655 3012.17
(1.76, 2.68) 287 2900.99
(0.80, 1.22)
23F 1559 3254.80
(3.65, 6.32) 549 3281.68
(1.27, 2.22)
Additional Serotypes
8 867 5081.71
(1.38, 2.12) 487 5020.97
(0.78, 1.20)
10A 4157 25701.62
(1.31, 2. 00) 2520 24371.03
(0.84, 1.28)
11A 7169 54201.32
(1.04, 1.68) 6417 52491.22
(0.96, 1.56)
12F 5875 30751.91
(1.51, 2.41) 3445 31051.11
(0.88, 1. 39)
15B 4601 30191.52
(1.13, 2.05) 3356 28741.17
(0.88, 1.56)
22F 7568 44821.69
(1.30, 2.20) 3808 42280.90
(0.69, 1.17)
33F 7977 56931.40
(1.10, 1.79) 5571 54451.02
(0.81, 1.30)
FDA-CBER-2021-5683-0951410
17Table 7. Comparisons of OPA GMTs 1 Month After Prevnar 20 in Adults 18 Through 49 or 50
Through 59 Years of Age to Adults 60 Through 64 Years of Age (Study 1)a,b,c,d
18–49 Years
(N = 251–317)60–64 Years
(N = 765–941)18–49 Years
Relative to
60–64 Years50–59 Years
(N = 266–320)60–64 Years
(N = 765–941)50–59 Years
Relative to
60–64 Years
GMTeGMTeGMT Ratioe
(95% CI)eGMTeGMTeGMT Ratioe
(95% CI)e
Abbreviations: CI =confidence interval; GMT = geometric mean titer; LLOQ =lower limit of quantitation; N =number of
participants; OPA =opsonophagocytic activity; PPSV23 =pneumococcal polysaccharide vaccine 23 -valent vaccine .
a.Study 1 was conducted in the United States and in Sweden (NCT03760146 ).
b.Immunobridging for a serotype w as met if the low er bound of the 2 -sided 95% CI for the GMT ratio (ratio of younger age
group/60 through 64 years of age group) was greater than 0.5 (2 -fold success criterion).
c.Assay results below the LLOQ w ere set to 0.5 × LLOQ in the analysis.
d.Evaluable immunogenicity population.
e.GMTs, GMT ratios ,and the associated 2 -sided CIs were based on analysis of log -transformed OPA titers using a regression model
with age group, sex, smoking status, and baseline log -transformed OPA titers. The comparisons between adults 18 through 49
years of age and adults 60 through 64 years of age and between adults 50 through 59 years of age and adults 60 through 64 years
of age were based on separate regression models.
Immunogenicit y of Prevnar 20 in Adults Previously Vaccinated With Pneumococcal Vaccine
A randomized, open -label clinical trial (Study 6) described immune responses to Prevnar 20 in adults 65 years
of age and older previously vaccinated with PPSV23 ( ≥1 to ≤5 y ears prior to enrollment), previousl y vaccinated
with Prevnar 13 ( ≥6months prior to enrollment), or previousl y vaccinated with Prevnar 13 followed by
PPSV23 (with PPSV23 vaccination ≥1 y ear prior to enrollment). Participants in this clinical trial previously
vaccinated with Prevnar 13 (Prevnar 13 onl y or followed by PPSV23) were enrolled at sites in the United States
and participants previously vaccinated with PPSV23 only were also enrolled from Swedish sites (35.5% in that
category ).Immune responses elicited by Prevnar 20 were measured b y an OPA assay.
OPA GMTs in participants who rece ived PPSV23 1 to 5 y ears prior to Prevnar 20 were diminished compared to
OPA GMTs in participants who received Prevnar 13 at least 6 months previously and compared to OPA GMTs
in participants who received Prevnar 13 followed by PPSV23 ,with the last PPSV23 dose given at least 1 y ear
prior to Prevnar 20.
16HOW SUPPLIED/STORAGE AND HANDLING
Pre-filled Syringe, 1 Dose (10 per package) – NDC 0005 -2000 -10.
Pre-filled Syringe, 1 Dose (1 per package) – NDC 0005-2000-02.
After shipping, Prevnar 20 may arrive at temperatures between 2 ºC to 25 ºC (36 ºF to 77 ºF).
Upon receipt, store refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF).
Syringes should be stored in the refrigerator horizontally to minimize the resuspension time.
Do not freeze. Discard if the vaccine has been frozen.
Prevnar 20 should be administered as soon as possible after being removed from refrigeration.
Prevnar 20 can be administered provided total (cumulative multiple excursion s) time out of refrigeration (at
temperatures between 8 °C and 25 °C) does not exceed 96 hours. Cumulative multiple excursions between
FDA-CBER-2021-5683-0951411
180°Cand 2 °C are also permitted as long as the total time between 0 °C and 2 °C does not exceed 72 hours.
These are not, however, recommendations for storag e.
The tip cap and plunger stopper of the
pre-filled syringe are not made with natural rubber latex.
17PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual of the following:
The potential benefits and risks of immunization with Prevnar 20 [see Warnings and Precautions (5),
Adverse Reactions (6) ].
Any suspected adverse reactions should be reported to their healthcare professional.
This product’s label ingmay have been updated. For the most recent prescribing information, please visit
www.pfizer.com .
US Govt. L icense No. 3
LAB -1436 -1.0
CPT Code 90677
FDA-CBER-2021-5683-0951412