labeling.pfizer.com Open in urlscan Pro
148.168.80.135  Public Scan

Form analysis
0 forms found in the DOM

Text Content

ABRYSVO- respiratory syncytial virus vaccine 
Pfizer Laboratories Div Pfizer Inc


----------


HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ABRYSVO safely
and effectively. See full prescribing information for ABRYSVO.

ABRYSVOTM (Respiratory Syncytial Virus Vaccine) solution for intramuscular
injection
Initial U.S. Approval: 2023



INDICATIONS AND USAGE

ABRYSVO is a vaccine indicated for active immunization for the prevention of
lower respiratory tract disease (LRTD) caused by respiratory syncytial virus
(RSV) in individuals 60 years of age and older. (1)


DOSAGE AND ADMINISTRATION

•For intramuscular use only. (2)•Administer ABRYSVO as a single approximately
0.5 mL dose. (2.3)





DOSAGE FORMS AND STRENGTHS

Solution for injection. A single dose after reconstitution is approximately 0.5
mL. (3)


CONTRAINDICATIONS

History of severe allergic reaction (e.g., anaphylaxis) to any component of
ABRYSVO. (4)




ADVERSE REACTIONS

The most commonly reported solicited local and systemic adverse reactions (≥10%)
were fatigue (15.5%), headache (12.8%), pain at the injection site (10.5%), and
muscle pain (10.1%). (6.1)



To report SUSPECTED ADVERSE REACTIONS, contact Pfizer 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: 5/2023


FULL PRESCRIBING INFORMATION: CONTENTS*


1 INDICATIONS AND USAGE


2 DOSAGE AND ADMINISTRATION


2.1 DOSE AND SCHEDULE


2.2 PREPARATION FOR ADMINISTRATION


2.3 ADMINISTRATION


3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS


5.1 MANAGEMENT OF ACUTE ALLERGIC REACTIONS


5.2 SYNCOPE


5.3 ALTERED IMMUNOCOMPETENCE


5.4 LIMITATIONS OF VACCINE EFFECTIVENESS


6 ADVERSE REACTIONS


6.1 CLINICAL TRIALS EXPERIENCE


8 USE IN SPECIFIC POPULATIONS


8.1 PREGNANCY


8.2 LACTATION


8.4 PEDIATRIC USE


8.5 GERIATRIC USE


11 DESCRIPTION


12 CLINICAL PHARMACOLOGY


12.1 MECHANISM OF ACTION


13 NONCLINICAL TOXICOLOGY


13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY


14 CLINICAL STUDIES


14.1 EFFICACY IN INDIVIDUALS 60 YEARS OF AGE AND OLDER


16 HOW SUPPLIED/STORAGE AND HANDLING


16.1 HOW SUPPLIED


16.2 STORAGE AND HANDLING


17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not
listed.


FULL PRESCRIBING INFORMATION




1 INDICATIONS AND USAGE

ABRYSVO is a vaccine indicated for active immunization for the prevention of
lower respiratory tract disease (LRTD) caused by respiratory syncytial virus
(RSV) in individuals 60 years of age and older.


2 DOSAGE AND ADMINISTRATION


2.1 DOSE AND SCHEDULE

Administer a single dose (approximately 0.5 mL) of ABRYSVO intramuscularly.


2.2 PREPARATION FOR ADMINISTRATION

ABRYSVO is supplied in a kit that includes a vial of Lyophilized Antigen
Component (a sterile white powder), a prefilled syringe containing Sterile Water
Diluent Component and a vial adapter.

Vial of Lyophilized Antigen Component

Syringe of Sterile Water Diluent Component

Vial Adapter

To form ABRYSVO, reconstitute the Lyophilized Antigen Component with the
accompanying Sterile Water Diluent Component as described in the panels below.

Step 1. Preparation of vial and vial adapter

•Remove plastic flip off cap from vial and cleanse the rubber stopper.•Without
removing the vial adapter from its packaging, peel off the top cover.

Step 2. Attachment of vial adapter

•Hold the base of the vial on a flat surface.•Keep the vial adapter in the
packaging and orient it vertically over the center of the vial so that the
adapter spike aligns with the center of the vial’s rubber stopper. •Connect the
vial adapter to the vial with a straight downward push. The vial adapter will
lock into place.•Do not push vial adapter in at an angle as this may result in
leaking during use.•Remove the vial adapter packaging.

Step 3. Removal of syringe cap

•For all syringe assembly steps, hold the syringe only by the Luer lock adapter
located at the tip of the syringe. This will prevent the Luer lock adapter from
detaching during use.•Remove the syringe cap by slowly turning the cap
counter-clockwise while holding the Luer lock adapter.

Step 4. Connection of syringe to vial adapter

•Hold the syringe’s Luer lock adapter and connect it to the vial adapter by
turning clockwise.•Stop turning when you feel resistance, overtightening the
syringe may result in leaking during use.•Once the syringe is securely attached
to the vial adapter, there will be a small space between the top of the vial
adapter and the Luer lock adapter of the syringe.

Step 5. Reconstitution of Lyophilized Antigen Component to form ABRYSVO

•Inject the entire contents of the syringe containing the Sterile Water Diluent
Component into the vial.•Do not remove the empty syringe.•While holding the
plunger rod down, gently swirl the vial in a circular motion until the powder is
completely dissolved (less than 1 minute).•Do not shake.

Step 6. Withdrawal of reconstituted vaccine

•Invert the vial completely with the vial adapter and syringe still
attached.•Slowly withdraw the entire contents into the syringe to ensure an
approximately 0.5 mL dose of ABRYSVO for administration.•Do not pull the plunger
rod out.

Step 7. Disconnection of syringe

•Hold the Luer lock adapter of the syringe and disconnect the syringe from the
vial adapter by turning counter-clockwise.

Step 8. Attachment of needle

•Attach a sterile needle suitable for intramuscular injection to the syringe
containing ABRYSVO.

Step 9. Visual inspection

•ABRYSVO is a clear and colorless solution.•Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Discard if either
condition is present.


2.3 ADMINISTRATION

For intramuscular injection only

After reconstitution, administer ABRYSVO immediately or store at room
temperature [15°C to 30°C (59°F to 86°F)] and use within 4 hours. Discard
reconstituted vaccine if not used within 4 hours.


3 DOSAGE FORMS AND STRENGTHS

ABRYSVO is a solution for injection. A single dose after reconstitution is
approximately 0.5 mL.


4 CONTRAINDICATIONS

Do not administer ABRYSVO to individuals with a history of a severe allergic
reaction (e.g., anaphylaxis) to any component of ABRYSVO [see Description (11)].


5 WARNINGS AND PRECAUTIONS


5.1 MANAGEMENT OF ACUTE ALLERGIC REACTIONS

Appropriate medical treatment used to manage immediate allergic reactions must
be immediately available in the event an anaphylactic reaction occurs following
administration of ABRYSVO.


5.2 SYNCOPE

Syncope (fainting) may occur in association with administration of injectable
vaccines, including ABRYSVO. Procedures should be in place to avoid injury from
fainting.


5.3 ALTERED IMMUNOCOMPETENCE

Immunocompromised individuals, including those receiving immunosuppressive
therapy, may have a diminished immune response to ABRYSVO.


5.4 LIMITATIONS OF VACCINE EFFECTIVENESS

Vaccination with ABRYSVO may not protect all vaccine recipients.


6 ADVERSE REACTIONS

In clinical trials, the most commonly reported (≥10%) adverse reactions were
fatigue (15.5%), headache (12.8%), pain at the injection site (10.5%), and
muscle pain (10.1%).


6.1 CLINICAL TRIALS EXPERIENCE

Because clinical 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 practice.

The safety of ABRYSVO was evaluated in Study 1 (NCT05035212) in which 17,215
participants received ABRYSVO and 17,069 received placebo (0.5 mL dose,
containing the same buffer ingredients in the same quantities as in a single
dose of ABRYSVO [see Description (11)]). Study 1 is an ongoing Phase 3,
multicenter, randomized, double-blind, placebo-controlled study to assess the
efficacy and safety of ABRYSVO in individuals 60 years of age and older. This
study is being conducted in the USA, South Africa, Japan, Canada, Finland, the
Netherlands, and Argentina. Demographic characteristics among participants who
received ABRYSVO and those who received placebo were generally similar with
regard to age, sex, race, and ethnicity. Of the participants in the study, 51%
were male and 78% were White, 13% were Black or African American, and 37% were
Hispanic/Latino. The median age of participants was 67 years (range 59-97
years).

Solicited local and systemic reactions were collected using electronic diaries
for 7 days after study vaccination in 7,169 participants (3,630 ABRYSVO
participants and 3,539 placebo recipients) from a subset of sites. For all
participants, unsolicited adverse events were collected for one month after
study vaccination; serious adverse events (SAEs) are collected throughout study
participation.

Solicited Local and Systemic Reactions in Study 1

Solicited local and systemic reactions reported within 7 days after vaccination
in Study 1 are presented in Tables 1 and 2.

Table 1     Percentage of Participants with Local Reactions Reported, by Maximum
Severity, within 7 Days after Vaccination – Study 1*Local ReactionsABRYSVO
N=3,619-3,621†
%PLACEBO
N=3,532-3,539†
%*NCT05035212†N = number of participants who provided e-diary data for a
specific reaction after vaccination.‡Mild: does not interfere with activity;
moderate: some interference with activity; severe: prevents daily activity.§Any
includes all participants who reported a reaction as mild, moderate, or severe
during Day 1 to Day 7 after vaccination.¶Mild: 2.5 cm to 5 cm; moderate: >5 cm
to 10 cm; severe: >10 cm (for data reported from e-diaries).

Injection site pain‡

  Any§

10.5

6.0

  Mild

9.4

5.3

  Moderate

1.1

0.7

  Severe

<0.1

0

Redness§¶

  Any§

2.7

0.7

  Mild

1.5

0.5

  Moderate

1.1

0.2

  Severe

0.1

0

Swelling§¶

  Any§

2.4

0.5

  Mild

1.5

0.2

  Moderate

0.9

0.2

  Severe

0.1

<0.1

Table 2     Percentage of Participants with Systemic Reactions Reported, by
Maximum Severity, within 7 Days after Vaccination – Study 1*Systemic
ReactionsABRYSVO
N=3,619-3,621†
%PLACEBO
N=3,532-3,539†
%*NCT05035212†N = number of participants who provided e-diary data for a
specific reaction after vaccination.‡Mild: does not interfere with activity;
moderate: some interference with activity; severe: prevents daily routine
activity.§Any includes all participants who reported a reaction as mild,
moderate, or severe during Day 1 to Day 7 after vaccination.¶Mild: 1 to 2 times
in 24 hours; moderate: >2 times in 24 hours; severe: requires intravenous
hydration.#Mild: 2 to 3 loose stools in 24 hours; moderate: 4 to 5 loose stools
in 24 hours; severe: 6 or more loose stools in 24 hours.

Fever (≥38.0℃)

  ≥38.0°C

1.4

1.4

  38.0°C to 38.4°C

0.6

0.8

  >38.4°C to 38.9°C

0.8

0.6

  >38.9°C to 40.0°C

<0.1

<0.1

  >40.0°C

0

<0.1

Fatigue‡

  Any§

15.5

14.4

  Mild

9.3

8.4

  Moderate

5.9

5.8

  Severe

0.3

0.1

Headache‡

  Any§

12.8

11.7

  Mild

9.0

8.4

  Moderate

3.7

3.2

  Severe

0.1

<0.1

Muscle pain‡

  Any§

10.1

8.4

  Mild

6.5

5.5

  Moderate

3.5

2.8

  Severe

0.2

<0.1

Joint pain‡

  Any§

7.5

6.9

  Mild

4.5

3.9

  Moderate

2.9

2.9

  Severe

<0.1

<0.1

Nausea‡

  Any§

3.4

3.7

  Mild

2.5

3.1

  Moderate

0.9

0.6

  Severe

0

<0.1

Vomiting¶

  Any§

0.9

0.8

  Mild

0.7

0.7

  Moderate

0.2

0.1

  Severe

0

<0.1

Diarrhea#

  Any§

5.9

5.2

  Mild

4.4

4.2

  Moderate

1.3

0.9

  Severe

0.1

0.1

Solicited local and systemic reactions had a median duration of 1-2 days.

Unsolicited Adverse Events in Study 1

Unsolicited adverse events occurring within 1 month after vaccination were
similar between groups, reported in 8.9% and 8.5% of participants who received
ABRYSVO and placebo, respectively.

Within 30 days after vaccination, atrial fibrillation was reported in 10 vaccine
recipients and 4 placebo recipients (of which 4 in the ABRYSVO group and 3 in
the placebo group were serious adverse events); the onset of symptoms was 18 to
30 days post vaccination. The currently available information on atrial
fibrillation is insufficient to determine a causal relationship to the vaccine.
There were no other notable patterns or numerical imbalances between groups for
specific categories of unsolicited adverse events.

Serious Adverse Events in Study 1

In Study 1, SAEs were reported by 2.3% of participants in both the ABRYSVO and
placebo groups. Three participants in the ABRYSVO group had SAEs which were
assessed as possibly related to study vaccination: Guillain-Barre Syndrome
reported 7 days after vaccination, Miller Fisher Syndrome reported 8 days after
vaccination, and hypersensitivity reported 8 hours after vaccination.


8 USE IN SPECIFIC POPULATIONS


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 miscarriages in clinically recognized pregnancies is 2% to 4%, and 15% to
20%, respectively, and the estimated background risk of fetal deaths after 20
weeks is 0.6%. ABRYSVO is not approved for use in individuals younger than 60
years of age.

Data from a clinical trial (NCT04424316) that enrolled pregnant individuals who
were randomly assigned 1:1 to receive ABRYSVO or placebo (0.5 mL dose,
containing the same buffer ingredients in the same quantities as in a single
dose of ABRYSVO [see Description (11)]) at 24 through 36 weeks’ gestation
revealed no evidence for vaccine-associated increase in the risk of congenital
anomalies or fetal deaths. In this study, there was a numerical imbalance in
preterm births, with more preterm infants born to individuals in the ABRYSVO
group compared to individuals in the placebo group (see Human Data).

A developmental and reproductive toxicity study was performed in female rabbits
administered a vaccine formulation containing two times the antigen content of a
single human dose of ABRYSVO prior to and during gestation. The study showed no
evidence of harm to the fetus or to postnatal survival, growth, or development
(see Animal Data).

Data

Human Data

In a randomized controlled clinical trial (NCT04424316), 3,682 pregnant
individuals received ABRYSVO and 3,676 received placebo (0.5 mL dose, containing
the same buffer ingredients in the same quantities as in a single dose of
ABRYSVO [see Description (11)]) at 24 through 36 weeks’ gestation. The infant
safety population included 3,568 and 3,558 infants born to individuals in the
ABRYSVO or placebo group, respectively. Among the infants born to individuals in
the ABRYSVO group and in the placebo group, 202 (5.7%) and 169 (4.7%),
respectively, were born prematurely and 174 (4.9%) and 203 (5.7%), respectively,
had reported congenital malformations or anomalies. There were 10 (0.3%) fetal
deaths in the ABRYSVO group and 8 (0.2%) in the placebo group.

Animal Data

A developmental toxicity study was performed in female New Zealand White
rabbits. Rabbits were administered 4 doses by intramuscular injection: at 3
weeks and at 1 week prior to mating, and on gestation days 10 and 24. On each
occasion, rabbits received 0.5 mL of a vaccine formulation containing twice the
antigen content of F glycoproteins of RSV A and RSV B (120 mcg RSV preF A and
120 mcg RSV preF B), stabilized in prefusion conformation as contained in a
single human dose of ABRYSVO [see Description (11)]. No adverse effects on
mating, female fertility, or on embryo/fetal or post-natal survival, growth, or
development were observed. There were no vaccine-related fetal malformations or
variations.


8.2 LACTATION

Risk Summary

It is not known whether ABRYSVO is excreted in human milk. Data are not
available to assess the effects of ABRYSVO 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 ABRYSVO and any
potential adverse effects on the breastfed child from ABRYSVO or from the
underlying maternal condition. For preventative vaccines, the underlying
maternal condition is susceptibility to disease prevented by the vaccine.
ABRYSVO is not approved for use in individuals younger than 60 years of age.


8.4 PEDIATRIC USE

The safety and effectiveness of ABRYSVO in individuals younger than 18 years of
age have not been established.


8.5 GERIATRIC USE

ABRYSVO is approved for use in individuals 60 years of age and older. In Study
1, of the 17,215 recipients who received ABRYSVO 62% (n=10,756) were aged 60-69
years of age, 32% (n=5,488) were 70-79 years of age and 6% (n=970) were ≥80
years of age [see Adverse Reactions (6.1) and Clinical Studies (14.1)].


11 DESCRIPTION

ABRYSVO (Respiratory Syncytial Virus Vaccine) is a sterile solution for
intramuscular injection. The vaccine is supplied as a vial of Lyophilized
Antigen Component that is reconstituted at the time of use with a Sterile Water
Diluent Component. The antigen component contains recombinant RSV preF A and RSV
preF B.

The RSV preF A and RSV preF B recombinant proteins are expressed in genetically
engineered Chinese Hamster Ovary cell lines grown in suspension culture using
chemically-defined media, without antibiotics or animal-derived components. The
recombinant proteins are purified through a series of column chromatography and
filtration steps followed by formulation, filling into vials, and
lyophilization.

After reconstitution, each dose of ABRYSVO is approximately 0.5 mL. The vaccine
is formulated to contain 120 mcg of RSV stabilized prefusion F proteins (60 mcg
RSV preF A and 60 mcg RSV preF B) per 0.5 mL. ABRYSVO also contains the
following buffer ingredients: 0.11 mg tromethamine, 1.04 mg tromethamine
hydrochloride, 11.3 mg sucrose, 22.5 mg mannitol, 0.08 mg polysorbate 80, and
1.1 mg sodium chloride per 0.5 mL. ABRYSVO is a sterile, clear, and colorless
solution.

ABRYSVO contains no preservatives. Each dose may also contain residual amounts
of host cell proteins (≤0.1% w/w) and DNA (<0.4 ng/mg of total protein) from the
manufacturing process.

The vial stopper and tip cap and rubber plunger of the prefilled syringe are not
made with natural rubber latex.


12 CLINICAL PHARMACOLOGY


12.1 MECHANISM OF ACTION

ABRYSVO induces an immune response against RSV pre F that protects against lower
respiratory tract disease caused by RSV.


13 NONCLINICAL TOXICOLOGY


13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

ABRYSVO has not been evaluated for the potential to cause carcinogenicity,
genotoxicity, or impairment of male fertility. A developmental and reproductive
toxicity study in female rabbits revealed no evidence of impaired female
fertility [see Use in Specific Populations (8.1)].


14 CLINICAL STUDIES


14.1 EFFICACY IN INDIVIDUALS 60 YEARS OF AGE AND OLDER

Study 1 is an ongoing Phase 3, multicenter, randomized, double-blind,
placebo-controlled study to assess the efficacy and safety of ABRYSVO in the
prevention of RSV-associated lower respiratory tract disease in individuals 60
years of age and older. Participants are planned to be followed for up to two
RSV seasons, approximately 25 months.

Participants were randomized (1:1) to receive ABRYSVO (n=17,197) or placebo
(n=17,186). Randomization was stratified by age, 60-69 years (n=21,499, 63%),
70-79 years (n=10,948, 32%), and ≥80 years (n=1,934, 6%). Healthy adults and
adults with stable chronic diseases were included. Among enrolled participants
15% had stable chronic cardiopulmonary conditions such as chronic obstructive
pulmonary disease (COPD), asthma, or congestive heart failure (CHF).

Starting 14 days after study vaccination (study Day 15), all participants were
actively monitored for onset of acute respiratory illness (ARI) symptoms: new or
increased sore throat, nasal congestion, nasal discharge, cough, wheezing,
sputum production, or shortness of breath. If the participant experienced 1 or
more ARI symptoms, a mid-turbinate nasal swab was collected within 7 days of
onset of symptoms and tested by reverse transcriptase polymerase chain reaction
(RT-PCR) for RSV.

RSV-associated lower respiratory tract disease (RSV-LRTD) was evaluated in Study
1. A case of RSV-LRTD was defined as an RT-PCR confirmed RSV illness with two or
more, or three or more, of the following respiratory symptoms within 7 days of
symptom onset and lasting more than 1 day during the same illness: new or
increased cough, wheezing, sputum production, shortness of breath, or tachypnea
(≥25 breaths/min or 15% increase from resting baseline). A case of
RSV-associated severe lower respiratory tract disease was defined as a case
meeting the RSV-LRTD criteria plus at least one of the following:
hospitalization due to RSV-LRTD, new or increased oxygen supplementation, or
mechanical ventilation including Continuous Positive Airway Pressure (CPAP).

Efficacy against Respiratory Syncytial Virus-associated Lower Respiratory Tract
Disease

Vaccine efficacy (VE), against RSV-LRTD, defined as the relative risk reduction
of first episode of RSV-LRTD in the ABRYSVO group compared to the placebo group
in the first RSV season, was assessed.

The study met the pre-specified success criteria for demonstration of efficacy
of ABRYSVO for the primary objectives of prevention of RSV-LRTD with ≥2 symptoms
and prevention of RSV-LRTD with ≥3 symptoms. The median duration of follow-up
for efficacy was 7 months.

Vaccine efficacy information is presented in Table 3.

Table 3     Vaccine Efficacy of ABRYSVO Against RSV-LRTD - Individuals 60 years
of Age and Older (Study 1)*CI – confidence interval; N – number of participants;
n = number of cases; RSV – respiratory syncytial virus; VE – vaccine efficacy
(VE based on case count ratio is calculated as 1-(P/[1-P]), where P is the
number of RSVpreF cases divided by the total number of
cases)*NCT05035212†Evaluable efficacy population

Efficacy Endpoint

ABRYSVO

N=16,306†

n

Placebo

N=16,308†

n

VE (%)

(96.66% CI)

First episode of RSV-associated lower respiratory tract disease with ≥2 symptoms

11

33

66.7 (28.8, 85.8)

First episode of RSV-associated lower respiratory tract disease with ≥3 symptoms

2

14

85.7 (32.0, 98.7)

There were 2 cases of RSV associated severe lower respiratory tract disease in
the placebo group and no cases in the ABRYSVO group.


16 HOW SUPPLIED/STORAGE AND HANDLING


16.1 HOW SUPPLIED

ABRYSVO is supplied in a kit that includes a vial of Lyophilized Antigen
Component (NDC 0069-0207-01), a prefilled syringe containing Sterile Water
Diluent Component (NDC 0069-0250-01) and a vial adapter. The Lyophilized Antigen
Component is reconstituted with the Sterile Water Diluent Component to form a
single dose of ABRYSVO.

ABRYSVO is supplied in cartons of 1, 5, and 10 kits.

Carton: 1 kit

NDC 0069-0344-01

Carton: 5 kits

NDC 0069-0344-05

Carton: 10 kits

NDC 0069-0344-10

The vial stopper and the tip cap and rubber plunger of the prefilled syringe are
not made with natural rubber latex.


16.2 STORAGE AND HANDLING

Storage Before Reconstitution

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton. Do not
freeze. Discard if the carton has been frozen.

Storage After Reconstitution

After reconstitution, administer ABRYSVO immediately or store at room
temperature [15ºC to 30ºC (59ºF to 86ºF)] and use within 4 hours. Do not store
reconstituted vaccine under refrigerated conditions [2ºC to 8ºC (36ºF to 46ºF)].
Do not freeze reconstituted vaccine.


17 PATIENT COUNSELING INFORMATION

Prior to administration of this vaccine:

•Inform vaccine recipient of the potential benefits and risks of vaccination
with ABRYSVO.•Advise vaccine recipient to report any adverse events to their
healthcare provider or to the Vaccine Adverse Event Reporting System at
1-800-822-7967 and www.vaers.hhs.gov.

This product's labeling may have been updated. For the most recent prescribing
information, please visit www.pfizer.com.

Manufactured by
Pfizer Inc.
NY, NY 10001
US License No. 2001



LAB-1498-1.0



Revised: 7/2023
Document Id: a6436730-83f8-4519-9b83-588603e424b9
53404-0
Set id: be18292e-b1a2-4815-a0ed-003efaa6bea3
Version: 1
Effective Time: 20230717
 
Pfizer Laboratories Div Pfizer Inc