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Abrysvo powder and solvent for solution for injection {equilateral_black_triangle}

Active Ingredient:
respiratory syncytial virus vaccine (bivalent, recombinant)
Company:  
Pfizer Limited See contact details
ATC code: 
J07BX05
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About Medicine
{healthcare_pro_orange} This information is for use by healthcare professionals
Last updated on emc: 29 Nov 2023

 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

1. Name of the medicinal product

Abrysvo powder and solvent for solution for injection

Respiratory syncytial virus vaccine (bivalent, recombinant)

2. Qualitative and quantitative composition

After reconstitution, one dose (0.5 mL) contains:

RSV subgroup A stabilised prefusion F antigen1,2

60 micrograms

RSV subgroup B stabilised prefusion F antigen1,2

(RSV antigens)

60 micrograms

1glycoprotein F stabilised in the prefusion conformation

2produced in Chinese Hamster Ovary cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder and solvent for solution for injection.

The powder is white.

The solvent is a clear, colourless liquid.

4. Clinical particulars
4.1 Therapeutic indications

Abrysvo is indicated for:

• Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. See sections 4.2 and 5.1.

• Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.

The use of this vaccine should be in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Pregnant individuals

A single dose of 0.5 mL should be administered between weeks 28 and 36 of gestation (see sections 4.4, 4.6 and 5.1).

Individuals 60 years of age and older

A single dose of 0.5 mL should be administered.

Paediatric population

The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants (see section 5.1).

Method of administration

Abrysvo is for intramuscular injection into the deltoid region of the upper arm.

The vaccine should not be mixed with any other vaccines or medicinal products.

For instructions on reconstitution and handling of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity and anaphylaxis

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting.

Concurrent illness

Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.

Thrombocytopenia and coagulation disorders

Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals.

Immunocompromised individuals

The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Abrysvo may be lower in immunosuppressed individuals.

Individuals less than 28 weeks of gestation

Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation and should not be used in pregnant individuals less than 28 weeks of gestation (see sections 4.2, 4.6 and 5.1).

Limitations of vaccine effectiveness

As with any vaccine, a protective immune response may not be elicited after vaccination.

Excipient

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

4.5 Interaction with other medicinal products and other forms of interaction

Abrysvo can be administered concomitantly with seasonal influenza vaccine (QIV, surface antigen, inactivated, adjuvanted). In a randomised study in adults 65 years of age and older, the criteria for non-inferiority of the immune responses in the co-administration versus the separate administration group were met. However, numerically lower RSV A and B neutralising titres and numerically lower influenza A and B haemagglutination inhibition titres were observed when Abrysvo and inactivated adjuvanted seasonal influenza vaccine were co-administered than when they were administered separately. The clinical relevance of this finding is unknown.

A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co-administered with Tdap in healthy non-pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co-administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co-administration compared to separate administration and did not meet the criteria for non-inferiority. The clinical relevance of this finding is unknown.

4.6 Fertility, pregnancy and lactation

Pregnancy

Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity.

Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%).

No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (37%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (201 (6%) and 169 (5%), respectively), low birth weight (181 (5%) and 155 (4%), respectively) and congenital anomalies (174 (5%) and 203 (6%), respectively). As a precautionary measure until more data are available, Abrysvo should be administered to pregnant individuals between weeks 28 and 36 of gestation to minimise any potential risk of extremely premature birth (see section 4.2).

Breast-feeding

It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.

Fertility

No human data on the effect of Abrysvo on fertility are available.

Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

4.7 Effects on ability to drive and use machines

Abrysvo has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Summary of the safety profile

Pregnant individuals

In pregnant women at 24-36 weeks of gestation the most frequently reported adverse reactions were vaccination site pain (41%), headache (31%) and myalgia (27%). The majority of local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.

Individuals 60 years of age and older

In individuals 60 years of age and older the most frequently reported adverse reaction was vaccination site pain (11%). The majority of reactions were mild to moderate in severity and resolved within 1-2 days of onset.

Tabulated list of adverse reactions

The safety of administering a single dose of Abrysvo to pregnant women at 24-36 weeks of gestation (n=3 682) and to individuals 60 years of age and older (n=18 575) was evaluated in phase 3 clinical trials.

Adverse reactions are listed according to the following frequency categories:

Very common (≥1/10);

Common (≥1/100 to <1/10);

Uncommon (≥1/1 000 to <1/100);

Rare (≥1/10 000 to <1/1 000);

Very rare (<1/10 000);

Not known (cannot be estimated from the available data).

Adverse reactions reported are listed per system organ class, in decreasing order of seriousness.

Table 1 Adverse reactions following administration of Abrysvo

System organ class

Adverse drug reactions

pregnant individuals ≤49 years

Adverse drug reactions

individuals ≥60 years

Immune system disorders

Hypersensitivity

Very rare

Nervous system disorders

Headache

Very common

Guillain-Barré syndrome

Rarea

Musculoskeletal and connective tissue disorders

Myalgia

Very common

General disorders and administration site conditions

Vaccination site pain

Very common

Very common

Vaccination site redness

Common

Common

Vaccination site swelling

Common

Common

a In a study in individuals 60 years of age and older, one case of Guillain-Barré syndrome and one case of Miller Fisher syndrome were reported with onset of 7 and 8 days, respectively, after receiving Abrysvo and assessed by the investigator as possibly related to the administered vaccine. Both cases had either confounding factors or an alternative aetiology. One additional case, with onset 8 months after receiving Abrysvo, was assessed as not related to the administered vaccine by the investigator. One case of Guillain-Barré syndrome was reported in the placebo group 14 months after administration.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose with Abrysvo is unlikely due to its single dose presentation.

There is no specific treatment for an overdose with Abrysvo. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vaccines, other viral vaccines; ATC code: J07BX05

Mechanism of action

Abrysvo contains two recombinant stabilised RSV prefusion F antigens representing subgroups RSV-A and RSV-B. Prefusion F is the primary target of neutralising antibodies that block RSV infection. Following intramuscular administration, the prefusion F antigens elicit an immune response, which protects against RSV-associated lower respiratory tract disease.

In infants born to mothers who were vaccinated with Abrysvo between weeks 24 and 36 of gestation, protection against RSV-associated lower respiratory tract disease is due to transplacental transfer of RSV neutralising antibodies. Adults 60 years of age and older are protected by active immunisation.

Clinical efficacy

Infants from birth through 6 months of age by active immunisation of pregnant individuals

Study 1 is a phase 3, multicentre, randomised (1:1), double-blind, placebo -controlled study to assess the efficacy of a single dose of Abrysvo in the prevention of RSV-associated lower respiratory tract disease in infants born to pregnant individuals vaccinated between weeks 24 and 36 of gestation. The need for revaccination with subsequent pregnancies has not been established.

RSV-associated lower respiratory tract illness was defined as a medically attended visit with a reverse transcription-polymerase chain reaction (RT-PCR) confirmed RSV illness with one or more of the following respiratory symptoms: fast breathing, low oxygen saturation (SpO2 <95%) and chest wall indrawing. RSV-associated severe lower respiratory tract illness was defined as an illness that met the lower respiratory tract illness RSV criteria plus at least one of the following: very fast breathing, low oxygen saturation (SpO2 <93%), high-flow oxygen supplementation via nasal cannula or mechanical ventilation, ICU admission for >4 hours and/or failure to respond/unconscious.

In this study, 3 695 pregnant individuals with uncomplicated, singleton pregnancies were randomised to the Abrysvo group and 3 697 to placebo.

Vaccine efficacy (VE) was defined as the relative risk reduction of the endpoint in the Abrysvo group compared to the placebo group for infants born to pregnant individuals who received the assigned intervention. There were two primary efficacy endpoints, assessed in parallel, severe RSV-positive medically attended lower respiratory tract illness and RSV-positive medically attended lower respiratory tract illness, occurring within 90, 120, 150 or 180 days after birth.

Of the pregnant women who received Abrysvo, 65% were White, 20% were Black or African American and 29% were Hispanic/Latino. The median age was 29 years (range 16-45 years); 0.2% of participants were under 18 years of age and 4.3% were under 20 years of age. The median gestational age at vaccination was 31 weeks and 2 days (range 24 weeks and 0 days to 36 weeks and 4 days). The median infant gestational age at birth was 39 weeks and 1 day (range 27 weeks and 3 days to 43 weeks and 6 days).

Vaccine efficacy is presented in Tables 2, 3, 4 and 5.

Table 2 Vaccine efficacy of Abrysvo against severe medically attended lower respiratory tract illness caused by RSV in infants from birth through 6 months of age by active immunisation of pregnant individuals – Study 1

Time period

Abrysvo

Number of cases

N=3 495

Placebo

Number of cases

N=3 480

VE %

(CI)a

90 days

6

33

81.8 (40.6, 96.3)

120 days

12

46

73.9 (45.6, 88.8)

150 days

16

55

70.9 (44.5, 85.9)

180 days

19

62

69.4 (44.3, 84.1)

CI = confidence interval; VE = vaccine efficacy

a 99.5% CI at 90 days; 97.58% CI at later intervals

Table 3 Vaccine efficacy of Abrysvo against medically attended lower respiratory tract illness caused by RSV in infants from birth through 6 months of age by active immunisation of pregnant individuals – Study 1

Time period

Abrysvo

Number of cases

N=3 495

Placebo

Number of cases

N=3 480

VE %

(CI)a

90 days

24

56

57.1 (14.7, 79.8)

120 days

35

81

56.8 (31.2, 73.5)

150 days

47

99

52.5 (28.7, 68.9)

180 days

57

117

51.3 (29.4, 66.8)

CI = confidence interval; VE = vaccine efficacy

a 99.5% CI at 90 days; 97.58% CI at later intervals

Table 4 Vaccine efficacy of Abrysvo against severe medically attended lower respiratory tract illness caused by RSV in infants from birth through 6 months of age by active immunisation of pregnant individuals between weeks 28 and 36 of gestation – Study 1a

Time period

Abrysvo

Number of cases

N=2 602

Placebo

Number of cases

N=2 609

VE %

(CI)b

90 days

2

22

90.9 (62.9, 99.0)

120 days

5

31

83.8 (58.0, 95.1)

150 days

6

38

84.2 (62.3, 94.5)

180 days

8

43

81.3 (59.9, 92.4)

CI = confidence interval; VE = vaccine efficacy

a This post-hoc descriptive subgroup analysis was not controlled for multiple comparisons

b 95% CI

Table 5 Vaccine efficacy of Abrysvo against medically attended lower respiratory tract illness caused by RSV in infants from birth through 6 months of age by active immunisation of pregnant individuals between weeks 28 and 36 of gestation – Study 1a

Time period

Abrysvo

Number of cases

N=2 602

Placebo

Number of cases

N=2 609

VE %

(CI)b

90 days

18

43

58.0 (25.7, 77.2)

120 days

25

61

58.9 (33.6, 75.3)

150 days

30

76

60.4 (38.9, 75.0)

180 days

35

90

61.0 (41.8, 74.4)

CI = confidence interval; VE = vaccine efficacy

a This post-hoc descriptive subgroup analysis was not controlled for multiple comparisons

b 95% CI

Active immunisation of individuals 60 years of age and older

Study 2 is a phase 3, multicentre, randomised, double-blind, placebo-controlled study to assess the efficacy of Abrysvo in the prevention of RSV-associated lower respiratory tract illness in individuals 60 years of age and older.

RSV-associated lower respiratory tract illness was defined as 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 tachypnoea (≥25 breaths/min or 15% increase from resting baseline).

Participants were randomised (1:1) to receive Abrysvo (n=18 488) or placebo (n=18 479). Enrollment was stratified by age 60-69 years (63%), 70-79 years (32%) and ≥80 years (5%). Subjects with stable chronic underlying conditions were eligible for this study and 52% of participants had at least 1 prespecified condition; 16% of participants were enrolled with stable chronic cardiopulmonary conditions such as asthma (9%), chronic obstructive pulmonary disease (7%) or congestive heart failure (2%). Immunocompromised individuals were ineligible.

The primary objective was assessment of vaccine efficacy (VE), defined as the relative risk reduction of first episode of RSV-associated lower respiratory tract illness in the Abrysvo group compared to the placebo group in the first RSV season.

Of the participants who received Abrysvo, 51% were male and 80% were White, 12% were Black or African American and 41% were Hispanic/Latino. The median age of participants was 67 years (range 59-95 years).

At the end of the first RSV season the analysis demonstrated statistically significant efficacy for Abrysvo for reduction of RSV-associated lower respiratory tract illness with ≥2 symptoms and with ≥3 symptoms.

Vaccine efficacy information is presented in Table 6.

Table 6 Vaccine efficacy of Abrysvo against RSV disease - active immunisation of individuals 60 years of age and older – Study 2

Efficacy endpoint

Abrysvo

Number of cases

N=18 058

Placebo

Number of cases

N=18 076

VE (%)

(95% CI)

First episode of RSV-associated lower respiratory tract illness with ≥2 symptomsa

15

43

65.1 (35.9, 82.0)

First episode of RSV-associated lower respiratory tract illness with ≥3 symptomsb

2

18

88.9 (53.6, 98.7)

CI – confidence interval; RSV – respiratory syncytial virus; VE – vaccine efficacy

a In an exploratory analysis in RSV subgroup A (Abrysvo n=3, placebo n=16 VE was 81.3% (CI 34.5, 96.5); and in RSV subgroup B (Abrysvo n=12, placebo n=26) VE was 53.8% (CI 5.2, 78.8).

b In an exploratory analysis in RSV subgroup A (Abrysvo n=1, placebo n=5) VE was 80.0% (CI -78.7, 99.6); and in RSV subgroup B (Abrysvo n=1, placebo n=12) VE was 91.7% (CI 43.7, 99.8).

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Abrysvo in children from 2 to less than 18 years of age in prevention of lower respiratory tract disease caused by RSV (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity and toxicity to reproduction and development.

6. Pharmaceutical particulars
6.1 List of excipients

Powder

Trometamol

Trometamol hydrochloride

Sucrose

Mannitol

Polysorbate 80

Sodium chloride

Hydrochloric acid (for pH adjustment)

Solvent

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

2 years

The unopened vial is stable for 5 days when stored at temperatures from 8°C to 30°C. At the end of this period Abrysvo should be used or discarded. This information is used to guide healthcare professionals in case of temporary temperature excursions only.

After reconstitution

Abrysvo should be administered immediately after reconstitution or within 4 hours if stored between 15°C and 30°C. Do not freeze.

Chemical and physical in-use stability has been demonstrated for 4 hours between 15°C and 30°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4 Special precautions for storage

Store in a refrigerator (2°C - 8°C).

Do not freeze. Discard if the carton has been frozen.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Powder

Powder for 1 dose in a vial (type 1 glass or equivalent) with a stopper (synthetic chlorobutyl rubber) and a flip off cap

Solvent

Solvent for 1 dose in a pre-filled syringe (type 1 glass) with a stopper (synthetic chlorobutyl rubber) and a tip cap (synthetic isoprene/bromobutyl blend rubber)

Vial adaptor

Sterile vial adaptor

Pack size

Pack containing 1 vial of powder, 1 pre-filled syringe of solvent, 1 vial adaptor with 1 needle or without needles.

Pack containing 5 vials of powder, 5 pre-filled syringes of solvent, 5 vial adaptors with 5 needles or without needles.

Pack containing 10 vials of powder, 10 pre-filled syringes of solvent, 10 vial adaptors with 10 needles or without needles.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Abrysvo must be reconstituted prior to the administration by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder using the vial adaptor.

The vaccine must be reconstituted only with the solvent provided.

Preparation for administration

Step 1. Prepare vial adaptor

• Remove plastic flip off cap from vial and wipe the rubber stopper.

• Open the packaging containing the vial adaptor by peeling the top cover off.

• Do not remove the vial adaptor from its package.

Step 2. Attach the vial adaptor to the vial containing antigens for Abrysvo

• Hold the base of the vial on a flat surface.

• Keep the vial adaptor in the packaging and orient it vertically over the centre of the vial so that the adaptor spike aligns with the centre of the vial's rubber stopper.

• Connect the vial adaptor to the vial with a straight downward push. The vial adaptor will lock into place.

• Do not push vial adaptor in at an angle as this may result in leaking during use.

• Remove the vial adaptor packaging.

Step 3. Remove syringe cap

• For all syringe assembly steps, hold the syringe only by the Luer lock adaptor located at the tip of the syringe. This will prevent the Luer lock adaptor from detaching during use.

• Remove the syringe cap by slowly turning the cap anti-clockwise while holding the Luer lock adaptor.

Step 4. Connect syringe to the vial adaptor

• Hold the syringe's Luer lock adaptor and connect it to the vial adaptor 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 adaptor, there will be a small space between the top of the vial adaptor and the Luer lock adaptor of the syringe.

Step 5. Inject solvent and gently swirl

• Inject the entire contents of the syringe containing the solvent 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 (approximately 1-2 minutes).

• Do not shake.

Step 6. Withdraw the contents

• Invert the vial completely with the vial adaptor and syringe still attached.

• Slowly withdraw the entire contents into the syringe.

• Drawing up all obtainable content ensures a complete 0.5 mL dose for administration.

• Do not pull the plunger rod out.

Step 7. Disconnect syringe

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

Step 8. Attach needle

• Attach a sterile needle suitable for intramuscular injection to the pre-filled syringe by turning clockwise.

• Do not overtighten the needle as this may result in leaking during use.

Step 9. Visual inspection

• The prepared vaccine is a clear and colourless solution.

• Visually inspect the vaccine for large particulate matter and discolouration prior to administration. Do not use if large particulate matter or discolouration is found.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

8. Marketing authorisation number(s)

PLGB 00057/1722

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 21 November 2023

10. Date of revision of the text

11/2023

Ref: bAB 1_4

Pfizer Limited
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