Safety Profile for mRESVIA® (Respiratory Syncytial Virus Vaccine) |HCP

Well tolerated in adults aged 60 or older¹

In the placebo-controlled, observer-blinded clinical study of mRESVIA, local and systemic adverse reactions (ARs) were solicited electronically for 7 days following administration.¹

Rates of SAEs were similar between those taking mRESVIA and those taking placebo¹*

ARs were mostly mild or moderate in severity¹

Most ARs lasted an average of 1 to 2 days^1†

Solicited local adverse reactions reported in individuals aged
60 or older (mRESVIA vs placebo)^1‡§

	mRESVIA	Placebo
Injection Site Pain, Any Grade^\|\|	55.9%	13.8%
Injection Site Pain, Grade 3^\|\|	1.7%	1.1%
Erythema, Any Grade	2.0%	0.6%
Erythema, Grade 3	0.6%	0.3%
Swelling, Any Grade	3.7%	0.3%
Swelling, Grade 3	0.9%	<0.1%
Axillary swelling or tenderness, Any Grade^¶	15.2%	6.1%
Axillary swelling or tenderness, Grade 3^¶	0.8%	0.6%

Solicited systemic adverse reactions reported in individuals aged
60 or older (mRESVIA vs placebo)^1†‡

	mRESVIA	Placebo
Fever, Any Grade	2.7%	1.3%
Fever, Grade 3	0.4%	0.2%
Fever, Grade 4	0.2%	0.2%
Headache, Any Grade^#	26.7%	18.8%
Headache, Grade 3^#	1.5%	1.1%
Fatigue, Any Grade**	30.8%	20.0%
Fatigue, Grade 3**	1.7%	1.2%
Myalgia, Any Grade^††	25.6%	14.4%
Myalgia, Grade 3^††	1.4%	0.8%
Arthralgia, Any Grade^††	21.7%	14.0%
Arthralgia, Grade 3^††	1.1%	0.7%
Nausea/vomiting, Any Grade^‡‡	7.0%	5.2%
Nausea/vomiting, Grade 3^‡‡	0.4%	0.4%
Chills, Any Grade^§§	11.6%	6.8%
Chills, Grade 3^§§	0.6%	0.4%

The most frequent AR with mRESVIA was pain at the injection site (Grades 1-3)¹

*Serious adverse reactions were reported at similar rates in 7.8% of the mRESVIA group and 7.9% of the placebo group.¹

^†With the exception of fever, no Grade 4 solicited systemic ARs were reported.¹

^‡Placebo is 0.9% sodium chloride (normal saline) injection.¹

^§No Grade 4 solicited local adverse reactions were reported.¹

^||Injection site pain grading scale: Does not interfere with activity (Grade 1); repeated use of over-the-counter pain reliever >24 hours or interferes with activity (Grade 2); any use of prescription pain reliever or prevents daily activity (Grade 3).¹

^¶Axillary (underarm) swelling or tenderness grading scale: No interference with activity (Grade 1); repeated use of over-the-counter pain reliever >24 hours or some interference with activity (Grade 2); any use of prescription pain reliever or prevents daily activity (Grade 3).¹

^#Headache grading scale: No interference with activity (Grade 1); repeated use of over-the-counter pain reliever >24 hours or some interference with activity (Grade 2); significant, any use of prescription pain reliever or prevents daily activity (Grade 3).¹

**Fatigue grading scale: No interference with activity (Grade 1); some interference with activity (Grade 2); significant, prevents daily activity (Grade 3).¹

^††Myalgia and arthralgia grading scales: No interference with activity (Grade 1); some interference with activity (Grade 2); significant, prevents daily activity (Grade 3).¹

^‡‡Nausea/vomiting grading scale: No interference with activity or 1 to 2 episodes per 24 hours (Grade 1); some interference with activity or >2 episodes per 24 hours (Grade 2); prevents daily activity, requires outpatient intravenous hydration (Grade 3).¹

^§§Chills grading scale: No interference with activity (Grade 1); some interference with activity not requiring medical intervention (Grade 2); prevents daily activity and requires medical intervention (Grade 3).¹

Any = Grade 1 or above; percentages were based on the number of exposed participants who submitted any data for the event; N = number of vaccinated participants with available data for the events listed.

AR = adverse reaction; LRTD = lower respiratory tract disease; RSV = respiratory syncytial virus; RSV-LRTD = respiratory syncytial virus-associated lower respiratory tract disease; SAE = serious adverse event.

Indication and Important Safety Information

Indication

mRESVIA® (Respiratory Syncytial Virus Vaccine) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

Important Safety Information

Contraindications

Do not administer mRESVIA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of mRESVIA.

Warnings and Precautions

Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mRESVIA.
Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including mRESVIA. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to mRESVIA.

Adverse Reactions

In a clinical trial, the most commonly reported (≥10%) adverse reactions were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%) and chills (11.6%).

To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please click for mRESVIA Full Prescribing Information.

References

mRESVIA Prescribing Information. ModernaTX, Inc.
AREXVY Prescribing Information. GlaxoSmithKline Biologics SA.
ABRYSVO Product Information. Pfizer Inc.

For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure

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