It’s time to rethink defense against RSV.
mRESVIA – now available to help safeguard your patients against LRTD caused by RSV
mRESVIA® (Respiratory Syncytial Virus [RSV] mRNA Vaccine) is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older, and adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.1
mRESVIA: demonstrated vaccine effectiveness across all studied populations1
In adults aged ≥60 years†
mRESVIA proved effective in prevention of first episode of RSV-LRTD (with ≥2 signs/symptoms) starting 14 days post-injection
Primary analysis (3.7 months median follow-up)
84%
efficacy demonstrated against RSV-LRTD with ≥2 signs/symptoms‡
(% CI: 66.0, 92.2)§
Cases: mRESVIA (9/17,572) vs. placebo (55/17,516)
82%
efficacy demonstrated against RSV-LRTD with ≥3 signs/symptoms‡
(% CI: 34.8, 95.3)§
Cases: mRESVIA (3/17,572) vs. placebo (17/17,516)
Assessed in over 36,500 adults – including 706 Canadians – across 22 countries
Efficacy of mRESVIA to prevent first episode of RSV-LRTD (with ≥2 signs/symptoms) by subgroup
Per-protocol efficacy set (8.6 months median follow-up)
Population | mRESVIA Cases | Placebo Cases | Vaccine Efficacy (VE) |
|---|---|---|---|
Aged 60–69 years¶ | 31/11,219 | 77/11,170 | 60% |
Aged 70–79 years¶ | 10/5,464 | 45/5,439 | 78% |
Aged ≥60 years with ≥1 comorbidity|| | 16/5,361 | 51/5,249 | 69% |
Aged ≥60 years considered vulnerable/frail# | 9/3,817 | 17/3,884 | 47% |
Population | mRESVIA Cases |
|---|---|
Aged 60–69 years¶ | 31/11,219 |
Aged 70–79 years¶ | 10/5,464 |
Aged ≥60 years with ≥1 comorbidity|| | 16/5,361 |
Aged ≥60 years considered vulnerable/frail# | 9/3,817 |
Population | Placebo Cases |
|---|---|
Aged 60–69 years¶ | 77/11,170 |
Aged 70–79 years¶ | 45/5,439 |
Aged ≥60 years with ≥1 comorbidity|| | 51/5,249 |
Aged ≥60 years considered vulnerable/frail# | 17/3,884 |
Population | Vaccine Efficacy (VE) |
|---|---|
Aged 60–69 years¶ | 60% |
Aged 70–79 years¶ | 78% |
Aged ≥60 years with ≥1 comorbidity|| | 69% |
Aged ≥60 years considered vulnerable/frail# | 47% |
Adapted from mRESVIA Product Monograph.
In adults aged 18–59 years at increased risk for RSV-LRTD**
mRESVIA established noninferiority for the co-primary objectives, allowing effectiveness to be inferred through immunobridging to Study 1
Geometric mean ratio (GMR) of nAb titers at Day 29 for RSV-A and -B
1.2x
nAb concentration against RSV-A
vs. adults aged ≥60 years
(Study 1 population)
(95% CI: 1.053, 1.285)
1.1x
nAb concentration against RSV-B
vs. adults aged ≥60 years
(Study 1 population)
(95% CI: 1.037, 1.242)
Seroresponse rate (SRR) difference at Day 29 for RSV-A and -B††
11.8%
difference in SSR RSV-A
vs. adults aged ≥60 years
(Study 1)
(95% CI: 7.8, 15.5)
10.8%
difference in SSR RSV-B
vs. adults aged ≥60 years
(Study 1)
(95% CI: 5.9, 15.6)
Assessed in over 501 adults at increased risk for LRTD – including 39 Canadians
mRESVIA: an established safety profile1
Most solicited local and systemic adverse reactions:
Were mild to moderate in severity with a median
onset within 1–2 days after injection
Were mild to moderate in severity with a median
onset within 1–2 days after injection
Had a median
duration of 1–2 days
Had a median
duration of 1–2 days
In subjects aged ≥60 years, the most commonly reported (≥15%) solicited adverse reactions (local and systemic) within 7 days of vaccination were:
injection site pain
(55.9% vs. 13.8% placebo)
injection site pain
(55.9% vs. 13.8% placebo)
fatigue
(30.8% vs. 20.0% placebo)
fatigue
(30.8% vs. 20.0% placebo)
headache
(26.7% vs. 18.8% placebo)
headache
(26.7% vs. 18.8% placebo)
myalgia
(25.6% vs. 14.4% placebo)
myalgia
(25.6% vs. 14.4% placebo)
arthralgia
(21.7% vs. 14.0% placebo)
arthralgia
(21.7% vs. 14.0% placebo)
axillary swelling or tenderness
(15.2% vs. 6.1% placebo)
axillary swelling or tenderness
(15.2% vs. 6.1% placebo)
In subjects aged 18–59 years at increased risk for LRTD caused by RSV, the most commonly reported (≥15%) solicited adverse reactions (local and systemic) within 7 days of vaccination were:
injection site pain
(73.9%)
injection site pain
(73.9%)
fatigue
(36.9%)
fatigue
(36.9%)
headache
(33.3%)
headache
(33.3%)
myalgia
(28.9%)
myalgia
(28.9%)
arthralgia
(22.7%)
arthralgia
(22.7%)
chills
(19.9%)
chills
(19.9%)
axillary swelling or tenderness
(17.1%)
axillary swelling or tenderness
(17.1%)
CHF=chronic heart failure; CI=confidence interval; COPD=chronic obstructive pulmonary disease; HR=hazard ratio; LRTD=lower respiratory tract disease; nAb=neutralizing antibody; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.
* With domestic and imported parts.
† Study 1: an ongoing randomized, placebo-controlled, observer-blind Phase 2/3 case-driven clinical trial to evaluate safety and efficacy of mRESVIA to prevent RSV-LRTD in adults aged ≥60 years with or without underlying medical conditions for up to a year after single vaccination of mRESVIA. Participants were randomized 1:1 to a single injection of mRESVIA or placebo. Randomization was stratified by age (60–74 years; ≥75 years) and risk factors for LRTD (defined as CHF and/or COPD) at screening. Primary efficacy analysis population (per-protocol efficacy set) included 35,088 subjects who received either mRESVIA (n=17,572) or placebo (n=17,516). Primary efficacy endpoints were the prevention of a first episode of RSV-LRTD with ≥2 or ≥3 signs/symptoms between 14 days and 12 months post-injection.
‡ VE is defined as 100% x (1-HR (mRESVIA vs. placebo)). The CI for VE is based on a stratified Cox proportional hazard model with Efron's method of tie handling and with the treatment group as a fixed effect, adjusting for stratification factors at randomization.
§ For primary analysis for RSV-LRTD with ≥2 symptoms, 95.88% CI where the alpha value of 4.12% was derived from the Lan-DeMets approximation to the Pocock stopping boundary with an information fraction of 0.74 (64 out of total of 86 cases). For primary analysis for RSV-LRTD with ≥3 symptoms, 96.36% CI where the alpha value of 3.64% was derived from the Lan-DeMets approximation to the Pocock stopping boundary with an information fraction of 0.63 (20 out of total of 32 cases).
¶ VE is based on an exploratory analysis, subject to limitations.
|| Comorbidities included chronic cardiopulmonary conditions (e.g., CHF, COPD, asthma) and chronic respiratory conditions, as well as diabetes, advanced liver and advanced kidney diseases.
# According to the Edmonton Frail Scale.
** Study 2: a Phase 3, randomized, double-blind trial to evaluate the immunogenicity and safety of mRESVIA in adults aged 18–59 years at increased risk for LRTD caused by RSV (N=494). Effectiveness in this population is inferred based on immunobridging nAb levels at Day 29 to those observed in Study 1, which was conducted in adults aged ≥60 years (N=1,515). Adults with documented confirmation of ≥1 of the following were enrolled: CAD and/or CHF, chronic lung disease (including, but not limited to COPD or persistent asthma), or Type 1 or Type 2 diabetes mellitus. Co-primary immunogenicity objectives of Study 2 were to evaluate nAb responses after a single dose of 50 mcg mRESVIA using the GMR as the key measure. Noninferiority was met, and effectiveness inferred, if the lower bound of the 95% CI of the GMR was >0.667.
†† Seroresponse at participant level defined as a change from below the LLOQ to ≥4 x LLOQ, or ≥4-fold increase if baseline is equal to or above the LLOQ. 95% CI calculated using the Miettinen-Nurminen (score) confidence limits.
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Important information
Indications and clinical use:
mRESVIA® (Respiratory Syncytial Virus [RSV] mRNA Vaccine) is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older, and adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
Pediatrics: safety and efficacy in individuals under 18 years of age have not been established. mRESVIA is not indicated for pediatric use.
Contraindications:
- Hypersensitivity to mRESVIA or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
- Children less than 2 years of age due to an increased risk of severe and/or life-threatening RSV-enhanced respiratory disease reported in infants during a pediatric study. The risk of RSV-enhanced respiratory disease is not applicable to adults.
Relevant warnings and precautions:
- Postpone vaccination in individuals with an acute severe febrile illness
- Syncope
- Anaphylaxis
- Use in individuals with thrombocytopenia or coagulation disorders
- mRESVIA may not protect all vaccine recipients
- Use in immunocompromised individuals
- Not recommended during pregnancy
- Use in breastfeeding individuals
For more information:
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing information, which has not been discussed in this piece. The Product Monograph is also available by calling us at 1-866-MODERNA (1-866-663-3762).
Reference
- mRESVIA Product Monograph. Moderna Biopharma Canada Corp.
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