Video transcript
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SAFETY PROFILE
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
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AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)
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A subset of study participants was monitored for adverse reactions the day of vaccination with AREXVY or placebo, and 3 days following.
Let's look at the safety profile of these individuals. Safety is very important.
We want to be able to monitor unsolicited or solicited adverse events.
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A Demonstrated Safety Profile1
Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults aged 60 years and older (solicited safety set with 4-day diary card)
(Adverse Events Chart, showing AE, % AREXVY [N=879], and % Placeboa [N=874])
Local Adverse Reactions
Pain, Anyb 60.9, 9.3
Pain, Grade 3b 1, 0
Erythema, >20 mm 7.5, 0.8
Erythema, >100 mm 0.2, 0
Swelling, >20 mm 5.5, 0.6
Swelling, >100 mm 0.2, 0
AREXVY % (N=879); Placeboa % (N=878)
Systemic Adverse Reactions
Fatigue, Anyc 33.6, 16.1
Fatigue, Grade 3c 1.7, 0.5
Myalgia, Anyc 28.9, 8.2
Myalgia, Grade 3c 1.4, 0.3
Headache, Anyc 27.2, 12.6
Headache, Grade 3c 1.3, 0
Arthralgia, Anyc 18.1, 6.4
Arthralgia, Grade 3c 1.3, 0.6
Fever, ≥38.0 °C/100.4 °Fd 2.0, 0.3
Fever, >39.0 °C/102.2 °Fd 0.1, 0.1
N=exposed set for solicited safety set included all participants with at least 1 documented dose.
aPlacebo was a saline solution.
bAny grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
cAny grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
dTemperature taken by any route (oral, axillary, or tympanic).
In the solicited safety set, the local administration site adverse reactions reported with AREXVY had a median duration of 2 days.
The systemic adverse reactions reported with AREXVY had a median ranging between 1 and 2 days.
Similar rates of SAEs (4.2% vs 4.0%), deaths (0.4% vs 0.5%), and iPMDs (0.3% vs 0.3%) were reported between AREXVY and placebo, respectively.
pIMD=potential immune-mediated disease; SAE=serious adverse event.
1. Prescribing Information for AREXVY.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
So, we looked at 879 participants who received AREXVY, and 874 who received placebo.
Injection site pain was the most common adverse reaction for which data were solicited.
60.9% of the participants in the AREXVY group had this pain. 9.3% of those in the placebo group had this pain.
When we look at solicited systemic reaction, fatigue was the most common. 33.6% of patients in the AREXVY group and 16.1% of patients in the placebo group reported fatigue. So, again, of the solicited local administration site adverse reactions reported, we had a median duration of 2 days, and a median duration of systemic adverse reactions with AREXVY, we ranged between 1 and 2 days. So, within a couple of days, their symptoms resolved.
So, in all participants from the study, unsolicited adverse events were monitored using paper diary cards during the 30-day period following vaccination in the exposed set. 24,966 participants 60 years of age and older received at least 1 dose of AREXVY or placebo.
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Unsolicited and Serious Adverse Events1
(Bar chart of “Exposed Set, AREXVY N=12,467, Placebo N=12,499; y-axis: Participants, %)
Unsolicited AEs, Within 30 days
AREXVY 33.0%, placebo 17.8%
SAEs Up to 6 months post vaccination
AREXVY 4.2%, placebo 4.0%
pIMDs Up to 6 months post vaccination
AREXVY 0.3%, placebo 0.3%
Deaths*
AREXVY 0.4%, placebo 0.5%
*From vaccination through first analysis.
AE=adverse event; pIMD=potential immune-mediated disease; SAE=serious adverse event.
1. Prescribing Information for AREXVY.
PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.
Audio
Unsolicited adverse events occurring within the 30 days of vaccination reported in 33% and 17.8% of participants, respectively—that is, 33% in the AREXVY group; 17.8% in the placebo group for unsolicited adverse events.
So, participants were monitored for all serious adverse events. Serious adverse events with an onset within that 6 months following vaccination were reported in participants who received AREXVY—12,467 —(4.2%)—or, in placebo, which was 12,499 participants, 4%. So, you saw serious adverse events in both groups within 30 days after vaccination.
Patients were monitored for potential immune-mediated diseases. We wanted to monitor those diseases that occurred during the 6-month period following administration of AREXVY or placebo. So, new onset immune-mediated disease, or exacerbations of existing immune-mediated diseases within 6 months following vaccine or placebo, and it was reported in 0.3% of participants who received AREXVY, and 0.3% of participants who received placebo. Deaths from vaccination through the first analysis to adverse events leading to death were reported for 49 participants who received AREXVY, and actually 58 participants who received placebo. Based on available information, there's no evidence of a causal relationship to AREXVY.
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Intended for US healthcare professionals only.
Trademarks are owned by or licensed to the GSK group of companies.
©2023 GSK or licensor.
RSAVID230041 July 2023
Produced in USA.
Please see Important Safety Information and full Prescribing Information available on this website.
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