GSK RSV Vaccine Phase III Trials Show Positive Preliminary Results

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GSK RSV Vaccine Phase III Trials Show Positive Preliminary Results, Expanding Eligibility to the 50-59 Age Group!

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GSK RSV Vaccine Phase III Trials Show Positive Preliminary Results, Expanding Eligibility to the 50-59 Age Group!

On October 25, GlaxoSmithKline (GSK) released positive preliminary results for the Phase III trial of their respiratory syncytial virus (RSV) vaccine, Arexvy (NCT05590403).

The results indicate that Arexvy’s immune response in adults aged 50-59 is not inferior to its performance in adults aged 60 and older, including those with underlying health conditions.

RSV is a highly common airborne RNA virus that poses a risk primarily to infants and the elderly, causing symptoms such as fever, cough, and, in severe cases, respiratory distress leading to airway blockage, respiratory failure, and potentially death. While RSV is typically a greater threat to infants and the elderly, individuals with comorbidities like chronic obstructive pulmonary disease (COPD) or asthma are at an increased risk.

NCT05590403 is a placebo-controlled, observer-blinded, randomized, multinational immunogenicity Phase III trial designed to evaluate the non-inferiority of the immune response and safety in participants aged 50-59 receiving a single dose of the GSK RSV vaccine compared to older individuals at increased risk of RSV-Lower Respiratory Tract Disease (RSV-LRTD). This trial assesses the immune response of participants aged 50-59 with pre-defined stable chronic conditions that increase the risk of RSV disease (n=570). These conditions include chronic lung disease, chronic cardiovascular disease, diabetes, chronic kidney disease, or chronic liver disease. The trial recruited approximately 1520 participants from eight countries.

The primary endpoint of the trial is to compare the RSV-A and RSV-B neutralization titers between the two age groups (50-59 and 60+ years) one month after vaccination. Secondary and tertiary endpoints include safety and immunogenicity. The trial is ongoing, with further immunization data to be collected at 6 and 12 months post-vaccination.

Notably, the safety and reactogenicity data for Arexvy in this trial align with the initial Phase III plan. The most common adverse events were pain, fatigue, and headache, with most being mild and transient. While the statement does not provide detailed data, GSK has announced plans to reveal the trial results at the Immunization Practices Advisory Committee (ACIP) meeting of the Centers for Disease Control and Prevention in the United States.

Furthermore, GSK’s Chief Scientific Officer, Tony Wood, stated in a release that the Phase III results suggest that Arexvy “has the potential to help protect adults aged 50-59.” He further mentioned, “We will seek regulatory review of this data as quickly as possible with the aim of providing a vaccine option for this age group for the first time.” The company intends to present the full findings and analysis of the trial at upcoming medical conferences.

Arexvy is the first RSV vaccine approved by the FDA. However, its approved age group currently includes adults aged 60 and older. Pfizer’s Abrysvo received approval a month later for the same age group. In August, Abrysvo expanded its indications, offering protection to pregnant women during pregnancy. Pfizer also announced plans to test Abrysvo in the 18-60 age group, which includes individuals with underlying health conditions, putting them at greater risk. Notably, both GSK and Pfizer’s RSV vaccines were featured in Time magazine’s list of the Best Inventions of 2023.

Concerning RSV vaccines, GSK and Pfizer are also embroiled in patent disputes. In August 2023, GSK accused Pfizer of infringing on four patents related to the antigen used in Arexvy. In a lawsuit filed in the Delaware federal court, GSK claimed that Pfizer’s Abrysvo utilized GSK’s protected invention. Currently, GSK is seeking a jury trial and monetary compensation, while Pfizer denies these allegations and asserts they will defend their position.

As for Arexvy’s market performance, GSK, in its Q2 2023 earnings report, anticipated that Arexvy’s sales would be lower than Shingrix, a vaccine for shingles. However, Arexvy’s vaccine administration is poised to be a robust driver of growth, especially given its expected approval before the 2023-2024 RSV season. GSK estimates that around 80 million elderly individuals in the United States are ready to receive their first RSV vaccine. Additionally, at a meeting with the ACIP on Wednesday, GSK stated that, as of mid-October, over two million doses of the vaccine had been administered in a retail setting.

In the global RSV vaccine market, alongside Pfizer and GSK, Moderna’s RSV vaccine, MRNA-1345, was submitted for regulatory approval in multiple countries in July 2023 for the prevention of RSV-Lower Respiratory Tract Disease (RSV-LRTD) and Acute Respiratory Disease (ARD) in adults aged 60 and over.

References:

[1]GSK Looks to Push RSV Vaccine to Younger Seniors with New Phase III Data. Published: Oct 25, 2023 By Tristan Manalac.

[2]GSK says RSV vaccine triggered immune response in adults as young as 50 years old. Nicole DeFeudis.October 25, 2023 03:00 PM EDT.

[3]GSK official website.

GSK RSV Vaccine Phase III Trials Show Positive Preliminary Results, Expanding Eligibility to the 50-59 Age Group!

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