EMA Accepts Marketing Authorization Application for GSK’s Adjuvanted RSVPreF3 OA Vaccine for Adults Aged 60 and Older

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October 29, 2022 /BioValleyBIOON/ -- GlaxoSmithKline (GSK) recently announced that the European MedicinesManagementThe European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for the respiratory syncytial virus (RSV) candidate vaccine for older adults (OA) — the single-dose adjuvanted RSVPreF3 OA vaccine: intended for use in adults aged 60 years and older to prevent RSV-caused lower respiratory tract disease (LRTD). This marks the second significant regulatory milestone for this candidate vaccine following its acceptance in Japan. Data from pivotal Phase 3 clinical trials demonstrate that the RSVPreF3 OA vaccine is effective in preventing RSV lower respiratory tract disease in adults aged 60 years and older, with a favorable safety profile.

RSVPreF3 OA Candidate Vaccine Contains Recombinant Subunit Prefusion RSV F Glycoprotein Antigen (RSVPreF3) and is Combined with GSK's Proprietary AS01 Adjuvant. AS01 Has Been Used in Several Adjuvanted Vaccines Commercialized by GSK. The Antigen-Adjuvant Combination May Help Overcome Age-RelatedImmunityThis naturally decreases in strength, which helps protect the elderly from the challenges of RSV disease.

If the EMA's Committee for Medicinal Products for Human Use (CHMP) determines that the product is of major public health interest and therapeutic innovation, the MAA may qualify for an accelerated assessment. The European regulatory authority is expected to make an approval decision in the third quarter of 2023. If approved, this RSV vaccine for older adults (RSVPreF3 OA) has the potential to become the first vaccine product available to protect elderly individuals from RSV lower respiratory tract disease (LRTD).

MAA Based on Positive Data from Pre-specified Interim Analysis of Pivotal AReSVi-006 Phase III Clinical Trial. The trial demonstrated that a single dose of the adjuvanted RSVPreF3 OA candidate vaccine showed high overall vaccine efficacy against RSV-LRTD in adults aged 60 years and above, with a favorable safety profile. Additionally, consistently high vaccine efficacy against LRTD was observed in severe disease cases, adults aged 70-79, adults with underlying comorbidities, and both RSV A and B strains.

RSV is a common contagious virus that affects the lungs and respiratory tract. RSV is one of the major remaining infectious diseases without a vaccine or specific treatment. In adults, RSV infections are usually mild but can lead to severe consequences. Due to age-related decline in immunity and underlying conditions, the elderly are at high risk of severe RSV disease. RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, and chronic heart failure, and may lead to serious outcomes like pneumonia, hospitalization, and death. Each year, RSV causes over 420,000 hospitalizations and 29,000 deaths among adults aged 60 and above in industrialized countries. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates compared to those without these conditions.

According to the AReSVi-006 Phase III clinical trial, the adjuvanted RSVPreF3 OA candidate vaccine is the first to demonstrate efficacy in adults aged 60 years and older.StatisticsRSV vaccine with statistical and clinical significance. Despite over 60 years of research, RSV remains one of the major infectious diseases without a vaccine. The pivotal AReSVi-006 Phase III clinical trial demonstrated the high efficacy of the adjuvanted RSVPreF3 OA candidate vaccine. This vaccine has the potential to help reduce the significant global burden of RSV-related diseases in the elderly population, including those at risk of severe outcomes due to age or underlying comorbidities.

AReSVi-006 Trial Results (Source: GSK)

AReSVi-006 is a randomized, placebo-controlled, observer-blind, multinational Phase 3 trial designed to evaluate the efficacy of a single dose of the adjuvanted RSVPreF3 OA candidate vaccine in adults aged 60 years and older. The trial enrolled approximately 25,000 participants from 17 countries.

The results showed that the trial met its primary endpoint: the adjuvanted RSVPreF3 OA candidate vaccine was highly effective in adults aged 60 years and older, with an overall vaccine efficacy of 82.6% (96.95% CI: 57.9-94.1; 7 cases in 12,466 vs 40 cases in 12,494) in preventing RSV lower respiratory tract disease (RSV-LRTD).

In addition, a consistent high vaccine efficacy was observed across a series of pre-specified secondary endpoints, highlighting the potential impact of the adjuvanted RSVPreF3 OA candidate vaccine on populations at the highest risk of severe RSV outcomes. The vaccine efficacy of the adjuvanted RSVPreF3 OA candidate vaccine in preventing severe RSV-LRTD was 94.1% (95% CI: 62.4-99.9; 1 case in 12,466 vs 17 cases in 12,494). Severe RSV-LRTD was defined as LRTD with at least two lower respiratory tract symptoms, or as assessed by the investigator as severe.

In subjects with comorbidities (e.g., underlying cardiopulmonary and endocrine metabolic diseases), the vaccine efficacy was 94.6% (95% CI: 65.9-99.9; 1 case in 4937 vs 18 cases in 4861); in the elderly population aged 70-79 years, the observed vaccine efficacy was 93.8% (95% CI: 60.2-99.9; 1 case in 4487 vs 16 cases in 4487).

Moreover, the adjuvanted RSVPreF3 OA candidate vaccine showed consistent vaccine efficacy in preventing RSV-A and RSV-B subtype LRTD (A subtype: 84.6%, 2 cases in 12,466 vs 13 cases in 12,494; B subtype: 80.9%, 5 cases in 12,466 vs 26 cases in 12,494), which aligns with the robust neutralizing antibody responses generated against these two subtypes.

In the trial, the candidate vaccine was well tolerated and had a good safety profile. The observed adverse events were generally mild to moderate and transient, with the most common being injection site pain, fatigue, myalgia, and headache.

AReSVi-006 is part of GSK's comprehensive RSV evidence generation program. The trial will continue to evaluate the annual re-vaccination schedule and long-term protection across multiple seasons after a single dose of the adjuvanted RSVPreF3 OA candidate vaccine. The trial's safety is being closely monitored, and safety data will be continuously reviewed by internal and external Independent Data Monitoring Committees. (Bioon.com)

Source of the original text:GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment