In the competitive landscape of the respiratory syncytial virus (RSV) vaccine market, GlaxoSmithKline (GSK) stands out with its well-timed strides. GSK secured the first FDA approval in May for its Arexvy vaccine, specifically designed for adults aged 60 and above. This accomplishment put it ahead of its rivals, Pfizer and Moderna. In a strategic move, GSK has now made Arexvy available in major US retail pharmacies well in advance of the upcoming fall and winter RSV season.
Of particular note is the financial accessibility of Arexvy for certain patient groups. Under the Inflation Reduction Act, Medicare Part D patients will be able to receive the vaccine at no out-of-pocket cost. Moreover, under the Affordable Care Act, patients covered by commercial insurance could potentially have their costs covered for in-network administration of Arexvy.
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The significance of this vaccine becomes apparent as one considers the ACIP’s recommendation in June. The Advisory Committee on Immunization Practices advised individuals aged 60 and above, especially those with compromised immune systems due to conditions such as heart disease, lung disease, or diabetes, to consult their healthcare providers regarding RSV vaccination. This virus poses an elevated risk of hospitalization and pneumonia among the elderly population, with approximately 177,000 Americans hospitalized and 14,000 succumbing to RSV infections annually.
“We are excited to announce that AREXVY is now available to older adults in major retail pharmacies across the US ahead of this year’s RSV season. As the makers of the first FDA-approved RSV vaccine for older adults, we’re hopeful that RSV vaccines, like AREXVY, will help reduce the considerable clinical, economic, and human impact that RSV has on older adults and our public health system.”
– Rob Truckenmiller, Senior Vice President, Head of US Vaccines, GSK
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GSK’s proactive marketing strategy for Arexvy is also noteworthy, featuring basketball icon Earvin “Magic” Johnson in a campaign named “Sideline RSV.” This approach underscores the intense competition within the RSV vaccine market, which analysts estimate could yield over $10 billion in annual revenue. Pfizer, a key competitor, earned FDA endorsement for its Abrysvo RSV vaccine, gaining ACIP’s tentative approval for individuals aged 60 and above. Both GSK and Pfizer encountered some hesitation from ACIP regarding their vaccines’ endorsement for those aged 65 and above due to limited trial enrollments in that age group.
A key concern was the potential interaction between RSV, COVID-19, and flu shots, as all three are slated for administration within a similar timeframe. Questions arose about potential compromises in immune responses. Moderna, in parallel, is advancing with its Phase III RSV vaccine trial and submitting for FDA approval for the vaccine’s use in adults aged 60 and above.
Shifting the focus to infants, the FDA granted approval in July for Sanofi and AstraZeneca RSV antibody, Beyfortus, targeting infants and toddlers up to 24 months old. Pfizer awaits approval for maternal vaccination to safeguard infants in the US, with a decision anticipated this month. These developments collectively highlight the dynamic and highly competitive landscape of the RSV vaccine market, where timing, efficacy, and accessibility are pivotal factors for success.
