Yahoo Finance Pfizer (PFE) Touts RSV Jab Benefit in Immunocompromised Adults
Pfizer PFE announced positive top-line data from substudy B of the ongoing pivotal late-stage MONeT study. The study is evaluating two doses of its RSV vaccine Abrysvo in immunocompromised adults who are at risk of developing severe RSV-associated lower respiratory tract disease (LRTD).
While this substudy evaluated two 120 µg doses of Abrysvo, management reported that a single dose of the vaccine generated strong neutralizing responses against both RSV subtypes (RSV-A and RSV-B) across all cohorts and age groups. The safety profile of Abrysvo was also consistent with the findings from other studies of the vaccine. Per management, these results serve as evidence that its vaccine is effective in high-risk adults.
The above findings are based on data gathered from a total of 203 adults who were divided into four groups — one with non-small cell lung cancer, another on hemodialysis, those receiving active immunomodulator therapy for autoimmune inflammatory disorder and solid organ transplant recipients. Nearly half of the study participants were aged between 18 and 59, with the remaining half aged 60 years and above.
Abrysvo is currently approved for the prevention of RSV-associated LRTD in older adults (aged 60 years and above) and in infants via maternal immunization.
Pfizer’s shares have lost 1.2% year to date against the industry’s 22.0% rise.
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Up until last year, there were no FDA-approved vaccines against RSV infections anywhere in the world. The Pfizer vaccine is one of the first RSV vaccines approved in the United States alongside GSK’s GSK Arexvy, which is approved for RSV-LRTD prevention in older adults. The GSK vaccine is also approved in adults aged 50-59 who are at an increased risk of RSV disease.
Despite these broad labels, the U.S. Centers for Disease Control and Prevention (CDC) revised their recommendation for the use of RSV vaccines for the 2024-25 respiratory virus season. Unlike last year, when the CDC endorsed vaccine shots for all individuals aged 60 years and older, this time, the agency recommended the vaccine for use in adults aged 75 years and older. For individuals aged between 60 and 74, the agency recommended vaccinations only for those at higher risk of severe RSV due to underlying medical conditions.
The CDC also clarified that it is not recommending RSV vaccines on an annual basis, which is usually the case seen with vaccines for the prevention of other respiratory viruses like COVID-19 and influenza. It also postponed a vote on recommending the use of the RSV vaccine in adults aged 50-59 at increased risk of disease until the availability of additional data — a significant setback to GSK, which is currently the only FDA-approved vaccine for this age group.
This recommendation narrows down the target market in the United States for both these RSV vaccines. On top of that, the upcoming respiratory virus season also welcomed a new entrant into the RSV vaccine space, Moderna MRNA, which secured FDA approval for its mRNA-based RSV vaccine, mResvia, this June. Earlier this month, Moderna claimed that it had already started shipping mResvia doses. This will likely be detrimental to Pfizer and GSK who are already under pressure to compete in a trimmed U.S. market.
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