Pfizer gets a leg up in RSV as FDA clears jab for all adults

The FDA has recently granted Pfizer a wider approval for its RSV vaccine, Abrysvo, compared to the vaccines from GSK and Moderna. However, this distinction might not significantly impact the competition for market share.

The American regulatory agency has approved Abrysvo for adults between 18 and 59 who are at risk for diseases linked to RSV. This approval expands the previous label, which only included individuals aged 60 and older.

GSK's top-selling vaccine, Arexvy, is currently approved for individuals aged 50 and older. Meanwhile, Moderna's new vaccine, mResvia, is only authorized for use in those aged 60 and above at this time.

Abrysvo stands out with the most extensive range of uses compared to the other two vaccines, as it is uniquely authorized for pregnant individuals to help safeguard their babies from birth through six months old.

The challenge for Pfizer, GSK, and Moderna is that the US government is scaling back its guidelines for RSV vaccinations, focusing more on older adults instead of younger groups.

Last year, the Advisory Committee on Immunization Practices (ACIP) of the US Centers for Disease Control and Prevention (CDC) suggested that all adults aged 60 and above should receive RSV vaccinations. For the upcoming season, though, this guidance has been adjusted to include only individuals aged 75 and older, while those between 60 and 74 can only receive the vaccine if they are at a higher risk of severe illness.

This decision was made in response to worries expressed earlier this year regarding a potential connection between RSV vaccination and a higher chance of developing Guillain-Barré syndrome (GBS), a rare condition that leads to muscle weakness and, in some instances, paralysis. While a handful of cases were noted during the clinical trials for Arexvy and Abrysvo, no such cases were observed in the mResvia studies.

In the meantime, the CDC recommends that individuals who got the RSV vaccine last year do not need to get another dose this year.

The sales performance of all three FDA-approved vaccines during the 2024-25 season will be closely examined to assess the effects of the updated recommendations. In the previous year, Arexvy led the market with impressive sales of $1.6 billion, while Abrysvo generated $890 million. It's important to note that mResvia only received approval in May of this year.

In a statement, Pfizer's head of commercial operations mentioned that RSV poses a considerable risk to young adults who have specific long-term health issues.

The company referenced information from the CDC and other sources indicating that 9.5% of adults in the US aged 18 to 49 have an existing chronic health issue, including obesity, diabetes, COPD, heart failure, chronic kidney disease, and asthma. These conditions make them more vulnerable to lower respiratory tract infections due to RSV. This percentage increases to nearly 24.3% for individuals aged 50 to 64.