The FDA Grants Approval for Pfizer’s Abrysvo RSV Vaccine for Individuals Aged 18 to 59

The FDA Grants Approval for Pfizer’s Abrysvo RSV Vaccine for Individuals Aged 18 to 59

The FDA Grants Approval for Pfizer’s Abrysvo RSV Vaccine for Individuals Aged 18 to 59

The vaccine received its initial approval in May 2023 for individuals aged 60 and above, followed by authorization in August 2023 for expectant mothers, aimed at safeguarding infants from birth until they are six months old. In addition to Pfizer, other entities have also introduced FDA-authorized RSV vaccines, including Moderna’s mResvia and GSK’s Arexvy. Notably, Pfizer’s Abrysvo stands out as the first and only RSV vaccine approved for adults under 50.

“RSV poses a significant risk to younger adults with existing chronic health issues. After extensive vaccine research by Pfizer and the scientific community over the years, we are now positioned to significantly reduce the impact of RSV in this vulnerable adult segment,” stated Aamir Malik, Chief US Commercial Officer and Executive Vice President of Pfizer, in an official release.

Respiratory syncytial virus (RSV) is a virus that typically spikes during winter, affecting the throat, nose, and lungs. While it generally leads to mild, cold-like symptoms, it can result in severe complications for infants and older adults, including bronchiolitis—an inflammation of the small airways in the lungs—and pneumonia, a lung infection. In some cases, hospitalization may be necessary.

Annually, the US observes between 58,000 and 80,000 hospitalizations due to RSV​ in children under five years old, with an additional 100,000 to 160,000 hospitalizations amongst those 60 and older. However, young adults are also susceptible to severe RSV-related illnesses.

In the United States, 9.5% of adults aged 18 to 49 have underlying health conditions such as asthma, obesity, diabetes, heart failure, chronic kidney disease, and chronic obstructive pulmonary disease (COPD) that heighten their risk of RSV-LRTD and potential hospitalization. Pfizer’s Abrysvo is expected to mitigate the chances of severe RSV cases.

The FDA’s choice to broaden the approval of Abrysvo to younger adults is supported by findings from a critical phase 3 clinical trial known as MONeT. This trial evaluated the vaccine’s safety, tolerability, and immunogenicity among adults with specific chronic health conditions that increase their susceptibility to RSV-related diseases.