Health

‘A Wonderful Development’: FDA Approves Vaccine 60 Years In The Making

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The Food and Drug Administration (FDA) has approved the first-ever vaccine designed to protect against respiratory syncytial virus (RSV), a development 60 years in the making.

Approved for adults 60 years and older, Arexvy has received the green light for the prevention of lower respiratory tract disease caused by RSV, a May 3 press release stated.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stated in the release. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

Calling the vaccine “a wonderful development,” Dr. Ruth Karron, a professor of international health at Johns Hopkins Bloomberg School of Public Health, stressed that the vaccine was especially important for the elderly, according to CNN.

RSV is a highly contagious seasonal disease that affects all ages, but in older adults it can cause lower respiratory tract disease which can lead to life-threatening conditions such as pneumonia and bronchiolitis, the release stated.


Scientists have been working to develop an effective vaccine for RSV since the 1960s. The first such vaccine trial ended in tragedy after two children died and many others were hospitalized when the experimental shot enhanced the RSV infection, CNN reported.

“RSV has been one that’s taken us a while to be able to unlock its mysteries and secrets,” Dr. Steven Varga, dean of the Graduate School of Biomedical Sciences at St. Jude Children’s Research Hospital, admitted to CNN. Varga, who has dedicated his career to studying the virus added, “It’s a really exciting time. It’s been a long time coming.” (RELATED: NYU Researchers Say New Vaccine Cuts Risk Of Melanoma Recurrence By Almost Half)

The safety and effectiveness of the new vaccine has been established through analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted throughout the world in individuals 60 years of age and older, the press release stated. In the study, researchers followed approximately 12,500 individuals who had been given the vaccine and another 12,500 who had received a placebo.

“Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%” the release stated.

Two other studies on the vaccine were conducted involving approximately 2,500 participants 60 years of age and older. In one of the studies, some of the participants took Arexvy with an FDA-approved influenza vaccine. Two participants in that study developed acute disseminated encephalomyelitis (ADEM), a rare form of inflammation impacting the brain and spinal cord, which ultimately caused the death of one of the patients, the press release stated. In the other study, one individual developed Guillain-Barré syndrome nine days after Arexvy was administered, according to the release.

Though Arexvy is the first to win the FDA’s approval, three more vaccines designed to protect against RSV are on the way, one of which has been designed for pregnant women to offer protection to newborns, CNN reported.

“And I just think it’s fantastic, because RSV is a huge unmet medical need that a lot of people underestimate the importance of, and we will hopefully now have a number of effective vaccines that will help protect people,” Paul Chaplin, president and CEO of Bavarian Nordic, the company behind the Jynneos mpox vaccine, told CNN.