FDA approves first RSV vaccine after 60 years since failed experiment.

First-Ever RSV Vaccine Approved by FDA

After nearly 60 years of failed attempts, the Food and Drug Administration has finally approved the first-ever RSV vaccine. The vaccine, called Arexvy, was developed by British pharmaceutical company GSK and is intended for those 60 years old and up. According to the FDA, RSV attacks the lungs and breathing passages, and can cause pneumonia and bronchitis in older adults. The Centers for Disease Control and Prevention estimates that up to 10,000 people aged 65 and older in the U.S. die after contracting RSV each year.

Protecting Infants and Older Adults

RSV also poses a higher risk to infants, with between 100-300 babies dying in the U.S. from the virus each year. Along with the new RSV shot for older adults, the FDA is also currently considering granting approval to a first-of-its-kind Pfizer vaccine that is administered to expectant mothers during the second half of their pregnancy to protect infants against RSV. According to the late-stage trial data, Pfizer’s experimental vaccine was 82% effective in preventing severe cases of the potentially deadly virus in infants 90 days after birth.

High Hopes for RSV Vaccines

An international study on the GSK vaccine looked at 25,000 people 65 and older and found that one dose of the vaccine was nearly 83% effective at preventing lung infections that stem from RSV. The trial data also showed that the risk of severe infections was reduced by 94%. Pfizer also has a vaccine for older adults similar to Arexvy that the FDA is currently considering approval for.

History of RSV Vaccine Development

The first try at producing an RSV vaccine in the late 1960s ended in disaster when two children died and many were hospitalized with severe RSV after taking the experimental vaccines. During the trial, 80% of the vaccinated children were hospitalized compared to only 5% who got the placebo. After eight years of study, researchers at Johns Hopkins University revealed findings in 2008 that showed the late 1960s RSV vaccine trial failed because children’s antibodies were not binding to the inactivated virus strongly enough. Now, scientists have high hopes for the rollout of RSV vaccines.

Final Thoughts

The FDA’s approval of the GSK vaccine is an important public health achievement to prevent a disease that can be life-threatening. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “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.” Protecting vulnerable populations from RSV is crucial, and the approval of these vaccines is a significant step forward in achieving that goal.

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