RSV vaccine succeeds in phase 3 trial

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Respiratory syncytial virus (RSV) is perhaps best known for causing severe illness in infants in children, but it leads up to 150,000 hospitalizations and 10,000 deaths in adults aged 65 and older each year, according to the Centers for Disease Control and Prevention (CDC).

The ability of this virus to cause severe illness isn’t its only claim to fame, though. It’s been notoriously difficult to develop a vaccine for — but that might be about to change.

A new study published in the New England Journal of Medicine reveals that a new vaccine candidate against RSV was about 80% effective in preventing lower respiratory tract infections, and 94% effective in preventing severe disease.

The study used data from more than 25,000 patients aged 60 and older scattered across 17 countries between May 2021 and January 2022. Participants in the study received either one dose of the AS01E-adjuvanted RSV prefusion F protein–based candidate vaccine (RSVPreF3 OA) or a placebo. Follow-up continued for about 7 months after vaccination, and protection was found to be similar against both the A and B subtypes of RSV. Additionally, the study authors note that protection against RSV was similar in all participants regardless of age or the existence of other medical conditions.

Adverse events after vaccination were also similar across different demographic groups in the study, and these events were usually temporary and mild in nature.

The vaccine is currently in phase 3 of clinical trials, with no information available on when the vaccine manufacturer, GlaxoSmithKline, might seek approval from the U.S. Food and Drug Administration (FDA) to move to Phase 4.

Although not everyone who becomes infected with RSV requires hospitalization or becomes severely ill, young children and older adults are more at risk. Severe illness including pneumonia that requires hospitalization, inflammation of the airways, and bronchiolitis are all common complications in more vulnerable populations. Currently, there are no vaccines approved by the FDA to offer protection against RSV.

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