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The FDA’s approval followed the phase 3 clinical trial MATISSE, a randomised, double-blinded, placebo-controlled study designed to evaluate the vaccine’s efficacy and safety when received by pregnant patients. Children affected by RSV can be faced with lung and breathing issues, which can proceed to cause death or severe illnesses.

Annaliesa Anderson, Pfizer’s chief scientific officer of Vaccine Research and Development, commented: “Abrysvo’s approval as the first and only maternal immunisation to help protect newborns immediatelyatbirththroughsixmonthsfrom RSV marks a significant milestone for the scientific community and for public health.

We are incredibly grateful to the clinical trial participants and study investigator teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available. Today, a long-soughtafter goal to deliver a maternal vaccine that will help protect infants six months of age or younger – when they are at greatest risk of possible serious consequences from RSV – has been achieved.”

Eric A F Simões, clinical professor at University of Colorado School of Medicine, US, stated: “Newborns and young infants – whose immune systems are still developing and are not yet strong enough to defend against infections – may now be protected from RSV from the moment of birth through maternal immunisation. The approval of Pfizer’s Abrysvo is a major triumph as it helps ensure no delay in potential RSV protection during an infant’s most vulnerable first six months of life and offers healthcare providers a new opportunity to help prevent severe RSV.”