The injection, made by AstraZeneca and Sanofi, is the first to offer broad protection against respiratory syncytial virus among all newborns and infants.
The European Commission on Friday approved the first monoclonal antibody to prevent respiratory syncytial virus among all infants and newborns, amid a rise of cases of the highly contagious virus, which can pose a danger to infants and older adults.
It’s the first regulatory body to approve the injection, basing its decision on clinical trial results, which showed Beyfortus was safe compared to a placebo and reduced the incidence of lower respiratory tract infections caused by RSV by 74.5%, according to the pharmaceutical companies. The approval marks a “significant achievement for the scientific community” to address a “persistent, global unmet need in RSV prevention, Iskra Reic, the executive vice president of vaccines and immune therapies at AstraZeneca, said in a statement.
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