EU Approves First Monoclonal Antibody To Prevent RSV In All Children As U.S. Cases Surge
Madeline Halpert
Former Staff
Nov 4, 2022,03:00am EDT
Nov 4, 2022,03:00am EDT
Madeline Halpert
The European Commission on Friday approved the first monoclonal antibody to prevent respiratory syncytial virus (RSV) 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.
KEY FACTS
Madeline Halpert
Former Staff
Nov 4, 2022,03:00am EDT
Nov 4, 2022,03:00am EDT
Madeline Halpert
The European Commission on Friday approved the first monoclonal antibody to prevent respiratory syncytial virus (RSV) 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.
KEY FACTS
- The European Commission approved Beyfortus, an injection manufactured by AstraZeneca and Sanofi to be given to infants from birth through their first RSV season—which typically begins in late fall—to protect against the virus, which is the most common cause of lower respiratory tract infections like bronchiolitis and pneumonia in infants.
- 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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