Ask the Experts: RSV (Respiratory Syncytial Virus): RSV Preventive Antibody Product (Nirsevimab)

Vaccination involves active immunization, where an antigen is administered to a recipient to activate the recipient’s immune system and generate an immune response (which includes developing antibodies). Active immunization may require up to 2 weeks to have its full protective effect, and sometimes a series of vaccinations is required. Protection may last for months or be life-long, depending upon the type of immune response triggered. The effectiveness of a vaccine depends on the recipient’s immune system.

Nirsevimab (Beyfortus, Sanofi) is an injectable, long-acting monoclonal antibody product that gives the recipient direct, immediate protection through passive immunization. The antibodies of nirsevimab circulate in the bloodstream and recognize and attach to the RSV virus if encountered, leading to elimination of the virus. These antibodies protect the patient for at least 5 months until they gradually break down and disappear. The highest risk of severe RSV infection and hospitalization for children is during their first RSV season as an infant. Nirsevimab will not prevent children from getting RSV infections in future seasons, but the general risk of hospitalization due to RSV in childhood is far lower after infancy.

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Clinical trials of nirsevimab (Beyfortus, Sanofi) in infants less than 8 months old born during or entering their first RSV season showed that giving nirsevimab reduced the risk of RSV-associated lower respiratory tract infection (LRTI) requiring a medical visit or hospitalization by approximately 80 percent and reduced the risk of ICU admission for this reason by 90 percent.

Clinical trials did not study hospitalization rates among older infants and toddlers at high risk of severe RSV disease in their second RSV season. Instead, a study was done to measure blood levels of nirsevimab given to infants and toddlers at increased risk for severe RSV disease (certain preterm infants and those with serious heart or lung disease). The blood levels of nirsevimab were equivalent to the levels in healthy infants in the clinical trial who received nirsevimab in their first RSV season. Based on this finding, it is estimated that their protection from serious infection would also be similar.

The nirsevimab (Beyfortus, Sanofi) clinical trials demonstrated effective protection lasted at least 5 months (150 days) in preventing severe RSV disease (disease requiring medical attention, hospitalization or ICU admission). Protection may persist longer than 5 months, but this was the period of time studied in the trials.