A groundbreaking advancement in infant health has arrived in Malaysia! Beyfortus® (nirsevimab) is now available to safeguard all newborns and infants from the potentially devastating effects of respiratory syncytial virus (RSV) disease.
But here’s the game-changer: Beyfortus is designed to protect every infant, regardless of their birth circumstances. Whether born full-term or pre-term, healthy or with underlying health conditions, Beyfortus offers a shield against RSV with impressive efficacy and safety. And the evidence is compelling. In the HARMONIE trial, it reduced RSV hospitalizations in infants by a staggering 82.7% (95% CI: 67.8 to 91.5; p<0.0001) over six months. This is a significant milestone, as RSV is a leading cause of hospitalization in infants, with a high rate of 84.5% among infected children below 2 years old.[4]
Real-world data from global immunization programs further emphasize the urgency of RSV prevention and validate Beyfortus’ effectiveness. It has consistently demonstrated real-world effectiveness exceeding 80% with a high acceptance rate, ensuring that infants are protected during their first year of life, when they are most at risk.
The approval of Beyfortus in Malaysia is a collaborative effort between Sanofi and AstraZeneca, and it’s a significant step forward in infant healthcare. Datuk Dr Zulkifli Ismail, Technical Chairman of Immunise4Life, highlights the burden of RSV in Malaysia, which often goes under-recognized. Most infants admitted with RSV are full-term and healthy, emphasizing the need for widespread prevention.
And this is where it gets exciting: Zainab Sadat, Vaccines General Manager at Sanofi Southeast Asia & India, promises a brighter future for Malaysian infants. With the availability of Beyfortus, parents now have the power to protect their babies during their most vulnerable first year. The goal is to ease the burden on families and the healthcare system by raising awareness and fostering cross-industry collaboration.
The clinical development program for Beyfortus is extensive, involving diverse infant populations. It consistently demonstrated high efficacy against RSV disease for at least six months, with a favorable safety profile. The single-dose administration makes it convenient and well-tolerated, with adverse event rates comparable to a placebo, and most events being mild or moderate.
In temperate countries, Beyfortus is administered at the start of the RSV season for babies born prior, or at birth for those born during the season. Clinical trials showed its effectiveness in preventing RSV disease requiring medical care across various infant populations, including those with specific health vulnerabilities.
RSV is a serious concern, but with Beyfortus, we now have a powerful tool to protect our youngest and most vulnerable. But is this enough? Should we be doing more to raise awareness about RSV and its impact? Share your thoughts in the comments below!