As parents, we spend so much time making sure our babies are safe – from how they sleep to what they eat to whether they’re warm enough at night.
But one thing many families don’t expect is how quickly RSV (respiratory syncytial virus) can spread, or how serious it can become, particularly for infants under one.
For the first time, parents in Malaysia have access to Beyfortus® (nirsevimab)1 a new preventive option.
Beyfortus® (nirsevimab) has been approved by NPRA to help protect all infants – whether born full-term or preterm, healthy or with underlying conditions – during their first RSV season.1
It’s a single dose designed to provide long-lasting protection of up to 5-6 months when babies need it the most.
Why RSV Is a Concern for All Parents
RSV is a highly contagious virus that can lead to serious respiratory illness for infants.
In Malaysia, infants under one year old make up the majority of RSV cases, and studies show that children under two have a hospitalisation rate of 84.5% when infected.4,5
For Malaysian families, because we live in a tropical climate, RSV doesn’t follow a typical “winter season”, and instead, it circulates all year round, with certain months seeing sharper peaks.4,5
What many parents don’t realise is that most RSV hospitalisations happen in full-term, healthy infants.4,5
Datuk Dr Zulkifli Ismail, Technical Chairman of Immunise4Life and former president of the Malaysian Paediatric Association, explains:
In Malaysia, RSV remains a significant but under-recognised public health burden. Hospital data consistently show that the majority of infants admitted with RSV are full-term and generally healthy, which highlights the importance of preventive solutions that extend protection to all babies across the board.
Broader awareness and stronger cross-industry collaboration will be critical in easing the burden RSV places on families and our healthcare system overall.
What Beyfortus® Offers to Parents
Beyfortus® is designed to provide protection for all infants, whether they are full-term, preterm, healthy, or living with underlying conditions.1
Beyfortus® is a monoclonal antibody provided directly to newborns and infants as a single dose1, offering protection to help prevent lower respiratory tract disease caused by RSV without requiring activation of the immune system.
Key points parents may want to know include:
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Single-dose protection that lasts for at least six months.
- Beyfortus® can be given during the first year of life, including at birth or as early as possible, based on a doctor’s recommendation.1
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An 82.7% reduction in RSV hospitalisations observed in the HARMONIE trial, 82.7% (95% CI: 67.8 to 91.5; p<0.0001) through six months (180 days).2
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Real-world effectiveness and a consistent above 80% acceptance rate, based on data from multiple national immunisation programmes.3
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Favourable safety profile with most adverse events reported as mild or moderate, with overall rates similar to placebo, plus high and sustained levels of neutralising antibodies through 361 days post-dose7

Zainab Sadat, Vaccines General Manager for Sanofi Southeast Asia and India, describes the significance of this approval:
Today, Malaysia joins other countries worldwide where an innovative immunisation solution is now available to protect all infants against RSV.
The approval of Beyfortus marks a critical step towards giving parents the ability to protect their babies during their first year of life, when they are most vulnerable to severe RSV disease.
We are committed to working with stakeholders across the RSV care continuum to ensure seamless implementation and broad availability of this innovative preventive solution, because every baby needs protection.
Our goal is simple: to help parents protect their babies, and give them peace of mind.
How Beyfortus® Works
Beyfortus® is a monoclonal antibody with an extended half-life of 69 days.1
After one dose, it maintains a high level of RSV-neutralising antibodies for months, providing sustained protection throughout an infant’s first RSV season.
In clinical trials and real-world studies, Beyfortus® has shown consistent results across various infant groups, including healthy full-term babies, preterm infants, and those with underlying health conditions.1
It has been approved for use in many countries and is supported by a strong body of evidence demonstrating its effectiveness in preventing RSV disease requiring medical attention, such as clinic visits, emergency care, and hospitalisation.
Supporting Parents Through Vulnerable Months
RSV can be unpredictable and may progress quickly in infants.
Having an additional preventive option like Beyfortus® gives families more room to plan, prepare, and protect their infants during a critical stage of development.
It is especially reassuring for parents to know that protection is available for all babies, not only those considered high-risk.
The arrival of Beyfortus® in Malaysia reflects global efforts to reduce RSV-related hospitalisations and improve infant health outcomes.
With extensive clinical trial data and real-world evidence supporting its use, Beyfortus® provides parents and healthcare providers with a new, research-backed option to help protect infants during their first months of life.
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Disclaimer: The information provided in this article is for informational purposes only and should not be considered as medical advice from Motherhood. For any health-related concerns, it is advisable to consult with a qualified healthcare professional or medical practitioner.
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