Nirsevimab 50mg/0.5mL and 100mg/1mL Injection — Long-Acting Monoclonal Antibody for RSV Prevention in Infants
Beyfortus® (Nirsevimab) — Preventive Monoclonal Antibody for RSV Disease in Infants
A Sourcing Guide for Hospitals, Paediatric Centres, and Immunisation Programmes
Beyfortus® (Nirsevimab) is a long-acting monoclonal antibody indicated, according to its approved prescribing information, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. As with all preventive immunobiologics, the decision to administer Beyfortus rests entirely with the treating paediatrician or immunisation programme, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and clinics, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharmaceutical distributor in Delhi, A.K. Pharma supplies genuine Beyfortus (Nirsevimab) pre-filled syringes to hospitals, paediatric centres, and pharmacies across India, manufactured by Sanofi and AstraZeneca. Hospitals managing seasonal RSV preparedness can also source companion medicines through A.K. Pharma’s full product range.
Beyfortus contains Nirsevimab, a recombinant human IgG1 kappa monoclonal antibody engineered to neutralise respiratory syncytial virus (RSV).
RSV Disease Burden in Infants:
According to published paediatric infectious disease literature, RSV is a leading cause of lower respiratory tract infection and hospitalisation in infants and young children worldwide, with the highest disease burden and risk of severe illness occurring in the first year of life. Unlike a conventional vaccine, which stimulates the infant’s own immune system to produce antibodies over time, Nirsevimab delivers antibody protection directly, making it suitable for immediate protection from birth or early infancy, when an infant’s own immune response would otherwise take too long to develop adequate defence against the virus.
Nirsevimab’s Mechanism: According to the manufacturer’s prescribing information, Nirsevimab binds to a highly conserved site on the RSV fusion (F) protein, neutralising the virus by inhibiting the conformational changes in the F protein necessary for the virus to fuse with and enter host cells. A specific triple amino acid substitution (known as YTE) engineered into the Fc region of the antibody extends its serum half-life, according to published pharmacology data, allowing a single dose to provide protection for the duration of a typical RSV season — a distinguishing design feature compared to shorter-acting RSV antibody products used historically.
Full prescribing information is available at the FDA label for Nirsevimab, with additional background on RSV disease available via the Centers for Disease Control and Prevention (CDC) and the World Health Organization.
MELODY Trial (Nirsevimab in Healthy Late-Preterm and Term Infants)
Published in the New England Journal of Medicine (2022), the pivotal MELODY trial evaluated a single dose of Nirsevimab against placebo in healthy late-preterm and term infants entering their first RSV season. Key findings demonstrated a significant reduction in medically attended RSV lower respiratory tract infection compared to placebo, supporting its role in broad infant RSV prevention rather than only in high-risk preterm populations.
Trial 03/MEDLEY (Nirsevimab in Preterm and High-Risk Infants)
This trial, referenced in regulatory submissions, evaluated Nirsevimab in preterm infants born between 29 weeks 0 days and 34 weeks 6 days of gestation, further establishing its safety and efficacy profile in a higher-risk preterm population, alongside data from Griffin et al. (2020) supporting its use in this group.
Duration of Protection Data
According to pharmacokinetic and clinical data referenced in the prescribing information, infants receiving Nirsevimab maintained RSV neutralising antibody levels substantially above baseline through at least 150 days following a single dose, with a minimum duration of protection of at least 5 months — spanning the typical length of a seasonal RSV epidemic.
For broader clinical guidance on RSV prevention strategies, the American Academy of Pediatrics (AAP) and the Advisory Committee on Immunization Practices (ACIP) publish ongoing immunisation recommendations.
Beyfortus is supplied as:
| Presentation | Strength |
|---|---|
| Beyfortus Pre-Filled Syringe | 50mg/0.5mL |
| Beyfortus Pre-Filled Syringe | 100mg/1mL |
Standard Dosing (per approved prescribing information):
| Population | Dose |
|---|---|
| Infants weighing less than 5kg, first RSV season | 50mg, single IM injection |
| Infants weighing 5kg or more, first RSV season | 100mg, single IM injection |
| Children up to 24 months at increased risk, second RSV season | 200mg (two 100mg injections), single administration |
For infants undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended as soon as the infant is stable after surgery, per weight-based or fixed dosing depending on timing, per the approved label.
Prevention of RSV Lower Respiratory Tract Disease — First RSV Season:
Prevention of Severe RSV Disease — Second RSV Season:
For detailed indication information refer to MedlinePlus RSV and the Respiratory Syncytial Virus Foundation.
Immediate Protection From Birth
Unlike vaccines that rely on the infant’s immune system to generate protective antibodies over time, Beyfortus delivers ready-made antibody protection, making it suitable for immediate use in neonates and young infants.
Single-Dose Seasonal Protection
The engineered YTE modification extends Nirsevimab’s half-life, allowing a single injection to provide protection for at least 5 months, spanning a typical RSV season, without requiring repeat dosing.
Broad Applicability Across Infant Populations
MELODY trial data supports use in healthy late-preterm and term infants, not only those born prematurely or with other risk factors, broadening the population that can benefit from RSV prevention.
Extended Protection Option for Vulnerable Second-Season Children
For children who remain at increased risk of severe RSV disease into their second season, Beyfortus offers continued preventive coverage beyond the first year of life.
Administration of Beyfortus is performed by a qualified healthcare professional. General information from the manufacturer’s prescribing information includes:
Precautions During Administration:
Full administration guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating paediatrician.
Beyfortus is administered by paediatricians, neonatologists, and immunisation programmes for:
Beyfortus is administered in hospital, clinic, or structured immunisation programme settings. A.K. Pharma supplies Beyfortus to hospitals and paediatric centres across Delhi and India.
Common side effects reported in clinical trials include rash and injection site reactions.
Serious side effects include:
Hypersensitivity Reactions, Including Anaphylaxis: Serious hypersensitivity reactions have been reported following administration, including urticaria, dyspnoea, cyanosis, and hypotonia. Appropriate treatment should be available and initiated promptly if signs or symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur.
Full side effect information is available at FDA Nirsevimab Safety Information.
As a responsible medicine distributor in Delhi, A.K. Pharma stores all preventive biologics including Beyfortus under manufacturer-recommended cold chain conditions ensuring product integrity for every supply.
Beyfortus (Nirsevimab) is manufactured by Sanofi and AstraZeneca. Nirsevimab received FDA approval in July 2023 as the first long-acting monoclonal antibody for the prevention of RSV disease in neonates and infants, with subsequent expanded indication for at-risk children entering their second RSV season. A.K. Pharma supplies only genuine Beyfortus sourced from authorised distributors. Learn more about Sanofi’s vaccines and preventive care portfolio directly from the manufacturer.
Q. What is Beyfortus used for?
Beyfortus (Nirsevimab) is used to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Q. What is the generic name and strength of Beyfortus?
The generic name of Beyfortus is Nirsevimab, available in 50mg/0.5mL and 100mg/1mL pre-filled syringe strengths, manufactured by Sanofi and AstraZeneca.
Q. Is Beyfortus a vaccine?
No. Beyfortus is a monoclonal antibody that provides ready-made, passive antibody protection against RSV, rather than a vaccine, which stimulates the body’s own immune system to produce antibodies over time.
Q. How long does a single dose of Beyfortus protect an infant?
Clinical and pharmacokinetic data support a minimum duration of protection of at least 5 months following a single dose, covering the typical length of an RSV season.
Q. Can Beyfortus be given alongside routine childhood vaccines?
Clinical trial data has evaluated coadministration with routine childhood vaccines, showing a similar safety and reactogenicity profile compared to vaccines given alone, though Beyfortus should not be mixed with any vaccine in the same syringe.
Q. Is Beyfortus available in India?
Beyfortus can be supplied to hospitals and paediatric centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi and pharmaceutical distributor in Delhi — for availability and pricing.
Q. What is the price of Beyfortus in India?
Beyfortus price in India varies by strength and order quantity. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Beyfortus from A.K. Pharma?
You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Beyfortus in bulk?
Yes. A.K. Pharma supplies Beyfortus in bulk to hospitals, paediatric centres, and immunisation programmes across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions, including patient eligibility and dosing, should be made by a qualified healthcare professional in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
