Shortage of Synagis supply announced…normalized by May

Shortage of supply of infant RSV vaccine Synagis announced... supply will be normalized by end of May

AZ points to a surge in demand as the reason... Two dosage forms - 50 and 100 mg - to be in shortage

With a shortage in the supply of Synagis (palivizumab), a preventive antibody for respiratory syncytial virus (RSV), which is a main cause of pneumonia and bronchiolitis in infants and young children, expected in Korea, concern arises on how the lack of supply may hinder disease prevention for children in high-risk groups.

 

On the 11th, AstraZeneca Korea notified the Ministry of Food and Drug Safety of a shortage of Synagis 50 mg and 100 mg through a report on supply discontinuation and shortage of drugs.

 

RSV is the most common cause of lower respiratory tract infections in infants and young children, and infants born prematurely, underweight, or with a history of congenital heart disease or bronchopulmonary dysplasia are classified as high-risk groups for RSV infection.

 

Synagis can be administered monthly for 5 months from October to March, during the RSV epidemics season.

 

The first dose should be administered in September before the RSV season begins and should be administered once a month during the RSV season, which lasts until March.

 

The recommended dose is 15 mg per kg of body weight, and the product is available in vials (injections) of 50 mg and 100 mg.

 

AstraZeneca said, “The number of RVS patients has increased more than in previous years, causing a surge in demand for Synagis 50 and 100 mg.

 

Its supply may be temporarily insufficient, due to the current domestic inventory and planned import amounts.” As the hospitalization rate is decreasing as in previous years this March, the current will be of no major concern for patients who have completed receiving the five doses during this RSV epidemic.

 

However, due to the supply shortage in March and April, there is a concern that the preventive effect may be reduced and increase the number of hospitalizations due to RSV infection for the patient group who were unable to receive all the recommended 5 doses.

 

In particular, there is a high possibility that the drug will not be sufficiently effective in preventing the disease in indicated high-risk children.

 

AstraZeneca said, “We will focus on normalizing supply by coordinating the import and domestic release schedules as soon as possible.

 

The expected date for normalization of supply is May 28, 2025.” Meanwhile, Synagis and Sanofi Pasteur Korea's ‘Beyfortus (nirsevimab)' is available in Korea as a preventive vaccine for RSV, but it has different indications.

 

Synagis was approved for the prevention of severe lower respiratory tract disease requiring hospitalization due to RSV in children at high risk of RSV disease, and Beyfortus is indicated for the prevention of lower respiratory tract disease due to RSV.

 

In the case of Synagis, the drug is being administered to high-risk infants and toddlers who are expected to be at high risk of severe RSV disease, such as premature infants.