This winter, respiratory syncytial virus (RSV) infections are spreading, leading to a shortage of preventive antibodies for infants and toddlers. Vaccines induce an immune response to produce antibodies in the human body, but preventive antibodies are medications that enter the human body to provide temporary protection against infection.
According to the Ministry of Food and Drug Safety on the 12th, Korea AstraZeneca reported the RSV infection preventive antibody injection "Synagis (active ingredient palivizumab)" as a drug in short supply.
Synagis is an RSV infection preventive antibody targeting infants under 6 months and children under 2 years at high risk of RSV infection due to bronchial or heart diseases. Vaccination can begin in the fall before the RSV infection outbreak, with a total of five injections given once a month. Synagis provides RSV infection prevention for one month after vaccination.
RSV is an acute respiratory infection virus that exhibits symptoms similar to those of a common cold. Adults typically show mild symptoms similar to a cold and recover naturally within 1 to 2 weeks, but infants and the elderly, who have weak immune systems, can develop pneumonia. Most hospitalized infant patients with respiratory diseases in late fall and winter are RSV infected.
According to the Korea Disease Control and Prevention Agency, the number of RSV infection patients in the country showed a continuous increase over 10 weeks starting from Oct. 21 last year (the 43rd week), followed by a slight decrease at the beginning of this year. The number of patients is 34% higher than the same period last year. As the number of RSV infection patients increases, the demand for preventive antibodies is surging. Korea AstraZeneca announced that the shortage of Synagis began on the 4th.
The shortage of Synagis is due to the rapid spread of RSV infections both domestically and internationally. In the United States, concerns are growing about a 'quadro-demic' in which four infectious diseases—influenza, COVID-19, RSV, and norovirus—are simultaneously prevalent. The European Centre for Disease Prevention and Control (ECDC) reported on the 28th of last month that "the number of RSV infection patients this winter is the second highest in the last five years" and noted that "there has been a slight decrease since February, but the simultaneous prevalence of influenza and RSV is increasing the medical burden."
Korea AstraZeneca expressed concern that the shortage of Synagis could lead to an increase in hospitalizations among infant and toddler patients. GlaxoSmithKline’s RSV preventive vaccine "Arexvy" received approval from the Ministry of Food and Drug Safety in December last year, but there are currently no institutions available for vaccination. Currently, only Synagis and Sanofi's preventive antibody "Bepotutis" can be administered in the country.
Korea AstraZeneca announced through the Ministry of Food and Drug Safety that due to the shortage of supply from March to April, there is concern that preventive effects may diminish for patients who have not received the five injections, leading to an increase in hospitalizations. They especially noted that there is a high possibility that high-risk children will not receive adequate preventive benefits.
The resumption of Synagis supply is expected to be possible only after May. Korea AstraZeneca stated, "We will focus on normalizing supply by coordinating domestic shipping test schedules and import dates," adding that "the expected date for normal supply is May 28."