Joseph R. Anticaglia, MD
Medical Advisory Board
On December 12, 2024, the FDA in a briefing document “put on hold” all clinical trials of vaccines for respiratory syncytial virus (RSV) in infants. The FDA said it was notified by Moderna, in July 2024 that their findings from a clinical trial signaled safety concerns in infants. The two vaccine candidates were being evaluated during Phase 1 trial which primarily evaluates the drug’s, or vaccine’s safety and dose range.
Moderna notified the FDA that the two experimental vaccines failed to protect the six to eight month old babies in the trial. Their results demonstrated that the RSV vaccines made the babies sicker by causing them to contract RSV, or another respiratory virus.
During the clinical trial, 5 cases of severe to very severe lower respiratory tract infections were documented. Five of the 6 babies required hospitalization, with 1 necessitating mechanical ventilation. There was one case of hospitalization in the placebo group.
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung), and pneumonia (infection of the lungs) in children younger than 1 year of age in the United State. And it’s the leading cause of infant hospitalization annually in the U. S.
Many feel Moderna RSV trial-one experiments are a strong affirmation of scientific decisions being driven by data used to evaluate a drug or vaccine on the merits of their safety, tolerability, efficacy, or side effects before going to market. As a result of their findings, Moderna decided to halt the RSV trial after five children were hospitalized, and discontinued the project for the development of the vaccines.
This article is intended solely as a learning experience. Please consult your physician for diagnostic and treatment options.
