Serious setback for vaccine research: A US authority has stopped the test phase of an RSV vaccine. The reason for this is serious illnesses in children.
It was only in late summer that an mRNA vaccine against the respiratory syncytial virus (RSV) was approved for adults in this country. Such a vaccine is also being developed for infants, as they are particularly at risk from RSV infection. Worldwide, up to 100,000 children under the age of five die every year as a result of the disease. But the vaccine study by the manufacturer Moderna is currently paused – there are worrying warning signs.
Back in July, Moderna itself interrupted its Phase I clinical trials after worrying incidents occurred in Panama. Relevant safety signals were identified in the tolerability tests of the two vaccine candidates (mRNA-1345 and mRNA-1365):
These events ultimately led to the US Food and Drug Administration (FDA) stepping in and halting all studies of the mRNA-RSV vaccine in infants. “It is very clear that there is a safety signal… We are faced with a very complicated situation,” Prof. Arnold Monto, a member of the FDA expert team, was quoted as saying in a report by the news portal Biopharmadive.
The health authority also requested further information about the studies at Moderna. It is currently unknown whether and how vaccine development will continue.