FDA approves new vaccine to prevent neonatal illness in infants

By Lillian Brunner, MD

The US Food and Drug Administration (FDA) today approved Elanco Animal Health’s new prevention treatment for infants born prematurely with pancreatic necrosis disease, or PND, in the children ages one to nine months. Elanco Bayer LY vaccine ABRH is the first product specifically approved for this indication by the FDA since 2008. PND is a serious disease that impacts about 1 in every 10,000 live births, and about half of the infants affected by PND die of complications. The new therapeutic regimen is provided during the first trimester of pregnancy, with a one-time administration of the ABRH vaccine.

PND is a genetic disorder caused by a defective spindle protein (a key component of a living cell). If not diagnosed or treated, it is a leading cause of death and permanent disability in infants. PND is estimated to be caused by mutations in an enzyme called sirolimus-binding protein. The new product is very safe for pregnant women, children, and adults. ABRH also may be used to prevent diseases in an adult population which may be hereditary, for people with disease-related antibodies, or for people with disease-related sensitivities or intolerances to antibodies, drugs, or drugs-based vaccines.

“The FDA’s continued review of therapeutic products to prevent and treat life-threatening medical conditions of children within two months of birth represents a commitment to the advancements available to meet the needs of the most vulnerable members of our community,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Thanks to the outstanding work of our collaborators at the centers and programs that are engaged in clinical trials, we are able to introduce therapies that address a growing body of scientific evidence on safe and effective treatment strategies for children that are born prematurely and at risk of serious medical problems.”

ABRH reduces the risk of developing PND in infants in the first trimester by stimulating the expression of a protein that promotes the formation of the protein for spindle protein aggregation. This protein enhances the safety and ability of cells in the pancreas to resist sirolimus-binding protein of predation by immunoglobulin.

The most common side effects reported in infants receiving ABRH vaccine (per1,000 children doses) were a decrease in white blood cell count; an increase in monocytes (infectious cells that make up the body’s defense against infection); a decrease in leukocytes (immune cells that maintain and enhance immunity); a reduction in production of clotting factors (which control blood clotting); and alterations in liver function.

FDA granted this application orphan drug designation for the treatment of PND in infants to help spur development of a consistent, effective, safe vaccine that may reduce the need for off-label immunizations in the first trimester of pregnancy.

ABRH is not approved for children who are more than two months of age.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Leave a Comment