Merck’s ERVEBO Vaccine Now Approved for Children to Combat Zaire Ebolavirus Disease

In a significant development in the realm of public health protection, Merck, known as MSD outside of the United States and Canada, has announced the expansion of ERVEBO’s indication. The U.S. Food and Drug Administration (FDA) has granted approval for the usage of ERVEBO in preventing disease caused by Zaire ebolavirus in individuals as young as 12 months old. This expanded approval marks a vital milestone in the ongoing efforts to combat Zaire ebolavirus, a highly contagious and potentially fatal disease.

Initially approved for individuals 18 years and older, ERVEBO’s expanded indication now encompasses a broader age range, providing a new layer of protection against Zaire ebolavirus. However, it’s important to note that ERVEBO doesn’t safeguard against other species of Ebolavirus or Marburgvirus. Furthermore, the duration of protection conferred by ERVEBO remains unknown.

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development, and Chief Medical Officer at Merck Research Laboratories, emphasized the significance of this milestone. “Ebola virus disease is contagious and potentially deadly in both children and adults,” he stated. “We’re proud of the approval of ERVEBO for the prevention of disease caused by Zaire ebolavirus in children as young as 12 months old, which is another milestone in our continued commitment to help address the global health threat caused by Zaire ebolavirus.”

The recent approval in the United States closely follows a similar development in the European Union. On July 20, 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the expansion of ERVEBO’s approval to include active immunization for individuals 1 year of age or older. This recommendation follows ERVEBO’s existing authorization for use in the European Union for individuals 18 years and older. The final decision regarding this recommendation is anticipated in the third quarter of 2023.

Notably, Merck has taken proactive measures to ensure global preparedness for potential Zaire ebolavirus outbreaks. In January 2021, the company collaborated with UNICEF to establish the world’s first global Ebola vaccine stockpile, utilizing ERVEBO to support future outbreak preparedness and response efforts. This stockpile, administered by the International Coordinating Group on Vaccine Provision, has already received over 500,000 doses of ERVEBO as of March 2023.

While the vaccine’s effectiveness when administered concurrently with certain medications and treatments remains unknown, the expansion of ERVEBO’s indication to children as young as 12 months underscores the commitment to safeguarding the health and well-being of populations at risk of Zaire ebolavirus disease. As global efforts continue to combat infectious diseases, ERVEBO’s expanded approval offers renewed hope in the fight against this deadly threat.