Indication for Ebola Vaccine Expanded to Pediatric Patients

The FDA has approved an expanded indication for Merck's Ebola vaccine Ervebo, with patients age 12 months and older now eligible to receive the preventive treatment. The vaccine has been FDA-approved for individuals older than 18 years since December 2019.

According to the Centers for Disease Control and Prevention (CDC), Ervebo can also be known as “V920, rVSVΔG-ZEBOV-GP or rVSV-ZEBOV,” and is a replication-competent, live, attenuated recombinant vesicular stomatitis virus (rVSV) vaccine. Since the vaccine contains just a gene from the Ebola virus, and not the entire virus, it is not possible to become infected with Ebola. The vaccine contains the Ebola glycoprotein, replacing the gene for the native VSV glycoprotein.

Cases of Ebola that have occurred in the United States were results of “infections acquired by individuals in other countries who then traveled to the US, or health care workers who became ill after treating patients with Ebola,” according to the approval announcement from the FDA.

In an FDA supplemental approval letter for the 12-month and older indication, the review of Ervebo was associated with the PREVAC clinical trial (NCT 02876328). The phase 2, randomized, double-blind, and placebo-controlled trial included 2560 adults (53%) and 2229 children (47%). Results demonstrated that the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein was 72 (50, 116) EU/mL for 1090 participants.