FDA approves pediatric indication for Ebola vaccine
Ervebo has been approved by the FDA to prevent the Ebola virus for individuals aged 12 months and older, after being initially approved for those 18 years and older in 2019.
FDA approves pediatric indication for Ebola vaccine | Image Credit: © Calin - © Calin - stock.adobe.com.
The FDA recently approved an expanded indication of Ebola Zaire vaccine, live (Ervebo; Merck), a vaccine for the prevention of Ebola virus, in pediatric patients 12 months and older. Use of Ervebo has been FDA-approved for individuals older than 18 years since December, 2019, the federal agency stated in a press release.1
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.2
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 approval announcement from the FDA.1
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).3 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. 4
References:
- FDA Roundup: July 28, 2023. FDA. Press release. July 28, 2023. Accessed July 31, 2023. https://www.fda.gov/news-events/press-announcements/fda-roundup-july-28-2023
- Ebola vaccine: information about ERVEBO. Centers for Disease Control and Prevention. Updated February 22, 2023. Accessed July 31, 2023.
- Toerner JG. Supplement approval PMR fulfilled. FDA. July 27, 2023. Accessed July 31, 2023. https://www.fda.gov/media/170660/download
- Badio M, Lhomme E, Kieh M, et al. Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries [published correction appears in Trials. 2021 Sep 1;22(1):583]. Trials. 2021;22(1):86. Published 2021 Jan 23. doi:10.1186/s13063-021-05035-9
