The following is a summary of “Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign,” published in January 2023 issue of Infectious Diseases by Nyombayire, et al.
The Ad26.ZEBOV (adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein) and MVA-BN-Filo (modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and nucleoprotein from Tai Forest viruses) Ebola vaccine regimen was made available to Rwandans living near the border with the Democratic Republic of the Congo from 2019 to 2021.
Ages ≥2 years made non-pregnant people eligible. According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, unexpected adverse events (UAEs) were reported by phone calls or in-person visits, and serious adverse events (SAEs) were documented.
Following Ad26.ZEBOV, 216 113 vaccination recipients reported 0.68% of UAEs, which were more prevalent in younger children (aged 2–8 years, 1.2%) than older children (aged 9–17 years, 0.4%) and adults (aged ≥18 years, 0.7%). The most common symptoms mentioned were fever and headache. In addition, 10 postvaccination febrile convulsions ± gastroenteritis and 7 fever and/or gastroenteritis comprised the 17 SAEs linked to the vaccine in children 2 to 8 years old. Before using acetaminophen as a regular medication in December 2020, the incidence of febrile seizures was 8 out of 26,062 (0.031%) and 2 out of 15,897 (0.013%) after that. Males and females had nonobstetric SAEs that were comparable. The 20 fatalities had no connection to the vaccination. Adult women and young girls with UAEs were less likely than those without UAEs to get the second dosage. In 203,267 MVA-BN-Filo recipients, seven unconnected SAEs took place.
Ad26.ZEBOV rarely, but never before documented, caused febrile convulsions in young children following immunization that were controlled by using acetaminophen as directed. Other than that, the regimen was secure and well-tolerated.
Reference; academic.oup.com/jid/article/227/2/268/6625827
