Ebola Vaccination Policy Reversed, Pregnant and Lactating Women Now Included
Merck v920 Ebola virus vaccine candidate now offered to pregnant and lactating women in the Democratic Republic of Congo
An ethics committee of the World Health Organization (WHO) has now recommended the use of the Ebola virus disease (EVD) vaccine candidate v920 to pregnant and lactating women, and young children, in the Democratic Republic of the Congo (DRC).
This announcement is a change in the controversial policy by the Strategic Advisory Group of Experts (SAGE) on Immunization and the ethics committee of the DRC.
During October 2018, SAGE recommended deploying a ‘ring vaccination strategy’, which excluded pregnant women.
By February 2019, 695 ‘rings’ and two geographic zones were targeted for vaccination.
SAGE now advises that the use of Merck’s v920 (rVSV-ZEBOV-GP) vaccine candidate in pregnant women should be allowed but limited to the EVD outbreak affected areas in DRC.
Additionally, SAGE acknowledges the decision of the ethics committee of the DRC to also proceed with vaccinating lactating women and children under 1 year of age, given the ongoing outbreak and population risk.
SAGE is now reviewing the data, including modeling, in relation to the use of the v920 vaccine in these populations.
And, as recommended by the ethics committee, every effort must be made to collect data on the safety of the vaccine in these populations, including documentation of the related pregnancy outcomes.
This change in policy reflects the recommendations contained in the December 2018 report Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, issued by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group,
While the ongoing clinical trial of the v920 vaccine candidate is not finished, the preliminary analyses suggest it is working well for this version of the Ebola virus.
A study published in The Lancet during 2018 said ‘In vitro and in vivo data gathered during this study support the minimal risk of the vector-borne potential of the V920 vaccine.’
Moreover, the Ebola outbreak in the DRC continues to spread.
As of February 16, 2019, 838 cases of EVD have been reported including 773 confirmed cases and 65 probable cases. And, the number of deaths reported is 534.