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ARTICLE

Second Ebola Vaccine Authorized in DRC, as WHO Transparency Is Questioned

SEP 24, 2019 | MICHAELA FLEMING
Officials in the Democratic Republic of the Congo (DRC) have announced that a second experimental Ebola vaccine will be introduced into the outbreak response activities in mid-October.

The vaccine, manufactured by Johnson & Johnson, is administered in 2 doses, 56 days apart and will be used to vaccinate at-risk individuals in areas that are not experiencing active Ebola transmission in attempts to extend protection against the virus.

Back in May, the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) evaluated the Ebola vaccination situation in the DRC outbreak and recommended adjusting the dose of the Merck vaccine, evaluating a second vaccine, creating more opportunities to vaccinate hard-to-read individuals, and increasing the number of people vaccinated within communities with ongoing transmission.

“In everything we do, we are driven by science,” Tedros Adhanom Ghebreyesus, PhD, director-general the of the WHO said in a statement issued by the agency. “The advice we were given by SAGE in May has been applied, always taking into account community needs and preferences, as we know this will make the approach more effective. The changes made have saved thousands of lives in this outbreak.”

The announcement of the new vaccine implementation comes shortly after officials with Medicines Sans Frontieres (MSF) issued a statement calling into question the WHO’s decisions on who to vaccinate against Ebola. The statement suggests establishing an independent committee to “transparently” manage Ebola vaccination programs.

“The current Ebola outbreak has a mortality rate comparable to the West Africa outbreak, despite new treatments and vaccines being available,” the statement reads. “Not enough eligible people have been vaccinated, one reason for which is WHO’s strict limits on the number of doses used in the field.

According to the statement, increasing the pace of vaccination is both necessary and feasible and it is possible to vaccinate 2000-2500 individuals per day, a sharp increase from the 500-100 individuals currently being vaccinated daily. MSF also reports that nearly one-third of the frontline health workers in Beni, a hotspot in this outbreak, have reported that they have not been vaccinated.

MSF is working to encourage expanded access to vaccination and supplies to be able to respond to potential and new cases in a timely manner, while also cutting the risk of further transmission.

“Our capacity to carry out real-time assessments and react accordingly is severely undermined by a rigid system which is hard to comprehend,” Natalie Roberts, MD, MSF, emergency coordinator, said in the statement. “It’s like giving firefighters a bucket of water to put out a fire, but only allowing them to use 1 cup of water a day. Every day we see known contacts of confirmed Ebola patients who have not received their dose despite being eligible for vaccination.”

Thus far in the outbreak, the only vaccine which has been authorized for use is the rVSV-ZEBOV-GP, which is manufactured by Merck. This vaccine will continue to be administered to individuals who are at high risk for Ebola infection, including individuals who have had contact with a person confirmed to have the disease. The World Health Organization estimates that 223,000 individuals have already received the Merck vaccine during this outbreak.

As of September 22, 2019, there have been 3057 confirmed cases and 2007 confirmed deaths in the outbreak.

Last week the US Food and Drug Administration (FDA) accepted a Biologic License Application for Merck’s investigational Ebola vaccine. The Prescription Drug User Fee Act is set for March 14, 2020.
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