WHO rationing Ebola vaccines as outbreak still not under control in Democratic Republic of Congo

The World Health Organization (WHO) is rationing Ebola vaccines in the Democratic Republic of Congo (DRC) and hampering efforts to make them quickly available to all who are at risk of infection, said the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF).

Based on experts’ recommendations, 450,000-600,000 people in DRC should have received the vaccine by now, but only 225,000 people have as WHO controls the supply and imposes strict limits on the number of doses deployed to the people who need it, said MSF. As a result, the outbreak keeps “coming back” to areas that have supposedly been covered by vaccination, and some areas have remained active hotspots throughout most of the outbreak.

“WHO is restricting the availability of the vaccine in the field and the eligibility criteria and their application for reasons that are unclear,” said Dr. Isabelle Defourny, MSF’s director of operations. “We think that upping the pace of vaccination is necessary and feasible. At least 2,000-2,500 people could be vaccinated each day, instead of 500-1,000 as is currently the case.”

The organization is calling for the establishment of an independent, international coordination committee to facilitate more transparent management of the Ebola vaccination program in DRC. This would help increase the number of people protected against the disease that has killed more than 2,100 people since the outbreak was declared last year.

Even with a highly effective vaccine that could help prevent the spread of Ebola and therapeutic treatments that can improve a patient’s chances of survival now available, the Ebola outbreak in DRC has a mortality rate of 67 percent. This is comparable to the 2014-2016 West Africa Ebola outbreak that killed more than 11,000 people.

WHO has said there are enough vaccines to meet the needs. The vaccine, rVSV-ZEBOV, is produced by Merck and has shown very high levels of efficacy.

Despite the fact that known contacts—and contacts of contacts—of people with Ebola are supposed to be vaccinated as part of the outbreak response (as part of the “ring” vaccination strategy), MSF staff in DRC regularly report that the majority of new Ebola cases are known contacts of previously confirmed cases who had not been vaccinated. It has proven difficult to effectively use the “ring” approach for this outbreak as only around half of the new reported Ebola cases have been identified as contacts of previous confirmed cases before falling ill and seeking treatment.

“Even when it comes to frontline health workers—a known, easily reachable population—in a hotspot of the outbreak such as Beni in North Kivu province, almost a third of them reported they have not been vaccinated,” Dr. Defourny said.

Expanding the vaccination coverage beyond the “ring” approach and allowing some flexibility in the eligibility criteria would allow for a much higher number of people to be vaccinated and protected from the disease in the areas of active transmission and in the communities where people have tested positive to the virus.

An expanded approach should be feasible because there is now a vaccine that is proven to be safe and effective; there are medical teams ready to be deployed; there is no problem with the cold chain [that keeps vaccines cold so they don’t become less effective]; there are enough doses to cover the current needs and to allow for an extension of vaccination coverage; and when there is enough awareness, the vast majority of the population wants to be vaccinated, said MSF.

“Community mistrust and resistance have often been pointed out as the major obstacles in the fight against Ebola,“ said Dr. Natalie Roberts, MSF’s emergency coordinator. ”In reality, people would seek medical care at the onset of symptoms if we told them loud and clear that they can be cured with treatments recently proven to greatly increase their chances of survival. They would also come to be vaccinated in greater numbers if more people were aware they can be protected from the virus by a vaccine proven to be highly effective against Ebola. We need to stop blaming communities for their own deaths and make sure more people have access to treatments and vaccines.”

However, increasing the number of people who are vaccinated will not be possible as long as WHO continues to closely control the supply and eligibility criteria. This lack of transparency has directly impacted MSF’s efforts to expand access to vaccination as MSF vaccination teams have often been forced to remain on standby in North Kivu—one of the three affected provinces in DRC—waiting to receive a handful of doses reserved for only people on a pre-defined list. MSF has collaborated with DRC Ministry of Health (MoH) to vaccinate more than 5,000 frontline workers at various points during the epidemic and is currently contributing to vaccination activities in some health areas in Beni, the main epicentre of the outbreak.

“Time is of the essence in an outbreak. Medical teams should be able to rapidly provide treatments or vaccines based on what they see on the ground,” Dr. Roberts said. “If a mother has been caring for her sick child who is then diagnosed with Ebola, not only do we want to diagnose and treat the child, but also we also want to provide the mother with post-exposure prophylaxis that could potentially prevent her from developing the disease, and vaccinate her whole community so that if she does get sick, they will have already developed immunity. But our capacity to carry out real-time assessments and react accordingly is severely undermined by a rigid system which is hard to comprehend. It’s like giving firefighters a bucket of water to put out a fire, but only allowing them to use one 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”.

Such restrictions seem unjustified. The vaccine was determined to be safe and effective by a Phase III clinical trial in Guinea in 2015. In the absence of regulatory approval, the DRC MoH and the WHO allowed the vaccine to be used under an ”Expanded Access” framework during the ongoing outbreak in DRC. The manufacturer recently stated that, in addition to the 245,000 doses already delivered to WHO, they are ready to ship another 190,000 doses, if required, and that 650,000 additional doses will be available over the next 6-18 months.

However, more people can’t be vaccinated until WHO is more transparent about the number of doses available and make sure the those that are available are being quickly supplied to the communities that need them. “To allow for the best possible use of new tools in an outbreak context, transparency is key,” Dr. Roberts said. “How can we support the Congolese authorities in the deployment of these tools? How can we expect the Congolese population to trust a system that is not even transparent to front-line health workers like MSF?”

The independent, international coordination committee MSF is calling for should be based on the model of the International Coordination Group created in 1997 composed of MSF, the International Federation of Red Cross, UNICEF, and WHO, which proved successful in managing massive meningitis, cholera, and yellow fever outbreaks with limited vaccine supplies. The committee would bring partners together to improve coordination on vaccination, increase transparency in stock management, share data, foster an open dialogue with the pharmaceutical corporation that makes the vaccine, and ultimately ensure that the vaccine is provided to all those most at risk of being exposed to the virus.

In collaboration with DRC’s MoH, MSF has been active in the Ebola intervention in northeastern DRC since its declaration on August 1, 2018. MSF teams have provided care to confirmed and suspected Ebola patients, vaccinated frontline workers, strengthened infection prevention and control measures, and conducted community outreach. They have also been working with numerous health facilities in North Kivu and Ituri provinces in order to support access to general healthcare for the population during the Ebola epidemic and truly address the health concerns of the population.