WASHINGTON — Earlier this month, pregnant women in the Democratic Republic of the Congo finally started receiving a life-saving Ebola vaccine, but the months-long delay has put hundreds of women at risk.
The Ebola outbreak first declared in August has claimed 1,437 confirmed lives so far, making it the second-largest outbreak ever recorded.
As an Ebola outbreak worsens in Congo, one key group is being denied a life-saving vaccination.
An experimental vaccine — VSV-EBOV, produced by Merck — has helped to limit further spread. It had been administered to more than 126,000 individuals by the end of May, under a “ring vaccination” scheme in which it is being offered to frontline health workers and people who have come into contact with Ebola patients.
But it was not made available to pregnant and breastfeeding women due to a lack of evidence about its effects on mothers and infants — despite pregnant women facing mortality rates of up to 93% from Ebola, compared to an average of 50% in the general population.
According to DRC’s ministry of health, almost 1,000 pregnant and breastfeeding women registered as contacts of Ebola patients but could not be vaccinated.
After advocates pushed the issue — pointing to the disease's exceptionally high fatality rate and the problem of leaving holes in ring vaccination efforts, which increases the risk of infection for whole communities — the ministry of health, supported by the World Health Organization, cleared the vaccine for use on pregnant women in February.
But it still had to get past DRC's National Ethics Committee, which requested modifications to the protocol.
Those modifications included that pregnant women in their first trimester be excluded from vaccination, according to Professor Steve Ahuka, head of virology at DRC's National Institute of Biomedical Research, which helps to develop national vaccination protocol.
The amendments were made and approved by the committee on June 2. The first pregnant women finally received the vaccine on June 13 — 10 months after the outbreak started.
The delay, said Ahuka, is a reflection of how complicated the decision is.
“The vaccination of pregnant women is usually a very complex decision to make, especially ... when they are using a new vaccine which is still under a trial,” he said. Though several studies have shown the vaccine to be safe and effective, it has not yet been licensed.
In an escalating Ebola outbreak, however, time is of the essence. WHO confirmed earlier this month that the disease had spread to Uganda.
“Pregnant and lactating women in the DRC finally have access to ... one of the best prevention tools we have against this deadly virus,” said Carleigh Krubiner, a faculty member at Johns Hopkins Berman Institute of Bioethics. “Hopefully this will set a new precedent for ongoing and future Ebola vaccination efforts, avoiding costly delays in protocol approvals while women face the very real threats of Ebola infection.”
While data is limited, WHO spokesperson Tarik Jasarevic said a third of Ebola cases in the current outbreak have been women of reproductive age, that 53 of them reported being pregnant, and an additional 24 were breastfeeding.
Yet pregnant women have never been prioritized in clinical trials, according to research by David Schwartz, a professor of pathology and author of “Pregnant in the Time of Ebola.”
“It can be difficult to assure the safety to the mother and developing embryo and fetus of drugs and vaccines, and thus caution has traditionally guided their administration during pregnancy,” Schwartz wrote in a paper on the topic.
But public health experts including Schwartz maintain that a risk-benefit analysis in the case of Ebola falls in favor of vaccination.
“While we don’t yet know as much as we’d like to about this vaccine in pregnancy, there is a lot that we do know,” Krubiner said. “We know that Ebola is extremely deadly ... We know that in this epidemic, many more women than men have been infected ... And we also know that the vaccine is extremely efficacious.”
Since the beginning of the outbreak, breastfeeding and pregnant women have repeatedly requested the vaccine. Research in DRC’s Beni, Butembo, and Tchomia found that some breastfeeding women were temporarily weaning their infants in order to receive it, despite the prohibitive cost of formula and social stigma attached to its use.
“You tell us to protect yourself with the vaccine, and then you tell us we cannot get the vaccine. So we have nothing left,” one woman told Red Cross researchers anonymously in October.
Feedback gathered by the Red Cross also showed that suspicions about the vaccine rose in communities where pregnant women were excluded without effective explanation.
Now that it has been approved for use among this group, health workers have a challenging path ahead.
The response to the outbreak is complicated by its location in a volatile region. Rumors abound that the outbreak is fake, and the government has been accused by some of manipulating it for political gain.
“Communication will be key to explain the change in policy and to offer the best information we have about the benefits and risks of vaccinating in pregnancy,” Krubiner said.
It will also be important to track women who receive the vaccine to ensure any long-term effects are captured –– a complex task in a conflict zone with a highly mobile population.
But getting it right doesn't just matter for this outbreak. The policy change could also have implications for future epidemics, with growing evidence that pregnant women face outsized risk.
Lassa fever results in maternal death or fetal loss in 80% of pregnancies in the third trimester, for example. Hepatitis E is fatal for 30% of pregnant women, compared to less than 2% of the general population.
Despite the unknowns, for many women, the decision could not come soon enough.
"The situation in the field is getting very bad," said Ahuka. "[Pregnant women] are the most vulnerable group in this Ebola outbreak and that's why it is so important to protect them."