In among a fatal epidemic such as Ebola, should it receive an experimental vaccine that protects against 97.5% of the disease?
The candidates are clear who would immediately contact people who have developed Ebola, and their contacts. However, this rescue intervention is being denied to a whole group of vulnerable individuals who fall into these categories – women who are pregnant or breastfeeding for infants.
The vaccine, called rVSV-ZEBOV, being developed by Merck, has not yet been approved for commercial use. The vaccine is currently being used in the Democratic Republic of Congo, where more than 2,000 people have been infected with Ebola virus and almost 1,400 people have died, making it the second largest Ebola outbreak in the world.
To date, over 130,000 people have received an RVSV-ZEBOV in the DRC outbreak using a ring vaccination approach: The vaccine is offered to contacts of people diagnosed with Ebola, their contacts, and initial workers – if they are not pregnant or lactation. More than 300 pregnant women and over 600 breastfeeding women were not given the opportunity as contacts since the vaccination campaign began to get rVSV-ZEBOV.
One rationale for withholding the vaccine from pregnant or lactating women is that the vaccine was not tested in this group to assess its effects on the fetus or breastfeeding children.
In February, the DRC announced that pregnant and lactating women should be given access, as well as children under 1 year of age, to access to rVSV-ZEBOV, and refunded a decision. who have previously committed fire from public health experts.
Last week, an ethics committee of Kinshasa University School of Public Health endorsed this strategy by allowing the vaccination protocol to be approved, allowing vaccination of pregnant contacts outside the first trimester of pregnancy and those lactating.
This is an exciting step forward and we hope that it will be swiftly transferred to ensure that pregnant and lactating women who can avail of the vaccine receive it.
But it does not go long enough. We believe that the criteria for offering the vaccine should apply regardless of pregnancy or lactation status: The vaccine should be offered not only to pregnant women and lactors who are in contact with those who have been diagnosed with Ebola, but also t Pregnant and lactated health care workers, and pregnant and lactating women are contacts. To guide future vaccination efforts, data should be collected on pregnancy results. We also believe that the vaccine should be offered to pregnant women regardless of the quarter.
There are compelling reasons why it is imperative that pregnant women are not excluded from the current Ebola vaccination strategies. Pregnant women are not only infected with Ebola, but women appear to have higher rates of infection than men, due to their traditional role as carers for sick family members or because of greater vulnerability to the virus.
The risk of death is as high as pregnant women who are infected by Ebola at least in women who are not pregnant, and who may be higher. In addition to the risk associated with the pregnant woman herself, it is also important to consider the benefits and risks of fetal vaccination and newborn babies, as Ebola infection during pregnancy poses serious threats. on their health: Pregnant Ebola-infected women are at high risk of miscarriage, stillbirth, or neonatal death.
Due to the risk of Ebola for pregnant women and their children, the benefits of getting the vaccine to prevent Ebola's illness and death are clear.
To be sure, it is complicated the risks that could be associated with the vaccine of a pregnant woman and her fetus are weighed. There is no data available on the effects of this Ebola experimental vaccine on pregnant women or their fetus. There are, however, many years of experience with other vaccines during pregnancy that may help to compose this issue.
For many years, pregnant women in developing countries have been given the tetanus toxoid vaccine to prevent their baby dying tetanus, and there is no evidence of adverse effects on the fetus. Inactivated flu vaccine as well as toxoid tetanus, reduction of toxic toxin, and acetic pertussis vaccine (collectively called Tdap) are recommended regularly during pregnancy. Not only are these vaccines safe, but they have an added benefit: Antibodies produced by the mother cross the placenta to the fetus, providing protection against influenza and pertussis for both newborn babies, both fatal infants, for the first few. months of life.
The Ebola experimental vaccine is a permanent live vaccine, and live vaccines have not historically been given during pregnancy due to the theoretical risk that the weakened virus could cross the placenta and infect the fetus. However, when live vaccines were inadvertently vaccinated for pregnant women, no adverse effects were observed. With recommendations for a single live vaccine – the yellow fever vaccine – the risks and benefits for weighing pregnant women are highlighted, given the severity of the illness the vaccine could prevent.
Lessons from dolutegravir, treatment for HIV
Recent experience with a new HIV medication called dolutegravir gives some guidance here. Dolutegravir has been identified as having many benefits in the treatment of HIV, due to its ability to clean the virus quickly and consistently with fewer side effects and lower costs. But its use was limited to pregnant women due to concerns about fetal safety.
In July 2018, interim data from a study in Botswana indicated that women taking dolutegravir in the early stages of pregnancy may have a higher risk of having a child with a neural tube defect, such as spina bifida or anencephaly. While waiting for further details, recommendations were made that women planning pregnancy or not using consistent contraceptives should not take dolutegravir.
Since then, modeling data has indicated that women were less likely to die and free of HIV if the drug were to be greater than the risks. More importantly, following a meeting of African women living with HIV to discuss the safety signal, the group issued this powerful statement: “Not only is a pregnant mother, or a Any women who may be treating children as a child, but as an individual in their own right, deserve the best possible access to the evidence-based treatment available and t the right to have enough information to make a choice that she thinks is best for her. ”
A subsequent guide to the use of dolutegravir identified this issue: At present the WHO recommends that women should be advised of the benefits and risks that dolutegravir may have and allow use it or an alternative drug.
For women who are at high risk from contracting Ebola, rVSV-ZEBOV shows a more stark example than ever to mediate your rescue. Ebola kills women and their children. There is an ethical obligation not to exclude women from similar intervention such as rVSV-ZEBOV because they are pregnant or lactating. They should be given the best information available to decide on vaccination and, if they choose to proceed, they should be offered the Ebola vaccine regardless of pregnancy or lactation status.
Because of the presence of tidromide as a cause of limb defects in the 1960s, clinicians and researchers have emphasized the protection of the fetus from harmful exposures. While this is a commendable goal, women should not automatically get a pregnancy from life-saving therapies. Pregnant women and their fetuses have the opportunity to be protected from serious disease and death. As with the general public, the focus must remain on the benefits of intervention and whether these are greater than the potential risks.
Based on the known effects of the Ebola virus on a woman and her fetus and the preliminary data on Ebola vaccine efficacy, the benefits of the Ebola vaccine are greater than the potential risks, even in the first instance. quarter when the fetus organs are coming.
The way forward should be clear: The Ebola vaccine should be offered to lactation and pregnant women regardless of the theme of pregnancy to protect women and their fetus from ill-health and death.
Sonja A. Rasmussen, M.D., is a pediatrician and epidemiologist at the University of Florida Medical College and the College of Public Health and Health Professions. Denise J. Jamieson, M.D., is a midwife-gynecologist in Emory University Medical School. Both of them worked for 20 years previously at the Centers for Disease Control and Prevention responding to public health emergencies, including H1N1 influenza viruses, Ebola, and Zika.