zika « Berman Institute Bioethics Bulletin

Features

News roundups

Announcements

Pregnant Women & the Zika Virus Vaccine Research Agenda: Interactive Ethics Guidance

September 20, 2017

Ethics guidance on priorities, inclusion, and evidence generation – enriched with additional links and resources, and broken into expandable sections for ease of reading and reference

Quick Read

Texas Calls In US Air Force to Counter Post-Storm Surge In Mosquitoes

September 13, 2017

Texas has launched aerial attacks on mosquitoes swarming coastal regions of the state and threatening to spread disease and hinder disaster recovery in the aftermath of Hurricane Harvey

Quick Read

Sanofi Quietly Pulls the Plug on Its Zika Vaccine Project

September 5, 2017

Vaccine giant Sanofi Pasteur has quietly pulled the plug on its Zika vaccine project, a move that underscores how difficult it may be at this stage to develop a vaccine against the virus

Quick Read

Pregnant Women Absent from Zika Vaccine Trials

August 15, 2017

Some vaccine developers are taking steps to include them, in line with bioethicists’ urging, but it will likely take years before any expectant mothers are enrolled

Quick Read

How Pregnant Women Are Sidelined By Science

July 26, 2017

Carleigh Krubiner and Ruth Faden‚ from Johns Hopkins University in the US‚ said there was a desperate need to “protect women through research‚ not just from research”

Quick Read

Zika Rewrites Maternal Immunization Ethics

July 20, 2017

Researchers have been too reticent to include pregnant women in clinical trials of vaccines, contends the working group behind the report. “Even for the vaccines we now recommend in pregnancy, pertussis and flu, the original trials did not include pregnant women,” says Carleigh Krubiner, a bioethicist at the Johns Hopkins Berman Institute of Bioethics, who is part of the group, “This project is trying to be more proactive.”

Quick Read

Zika Rewrites Maternal Immunization Ethics

Thursday, July 20th, 2017

Ever since the shocking realization in 1961 that the morning sickness pill thalidomide caused shortened limbs in babies, doctors have been extremely wary of giving any medicine to a pregnant woman—and testing experimental drugs has raised even more concerns. But the recent discovery that exposure to Zika virus in utero can cause severe brain damage and other problems in children triggered an international effort to develop a vaccine for pregnant women. A new report written by an ad hoc group of prominent researchers, bioethicists, clinicians, and drugmakers concludes that pregnant women should be included in trials of Zika vaccines, once safety in animals and nonpregnant adults is demonstrated. The risk/benefit issues spelled out in the report also apply to experiments with maternal immunization for other diseases, which are winning increasing support.

Researchers have been too reticent to include pregnant women in clinical trials of vaccines, contends the working group behind the report. “Even for the vaccines we now recommend in pregnancy, pertussis and flu, the original trials did not include pregnant women,” says Carleigh Krubiner, a bioethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, who is part of the group, which was sponsored by the London-based Wellcome Trust. “This project is trying to be more proactive.”

The half-dozen Zika vaccine trials now taking place only enroll women of childbearing age who are on contraception or have a sterile male partner. That is appropriate, according to the risk/benefit analyses spelled out in the report, as these early studies assess only safety and basic immune responses. But once those have been demonstrated, “it is unethical to presumptively exclude pregnant women from participation,” the report concludes. A woman who becomes aware of a pregnancy after enrolling in a study should be “guaranteed” a chance to stay in the trial, the report adds.

Be the first to like.

Unlike

http://science.sciencemag.org/content/357/6348/241.full

Why Zika Is Especially Hard On The Women Of Brazil

July 19, 2017

Did the Zika virus put a heavier burden on women than it did on men when the virus swept through Brazil? A new report by Human Rights Watch argues that the answer is yes

Quick Read

Zika Vaccines And Pregnant Women: Here’s What Ethics Experts Say

July 10, 2017

Time to call in the ethics experts. That’s what the Wellcome Trust did in supporting the formation of the “Ethics Working Group on Zika Virus Research & Pregnancy.” Consider this a Justice League of ethics, vaccine, infectious disease, Zika, and OB/GYN experts that included Ruth Faden, PhD, MPH, Annie Lyerly, MD, MA,, and Maggie Little, BPhil, PhD, The website lists other members of the Working Group.

Quick Read

Zika Vaccines And Pregnant Women: Here’s What Ethics Experts Say

Monday, July 10th, 2017

Avril Lavigne once sang, “Tell me, why’d you have to go and make things so complicated?” Since that was from her 2002 album Let Go, chances are she was not singing to the Zika virus…unless she knew something that we didn’t at the time. But nowadays her Complicated song could certainly apply to nearly everything about the Zika virus…including the Zika vaccines that are currently under development.

I’ve previously written about how the Zika virus has turned out to be a trickier than initially thought. But what’s so complicated about Zika vaccines besides the fact that vaccine development in general is complicated? Well, the biggest risk of Zika infection is to pregnant women, because the virus can cause devastating birth defects in the fetus. Therefore, pregnant women could certainly use a Zika vaccine for protection, but…. Don’t we usually avoid testing vaccines or other medications on pregnant women, because of potential risk to the fetus and the woman and the many changes a body undergoes while pregnant? A pregnant woman is not the same as a non-pregnant woman in many ways physiologically. A two-weeks pregnant woman is not the same as 2-months pregnant woman. One pregnant woman is not the same as another pregnant woman. These physiologic changes and ethical issues make Zika vaccine development and testing more…complicated, as Lavigne sang, “Uh huh, uh huh. That’s the way it is.” Time to call in the ethics experts.

That’s what the Wellcome Trust did in supporting the formation of the “Ethics Working Group on Zika Virus Research & Pregnancy.” Consider this a Justice League of ethics, vaccine, infectious disease, Zika, and OB/GYN experts that included R uth Faden, PhD, MPH, Founder and former Director of the Johns Hopkins Berman Institute of Bioethics and the inaugural Philip Franklin Wagley Professor of Biomedical Ethics at Johns Hopkins University, Annie Lyerly, MD, MA, Professor of Social Medicine at the University of North Carolina, and Maggie Little, BPhil, PhD, Director of the Kennedy Institute of Ethics and Professor of Philosophy at Georgetown University. The website lists other members of the Working Group. Their role was to provide guidance to the scientific, health, and policy communities on how to proceed with Zika vaccine development, testing, and roll-out (if and when it occurs) with regards to pregnant women and women of child-bearing age.

Be the first to like.

Unlike

Forbes

Pregnant Women & the Zika Virus Vaccine Research Agenda: Interactive Ethics Guidance

Pregnant Women & the Zika Virus Vaccine Research Agenda: Interactive Ethics Guidance

Texas Calls In US Air Force to Counter Post-Storm Surge In Mosquitoes

Texas Calls In US Air Force to Counter Post-Storm Surge In Mosquitoes

Sanofi Quietly Pulls the Plug on Its Zika Vaccine Project

Sanofi Quietly Pulls the Plug on Its Zika Vaccine Project

Pregnant Women Absent from Zika Vaccine Trials

Pregnant Women Absent from Zika Vaccine Trials

How Pregnant Women Are Sidelined By Science

How Pregnant Women Are Sidelined By Science

Zika Rewrites Maternal Immunization Ethics

Zika Rewrites Maternal Immunization Ethics

Why Zika Is Especially Hard On The Women Of Brazil

Why Zika Is Especially Hard On The Women Of Brazil

Zika Vaccines And Pregnant Women: Here’s What Ethics Experts Say

Zika Vaccines And Pregnant Women: Here’s What Ethics Experts Say

Follow Us

Twitter Feed

Twitter Feed