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12/06/2018 - 11:09am

The US Department of Health and Human Services is vigorously contesting a report, published by The Washington Post, that it has decided to cancel a $2-million-a-year contract that funds work using human fetal tissue to develop mice with humanlike immune systems for testing drugs against HIV

12/06/2018 - 9:15am

Providing evidence for cooperation and action on what is one of the most pressing issues of the 21st century. The Commission’s foundation is that migration and health are inextricably linked—and key to sustainable development. Commission members include our Leonard Rubenstein

12/06/2018 - 9:05am

Failure to vaccinate pregnant women during deadly infectious disease outbreaks is putting them and their unborn children at risk, a new report has warned

12/06/2018 - 8:59am

Health and Bioethics Experts: “The treatment of pregnant women in vaccine research
and deployment is unacceptable. Business as usual simply cannot continue.”

 

New Report Lays out Recommendations for Policymakers, Researchers, and Global Health Organizations on Including Pregnant Women in Epidemic Vaccine Development and Deployment

 

PREVENT: Toward Ethical Inclusion of Pregnant Women in Preparedness, R&D, and Response from PREVENT on Vimeo.

 

Even as health care responders valiantly battle the ongoing Ebola outbreak in the Democratic Republic of Congo, one highly vulnerable group is being denied a potentially life-saving vaccine: pregnant and lactating women. This and other recent epidemics of Zika, Lassa Fever, and Hepatitis E have shown how infectious disease outbreaks can severely – and at times uniquely – affect the health of pregnant women and their offspring. Despite a significantly higher risk of serious disease and death, vaccines against these devastating diseases are rarely developed and approved for pregnant women.

 

Changing institutional and government practices so that we have vaccines to offer pregnant women in an epidemic is one of 22 long overdue recommendations contained in the new report Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, issued today by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy. The report aims to ensure that pregnant women are no longer excluded from receiving vaccines against emerging infectious diseases.

 

“The self-perpetuating cycle of excluding pregnant women from research and from the benefits of vaccination must end,” said Carleigh Krubiner, a lead author of the report jointly appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development. “With global efforts now underway to develop a range of vaccines against devastating epidemic threats, we have to make sure pregnant women are on the agenda, so they will never again be left unprotected in the face of future outbreaks.”

 

The report lays out concrete steps for equitably addressing the needs of pregnant women in public health preparedness, vaccine research and development, and the deployment of vaccines during epidemics. Its recommendations include:

 

  • During an epidemic, the default should be to offer vaccines to pregnant women—not the reverse.
  • Vaccines that can be safely given to pregnant women need to be developed. For these vaccines, evaluation in pregnancy needs to occur as early in the clinical development process as possible.
  • During an epidemic, decisions about whether pregnant women will be offered vaccines should consider not only any potential risks of the vaccine but also, and importantly, the risks pregnant women and their babies face if vaccine is denied.
  • All decisions about inclusion or exclusion of pregnant women should be informed by those with the relevant expertise in maternal and neonatal health as well as in vaccinology and virology.
  • The perspectives of pregnant women themselves should inform vaccine research and deployment decisions that may mean life or death for them and/or their babies.

 

The full recommendations are available at http://vax.pregnancyethics.org/prevent-guidance.

 

“The way we have treated pregnant women in vaccine research and deployment is utterly unacceptable. Business as usual cannot be permitted to continue,” said Ruth R. Faden, a lead author of the report and founding director of the Johns Hopkins Berman Institute of Bioethics. “Ensuring that pregnant women affected by outbreaks have safe and effective vaccines is not only a matter of justice and health equity, it’s also critical to the public health response.”

 

That pregnant women affected by the ongoing Ebola crisis in the Democratic Republic of the Congo are not being offered vaccine demonstrates how urgent and serious the consequences are of the status quo exclusions of pregnant women from vaccine research and delivery. In recent UNICEF interviews, pregnant women “clearly articulated that they wanted to choose whether to be vaccinated or not.”  As one woman said, ‘now there is no option, you just send us to death.’”

 

“As we continue to develop new vaccines against pathogens with serious and often lethal consequences in pregnancy, pregnant women must be on the agenda every step of the way,” said Ruth A. Karron, a lead author of the report and director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative at Johns Hopkins Bloomberg School of Public Health. “We simply can’t continue to fail pregnant women as we develop new vaccines against emerging threats.  We need to generate an evidence base for safe and effective use of these vaccines during pregnancy.”

 

To read the full report visit vax.pregnancyethics.org/prevent-guidance. In conjunction with the report release, PREVENT has also released a video that discusses the risks of the status quo, and describes why urgent action is needed. You can watch the video at vax.pregnancyethics.org.

 

PREVENT is a grant-funded project led by faculty at Johns Hopkins University alongside co-investigators at Georgetown University and the University of North Carolina at Chapel Hill, with external contributions from Working Group Members. The PREVENT Project is funded by the Wellcome Trust (203160/Z/16/Z).

12/06/2018 - 5:22am
Here are some interesting slides from the past two days at the VIII International Symposium on Brain Death in Cuba.
12/06/2018 - 5:22am

Here are some interesting slides from the past two days at the VIII International Symposium on Brain Death in Cuba.

12/06/2018 - 3:30am

The Nuffield Council has released a new briefing note on "Patient access to experimental treatments."

The use of experimental treatments can raise ethical issues such as: difficulties in assessing efficacy and safety; ensuring fairness of access; challenges around decision making and consent; potential impacts on knowledge generation; and ensuring healthcare professionals act responsibly....

12/06/2018 - 3:30am

The Nuffield Council has released a new briefing note on "Patient access to experimental treatments."

Patients might access experimental treatments if other treatments have not worked or are not available. There are several ways in which experimental treatments can be offered legally to UK patients, or patients may travel abroad to access treatments not offered in the UK.

The use of experimental treatments can raise ethical issues such as: difficulties in assessing efficacy and safety; ensuring fairness of access; challenges around decision making and consent; potential impacts on knowledge generation; and ensuring healthcare professionals act responsibly.

Particular issues are raised in the context of experimental advanced therapies (such as gene and stem cell therapies), fertility treatment ‘add-ons’, and innovation in surgery.

A core challenge is balancing the interests of patients in accessing experimental treatments and the need to support innovation, with ensuring there are sufficient safeguards to protect patients from potential harm(s).


12/05/2018 - 10:38pm

This blog post will appear in a future issue of the American Journal of Bioethics

by Nita Farahany, JD, PhD; Saheel Chodavadia; and Sara H. Katsanis, MS

In the summer of 2018, U.S. Customs and Border Protection Officers removed over 2,600 migrant children from their families at the U.S.-Mexico border (Gonzalez, Republic, & Gomez 2018). The rationale behind the separations ranged from the criminal prosecution of illegally entering adults accompanying the children to uncertainty over the true relationships between the adults and children.…

12/05/2018 - 2:39pm

The world’s first baby born by a uterus transplant from a deceased donor is healthy and nearingher first birthday, according to a new case study published Tuesday in the Lancet