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March 11, 2019

Pregnant Women & Vaccines Against Emerging Epidemic Threats (Johns Hopkins University Berman Institute of Bioethics)

Ethics Guidance for Preparedness, Research, and Response

Presenter: Dr. Carleigh Krubiner, Policy Fellow, Center for Global Development & Associate Faculty, Johns Hopkins Berman Institute of Bioethics

Moderator: Joseph Ali - Johns Hopkins Berman Institute of Bioethics and Johns Hopkins Bloomberg School of Public Health

Summary: The Johns Hopkins Fogarty African Bioethics Training Program, the Addis Ababa University, and the University of Zambia invite you to join a one-hour research ethics webinar. Dr. Carleigh Krubiner will present on the ethics of including pregnant women's health needs in the research agenda for Zika and other public health emergencies. Dr. Krubiner will also discuss her work on the ethical guidance to ensure that the development and deployment of vaccines against emerging pathogens fairly include the interests of pregnant women and their offspring.

Click here to watch the webinar!

February 25, 2019

Pregnant women in DRC to be provided with Ebola vaccine (European Scientist)

From the article:

Last Wednesday 20 February, a committee advising the Congolese Ministry of Health made the decision to provide the Ebola vaccine to pregnant and breastfeeding women, as well as babies under one year old, in the eastern Democratic Republic of the Congo (DRC). In a policy U-turn, the decision was also backed by the World Health Organisation (WHO) based on the advice of an independent advisory body ― the strategic advisory group of experts on immunization (SAGE).

Current WHO estimates place the number of Ebola cases in the DRC at 853 and there have been 521 deaths since the beginning of the outbreak in August 2018. The outbreak is worsened by ongoing armed conflict in the North Kivu Province.


Advocates for vaccinating pregnant women against Ebola have long argued that under the given circumstances, the potential benefits far outweigh the potential harm. Moreover, unless the vaccine is actually given to pregnant women, there will be no data to determine whether it is safe or not. This knowledge would also be beneficial in future outbreaks, according to a statement given by Carleigh Krubiner, a policy fellow at the Center for Global Development.

Krubiner also added in her statement, “The DRC’s decision to extend Ebola vaccine coverage to pregnant women is a huge step forward, not only for pregnant women in areas affected by outbreaks but for all pregnant women who may face the threat of Ebola in the future.” The recent decision has been praised by many others as well, including Doctors Without Borders.

Vaccinated pregnant women in the DRC will be closely monitored until after they have given birth to determine whether the vaccine has any adverse effects. The panel of experts has also recommended including pregnant and breastfeeding women in trials of three other new experimental Ebola vaccines on at-risk populations in neighbouring areas.


February 21, 2019

Pregnant women to be given Ebola vaccine in WHO policy U-turn (The Telegraph)

From the article:

Pregnant and breastfeeding women will be given the experimental Ebola vaccine, marking a U-turn in World Health Organization (WHO) policy. 

A meeting of the WHO's expert vaccine advisory group reversed a previous decision to deny pregnant women the vaccine because there was not enough evidence of its safety.

Pregnant women are usually excluded from all immunisation campaigns because vaccines against infectious diseases like Ebola are rarely tested or approved for use in pregnant women.


Last year a report from an international group of experts called for pregnant women to be included in vaccine development and campaigns.

It said the exclusion of pregnant women from vaccine research and development was unacceptable and “business as usual simply cannot continue”.

Carleigh Krubiner, one of the authors of that report, welcomed WHO's policy reversal.

“This policy change will enable pregnant and lactating women to benefit from the protection the vaccine offers against Ebola infection, safeguarding their lives while also protecting their babies, families, and communities.

"It will also provide a critical opportunity to advance the evidence base on the rVSV-ZEBOV vaccine so that decision makers in the future will be able to make informed decisions about how best to protect their populations, including pregnant women, in the event of an outbreak,” she said. 

She added that pregnant women should no longer be left out of vaccine development strategies. "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.”


February 21, 2019

Ebola vaccine will be provided to women who are pregnant, marking reversal in policy (STAT)

From the article:

Women who are pregnant and lactating, as well as children under the age of 1, will be offered access to an experimental Ebola vaccine in the Democratic Republic of the Congo, officials said Wednesday, marking the reversal of a controversial policy that had drawn fire from public health experts.

The decision was made by a committee advising the Congolese Ministry of Health, but received the support of the World Health Organization.

The decision to exclude pregnant women from the vaccination program sparked blowback from some experts, with some calling the policy “indefensible.”


Carleigh Krubiner, a policy fellow at the Center for Global Development, welcomed the news.

“The DRC’s decision to extend Ebola vaccine coverage to pregnant women is a huge step forward, not only for pregnant women in areas affected by outbreaks but for all pregnant women who may face the threat of Ebola in the future,” Krubiner said in a statement.

To date, there have been 844 confirmed and probable cases in this outbreak, which is now in its seventh month. Of those, 528 people have died.

Krubiner said the policy reversal will not only offer pregnant women the protection of the vaccine, but also provide a critical chance to see how the vaccine, which is being developed by Merck, works in these women. That knowledge will be of benefit in future outbreaks, she said.

Reluctance to offer the vaccine to pregnant and lactating women has stemmed from the fact it is a live-virus vaccine. The virus it contains is not Ebola; it is a livestock virus called vesicular stomatitis virus that can infect, but does not sicken people. A key protein from the Ebola virus has been fused to the VSV virus, which then induces the immune system to develop a protective response when it encounters Ebola.

Traditionally there has been concern about using live-virus vaccines in pregnant women. Krubiner and others have argued that women ought to be informed of the risks and offered the choice.

February 6, 2019

Why can't pregnant women be vaccinated during epidemics? (Devex)

From the article:

NEW DELHI — The Democratic Republic of the Congo is currently facing the most severe Ebola outbreak in its history, with over 400 deaths confirmed since August, according to the World Health Organization. Much hope is pinned on a new vaccine — not yet licensed, but described by WHO as “safe and protective” — which has so far been used to immunize more than 60,000 people deemed most at risk of infection.

But one key group is denied access: Since the vaccine has not been tested for use during pregnancy, it is not being offered to pregnant women.


Carleigh Krubiner, a policy fellow at the Center for Global Development and one of the lead authors of a recent report on maternal immunization, noted that pregnant and breastfeeding women are often at greater risk of exposure to the virus, because of caregiving responsibilities and proximity with children. “There's significant fear that's been documented among women [in DRC] who are unable to receive the vaccine and know they're at disproportionate risk of exposure just given some of the social roles,” she told Devex.


Even as recently as the West Africa Ebola outbreak of 2014-2016, opportunities to “gather more robust data on pregnancy,” which could have helped to protect pregnant women the next time around, were missed, Krubiner said.

“There were recommendations to include pregnant women in those trials, especially given the risk-benefit calculus at the time, and ultimately for a whole host of reasons those recommendations were not taken up,” she said. “The cost of doing this research versus the cost of essentially denying women access to something that could be highly beneficial, there's really no comparison. We can't afford to leave this group unprotected.”


“The development community [as funders and advocates] really does hold a lot of power to reshape the agenda in a way that is much more inclusive to address the needs of pregnant women and their babies,” Krubiner said.

While a small but rising number of vaccines are now being developed specifically for use during pregnancy, pregnant women are still rarely included in the development of vaccines targeted at more general populations. But with increasing attention being paid to vaccine research for epidemics — through initiatives such as the Coalition for Epidemic Preparedness Innovations, a public-private coalition that aims to speed up vaccine research, and WHO’s blueprint for research and development — there is an opportunity for change, Krubiner said.

“There's a lot of effort right now to try and bring to market new and innovative vaccines so that the next time there is an outbreak of Lassa fever or Nipah virus or even Ebola we will have more tools at our disposal … All of those efforts that are happening now can be leveraged to proactively include pregnant women in the response,” she said.

“I think we have a moment right now to learn from our past failures and to really change, to shift the paradigm.”

January 15, 2019

As the world prepares to fight Lassa fever, the interests of pregnant women must be part of the planning (STAT)

From the article:

As health officials work to contain the continuing outbreak of Ebola in the Democratic Republic of Congo, lessons from that crisis can be applied to more equitably battle Lassa fever, another deadly infectious disease.

As 2019 begins, the Ebola outbreak in the DRC is a public health dilemma of tragic proportions. This outbreak, the second largest in history, disproportionally affects women of childbearing potential. Unfortunately, the only available Ebola vaccine has characteristics that make it problematic for use in women who are pregnant. Although they are at high risk of becoming infected and dying, clear recommendations to support giving the vaccine to pregnant women have not been forthcoming.

Read more here!

December 20, 2018

Experts Call for Inclusion of Pregnant Women in Vaccine Research (VOA)

From the article:

Pregnant women have been systematically overlooked in the development and deployment of new vaccines, undermining their health and their communities’ safety, according to guidelines released this month by an international team of researchers, scientists and health care providers.

The report, developed by the Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies (PREVENT) working group, identifies a cycle of exclusion that prevents pregnant women from accessing the benefits of vaccines.

“There’s a lot of reticence to include pregnant women in research,” said Carleigh Krubiner, the project director and a co-principal investigator for PREVENT.

And that’s led to a shortfall in data about how pregnant women respond to vaccines.

Krubiner, an associate faculty member at the Johns Hopkins Berman Institute of Bioethics, told VOA that researchers and health care providers tend to exclude pregnant women from trials, vaccinations and tracking because they lack evidence of the risks expectant mothers face.

“We continue to have this Catch-22 of not having enough evidence to feel like we can do the research. But if we don’t do the research, we don’t have the evidence,” Krubiner said.

December 10, 2018

Pregnant Women Should Be a Priority When It Comes to Vaccination R&D, New Report Urges (Contagion Live)

By Alexandra Ward

From the article:

Pregnant women have been routinely excluded from the vaccination research and development process, even though this vulnerable class is sometimes uniquely affected by infectious disease outbreaks.

In an effort to address and correct this inequity in vaccination coverage, a new report by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group, titled Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Responseis urging vaccination researchers, policymakers, and health groups across the globe to embark on a “paradigm shift” and change the default thinking when it comes to maternal vaccination.

Inclusion of pregnant women in vaccine research and development should be the default, not the exception, the group, funded by Wellcome Trust and made up of 17 multidisciplinary members, explained.

“There is nothing about pregnancy that makes women immune from infectious disease threats, and many infections pose increased risks to pregnant women themselves, the developing fetus, and usually both,” Carleigh Krubiner, PhD, a lead author of the report appointed at the Johns Hopkins Berman Institute of Bioethics and the Center for Global Development, told Contagion®. “[W]hen we’re developing vaccines to combat these infectious disease threats, we need to be considering pregnant women as part of the target population—when investment decisions are made and as we conduct the research to understand safety, immunogenicity, and ultimately, effectiveness.”


If pregnant women are sometimes uniquely susceptible to contracting infectious diseases, and can suffer distinctive consequences with some illnesses, why the historical hesitancy to vaccinate them?

“There are many factors contributing to this near categorical exclusion, including overinflated perceptions of risk in pregnancy as well as liability concerns,” Dr. Krubiner explained. “This is despite the fact there is no evidence of harm associated with the vast majority vaccines given to pregnant women, even among the category of replication-competent vaccines that give rise to the greatest concerns.”

The PREVENT team acknowledged that changing the status quo will be an uphill battle, but the risk of not doing so could have far more catastrophic consequences.

“Paradigm shifts are rarely easy,” Dr. Krubiner told Contagion. “Adopting these recommendations will require significant changes in how people think about pregnant women in the context of research and in the delivery of medical interventions. It will also require institutions to adopt new processes and, in some cases, make additional investments. But changing from business as usual is critically important, both as a matter of social justice and to have successful public health responses to outbreaks.”

Read the full article here

December 10, 2018

New guidance promotes vaccination access for pregnant women during epidemics (Infectious Diseases in Children)

By Katherine Bortz

From the article: 

Researchers in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy and vaccine development and policy have collaborated to provide guidance promoting the inclusion of pregnant women in vaccine studies for emerging diseases.

Carleigh Krubiner, PhD, associate faculty at the Johns Hopkins Berman Institute of Bioethics and project director at the Center for Global Development, said that this guidance was spurred by the Zika epidemic, where pregnant women “could not be ignored in the response.” After the group developed guidance on including women in the response to Zika epidemics, they expanded their scope to include vaccination against other threats, including Ebola, Lassa fever and “Disease X.”

“Unless there are good scientific or ethical reasons showing that the risks of vaccination are likely to be greater than the protection it may offer against an infectious disease threat, pregnant women should be offered the option to be vaccinated,” she told Infectious Diseases in Children. “Our 22 recommendations identify concrete solutions and actions to make this the reality, to close the evidence gap for pregnant women in epidemic responses and ensure that they have fair access to safe and effective vaccines just like other affected populations.”


The researchers acknowledged that these and the other recommendations provided in the guidance may be difficult to follow, but “addressing inequities in biomedical research and public health rarely comes cheaply or without hard work.”

“Because the guidance addresses a complex problem that is reinforced by existing norms across multiple systems, the recommendations are targeted at a wide range of actors in a position to make needed changes, including policymakers, funders, vaccine researchers, ethics committees, regulatory authorities, providers and aid workers,” Krubiner said. “Essentially, we are calling for a paradigm shift in the way people think about pregnant women in the contexts of vaccine research and epidemic responses.”

Read the full article here.

August 27, 2018

An ‘indefensible’ decision: not vaccinating pregnant and lactating women in an Ebola outbreak (STAT News)

By Ruth Faden, Ruth Karron, and Carleigh Krubiner

Days after the Democratic Republic of the Congo declared an end to a deadly Ebola outbreak in the western province of Équateur, a new one emerged in North Kivu province. With the number of cases and death toll rising rapidly, the country’s ministry of health, the World Health Organization, and partners are working to launch a rapid and effective response that includes the use of an experimental vaccine. But their decision not to vaccinate women who are pregnant or lactating unfairly deprives them of the protection they deserve against this deadly disease.

The latest outbreak is due to the Zaire strain of the Ebola virus, a highly lethal variant that was responsible for more than 11,000 deaths in the 2013-2016 epidemic in West Africa and which killed 60 percent of those infected in the recent initial DRC outbreak. The new Ebola eruption has the potential to be even more lethal, as the North Kivu Province is the site of an ongoing armed conflict that makes medical treatment far more difficult to provide.

Fortunately, an experimental vaccine called rVSV-ZEBOV has been shown to be highly effective against this strain of Ebola virus. The DRC’s ministry of health, along with WHO and partners, has already begun employing the vaccine using the highly successful ring vaccination strategy, in which contacts and contacts-of-contacts of people with Ebola are offered the vaccine to halt the spread of the disease. 

Read the full article here