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Research for Vaccination Should Include Pregnant Women: Experts

Pregnant women are continuously getting left out of the benefits of scientific advancement in medicine

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Ebola, pregnant women
A Congolese health worker administers Ebola vaccine to a woman who had contact with an Ebola sufferer in the Democratic Republic of Congo, Aug. 18, 2018. VOA
 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.

Women. Pregnant Women
Nicole Andreacchio, second right, who is seven months pregnant waits in line to receive the swine flu vaccine from the Montgomery County Health Department at Congregation Beth Or in Maple Glen, Penn. VOA

There’s a lot of fear’

Concerns over “theoretical harm” drive decisions to exclude pregnant women from interventions, Krubiner said. But the data scientists do have, often from women not known to be pregnant when they received vaccinations, suggest those concerns are overblown.

In the case of rubella, for example, a contagious viral infection, researchers didn’t find a connection between congenital rubella syndrome and the vaccine when thousands of pregnant women were vaccinated before their pregnancy status was known.

“There’s a lot of fear,” Krubiner said. “And there are certainly biologically plausible risks associated with different types of live replicating viral vaccines.”

Live-virus vaccines contain a weakened version of the disease designed to stimulate an immune response in recipients.

“Very often, the benefits of vaccinating do still outweigh the theoretical, or even real harms that may be posed to the fetus,” Krubiner said.

One vaccine known to cause harm to pregnant women and their fetuses, Krubiner added, is for smallpox. But even in that case, she said, if a threat were imminent, pregnant women should get vaccinated, given the seriousness of the disease. The Centers for Disease Control and Prevention support that guidance.

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A nurse holds a vial of measles, mumps and rubella vaccine at Boston Children’s Hospital in Boston, Feb. 26, 2015. VOA

‘Strongly recommended’

The advice pregnant women receive about vaccination should reflect what’s known about the particular vaccine and the specific circumstances of the outbreak, Krubiner said.

Recommendations should follow current knowledge about the disease in question, the severity of the threat, and the likelihood of exposure, she added.

But the general guidance is unambiguous.

“At minimum, vaccines should be offered to women, and in many cases they should be strongly recommended,” Krubiner said.

Among those cases is the vaccine for seasonal and pandemic flu, which pregnant women should be urged to receive, in light of the severity of the risks tied to infection — not just for the expectant mother, but the future child as well.

Pregnant women should also be encouraged to receive vaccines for H1N1, also known as swine flu, and DPT, which protects against diphtheria, whooping cough and tetanus.

Pregnant Women
More complex data collection will paint a more complete picture. Pixabay

Institutional change

Involving pregnant women in the benefits of vaccines will require systemic shifts, the PREVENT group said in its report this month.

An important step is to become more proactive in bringing pregnant women into what Krubiner called the “development and research pipeline.” By involving pregnant women early, she said, health care providers aren’t left with the kinds of blind spots about how vaccines will affect expectant mothers and their fetuses that lead to their exclusion.

Even basic information, such as pregnancy status in case reports, sometimes goes untracked, despite being easy to collect and providing insight into the unique burden pregnant women face in disease outbreaks.

More complex data collection will paint a more complete picture. Specific studies could be designed to examine the safety and efficacy of vaccines for pregnant women, for example, or to track effects at different points in gestation.

“Starting anywhere at this point would be better than the dearth of data that we have right now to really try to address the needs of pregnant women and their babies,” Krubiner said.

Pregnant women
There’s a lot of reticence to include pregnant women in research. Pixabay

Lessons learned

Disease outbreaks devastate communities. But they also provide opportunities to better prepare for, and respond to, the next epidemic.

In this year’s Ebola outbreaks in Congo, responders have applied lessons from West Africa’s 2014-16 epidemic to community engagement. And drug trials toward the end of the West Africa outbreak produced evidence about the vaccine that’s now being deployed.

But pregnant women weren’t included in those trials, and researchers collected little in the way of data about the burden pregnant women and their offspring face.

Also Read: Women Hit Especially Hard In Congo’s Worst Ebola Outbreak

“Pregnant women are continuously getting left out of the benefits of scientific advancement in medicine,” Krubiner said.

“If we continue to fail to collect the kinds of data that we need, to generate the kind of evidence that we need and to also have interventions that meet the broader population’s needs,” Krubiner said, “then we’re just going to continue to perpetuate the cycle.” (VOA)

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“EPA Will No Longer Fund Children’s Health Research”, Say Researchers

Research on children's health risks in doubt over EPA funds

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FILE - The U.S. Environmental Protection Agency (EPA) sign is seen on the podium at EPA headquarters in Washington, July 11, 2018. VOA

Long-running research projects credited with pivotal discoveries about the harm that pesticides, air pollution and other hazards pose to children are in jeopardy or shutting down because the Environmental Protection Agency will not commit to their continued funding, researchers say.

The projects being targeted make up a more than $300 million, federally funded program that over the past two decades has exposed dangers to fetuses and children. Those findings have often led to increased pressure on the EPA for tighter regulations.

Children’s health researchers and environmental groups accuse the EPA of trying to squelch scientific studies that the agency views as running counter to the Trump administration’s mission of easing regulations and promoting business.

“A lot of the centers, including mine, have identified a lot of chemicals that are associated with diseases in children,” said Catherine Metayer, an epidemiologist who directs research into children’s leukemia at University of California at Berkeley through the federal program.

The EPA awarded smaller than average funding for the research grants for this year, asked Congress to cut funding for it from its budget, and has refused to commit to future funding for the program.

“The EPA anticipates future funding opportunities that support EPA’s high priority research topics, including children’s health research,” spokesman James Hewitt said, while declining to answer questions on the future for the national research projects.

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FILE – 15-month-old August Goepferd received the measles, mumps and rubella booster shot at a clinic at Children’s Minnesota in Minneapolis. VOA

Children’s centers at universities around the country typically get joint funding from the EPA and National Institute of Environmental Health Sciences in three- and five-year packages, with most packages running out in 2018 and 2019. With no word on future funding, researchers overall “have been kind of scrambling to find a way to continue that work which is so important,” said Tracey Woodruff, director of the children’s center at the University of California at San Francisco.

Woodruff’s federally funded work includes looking at how flame-retardant chemicals and PFAS compounds – a kind of stain-resistant, nonstick industrial compound – affect the placenta during pregnancy. The Trump EPA has come under increasing pressure from states to regulate PFAS as it shows up in more water supplies around the country.

With no news from the EPA on any more funding in the future, “we’ve been winding down for about a year” on work funded through those grants, Woodruff said. On Tuesday, a banner across a website home page for the overall children’s research declared “EPA will no longer fund children’s health research.”

The EPA and National Institute of Environmental Health Sciences have jointly funded the children’s environmental health research since 1997, through grants to at least two dozen children’s environmental research centers around the country. The annual grants averaged $15 million through 2017. In the current fiscal year, the EPA contributed $1.6 million, agency spokeswoman Maggie Sauerhage said.

The research often involves enrolling women while they are still pregnant and then following their children for years, to study environmental exposures and their effects as children grow, said Barbara Morrissey, a toxicologist and chairwoman of the EPA’s Children’s Health Protection Advisory Committee.

The long-term projects often produce much stronger results overall than one-off studies do, Morrissey said. Each children’s center funded by the grants also works to spread information about environmental threats to local health workers and to families.

health risks
Children’s health researchers and environmental groups accuse the EPA of trying to squelch scientific studies that the agency views as running counter to the Trump administration’s mission of easing regulations and promoting business. VOA

The institute is under the National Institutes of Health, which has numerous other children’s environmental research studies underway but said with the EPA joint program left hanging, it was considering a new program to put lessons learned about pediatric risks into practice in communities.

EPA’s funding for the grants comes from the agency’s Science To Achieve Results, or STAR, program for research into environmental threats. The Trump administration 2020 budget request sought to eliminate funding for the STAR grants, and sought a nearly one-third cut in the EPA’s budget overall.

A House Appropriations subcommittee released its own budget proposal Tuesday to restore funding for the STAR grants and boost the agency’s overall budget from last year by 8%, rejecting the administration’s requests for cuts.

EPA spokespeople did not respond when asked why the EPA had asked Congress to end funding for the grant program, and whether the agency would commit to continuing the children’s health research if Congress overrides the EPA and restores funding for the grants, as expected.

The science journal Nature first reported funding concerns for the program. In a statement Tuesday, Ken Cook of the Environmental Working Group said “crippling research to protect children’s health, while bowing to the agenda of the chemical industry, is the calling card of the EPA in the Trump administration.”

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Even if the administration restores funding to previous levels, for one year or several years, the time span of grant cycles and grant-funded work means that uncertainty over continued federal support is making the intended multiyear research untenable, researchers and program supporters said.

“The whole point of these children’s centers is to be following children over time,” Morrissey, the chairwoman of the advisory committee to the EPA, said. “That’s why it’s so high-quality.” (VOA)