Early studies on the Covid vaccine ruled out pregnant women – and misinformation flourished
Biden administration health officials and maternal health experts have stepped up efforts to educate pregnant Americans. But some doctors and public health officials are also looking to the future, urging the medical profession to learn from the experience of Covid-19 by including pregnant and breastfeeding people in the first studies of new vaccines and treatments.
“If you needed proof to the face that the old way of doing things didn’t work, we have it now,” said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics, whose research has focused on women’s health.
There is a long history of drug companies excluding pregnant women from clinical trials for ethical and legal reasons, a reluctance that dates back to thalidomide-related birth defects of the early 1960s. The drug has never been approved by the FDA. , thanks to the actions of agency reviewer Frances Kelsey, but it was used extensively in Europe for several years to treat morning sickness. Thousands of children exposed to the drug in utero have been born with birth defects, including fin-like limbs.
Pregnant women in the United States, who are routinely advised to avoid everything from sushi and cold cuts to hot tubs, are often reluctant to do or take anything that has not been proven safe to their fetus. Many were naturally hesitant to be vaccinated against Covid-19 during the first months of the national deployment, without a clear recommendation from the health authorities.
This set the stage for a bleak summer, when Covid-19 cases skyrocketed as the Delta variant spreads, prompting the CDC to revise its vaccine approval in this population to reflect the urgency. The agency “strongly” recommended in a September 29 health advisory that people who were currently or recently pregnant, or who could become pregnant in the future, get vaccinated.
“The COVID-19 vaccination is recommended for all people 12 years of age and older, including those who are pregnant, breastfeeding, trying to get pregnant now, or who may become pregnant in the future,” the CDC said on its website, in a language he added. August 11.
But the CDC’s statements about vaccination against Covid during pregnancy have evolved since the vaccines first became available, which experts say has not helped allay the fears of expectant parents.
“I think it hurts us not to be able to strongly recommend these vaccines, instead of saying that pregnant women can choose to be vaccinated,” said Linda Eckert, ACOG liaison officer to the advisory committee. CDC independent on immunization.
Maternal health experts have worked for decades to change the approach of the medical community to include pregnant women in clinical research. The push became urgent during the respiratory virus pandemics of the early 2000s, including the H1N1 flu, and the Zika and Ebola epidemics of the 2010s. Faden’s Hopkins group and a federal task force issued statements. recommendations in 2018 in anticipation of the next pandemic.
They included the early initiation of non-clinical research – such as developmental and reproductive toxicology, or DART, studies in animals – required for trials in pregnant women before efficacy trials began. Another was to allow pregnant women to enroll in immunization studies during epidemics when the potential benefits outweigh the risks to them and their babies.
“Almost none of them have been followed up with regards to the pandemic,” Faden told POLITICO.
There was a “ridiculous lag” between when developing Covid vaccines looked promising and when pharmaceutical companies started investing in DART studies, Faden said, even though most Covid vaccine makers have received federal assistance.
“It was the one time that even the financial disincentives to do DART studies were removed,” she said, and it still wasn’t enough to start them early.
A task force created by the 21st Century Cures Act of 2016 released its own report in 2018 making similar recommendations regarding research on pregnant and breastfeeding people, as well as specific policy proposals to the Department of Health and Human Services. .
The group asked the FDA to remove pregnant women from the list of “vulnerable populations” described in the common rule, the country’s code of ethics for medical research in humans; The HHS did so in a regulatory rewrite that went into effect in 2018. Maternal health experts have long argued that the inclusion of pregnant people on this list of subjects that warrant special consideration has fueled a “presumption of” exclusion “from medical research.
“Our mantra is this: We need to protect pregnant women through research rather than research,” said Diana W. Bianchi, director of the NIH’s National Institute of Child Health and Human Development, who led the working group, nicknamed PRGLAC.
The group also recommended modifying the common rule to allow only maternal consent for participation in research, “taking into account the recognized autonomy of a pregnant woman, the evolution of the family structure, than for a child. only one parental signature is required for research to contribute to the benefit of the child and to align with parental consent for pediatrics. ”Certain types of research currently require the consent of both parents.
But not all problems have a clear recommendation. Liability issues that arise from conducting research on pregnant and breastfeeding women have proven difficult to resolve, the group acknowledged.
“Concerns about the accountability of researchers and clinicians working within the US health and legal systems are more prevalent than the issue of including pregnant and breastfeeding women in research only,” the task force said. PRGLAC in an August 2020 implementation plan.
He suggested implementing a mitigation strategy similar to the federal government’s vaccine victim compensation program – which assesses claims arising from 15 childhood vaccines and seasonal flu shots – or strengthening the power of the FDA. to require “clinically relevant data” to inform safety and dosage recommendations for pregnant and lactating women. people.
HELP Senate Speaker Patty Murray (D-Wash.), Who led the task force’s inclusion in the 2016 law, has had “several calls with the HHS” regarding its implementation of the PRGLAC recommendations, a committee assistant told POLITICO.
Pregnant people “deserve to know that they’ve been included in studies and trials, so they can get the information they need to feel confident about their health decisions,” Murray said. in a press release. “I’m pushing as hard as I can to make it happen.”
HHS did not respond to a request for comment on its implementation of the recommendations.
The FDA is still working to harmonize its regulations with the updated common rule, agency spokesman Chanapa Tantibanchachai said. The agency has supported expanding a reporting system to identify cases where existing drugs are being used in new ways to treat infectious diseases in pregnant people to cover Covid-19, she said.
The agency’s guidelines to developers of Covid drugs and vaccines encourage them to consider developing early data that could support the inclusion of pregnant people in late-stage clinical trials, Tantibanchachai said.
“The FDA remains committed to increasing the recruitment of diverse populations into medical product development and will continue to engage with federal partners, medical product manufacturers, medical professionals and health advocates to encourage this goal. important, ”she said.
“The will is there” nationally and globally to generate enough data on medical treatments to be able to officially recommend them to pregnant people, Faden said.
“The pandemic has crystallized – if there was any doubt about the cost of not changing this presumption of exclusion – it was very bad for pregnant women around the world and for their babies and for people who love them, ”Faden said. “I think there is a very good chance that this time pregnant women will not be left behind but have a seat at the table.”