Pregnant women need Covid shots. New CDC guidance is unethical

Health and Human Services Secretary Robert Kennedy’s proposal to end the government’s existing Covid vaccine recommendation for healthy pregnant women, if enacted, will be a major setback to decades’ worth of efforts to advance the health of pregnant people and their babies.

It also profoundly unethical.

Pregnant people are consistently left behind in biomedical R&D in ways that are deeply harmful to the health of both mother and child. In the decade before the Covid pandemic, consensus reports emerged denouncing this pregnancy evidence gap and providing road maps for how to ethically generate evidence during pregnancy within the confines of existing research regulations. I co-led one of these efforts, the PREVENT project, initiated in response to the Zika epidemic and completed in fall 2019. PREVENT specifically focused on how to ethically include pregnant women in the development and deployment of new vaccines for emerging pandemic threats.

In the early days of the Covid pandemic, many colleagues and I had hope that this time would be different, not only because reports provided road maps for ethical inclusion but also because Operation Warp Speed indemnified vaccine developers from litigation, eliminating legal risk that some viewed as the last remaining obstacle to conducting research with pregnant women.

Nothing changed, however. Vaccine developers made no serious effort to generate pregnancy-specific data. As a consequence, many countries, including the U.S., initially excluded pregnant women from the rollout of Covid-19 vaccines, over the strenuous objection of the American College of Obstetricians and Gynecologists and other relevant professional organizations. They argued that pregnant women and their newborns were at increased risk from Covid and that there was no plausible biological reason to think the vaccines were harmful.

Eventually, it became clear that pregnant people infected with Covid were being hospitalized at alarming rates; that their pregnancies were threatened by preterm labor, stillbirths, and other conditions; and that their newborns, also at elevated risk, could be protected by maternal antibodies. Although the U.S. was quicker than many other countries to reverse its position and designated pregnant women as a high-risk, high-priority group, damage was already done. We will never know how many preventable hospitalizations and maternal and neonatal deaths occurred because of the delay in including pregnant women in the vaccine rollout — a delay that also created a persistent cloud of doubt.

But the good news is that the Covid vaccine joined the flu vaccine as routinely recommended in pregnancy, to protect both the pregnant woman and her newborn.

That is, until now. Kennedy’s position is throwing back into chaos the hard-fought progress of the pandemic years, once again jeopardizing the health of pregnant people and babies alike. I am not aware of any evidence shifts that could justify this reversal. Millions of pregnant women have received Covid mRNA vaccines in the past four and a half years, without any concerning safety signals. Although it is possible that those who have had Covid or been vaccinated in the past have a level of antibodies that might provide them with some protection against their otherwise elevated risk of serious disease, they would likely still be better protected if vaccinated.

Moreover, even those who have experienced previous Covid infection will be able to better protect their infants if they are vaccinated during pregnancy. That’s because mothers protect their young infants against Covid and many other infectious diseases through antibodies that are transferred through the placenta. The more antibody a mother has, the more her infant can receive. Covid vaccination produces a rapid rise in Covid antibody, which means that mothers vaccinated while pregnant can provide their infants with much more of this protective antibody than if they are not vaccinated during this critical window.

It is squarely unethical to treat healthy pregnant people differently than other groups that are similarly at elevated risk of serious Covid illness. It appears that the federal government will continue to recommend Covid vaccine for people with asthma or diabetes. How can they justify not doing so for women who are pregnant, when pregnancy, like asthma and diabetes, is an established risk factor for bad Covid outcomes?

It is squarely unethical to deny infants the protection that maternal vaccination can afford them. Covid-19 in pregnancy increases the risk of stillbirth and preterm birth. Babies less than 6 months old are at greater risk of serious disease but are too young to be vaccinated themselves. The only way to protect babies from these risks to their health and lives is to vaccinate their mothers while they are pregnant.

And it is squarely unethical to require randomized clinical trials as a condition of recommending Covid vaccines in pregnancy. One of the foundational tenants of research ethics is that it is never ethically permissible to withhold an intervention of established benefit from research participants, but that is exactly what a vaccine trial in pregnancy with a placebo arm — what Kennedy’s HHS is calling “gold standard” science — entails.

Covid vaccines in pregnancy offer an established benefit to pregnant women and their babies. The only ethical path is for the CDC recommendation that was in place before Kennedy announced his position to remain in effect. To do otherwise — even to move from an affirmative recommendation to one that permits pregnant people to choose vaccination in consultation with their health care providers — will undermine decades of work to build much needed confidence among pregnant women, their partners, and those who provide care for them.  

Currently, the CDC website is providing the public with conflicting information. There is narrative on the website that continues to correctly characterize how Covid infection can harm mothers and babies and why Covid vaccine is safe in pregnancy. At the same time, the entry for pregnant women and the Covid vaccine on the CDC’s Adult Immunization Schedule is “no guidance/not applicable.” The CDC’s Advisory Committee on Immunization Practices, which hopefully will be asked to opine on this issue, is scheduled to meet at the end of June.

For this critical preventive intervention, the benefits to both mothers and their babies far exceed any risks. In the end, each pregnant woman will make her own decision about whether to be vaccinated. Conflicting messages from professional societies and federal public health agencies about the clinical value of being vaccinated will not make that decision any easier and will do more harm than good.

Ruth Faden is the Philip Franklin Wagley professor of biomedical ethics and founder of the Johns Hopkins Berman Institute of Bioethics. She also is a professor in Johns Hopkins University’s Bloomberg School of Public Health.