USA TODAY US Edition

No gauge of protection for pregnant women

- Shefali Luthra The 19th

“Pregnant women are now squarely in the higher risk population ...” Anne Lyerly Obstetrici­an and bioethicis­t at the University of North Carolina at Chapel Hill’s department of social medicine

This story was published in partnershi­p with The 19th, a nonprofit, nonpartisa­n newsroom reporting on gender, politics and policy.

Early results from two major COVID-19 vaccine trials have sparked hope that the worst of the pandemic may soon be over. But it’s still unclear if or when that relief would extend to pregnant people, who have been excluded from those vaccine trials.

Pfizer and Moderna, which are developing two high-profile vaccine candidates, have posted initial data from their large late-stage trials that suggests their products could be close to 90% or 95% effective in reducing risk of COVID-19 infection. Moderna’s data also suggests its vaccine would reduce the risk of severe illness caused by the coronaviru­s.

Both companies have indicated they will seek a federal emergency-use authorizat­ion, in which the government makes the drug available before having approved it, based on the strength of early results. That means vaccines could be available to the general public by next spring.

But since the vaccine trials have thus far excluded people who are pregnant or breastfeed­ing, it’s unclear when the immunizati­ons would be safely available for them.

The exclusion has sparked concern from health experts, especially since research from the Centers for Disease Control and Prevention has made it clear that pregnancy significan­tly increases COVID-19’s mortality risk. Pregnant people are also more likely to develop complicati­ons and require intensive medical care, including requiring a ventilator.

“Pregnant women are now squarely in the higher risk population, which makes thinking about a vax for them – it was already a pressing concern, but it’s even more pressing,” said Anne Lyerly, obstetrici­an and bioethicis­t at the University of North Carolina at Chapel Hill’s department of social medicine.

Pfizer spokespers­on Jerica Pitts said the company is working on a “potential pathway” to a pregnancy-related indication for the vaccine program, which would mean getting the vaccine approved for use during pregnancy. It is also currently doing early research – not yet conducting trials in humans – to see how the vaccine works in pregnancy, Pitts said.

Moderna has not specified its plans to research the vaccine in pregnant people. The company did not respond to The 19th’s requests for comment.

The federal Food and Drug Administra­tion, which will determine whether either vaccine candidate gets an emergency authorizat­ion, could approve the vaccine for all healthy adults. That would then allow health authoritie­s like the CDC to determine whether pregnant people should be eligible to get the immunizati­on or if they will have to wait until one is specifical­ly tested for them. The FDA could also approve a vaccine for healthy adults but specifical­ly advise against giving it to pregnant people, at least temporaril­y.

Experts are still debating when vaccines should in general be tested on those who are pregnant. Historical­ly, major vaccines have not been tested during pregnancy, because of concerns that both the pregnant person and fetus would be at risk for complicati­ons. But that thinking has shifted in recent years – particular­ly in light of the Ebola crisis, when, similarly to COVID-19, vaccines were not initially tested for pregnant people even though they were at severely heightened risk of mortality.

Some researcher­s, following convention­al wisdom, say later is better, when vaccines have been proven to be safe in pregnancy. But many others note that delaying when to include pregnant people in trials, as Moderna and Pfizer have done, will put them at risk.

“We need data collected in a systematic way to guide pregnant women and their health care providers regarding whether they should get a COVID-19 vaccine,” said Sonja Rasmussen, a 20-year CDC veteran and professor of pediatrics and epidemiolo­gy at the University of Florida.

Excluding those who are pregnant, she added, means much of the vaccines’ risks and benefits are still a question mark.

“Many questions need to be answered,” she said. “Is the vaccine effective during pregnancy? Is a different dose needed during pregnancy? Is the vaccine safe for the pregnant woman and her fetus? Will the vaccine provide some degree of protection to the newborn infant?”

The FDA typically recommends pregnant people be included in late-stage trials. In its COVID-19 recommenda­tions, the FDA advised companies to at least consider including those who are pregnant in vaccine trials, and in July, National Institutes of Health Director Frances Collins said inclusion of pregnant people in vaccine trials was “a top priority.”

Some Democratic lawmakers have also called on major vaccine companies to include pregnant people in their trials or otherwise ensure immunizati­ons are available to them. Sen. Elizabeth Warren and Rep. Lauren Underwood introduced legislatio­n to this effect in August.

Women of childbeari­ng age are also disproport­ionately represente­d amongst front-line worker groups, including health care profession­als and teachers – the very people who experts say need to receive the vaccine first.

“A significan­t number of health workers are women. Within that there are always, at any given time, a substantia­l number who are pregnant,” said Ruth Faden, a bioethicis­t at Johns Hopkins University who focuses on immunizati­ons for pregnant people. “What’s the right ethics stance towards a pregnant health worker?”

Without good data, it’s difficult to know what the implicatio­ns are for giving pregnant people either vaccine. But the mechanism underlying both vaccines – a new messenger RNA technology that helps the body develop antibodies to fight the coronaviru­s – has not been shown to cause harm during pregnancy, Lyerly said.

This gives her “reason for optimism” that even without being tested on pregnant people, the vaccine could be used to protect them, she said.

 ?? GETTY IMAGES ?? Trials for COVID-19 vaccines have so far excluded women who are pregnant or breastfeed­ing.
GETTY IMAGES Trials for COVID-19 vaccines have so far excluded women who are pregnant or breastfeed­ing.

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