Data on pregnancy and the Covid vaccine are scarce. These women are changing that.

When Caitlynn Ott of Silver Bow County, MT found out she was pregnant with her third child, her excitement was tinged with anxiety.

Ott, 32, knew that pregnancy increases a woman’s risk of becoming seriously ill if she catches the coronavirus. But she was unsure whether it was safe for pregnant women to be vaccinated against the virus – as there is no data on the subject yet.

So when one of her doctors mentioned that there was a new clinical trial of the Covid-19 vaccine by drugmaker Pfizer and its German partner, BioNTech, specifically for pregnant women, she decided to enroll. .

“We don’t have enough of this research, and that’s why I felt it was so important to do it,” said Ott, who is in nursing school. “I am so excited.”

But her husband and other family members were initially worried. With so little information about the vaccine, how could Ott be sure it wouldn’t harm her baby?

“I don’t think they would do this if it was absolutely not safe,” she said, adding that she was more concerned about the coronavirus than the unknowns about the vaccine.

Pfizer-BioNTech launched its clinical trial for pregnant women last week – the first of its kind in the United States. It’s a rare step in clinical research that maternal health advocates say is long overdue.

“We’ve been advocating for some time that there is a safe way to include pregnant women in clinical trials,” said Dr. Laura Riley, president of the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease and Public Health Preparedness Work. Group.

“By excluding pregnant women, you’re leaving us exactly where we are right now – in the midst of a pandemic with no information – which ultimately isn’t helpful for patients.”

Receiving vaccines during pregnancy is not uncommon.

To protect both a mother and her baby, it has been recommended for years, for example, that pregnant women be vaccinated against influenza and pertussis, vaccines with abundant safety data behind them.

But pregnant women have always been immune from large-scale clinical vaccine research. With the continuing threat posed by the pandemic, it would make no sense in this case, experts say.

“It is really important to study the effects of the vaccine on pregnant women now, as tens of thousands of women choose to be vaccinated,” said Dr. Denise Jamieson, professor and head of the department of gynecology and obstetrics at Emory University School of Medicine, which recommends the vaccine to all of its eligible pregnant patients. “It is our responsibility to make sure these vaccines are as safe as we think they are.”

The problem is urgent for another reason. While the overall risk of coronavirus for pregnant women is still generally low, according to the Centers for Disease Control and Prevention, pregnant women who are infected with it have an increased risk of complications such as premature labor, requiring intensive hospitalization. care unit or needing to use a ventilator.

The CDC, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine all agree that the vaccine should be offered to pregnant and breastfeeding women who are eligible for it.

But not all pregnant women are. Some states, like New York, have considered pregnancy an underlying condition, which means pregnant women can sign up for the vaccine now. In Montana, where Ott lives, healthy pregnant women have to wait their turns like everyone else.

The Pfizer trial in which she will participate aims to recruit 4,000 pregnant women in several countries, half receiving the Covid-19 vaccine and the other a placebo. Women will receive their injections 24 to 34 weeks after their pregnancy. Ott, due to arrive in July, is just 22 weeks old and is expected to receive his first dose during the trial in April.

“I know not everyone will jump on the vaccine board,” she said. “I don’t judge anyone for the decision they make. I just hope this gives more information for everyone. “

In the limited data that exists, “ no red flags ”

Efforts are underway to collect data on the behavior of pregnant women after being vaccinated against the coronavirus.

More than 20,000 people have been vaccinated to date in the United States – mostly pregnant health workers or women enrolled in previous Covid-19 vaccine trials who later found out they were pregnant.

The CDC and the Food and Drug Administration are monitoring these women and have so far noticed “no red flags,” said Dr Anthony Fauci, the nation’s leading infectious disease specialist.

The Pfizer trial will follow pregnant women and collect information on all side effects, including possible pregnancy loss. (In animal studies, there has been no indication of harmful effects from the vaccine, nor any evidence that it affects fertility.)

Pfizer hopes to share data from its pregnancy clinical trial in the fourth quarter of this year, according to Jerica Pitts, director of global media relations for Pfizer.

In the meantime, obstetricians are encouraging patients to consider their level of exposure if they are having trouble deciding whether to get the vaccine.

“If your risk is rampant, it plays into your decision making,” said Riley, who is also president of obstetrics and gynecology at Weill Cornell Medicine and chief obstetrician and gynecologist at NewYork-Presbyterian Hospital.

“I had a patient who said, ‘I’m not going anywhere. I only go out for my prenatal visits. For someone like that, she feels less compelled to get the vaccine in the absence of data.

Related

Experts say information about other vaccines can help women make an informed decision.

The first two coronavirus vaccines approved for use in the United States use a technology called messenger RNA, or mRNA, which works by teaching cells to make a protein that will trigger an immune response if exposed to Covid-19 .

While these particular injections are new, mRNA technology has been studied in clinical trials for other infections, such as Zika, the mosquito-borne virus that can cause devastating birth defects if a pregnant woman has it. catch.

In endorsing the idea that pregnant women should have access to the vaccine at the same rate as non-pregnant women, organizations such as the Society for Maternal-Fetal Medicine have drawn on decades of vaccine data, Dr. Christina Han, COVID Working Group member of the Society for Maternal-Fetal Medicine and Clinical Associate Professor of Obstetrics and Gynecology and Division Director of Maternal-Fetal Medicine at UCLA Health.

“We know that vaccination in general is safe and effective in pregnant women,” she said.

However, one type is not allowed during pregnancy, she said: live attenuated vaccines, which use weakened versions of a living germ that causes disease, like chickenpox. These are avoided in pregnant women for fear of reactivating a latent infection. Covid-19 vaccines are not live attenuated.

“If a person really wants to delay the vaccine, it’s absolutely the prerogative of every pregnant woman to do so,” Han said. “You just have to maintain the same precautions that we all have hopefully taken.

‘A weight is lifted from my shoulders’

Carla Chevalier, 32, of Norfolk, Va., Is a medical interpreter who spends her days in hospitals and clinics doing translations for patients and is due to accompany her second son on March 19.

Chevalier received his two Covid-19 vaccines in January. It’s a decision she came to after calculating her risk factors: she’s Hispanic, one of the many minorities disproportionately affected by the virus; she suffers from asthma; and she constantly faces potential exposure to the virus through work.

The side effects after her first injection were mild, she said, including a slight headache and some fatigue. After the second stroke, she had “terrible” body aches, she said, which lasted less than two full days.

“I would do it 1,000 times,” she says. “I would take this hellish day to catch the disease. It makes more sense. A day of pain or two days cannot be compared to the lottery you really take with your own life. “

All of her antenatal visits since her vaccination have been going well, she said, with the baby “kicking and moving – he’s doing perfectly fine.

In Rapid City, South Dakota, Mariah Slagle-Ashley, 24, a physician recruiting specialist who is due to have her first child, a daughter, on March 23, also chose to be vaccinated.

She used resources like the Mayo Clinic and spoke to her doctor and felt confident in her decision. But family members did not support him, she said. Some sent her links to unproven claims on social media of women who had suffered pregnancy loss and blamed the vaccine.

“There’s a reason doctors are doctors,” she says. “They’ve gone through a lot of hard work and a lot of school to get to where they are, so their opinions count more than anyone’s opinion on Facebook or any other social media platform.”

After getting the vaccine, Slagle-Ashley said it was “like a weight had been lifted from my shoulders.”

But not everyone is open to the vaccine. Some patients are “adamant they don’t want to be vaccinated” with something that has developed so quickly, Jamieson said.

Ott, Montana, is proud to participate in the vaccine trial. She plans to tell her son when he grows up that he has contributed to the research.

“I hope he thinks it’s super cool,” she said.