When Caitlynn Ott of Silver Bow County, Montana, discovered 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 did not know if it was safe for pregnant women to be vaccinated against the virus – because there is almost 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 pharmaceutical company Pfizer and its German partner, BioNTech, specifically for pregnant women, she decided to apply.
“We don’t have enough research, which is why I thought it was so important to do it,” said Ott, who is in nursing school. “I’m incredibly excited.”
But her husband and other family members were concerned at first. 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 that if it weren’t absolutely safe,” she said, adding that she was more concerned with the coronavirus than with the vaccine’s unknowns.
Pfizer-BioNTech launched its clinical trial for pregnant women last week – the first of its kind in the United States. It is a rare step in clinical research that advocates of maternal health say should have already taken place.
“We have long advocated 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 Ginecologists’ Immunization, Infectious Disease and Public Health Prontedness Working Expert Work Group.
“By excluding pregnant women, you leave us in exactly the same place as we are now – in the middle of a pandemic with no information – which is ultimately not useful for patients.”
“By excluding pregnant women, you leave us in exactly the same place as we are now – in the middle of a pandemic with no information – which is ultimately not useful for patients.”
Getting vaccines during pregnancy is not uncommon.
To protect the mother and baby, it has been recommended for years, for example, that pregnant women be vaccinated against influenza and pertussis, vaccines with abundant safety data.
But pregnant women have historically been protected from large-scale clinical research for vaccines. With the continuing threat posed by the pandemic, that would make no sense in this case, experts say.
“It is very important to study the effects of the vaccine on pregnant women now, because tens of thousands of women are choosing to be vaccinated,” said Dr. Denise Jamieson, professor and head of the gynecology and obstetrics department at Emory University School of Medicine, who is recommending the vaccine to all pregnant patients who are eligible. “It is our responsibility to ensure that these vaccines are as safe as we believe they are.”
The issue is urgent for another reason. Although the overall risk of coronavirus for pregnant women is still low, according to the Centers for Disease Control and Prevention, infected pregnant women have an increased risk of complications, such as premature birth, needing to be hospitalized in the intensive care unit or having to use a fan.
The CDC, the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine agree that the vaccine should be offered to pregnant and breastfeeding women who are eligible to receive it.
But not all pregnant women are. Some states, like New York, consider pregnancy to be an underlying condition, which means that pregnant women can apply for the vaccine now. In Montana, where Ott lives, healthy pregnant women must wait their turn like everyone else.
The Pfizer study in which she will participate aims to enroll 4,000 pregnant women in several countries, with half receiving the Covid-19 vaccine and the other half receiving a placebo. Women will receive their injections 24 to 34 weeks after pregnancy. Ott, who is due in July, is only 22 weeks old and is scheduled to receive her first test dose in April.
“I know that not everyone is going to be on the vaccine board,” she said. “I don’t judge anyone by the decision they make. I just hope it gives more information to everyone. “
In the limited data that exists, ‘no red flags’
There are ongoing efforts to collect data on how pregnant women fare after being vaccinated against the coronavirus.
More than 20,000 have so far been vaccinated in the United States – most are pregnant health workers or women enrolled in previous tests of the Covid-19 vaccine who later found out they were pregnant.
Both the CDC and the Food and Drug Administration are monitoring these women and have so far not noticed “any warning signs,” said Dr. Anthony Fauci, the country’s leading infectious disease specialist.
The Pfizer study will screen pregnant women and gather information about any side effects, including any potential pregnancy losses. (In animal studies, there was no indication of any harmful effects of the vaccine, nor any evidence that it affects fertility.)
Pfizer expects to share data from its clinical pregnancy trial sometime in the fourth quarter of this year, according to Jerica Pitts, director of global media relations at Pfizer.
In the meantime, obstetricians are encouraging patients to take their level of exposure into consideration if they are struggling to decide whether to be vaccinated.
“If your risk is excessive, it influences your decision making.”
“If your risk is excessive, it influences your decision making,” said Riley, who is also head of obstetrics and gynecology at Weill Cornell Medicine and obstetrician and chief gynecologist at NewYork-Presbyterian hospital.
“I had a patient who said, ‘I’m not going anywhere. I just go out to do my prenatal appointments. ‘For someone like that, she feels less obliged to be vaccinated in the absence of data. “
Experts say information about other vaccines can help women make an informed decision.
The first two coronavirus vaccines to be authorized for use in the United States use a technology called messenger RNA, or mRNA, that works by teaching cells to produce a protein that will trigger an immune response if exposed to Covid-19.
Although 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 contracts it.
In endorsing the idea that pregnant women should have access to the vaccine at the same rate as non-pregnant women, organizations like the Society for Maternal-Fetal Medicine have relied on decades of vaccine data, said Dr. Christina Han, a member of the Society for Maternal-Fetal Medicine COVID Task Force is an associate clinical professor of obstetrics and gynecology and director of the UCLA Health division of maternal and fetal medicine.
“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 live germ that causes a disease, like chicken pox. They are avoided in pregnant women for fear of reactivating a latent infection. Covid-19 vaccines are not attenuated live.
“If an individual really wants to postpone the vaccine, that is absolutely the prerogative of every pregnant woman,” said Han. “You just have to keep the same precautions that we’ve all been taking.”
‘A weight is lifted off my shoulders’
Carla Chevalier, 32, of Norfolk, Virginia, is a medical interpreter who spends her days in hospitals and clinics translating for patients and is pregnant with her second child on March 19.
Chevalier took his two doses of Covid-19 in January. It was a decision she made after calculating her risk factors: she is Hispanic, one of the many minorities affected disproportionately by the virus; she has asthma; and she is constantly facing potential exposure to the virus through work.
The side effects after the first injection were mild, she said, including a small headache and a little fatigue. After the second injection, she had “terrible” pains in the body, she said, that lasted less than two full days.
“I would do this again 1,000 times,” she said. “I would accept that day in hell to really get the disease. It makes more sense A day of pain or two days cannot be compared to the lottery you are actually winning with your own life. “
A day of pain or two days cannot be compared to the lottery you are actually winning with your own life. “
All of her prenatal consultations since the vaccination went well, she said, with the baby “kicking and moving – he is perfectly fine.”
In Rapid City, South Dakota, Mariah Slagle-Ashley, 24, a medical recruiting specialist who is with her first child, a girl, on March 23, also opted to get 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 it, she said. Some have sent links to unproven statements on social media from women who have lost pregnancies and blamed the vaccine.
“There is a reason that doctors are doctors,” she said. “They’ve gone through a lot of work and a lot of school to get where they are, so their opinions are more important than someone else’s opinion on Facebook or any other social media platform.”
After being vaccinated, Slagle-Ashley said it looked ‘as if a weight had been lifted off my shoulders’.
But not everyone is open to the vaccine. Some patients are “adamant that they don’t want to be vaccinated” with something that has developed so quickly, said Jamieson.
Ott, Montana, is proud to participate in the vaccine test. She plans to tell her son, when he grows up, that he helped contribute to the research.
“I hope he thinks this is really cool,” she said.