When Caitlynn Ott of Silver Bow County, Montana, found out she was pregnant with her third child, her excitement was colored with anxiety.
Ott (32) knew that pregnancy increases a woman’s risk of becoming seriously ill if she gets 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 information about it yet.
When one of her doctors mentioned that there was a new clinical trial with Covid-19 vaccine by drug manufacturer Pfizer and its German partner, BioNTech, specifically for expectant mothers, she decided to enroll.
“We don’t have enough of this research, which is why I felt it was so important to do it,” said Ott, who is in nursing school. “I’m so incredibly excited.”
But her husband and other family members were initially worried. With so little information about the vaccine, how could Ott be sure it would not harm her baby?
“I do not believe they would have done this if it were absolutely not safe,” she said, adding that she was more concerned about the coronavirus than the strangers of the vaccine.
Pfizer-BioNTech launched its clinical trial for pregnant women last week – the first of its kind in the United States. This is a rare step in clinical research that proponents of maternal health have been saying for a long time.
“We have been advocating for some time that there is a safe way to include pregnant women in clinical trials,” said Dr. Laura Riley, chair of the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease and Public Health Preparedness Expert Work, said. Group.
“By excluding pregnant women, you are leaving us in exactly where we are at the moment – in the midst of a pandemic without information – which ultimately is not helpful to patients.”
“By excluding pregnant women, you are leaving us in exactly where we are at the moment – in the midst of a pandemic without information – which ultimately is not helpful to patients.”
Receiving vaccines during pregnancy is not uncommon.
To protect a mother and her baby, for example, it has been recommended for years that pregnant women be vaccinated against flu and whooping cough. There are shots with abundant safety data behind them.
But expectant mothers have historically been protected from large-scale clinical research on vaccines. With the constant threat of the pandemic, it will not make sense in this case, experts believe.
“It is really important to study the effects of the vaccine on pregnant women now, because tens of thousands of women are choosing to be vaccinated,” says Dr. Denise Jamieson, Professor and Chair of the Department of Gynecology and Obstetrics at Emory University School. or Medicine, which recommends the vaccine for all of her eligible pregnant patients. “It is our responsibility to ensure that these vaccines are as safe as we believe.”
The problem is urgent for another reason. Although the overall risk of coronavirus for pregnant women is generally still low, the Centers for Disease Control and Prevention has an increased risk of complications such as preterm birth, which should be admitted to the intensive care unit, according to the Centers for Disease Control and Prevention. . care unit or should go on a fan.
The CDC, the American College of Obstetricians and Gynecologists, and the Association of Maternal-Fetal Medicine all agree that the vaccine should be offered to pregnant women and eligible nurses.
But not all pregnant women are. Some states, such as New York, have considered pregnancy as an underlying condition, meaning that women who are pregnant can apply to receive a vaccine now. In Montana, where Ott lives, healthy pregnant women like everyone else have to wait their turn.
The Pfizer trial in which she will take part wants to enroll 4,000 pregnant women in various countries, with half receiving the Covid-19 vaccine and half a placebo. The women get their injections 24 to 34 weeks from their pregnancies. Ott, who is due in July, is only 22 weeks away and is expected to receive her first dose in the trial in April.
“I do not know everyone is going to jump on the vaccine board,” she said. “I do not 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’
Attempts are constantly being made to collect data on how pregnant women are doing after being vaccinated against the coronavirus.
More than 20,000 have been vaccinated in the US so far – mostly pregnant health workers or women enrolled in previous Covid-19 vaccination trials who later found out they were pregnant.
Both 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 country’s leading expert on infectious diseases, said.
The Pfizer trial will track down pregnant women and gather information on any side effects, including possible pregnancy loss. (In animal studies, there was no indication of any harmful effects of the vaccine, nor any evidence that it affects fertility.)
Pfizer hopes to share data from its clinical trial for pregnancy somewhere in the fourth quarter of this year, according to Jerica Pitts, Pfizer’s director of global media relations.
Meanwhile, obstetricians encourage patients to consider their level of exposure if they struggle to ingest.
“If your risk is high, it plays a role in your decision-making.”
“If your risk is high, it plays a role in your decision-making,” Riley said. He is also the chair of obstetrics and gynecology at Weill Cornell Medicine and an obstetrician and gynecologist at New York Presbyterian Hospital.
“I had a patient who said, ‘I’m not going anywhere. I’m just going to make my antenatal visits. ‘For such a person she feels less obligated to get the vaccination if there is no information. ”
Experts believe that information about other vaccines can help women make an informed decision.
The first two coronavirus vaccines approved for use in the US use a technology called messenger RNA, or mRNA, which works by teaching cells to make a protein that will elicit an immune response when exposed to Covid -19.
Although these specific shots are new, mRNA technology has been studied in clinical trials for other infections, such as Zika, the mosquito-borne virus that can cause devastating congenital disorders if a pregnant woman gets it.
In the idea that pregnant women should have access to the vaccine at the same rate as non-pregnant women, organizations such as the Association for Maternal Fetal Medicine have used decades of data on vaccines, said Dr Christina Han, a member of the Society for Maternal-Fetal Medicine COVID Task Force and a Medical Clinical Professor in Obstetrics and Gynecology and Divisional Director of Maternal-Fetal Medicine at UCLA Health.
“We know that vaccination is generally safe and effective in pregnant women,” she said.
However, one type was not allowed during pregnancy, she said: live attenuated vaccines, which use attenuated versions of a living germ that causes a disease, such as chickenpox. It is avoided in pregnant women for fear that they will reactivate a latent infection. Covid-19 vaccines are not attenuated live.
“If an individual really wants to tolerate the vaccine, it is absolutely the privilege of every pregnant woman to do so,” Han said. “You just have to maintain the same precautions that we all hopefully took.”
‘A weight is taken 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 with her second son on March 19th.
Chevalier got both of her Covid-19 shots in January. It was a decision to which she calculated her risk factors: she is Spanish, one of the many minorities affected disproportionately by the virus; she has asthma; and she is constantly exposed to potential exposure to the virus through work.
The side effects after her first shot were mild, she said, including a mild headache and a bit of fatigue. After the second shot she had ‘terrible’ bodies, she lasted less than two full days.
“I would do it 1000 times again,” she said. ‘I would one day take it from hell to get the disease. It makes more sense. One day of pain or two days cannot be compared to the lottery you really take with your own life. ”
One day of pain or two days cannot be compared to the lottery you really take with your own life. ”
All of her visits to her prenatal age since vaccination went well, she said, while the baby “kicked and moved – he was perfectly fine.”
In Rapid City, South Dakota, Mariah Slagle-Ashley, 24, a doctor-recruiting specialist who, along with her firstborn, a girl, owed on March 23, was chosen to be vaccinated.
She uses sources like the Mayo Clinic and talks to her doctor and feels confident in her decision. But family members were not supportive, she said. Some have sent her links to unproven claims on social media of women who have had pregnancy losses, blaming the vaccine.
“There’s a reason doctors are doctors,” she said. “They went through a lot of work and a lot of school to get where they are, so their opinions are more important than anyone’s opinion on Facebook or any other social media platform.”
After being vaccinated, Slagle-Ashley said it felt like a weight was being taken off my shoulders. ‘
But not everyone is open to the vaccine. Some patients are “determined not to want to be vaccinated” with something that has developed so quickly, Jamieson said.
Ott, in Montana, is proud to be participating in the vaccine trial. She plans to tell her son when he grows up, that he helped contribute to research.
“I hope he thinks it’s super cool,” she said.