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To vaccinate or not to vaccinate – this is the question pregnant women are asking themselves as COVID-19 injections roll out across the country.
Like so many things involving the pandemic, there are no easy answers. The two vaccines that have received emergency use clearance from the Food and Drug Administration have not been tested for safety or effectiveness in pregnant women, so there is no solid data to continue on. .
The American College of Obstetricians and Gynecologists says vaccines “should not be refused to pregnant women who meet the criteria for vaccination,” such as healthcare workers who have been given priority access. The medical group also states that “pregnant patients who refuse vaccination must be supported in their decision.”
The Centers for Disease Control and Prevention agree that if pregnant women are eligible for a COVID-19 vaccine, “they can choose to be vaccinated.” But the agency stops before saying they should.
With as many as 300,000 pregnant women in the country’s health workforce, it is a difficult situation that neither patients nor their doctors can afford to ignore. And as access to vaccines expands to include people with health conditions that make them more vulnerable to a severe case of COVID-19, even more women will face the same dilemma.
The CDC and ACOG suggest that pregnant women weigh the benefits of a vaccine against the possible risks, noting that the benefits and harms may be different for each person. A consultation with a doctor can be helpful, but it should not be required, say the two organizations.
The picture is also unclear for women trying to get pregnant and for nursing mothers. ACOG and CDC agree that COVID-19 vaccines should be available for women of both groups.
Vaccines are routinely given to pregnant women to protect them and their developing babies from diseases like the flu and whooping cough, a pair of obstetricians and gynecologists noted this week in Annals of Internal Medicine. And “few, if any, vaccines” are considered dangerous for breastfeeding mothers, including the measles, mumps and rubella vaccine that contains live but weakened viruses.
Amid a pandemic that has killed at least 3,000 American women of childbearing age, adding a COVID-19 vaccine to the mix certainly makes sense, wrote Dr Laura Riley of Weill Cornell Medicine and Dr Denise Jamieson of Emory University School of Medicine.
Clinical trials conducted by Pfizer and Moderna can reassure pregnant women who are leaning towards vaccination.
The two vaccine makers gave pregnancy tests to women of childbearing age so that they could be excluded from their Phase 3 trials. Nonetheless, three dozen pregnant women arrived – or their pregnancies were too early to trigger a pregnancy. positive test result, or they conceived soon after receiving their first dose.
The Pfizer clinical trial included 12 pregnant women who received the vaccine and 11 who received the placebo. At least one of the volunteers in the placebo group had a miscarriage, according to a report by FDA scientists who reviewed data from Pfizer’s clinical trials. No miscarriages or other pregnancy-related problems were reported by the volunteers who received the vaccine.
Thirteen other pregnant women were enrolled in the Moderna clinical trial; six of them received the vaccine and seven received the placebo. Among the women in the placebo group, one miscarried and another had an elective abortion, FDA scientists reported. None of the women in the vaccinated group reported any problems with their pregnancy.
In both cases, “there is currently insufficient data to draw conclusions about the safety of the vaccine” in pregnant women, FDA scientists concluded.
Moderna scientists performed toxicity tests on rats, giving their vaccine to animals shortly before mating and to others who were already pregnant. The shots did not affect the fertility of the rats or the development of their puppies, FDA scientists found. Although some puppies are born with “skeletal variations,” these are common and usually resolve on their own without any treatment, the scientists added.
The ACOG said it expects the two COVID-19 vaccines to be about as safe and effective for pregnant women as they are for other people. However, the OB / GYN group acknowledged that without concrete data, “the potential risks to a pregnant person and the fetus are unknown”.
(ACOG has been pushing for pregnant women to be included in the initial Phase 3 clinical trials. Although this has not happened, trials involving pregnant women are planned for the future, the organization noted. .)
Pregnant women have good reason to get vaccinated. Although the risk of a severe case of COVID-19 is low for any woman of childbearing age, studies suggest that a pregnant COVID-19 patient is more likely to be admitted to the intensive care unit of ” a hospital, more likely to need respiratory assistance. of a mechanical ventilator, and more likely to die from the disease.
About 1% of pregnant women in the United States have required intensive care for COVID-19, and out of 1,000 pregnant women who develop COVID-19, 1.5 have died, Riley and Jamieson wrote in Annals.
Pregnant women with COVID-19 may also be at increased risk of giving birth prematurely or requiring a cesarean, among other problems.
“Thus, it is essential that pregnant women have the opportunity to be vaccinated if they otherwise meet the vaccination criteria,” the doctors wrote.
There is no biological reason to worry that the Pfizer-BioNTech or Moderna vaccine will make a pregnant woman sick, says ACOG.
None of these vaccines are made with an actual coronavirus, so there is no chance that it will cause an infection. Neither includes an adjuvant – an ingredient that helps produce longer lasting immunity – which could be dangerous to the mother or fetus. And although they provide the genetic instructions for cells to make a small piece of the coronavirus so that the immune system can make antibodies, the vaccines do not modify the recipient’s DNA.
Women also don’t need to have a pregnancy test before receiving a COVID-19 vaccine, ACOG and CDC agree. There is also no reason for a woman who has been vaccinated to avoid getting pregnant, they add.
The OB / GYN group advises women to get the vaccine even if they are “actively trying to get pregnant.” The ACOG and CDC agree that there is no need to delay or avoid pregnancy after receiving both doses of the Pfizer or Moderna vaccine.
New mothers who breastfeed have even less data on COVID-19 vaccines. The CDC advises breastfeeding women who wish to be vaccinated to go ahead and do so, and ACOG agrees that breastfeeding mothers should be eligible for vaccines. The benefits of vaccination are real and not outweighed by any “theoretical concerns” about the risks of vaccines, the group says.
This story originally appeared in the Los Angeles Times.
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