Should You Get the COVID-19 Vaccine During Pregnancy? This is what experts say.

For people who are pregnant, the introduction of COVID-19 vaccines raises painful questions about whether it is safer to get the vaccine or at risk of infection. Despite emerging evidence that the vaccines are generally safe and effective, there is virtually no data as to whether that is true for those expecting it, even though they are at greater risk of complications from the disease.

Regulators of the world have at times issued conflicting advice about pregnancy and COVID-19 vaccines. The Centers for Disease Control and Prevention (CDC) said the vaccines should be available to pregnant people, but ultimately leaves the decision to parents-to-be and their doctors. The World Health Organization (WHO) does not recommend it unless the pregnant person is at high risk.

So how does someone make an evidence-based decision about whether it is safe to receive the vaccine without safety data? “It’s all about the characteristics of your life,” said Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics in Maryland. Each person has to do some balance is known about the vaccine with what is known about their own risk of becoming infected.

Although experts suggest to keep talking These decisions with a medical provider, here’s a look at the facts available, what remains to be figured out, and why there is reason to be optimistic.

Scientists generally know a lot about vaccines and pregnancy – although historically it has taken longer to get that evidence than general safety data. Due to the ethical complexity of pregnancy – where parents and their fetuses face interrelated risks – and fears of legal liability, pregnant people are typically excluded from the randomized clinical trials necessary to obtain drug or vaccine approval.

In the past, it has taken years after vaccines were approved for general use to gather enough data to show how they work during pregnancy. Many of these follow-up studies are observational and involve fewer participants. As a result, women who are pregnant may be reluctant to receive a vaccine, and doctors may wait to recommend it.

“The result of this is decades of essentially dishonesty to pregnant women,” said Faden, who also leads the Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) project for pregnancy research. While it may sometimes make sense not to include expectant parents in the initial studies, she says, “we have protected pregnant women to death.”

But scientists have gathered irrefutable evidence that certain vaccines are safe, effective and, in some cases, badly needed. Today, the CDC strongly encourages pregnant people to get vaccinations against influenza, which is known to cause serious complications in pregnant women. Medical experts also recommend getting the pertussis (or whooping cough) vaccine, which can be fatal to newborns. Expectant people can also receive immunizations for a handful of other illnesses, including hepatitis and meningitis.

Lessons from those vaccines have shown that there is no reason to worry about the types of injections that use an inactivated virus to trigger an immune response because they cannot infect the parent or the baby, says Geeta Swamy, university associate professor of obstetrics and gynecology at Duke University School of Medicine in North Carolina and a leading researcher on maternal immunization.

On the other hand, vaccines that use a small amount of live virus – such as those for measles, mumps and rubella, and those for chicken pox – can cause low-grade infections that some scientists fear could harm a fetus. But, says Swamy, “even that’s based on theoretical concerns about risk,” not evidence that it occurs.

The Moderna and Pfizer-BioNTech vaccines for COVID-19 present a new challenge. Until now, the messenger RNA platform they use has not been approved for human use. As such, the only available pregnancy-related data comes from preclinical studies in laboratory animals and a handful of clinical trial participants who later found out they were pregnant. (Here’s the latest on COVID-19 vaccines.)

But we know quite a bit about how mRNA technology works. Rather than using inactivated or live virus, these vaccines contain fragments of genetic code encapsulated in lipids, or fat spheres, that protect the code from degradation. Once injected, the mRNA instructs cells to produce the SARS-CoV-2 spike protein, which triggers the body’s immune response.

Theoretically, this is all very promising because, like previous vaccines, no live virus is involved. “Anything that is believed to be biologically the case with regard to mRNA vaccines is incredibly reassuring,” says Faden. “It should not affect the pregnancy or pregnancy outcomes in any way.”

Anthony Fauci, the White House’s chief medical adviser, has also said the data “so far has no red flags” for pregnant people.

Still, scientists have been asking questions about how the mRNA vaccines will actually work. The main concern is whether mRNA can cross the placenta and generate the spike protein in the fetus. It wouldn’t necessarily be harmful if it did – and wouldn’t cause birth defects – but the concern is that the fetus could experience side effects such as pain, swelling, and fever. Swamy says the animal studies showed no signs of physical side effects, but this has yet to be tested in humans.

Side effects in the mother can also be a problem. Christina Chambers, a perinatal epidemiologist at the University of California, San Diego, is conducting a study on COVID-19 vaccinated pregnant women. She notes that it can be harmful to the baby if a pregnant woman has a high fever. “If that’s a side effect, you want to pay attention to that and talk to your provider about taking something to reduce the fever,” she says.

Clinical trials are in the pipeline to investigate the effects of the vaccines in pregnant women. Faden wishes these trials had begun as soon as the vaccines were approved by the FDA, but she points out that the process is still going faster than in the past.

“We used to feel like one or two lonely drums beating our drums in this vast silence,” she says. “Now we have a kind of percussion department calling for more data and involving pregnant women in the roll-out of the vaccine. And that’s a really good thing. “

On the other hand, we know a lot about the risks COVID-19 poses to expectant parents. “There is no doubt that things are worse for pregnant women than non-pregnant people,” says Swamy.

Studies have shown that pregnant people with COVID-19 are at an increased risk of hospitalization, ICU admission and mechanical ventilation. A study was published in the journal in January JAMA Internal Medicine found that COVID-19 was associated with a higher risk of blood pressure problems and premature birth, although there was no greater risk of stillbirth. And an October study found that one in four pregnant people could be COVID-19 “long-haul jets,” whose symptoms can last for weeks or even months.

But the risk of serious illness is expected to be lower than in other high-risk groups, such as the elderly or people with heart disease. So it is critical to look at individual factors that increase a person’s individual risks – including the number of daily contacts, access to tests and high-quality PPE and comorbidities such as asthma or obesity – and whether anything can be done to mitigate them. Reduce.

Timing must also be taken into account. Swamy says there is no evidence that a vaccine can cause developmental problems or miscarriage in the first trimester. But women with a lower risk of infection may choose not to be vaccinated during that time, which is vital for fetal organ development and when miscarriages usually occur. (The flu vaccine is safe at any time during pregnancy.)

For pregnant women at high risk of exposure and who do not have the ability to reduce that risk, it may make sense to consider getting the vaccine as soon as they become eligible. But to be sure, Chambers says, “there is an urgent need to collect data on people being vaccinated.”

There is reason to hope that soon scientists will have a better understanding of how the COVID-19 vaccines work during pregnancy. In the short term, scientists are looking forward to the data from pregnant health workers who started the vaccines in December. Faden says the data should be robust, as more than 15,000 pregnancies among the vaccinees were reported to the CDC on Jan. 20.

In addition to the mRNA vaccines, there are some new options on the horizon. Johnson & Johnson submitted its vaccine to the FDA for approval on Feb. 4, while AstraZeneca and Novavax recently released critical phase three study data. All three vaccines are based on technologies that have been studied in pregnant women in the past, which could provide further reassurance, according to Swamy. (Should People Use More Than One Type of COVID-19 Vaccine?)

Recent studies have also suggested that vaccination during pregnancy may have additional benefits. A study published in the journal JAMA Pediatrics showed that women infected with COVID-19 efficiently transfer protective antibodies to their babies, especially if infected earlier in pregnancy. The study does not suggest that this transmission will occur after vaccination, notes study co-author Karen Puopolo, who visits a neonatologist at Pennsylvania Hospital. But Swamy says the good news is that antibodies regularly cross the placenta in natural infection, and she expects vaccination to have a similar response.

“It tells us that vaccinating women could be about two-for-the-price of one,” she says, “that by vaccinating women, we also provide some benefit during early childhood.”