Pregnant women receive conflicting advice on the Covid-19 vaccine

Pregnant women looking for guidance on the Covid-19 vaccine face the turmoil that is causing the pandemic from the beginning. The US Centers for Disease Control and Prevention, the world’s leading public health organization, and the World Health Organization show a contradiction. advice.

Neither tissue explicitly prohibits or encourages immunity to pregnant women. However, when comparing the same limited studies, they offer different recommendations.

The CDC’s advisory board urged pregnant women to consult a doctor before they shook their heads. It was praised by several women’s health organizations as it continued to make decisions in the hands of pregnant mothers.

WHO recommended that pregnant women should not be vaccinated unless they are at high risk of Covid due to work exposure or chronic illness.It Issued guidance on modelna vaccine On Tuesday, it will stir up uncertainty between women and doctors on social media. (Similar publication earlier this month Pfizer-BioNTech Vaccine Guidance.. )

Some experts have expressed disappointment at WHO’s position, saying that the risk of Covid to pregnant women is far greater than the theoretical harm of vaccines.

“There is no documented risk to the fetal, no theoretical risk, no risk in animal studies,” said Dr. Anne Lyerly, a bioethicist at the University of North Carolina at Chapel Hill. “The more I think about it, the more disappointed and sad I am.”

The disagreement between the CDC and WHO is not rooted in scientific evidence, but its lack: pregnant women are barred from participating in clinical trials of the vaccine. This is a long-standing decision to exclude pregnant women. Although it is biomedical research, it is a research that is currently being challenged.

While the rationale is superficially to protect women and their foets, excluding pregnant women from research pushes risk out of the carefully controlled environment of clinical trials into the real world. This practice required patients and healthcare providers to weigh sensitive and anxious issues with little solid data on safety and efficacy.

Vaccines are generally considered safe and pregnant women should be vaccinated against influenza and other illnesses from the 1960s without rigorous clinical trials to test them. We sought.

Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of the Covid Experts Group at American College, said: “As an obstetrician, we often face difficult decisions about the use of interventions that are not properly tested during pregnancy. Obstetricians and gynecologists. Universities include pregnant and lactating women in vaccine trials. I insisted that.

“What many people miss is that doing nothing is risky,” said Dr. Jamison. “If there is a known serious risk of Covid amplified by pregnancy, it is not a wise strategy not to provide pregnant women with the opportunity to be vaccinated and protected.”

Uncertainty is not limited to Covid vaccines. Most medications, including widely used medications, have never been tested in pregnant women. Without studies with controls for comparison, it can take years or even decades for adverse side effects to become apparent.

“This is not a story that WHO and others are advising against vaccination during pregnancy,” said a Policy Fellow at the Global Development Center on Vaccine, Epidemiology and Pregnancy Research Ethics for New Technology Projects. Senior Researcher Curly Kurbiner said. (prevent). “This is the story of not being able to properly and timely include pregnant women in vaccination studies.”

Dr. Kurbiner said he understands that WHO and other advisory bodies rely on scientific research, adding: “In reality, we don’t yet have data on these vaccinations during pregnancy. Without that data, it’s very difficult to: come out and recommend full support.”

The CDC and WHO have provided dissonant advice many times during the pandemic process. In particular, the usefulness of masks and the potential for viruses to travel indoors in the air.

In a statement, the CDC said Thursday that “they are unlikely to pose a particular risk to pregnant women,” based on how the Pfizer-BioNTech and Moderna vaccines work.

The CDC’s recommendations may make sense for the United States, where women may be able to easily consult with their healthcare providers, said Joachim Hombach, WHO’s health adviser on vaccination. However, he said the WHO provides guidance to many low- and middle-income countries where women do not have access to doctors and nurses.

WHO’s recommendations were also made “in situations where the supply of vaccines was limited,” Dr. Honbach said. “I don’t think the words are discouraging, but the words tell the truth.”

Pfizer did not include pregnant women in its initial clinical trials because it followed the policy outlined by the Food and Drug Administration to conduct its first developmental and reproductive toxicity studies, a spokeswoman for the company, Jerika Pitts, said. Stated. Both Pfizer and Moderna provided the FDA with the results of toxicity studies in pregnant rats in December.

Pfizer plans to begin clinical trials in pregnant women in the first half of 2021, Pitz said. Moderna has established a register to record the outcomes of vaccinated pregnant women, according to a spokeswoman for the company, Colleen Hassy.

Critics of the company’s decision to exclude pregnant women from the trial say that reproductive toxicity studies could have been conducted much earlier as soon as promising vaccine candidates were identified. After it became clear that the benefits of the vaccine outweighed the potential harm, companies should have added a protocol for enrolling pregnant women, Dr. Kurbiner said.

“It’s hard to understand why the delay is happening and why it didn’t start early,” she said. “The bigger problem is that they lose months before they start.”

Akiko Iwasaki, an immunologist at Yale University Advocating vaccinations for pregnant women He questioned the underlying issues that prompted the WHO decision.

“Whatever it is, I hope WHO will be more transparent for the reasons behind this recommendation,” she said. “Women’s lives depend on it.”

Toxicity data published by Pfizer and Moderna in December did not find any adverse effects of the vaccine on pregnant rats — evidence cited by WHO in its guidance.

During the Ebola epidemic in the Democratic Republic of the Congo, health workers provide vaccines to all front-line workers, except if the contacts of those who have been confirmed to have them are pregnant. Breastfeeding is one of the extreme consequences of a conservative approach to vaccines. Without the vaccine, 98 percent of pregnant women infected with the Ebola virus died.

The rules were changed in response to public protests, but many pregnant women had died by then, Dr. Liery said.

Covid-19 has also proven to be dangerous for pregnant women. A large CDC study published in November found that pregnant women with symptomatological Covid Quite likely Hospitalized or died when compared to non-pregnant women who also had Covid symptoms.

Evidence has prompted authorities to add pregnancy to the list of conditions that increase the risk of serious illness and death from Covid.

CDC has set up a smartphone application called v-Safe to request reports of side effects From people who have been vaccinated. So far, about 15,000 pregnant women have been registered in the register, the authorities’ vaccination committee reported on Wednesday.

“I think that’s the best chance to get safety data quickly,” said Dr. Jamison.

The UK initially strongly recommended the Covid vaccine for pregnant women, but later Revised guidance Allow vaccination of front-line workers or other high-risk pregnant women. “WHO also wants to rethink,” said Dr. Jamison.

Some experts said the recommendations did not diverge at first glance. “The CDC tends to say that pregnant women should have access to the vaccine, but should discuss the situation with their providers,” said a reproductive health expert who heads the Women and Health Initiative at TH Chan School at Harvard University. One Dr. Analanger said. Of public health. “WHO’s interim recommendations state that women who are at particularly high risk of exposure or Covid infection should be vaccinated. So what’s the big difference here?”

Denise Grady Contribution report.