Pregnant women seeking guidance on Covid-19 vaccines are facing the kind of confusion that has plagued the pandemic since the beginning: the world’s leading public health organizations – the US Centers for Disease Control and Prevention and the World Health Organization. Health – are offering contradictory products addendum.
None of the organizations explicitly prohibits or encourages immunization of pregnant women. But despite the same limited studies, they provide different recommendations.
The CDC advisory committee asked pregnant women to consult their doctors before rolling up their sleeves – a decision applauded by several women’s health organizations because it kept decision-making in the hands of pregnant women.
The WHO recommended that pregnant women not receive the vaccine unless they were at high risk for Covid due to exposure at work or chronic conditions. He issued guidelines on the Modern vaccine on Tuesday, creating uncertainty among women and doctors on social media. (Earlier this month, it published similar guidelines on the Pfizer-BioNTech vaccine.)
Several experts expressed dismay at the WHO’s position, saying the risks to Covid’s pregnant women were far greater than any theoretical harm from vaccines.
“There are no documented risks to the fetus, there are no theoretical risks, there is no risk in animal studies,” from vaccines, said Dr. Anne Lyerly, bioethics at the University of North Carolina, Chapel Hill. “The more I think about it, the more disappointed and sad I feel about it.”
The difference of opinion between the CDC and the WHO is not rooted in scientific evidence, but in the absence of it: pregnant women were prevented from participating in clinical trials of vaccines, a decision in line with a long tradition of excluding pregnant women biomedical research, but that is now being challenged.
While the justification is ostensibly to protect women and their unborn babies, barring pregnant women from studies pushes the risk of the carefully controlled environment of a clinical trial into the real world. The practice has forced patients and providers to weigh sensitive and worrying issues with little concrete data on safety or effectiveness.
Vaccines are generally considered safe and pregnant women have been urged to immunize themselves against influenza and other illnesses since the 1960s, even in the absence of rigorous clinical tests to test them.
“As obstetricians, we are often faced with difficult decisions about the use of pregnancy interventions that have not been properly tested in pregnancy,” said Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of the American College Covid expert group Obstetrics and Gynecologists. The college strongly advocated the inclusion of pregnant and breastfeeding women in vaccine tests.
“What many people don’t realize is that there are risks in doing nothing,” said Jamieson. “Not offering pregnant women the opportunity to be vaccinated and to protect themselves, where there are known and serious Covid risks amplified by pregnancy, is not a wise strategy.”
The uncertainty is not limited to Covid vaccines: many, if not most, drugs, including widely used drugs, have never been tested in pregnant women. It may take years or decades for adverse side effects to appear in the absence of a study with a control group for comparison.
“This is not a story about WHO or other people advising against vaccination during pregnancy,” said Carleigh Krubiner, a researcher at the Center for Global Development and principal investigator on the Pregnancy in Research Ethics project for Vaccines, Epidemics and New Technologies (EVITA ). “It is a story about the failure to include pregnant women in vaccination studies in a timely and appropriate manner.”
Saying that she understood the commitment of WHO and other advisory bodies to rely on scientific studies, Dr. Krubiner added: “The reality is that we do not yet have data on these vaccinations in pregnancy, and it is very difficult without that data come and give a full support recommendation. “
The CDC and the WHO offered dissonant advice many times during the course of the pandemic – mainly about the usefulness of the masks and the possibility of the virus traveling by plane inside the home.
In a statement, the CDC said on Thursday that, based on how the Pfizer-BioNTech and Moderna vaccines work, “they are unlikely to pose a specific risk to pregnant women.”
The CDC’s recommendation may make sense for the United States, where women can easily consult their health care professionals, said Joachim Hombach, WHO health advisor on immunizations. But WHO provides guidance for many low and middle income countries where women do not have access to doctors or nurses, he said.
The WHO recommendation was also made “in the context of limited supply” of vaccines, said Dr. Hombach. “I don’t think the language is discouraging, but it does state the facts.”
Pfizer did not include pregnant women in its initial clinical tests because it followed the policies outlined by the Food and Drug Administration to first conduct studies of reproductive and developmental toxicity, said Jerica Pitts, a spokeswoman for the company. Pfizer and Moderna provided results of toxicity studies in pregnant rats to the FDA in December.
Pfizer plans to start a clinical study in pregnant women in the first half of 2021, said Pitts. Moderna is establishing a registry to record results in pregnant women who receive their vaccine, according to Colleen Hussey, a company spokesman.
Critics of the companies’ decisions to exclude pregnant women from testing say that reproductive toxicity studies could have been done much earlier – once the promising candidate vaccines were identified. Companies should have added a protocol to enroll pregnant women, as it became clear that the benefits of the vaccines outweighed the potential harm, said Dr. Krubiner.
“It is difficult to understand why this delay is happening and why it has not been started before,” she said. “The biggest problem is that we will have lost months when they start.”
Akiko Iwasaki, an immunologist at Yale University who advocates immunizations for pregnant women, questioned the underlying issue that motivated the WHO decision.
“Whatever it is, I would like WHO to be more transparent in its reasons behind this recommendation,” she said. “Women’s lives depend on it.”
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Answers to your vaccine questions
Currently, more than 150 million people – almost half the population – can be vaccinated. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents in long-term care facilities were the first to qualify. In mid-January, federal authorities urged all states to open eligibility for everyone aged 65 and over and adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. Adults in the general population are at the rear of the line. If federal and state health officials can resolve bottlenecks in vaccine distribution, everyone aged 16 and over will be eligible as early as this spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It may take months before a vaccine is available to anyone under the age of 16. Go to your state’s health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of your pocket to get the vaccine, although insurance information is requested. Even if you do not have insurance, you should receive the vaccine free of charge. Congress passed legislation this spring that prohibits insurers from applying any cost sharing, such as copayment or deductibles. He imposed additional protections, preventing pharmacies, doctors and hospitals from charging patients, including those without insurance. Even so, health experts fear that patients may run into loopholes that leave them vulnerable to unexpected bills. This can happen for those who pay a medical consultation fee with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get the vaccine at a doctor’s office or urgent care clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise bill, the best bet is to get your vaccine at a vaccination post in the health department or at a local pharmacy as soon as the vaccines are more widely available.
This must be determined. It is possible that Covid-19 vaccines will become an annual event, as well as the flu vaccine. Or it may be that the benefits of the vaccine last for more than a year. We have to wait and see how durable vaccine protection is. To determine this, the researchers will screen vaccinated people for “innovative cases” – those who fall ill with Covid-19 despite the vaccination. This is a sign of weakened protection and will give researchers clues as to how long the vaccine lasts. They will also monitor the levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster injection may be needed. It is conceivable that people need reinforcements every few months, once a year or just every few years. It is just a matter of waiting for the data.
The toxicity data released by Pfizer and Moderna in December found no harmful effects of vaccines for pregnant rats – evidence cited by WHO in its guide.
An extreme consequence of a conservative approach to vaccines that occurred during the Ebola epidemic in the Democratic Republic of Congo, when health professionals offered a vaccine for the disease to all frontline employees and contacts of people with confirmation of having it. – unless they were pregnant or breastfeeding. Without the vaccine, 98 percent of pregnant women infected with the Ebola virus died.
The rules were changed after a public outcry, but by that time many pregnant women had died, said Lyerly.
Covid-19 also proved to be dangerous for pregnant women. A large CDC study published in November found that pregnant women with Covid who were symptomatic were significantly more likely to be hospitalized or die when compared to non-pregnant women who also had symptoms of Covid.
The evidence led agency officials to add pregnancy to the list of conditions that increase Covid’s risk of serious illness and death.
The CDC created a smartphone app called v-safe to request reports of side effects from immunized people. Some 15,000 pregnant women have signed up to the registry so far, the agency’s immunization committee said on Wednesday.
“I think it’s our best chance to get security data quickly,” said Dr. Jamieson.
Britain initially strongly recommended against Covid vaccines for pregnant women, but has since revised its guidance to authorize the inoculation of pregnant women working on the frontline or at high risk. “I hope that WHO will also reconsider,” said Dr. Jamieson.
Some experts say the recommendations are not as divergent as they may at first appear. “The CDC is more inclined to say that pregnant women should have access to the vaccine, but they should discuss their circumstances with their providers,” said Dr. Ana Langer, a reproductive health specialist who leads the Women and Health Initiative at Escola TH Harvard Chan of Public Health. “The provisional WHO recommendation says that women who are at a particularly high risk of exposure or contracting Covid should get the vaccine. So, where’s the big difference here? “
Denise Grady contributed reports.