Pregnant women looking for guidance on Covid-19 vaccines are facing the kind of confusion that has dogged the pandemic from the start: The world’s leading public health organizations — the U.S. Centers for Disease Control and Prevention, and the World Health Organization — are offering contradictory advice.
Neither organization explicitly forbids or encourages immunizing pregnant women. But weighing the same limited studies, they provide different recommendations.
The C.D.C.’s advisory committee urged pregnant women to consult with 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 the expectant mothers.
The W.H.O. recommended that pregnant women not receive the vaccine, unless they were at high risk for Covid because of work exposures or chronic conditions. It issued guidance on the Moderna vaccine on Tuesday, stirring uncertainty among women and doctors on social media. (Earlier this month, it published similar guidance on the Pfizer-BioNTech vaccine.)
Several experts expressed dismay at the W.H.O.’s stance, saying the risks to pregnant women from Covid were far greater than any theoretical harm from the vaccines.
“There are no documented risks to the fetus, there’s no theoretical risks, there’s no risk in animal studies,” from the vaccines, said Dr. Anne Lyerly, a bioethicist at the University of North Carolina, Chapel Hill. “The more that I think about it, the more disappointed and sad I feel about it.”
The difference of opinion between the C.D.C. and the W.H.O. is not rooted in scientific evidence, but the lack of it: Pregnant women have been barred from participating in clinical trials of the vaccines, a decision in line with a long tradition of excluding pregnant women from biomedical research, but one that is now being challenged.
While the rationale is ostensibly to protect women and their unborn children, barring pregnant women from studies pushes the risk out of the carefully controlled environment of a clinical trial and into the real world. The practice has forced patients and providers to weigh sensitive, worrisome issues with little hard data about safety or effectiveness.
Vaccines are generally considered to be safe, and pregnant women have been urged to be immunized for influenza and other diseases since the 1960s, even in the absence of rigorous clinical trials to test them.
“As obstetricians we are often faced with difficult decisions about using interventions in pregnancy that have not been properly tested in pregnancy,” said Dr. Denise Jamieson, an obstetrician at Emory University in Atlanta and a member of the Covid expert group at the American College of Obstetrics and Gynecologists. The college strongly advocated including pregnant and breastfeeding women in the vaccine trials.
“What many people miss is that there are risks to doing nothing,” Dr. Jamieson said. “Not offering pregnant women the opportunity to be vaccinated and protect themselves, where there are known and severe risks of Covid amplified by pregnancy, is not a wise strategy.”
The uncertainty isn’t limited to Covid vaccines: Many if not most medications, including widely used drugs, have never been tested in pregnant women. It can take years or decades for adverse side effects to come to light in the absence of a study with a control group for comparison.
“This isn’t a story about the W.H.O. or other people advising against vaccination in pregnancy,” said Carleigh Krubiner, a policy fellow at the Center for Global Development and a principal investigator for the Pregnancy Research Ethics for Vaccines, Epidemics and New Technologies project (PREVENT). “It’s a story about the failure to timely and appropriately include pregnant women in vaccination studies.”
Saying she understood the commitment of the W.H.O. and other advisory bodies to rely on scientific studies, Dr. Krubiner added: “The reality is that we don’t yet have the data on these vaccinations in pregnancy, and it’s very difficult without that data to come out and give a full-throated recommendation in support.”
The C.D.C. and the W.H.O. have offered dissonant advice many times over the course of the pandemic — most notably on the usefulness of masks and the possibility of the virus traveling by air indoors.
In a statement, the C.D.C. said on Thursday that based on how the Pfizer-BioNTech and Moderna vaccines work, “they are unlikely to pose a specific risk for pregnant women.”
The C.D.C.’s recommendation may make sense for the United States, where women may easily be able to consult with their health care providers, said Joachim Hombach, a health adviser to the W.H.O. on immunizations. But the W.H.O. provides guidance to many low- and middle-income countries where women do not have access to doctors or nurses, he said.
The W.H.O.’s recommendation was also made “in the context of limited supply” of the vaccines, Dr. Hombach said. “I don’t think the language is discouraging, but the language is stating the facts.”
Pfizer did not include pregnant women in its initial clinical trials because it followed the policies outlined by the Food and Drug Administration to first conduct developmental and reproductive toxicity studies, said Jerica Pitts, a spokeswoman for the company. Pfizer and Moderna both provided results from toxicity studies in pregnant rats to the F.D.A. in December.
Pfizer plans to begin a clinical study in pregnant women in the first half of 2021, Ms. Pitts said. Moderna is establishing a registry to record outcomes in pregnant women who receive its vaccine, according to Colleen Hussey, a spokeswoman for the company.
Critics of the companies’ decisions to exclude pregnant women from trials say the reproductive toxicity studies could have been carried out much earlier — as soon as promising vaccine candidates were identified. The companies should have added a protocol to enroll pregnant women once it was clear the vaccines’ benefits outweighed potential harm, Dr. Krubiner said.
“It’s hard to understand why that delay is happening and why it wasn’t initiated sooner,” she said. “The bigger issue is, we’re going to have lost months by the time they start them.”
Akiko Iwasaki, an immunologist at Yale University who has advocated immunizations for pregnant women, questioned the underlying issue that prompted the W.H.O.’s decision.
“Whatever it is, I wish the W.H.O. would be more transparent in their reasons behind this recommendation,” she said. “Women’s lives depend on it.”
Currently more than 150 million people — almost half the population — are eligible to be vaccinated. But each state makes the final decision about who goes first. The nation’s 21 million health care workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials urged all states to open up eligibility to everyone 65 and older and to 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 back of the line. If federal and state health officials can clear up bottlenecks in vaccine distribution, everyone 16 and older will become eligible as early as this spring or early summer. The vaccine hasn’t been approved in children, although studies are underway. It may be months before a vaccine is available for anyone under the age of 16. Go to your state health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you don’t have insurance, you should still be given the vaccine at no charge. Congress passed legislation this spring that bars insurers from applying any cost sharing, such as a co-payment or deductible. It layered on additional protections barring pharmacies, doctors and hospitals from billing patients, including those who are uninsured. Even so, health experts do worry that patients might stumble into loopholes that leave them vulnerable to surprise bills. This could happen to those who are charged a doctor visit fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine from a doctor’s office or urgent care clinic, talk to them about potential hidden charges. To be sure you won’t get a surprise bill, the best bet is to get your vaccine at a health department vaccination site or a local pharmacy once the shots become more widely available.
That is to be determined. It’s possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it may be that the benefits of the vaccine last longer than a year. We have to wait to see how durable the protection from the vaccines is. To determine this, researchers are going to be tracking vaccinated people to look for “breakthrough cases” — those people who get sick with Covid-19 despite vaccination. That is a sign of weakening protection and will give researchers clues about how long the vaccine lasts. They will also be monitoring levels of antibodies and T cells in the blood of vaccinated people to determine whether and when a booster shot might be needed. It’s conceivable that people may need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
The toxicity data released by Pfizer and Moderna in December found no harmful effects from the vaccines to pregnant rats —…