Magee-Womens Research Institute & Foundation

Feb 8, 2021

With the first Covid-19 vaccines now launched, the world is hopeful for wide-scale vaccination. For months, serious thought went into developing equitable vaccine allocation plans, with a focus on the needs of those most at risk. In developing such plans, an issue that required serious attention was the needs of pregnant people, especially those on the frontlines of the pandemic—first responders and high-risk health care providers and staff. When the U.S. Food and Drug Administration approved the Pfizer-BioNTech vaccine for those at least 16 years old, it did so without any specific exclusion of pregnant people, but also without any accompanying data on pregnant people. As a result, there has been uncertainty around the potential risks and benefits of a COVID-19 vaccine for those who are nursing, pregnant, or considering a pregnancy.

The first priority group of Americans to receive the COVID-19 vaccine, known as Phase 1a, includes our frontline health care workers who face increased exposure to COVID-19. Our full-time, year-round health care workers are 75% women, many of whom are of reproductive age. As this first wave of vaccines is disseminated, many patient-facing personnel —doctors, nurses, personal support workers, technicians, administrative, and custodial staff who are pregnant, post-pregnant, or considering pregnancy—need to make a vaccination choice, just as non-pregnant workers will.

Pregnant people are often excluded from participating in trials with the intent of protecting the vulnerability of their unborn fetus. This has been no different for COVID-19, to date. Yet, what this means is that pregnant people must make the choice whether to use a vaccine to protect themselves from an illness that puts them at increased risk of death, but that has not been tested on their population. The uncertainty around the risks and benefits for them and their fetuses is significant. It is not known if a decision that benefits a pregnant person would similarly benefit their fetus or, in fact, put their fetus at greater risk. The true vulnerability for pregnant people is the lack of sufficient evidence available for them to make an informed vaccination choice.

Pregnant people should have the ability to make decisions for themselves based on the state of the science and their personal preferences. However, there is still much work to be done to support their decision making. Health organizations and governments have been offering mixed messaging. The World Health Organization previously recommended withholding vaccines from pregnant people unless they are at high risk of COVID19 exposure and other countries, including the UK, are limiting access for pregnant people. In the US, both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) issued a statement in response, recommending provision of the vaccine to those pregnant people who choose to receive it. These recommendations are based on the same small amounts of Pfizer-BioNtech and Moderna vaccine data. While these data suggest that contracting COVID-19 is almost definitely riskier than vaccinating, inconsistencies in recommendations from leading health organizations will only make pregnant people more susceptible to rumors and misinformation.

To help pregnant and lactating people make informed decisions, relevant knowledge around safety and efficacy from the biology of messenger RNA vaccines, as well as data from clinical and laboratory studies, should be clearly distilled and communicated to both pregnant people and their healthcare providers so that they have a starting point to make their choices as the vaccine continues to rollout. As data on pregnant people continue to be gathered across agencies and institutions, it is imperative that it be made publicly available, transparent, and interpretable as soon as possible. To adequately reach the general public, this information should be promoted by recognizable and trusted public figures. Healthcare providers should then use shared decision-making approaches that support the autonomy of pregnant people. The National Institutes of Health should fund research, not only on vaccine hesitancy, but also on efficient ways to disseminate the data and on the complex decision-making involved for this group. The Centers for Disease Control need to collect and collate data on pregnant and lactating people who were in the trials (albeit inadvertently) and the outcomes for this population as the first wave of people are vaccinated. The new Biden administration COVID-19 task force should oversee the process of ensuring that the unique challenges and concerns facing pregnant people are proactively addressed. We have a scientific, social and moral responsibility to decrease the pain of uncertainty and generate the information needed, as quickly as possible, for pregnant people faced with difficult decisions.