The US Food and Drug Administration officially approved the first COVID-19 vaccine for emergency use on Friday, which clears the way for a national campaign to inoculate enough Americans to suppress the spread of the coronavirus. But, considering that neither the Pfizer vaccine nor any other vaccine awaiting FDA approval has been tested on pregnant people or those currently breastfeeding, questions remain as to whether it's safe for those demographic groups to stand in line to receive a vaccine.
On Saturday, the FDA stated that they do not recommend the vaccine for pregnant people right now, but they are not excluding them from receiving one.
"This is one where I think you'd want to have, from a provider to an individual, a consideration of the potential benefits and the potential risks — what we don't know about the vaccine versus what we do," said Peter Marks, MD, PhD, the director of the FDA's Center For Biologics Evaluation and Research. He added: "Certainly COVID-19 in a pregnant woman is not a good thing, so someone might decide that they would like to be vaccinated, but that's not something that we're recommending at this time. That's something we're leaving to the individual."
In general, the FDA recommends caution in using any drug or therapy that does not have explicit data on safety in pregnant people. In the case of the COVID-19 vaccine, the United Kingdom has so far advised against vaccinating pregnant people or those who plan to become pregnant within three months of the first dose.
However, many experts argue that just because there is no affirmative data available, it doesn't necessarily mean that the vaccine would be harmful for those pregnant or lactating. In fact, pregnant people already routinely receive many vaccines, such as the flu vaccine, the Tdap vaccine, and the hepatitis B vaccine.
"COVID-19 vaccines should not be withheld from women solely based on their pregnancy or lactation status, when they otherwise meet criteria for vaccination."
A panel of experts in maternal-fetal medicine recently made the case that the known risks of infection with COVID-19 during pregnancy outweigh the "unlikely risks of vaccination." The group cited recent studies showing that pregnant women sick with COVID were at a higher risk for needing a ventilator — and for death — than women who were not pregnant. In fact, the Centers For Disease Control and Prevention noted that although some pregnant women have only mild cases when they contract coronavirus, "data demonstrate potentially increased risks of severe maternal illness and preterm birth due to COVID-19 disease."
Among the panel's recommendations, which were published in the American Journal of Obstetrics and Gynecology, Amanda Craig, MD, wrote, "COVID-19 vaccines should not be withheld from women solely based on their pregnancy or lactation status, when they otherwise meet criteria for vaccination." She said it should be up to them to assess their risk of exposure and make a decision with the advice of their healthcare providers.
It is unclear if the FDA will give further recommendations to pregnant people as more data is collected, but Stephen Hahn, MD, the FDA commissioner, is confident that their review is thorough. "That level of detail to provide as much information supported by data and science to providers so that they can counsel patients and that patients are aware of the issues is so critically important."
In the next few days, the FDA and the CDC will likely issue more formal approvals and recommendations around Pfizer's vaccine and vaccines finalizing trials, which will be crucial for those first in line to receive a vaccine: namely, healthcare workers. According to the CDC, 75 percent of this workforce is female and roughly 330,000 of them "could be pregnant or recently postpartum at time of vaccine implementation."
Anthony Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, noted that follow-up vaccine studies that include pregnant women and young children could begin as early as mid- to late January. "That will not necessarily be looking at efficacy, but we'll be looking at safety and immunogenicity to bridge to the efficacy in the adult non-pregnant population," he said in a conference on Thursday.
He also believes that under a so-called emergency use authorization, pregnant people will very likely not be prohibited from receiving the vaccine. "[They will be] free to make their own decision."