On December 11th, the FDA approved the emergency use of Pfizer-BioNTech COVID vaccine for people age 16 and older—and the approval did not explicitly exclude pregnant and lactating people.
The news comes during an unprecedented surge of COVID-19 cases; the Centers for Disease Control (CDC) estimates that the United States will have over 330,000 deaths by January 2021. Public health officials and the medical community hope that the slow but steady role out of the COVID vaccine will start to beat back these atrocious numbers.
Of course, the question on everyone's minds is, "when will the vaccine be available to me?" As previously reported, vaccine distribution will be determined by risk assessment, experts recommending that healthcare workers and the residents and workers of nursing homes be the first to receive the COVID vaccine.
But for pregnant people and the parents of young children, many questions remain; previous COVID vaccine testing has excluded testing on young children as well as pregnant and lactating people. But there is hope.
Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, stated that COVID vaccine testing for pregnant people and children could start in January of 2021—and this indeed progress to get excited about.
Dr. Fauci said that the study's primary objective will be to ensure that the COVID vaccine is safe in these populations; the efficacy of the vaccine is anticipated to remain high.
While we wait for these studies to start, pregnant people may start to have conversations with their providers about whether or not they should get the COVID vaccine, before the conclusive data to support their safety. There are many scientists and providers who feel that the risk of the COVID virus is worse than the risk of the vaccine—untested as it may be. For example, many pregnant healthcare and essentials workers confront COVID-19 routinely; it's possible that getting vaccinated as soon as possible is the right choice for them.
The American College of Obstetrics and Gynecology (ACOG) states that "Women who are pregnant and/or lactating should not be excluded from what are identified as high priority populations for the COVID-19 vaccine allocation strategy."
The FDA's deputy director for vaccine development, Dr. Doran Fink, told the New York Times that "we really have no data to speak to risks specific to the pregnant women or the fetus, but also no data that would warrant a contraindication to use in pregnancy at this time."
If you are pregnant, talk to your provider. There is no one size fits all approach to the COVID vaccine role out, so assessment of each individual's situation will be critical. As new information becomes available, your provider can help you determine what the best course of action is for you.
For parents of young children, we will continue to wait, as the FDA approval does explicitly exclude children under the age of 16. Pfizer is currently conducting studies of the COVID vaccine for children age 12 and older, and again, younger children may start to be tested next month.
For now, continue to stay informed, keep wearing masks, follow your local guidelines—and choose hope.