Clinical trials are underway for dozens of potential COVID-19 vaccines, but pregnant women have not been included in them yet. Five experts explain why that is the case and what it may mean in terms of when a vaccine may be available to them.
FLOR MUNOZ: This is a big question. And it's a very important question that is being addressed here in the United States and globally. The issue is that, certainly, the clinical studies that are happening right now for COVID vaccines focused on healthy adults, healthy young adults. And they have included older adults as well, because it is a population that is at risk. But none of the studies is looking at pregnant women right now.
CARLEIGH KRUBINER: The PREVENT Project essentially came out of longer-standing work to ensure that the interests of pregnant women and their future children would be equitably addressed in the context of research.
RUTH KARRON: One important thing for people to recognize is that these vaccines are, indeed, brand new. So it's really important before we consider studies in pregnant women to know that there is a safety record of these vaccines in other populations, because when we have new such kinds of new vaccines, we would never first give them to pregnant women. We would establish a safety record first in other populations.
RUTH FADEN: Ruth Karron has laid out the logic and the reasoning. And it's basically a sound and appropriate strategy. Then there's the urgency that comes from this particular pandemic. It is appropriate that pregnant women are not included right at the beginning.
But it is essential that the interests of pregnant women be top of mind from the beginning so that as the trials are being designed, there is really serious attention being paid to how quickly can we start to include pregnant women in the trials? It's possible, with all these thousands of people being enrolled in these vaccine trials, that there will be women who become pregnant during the course of the trial. We need to make sure that the trials include mechanisms to capture information about the experiences of those women as well.
CARLEIGH KRUBINER: It's absolutely essential to be systematically generating the evidence base so that when we have vaccines, we can offer pregnant women, their clinicians, and policymakers the types of information that they would need around the safety profiles of these vaccines and their efficacy so that we can offer some sort of protection to pregnant women who may face increased risk of exposures.
FLOR MUNOZ: Women and pregnant women represent a good proportion of the population that is at risk, especially when you think about even priority groups, such as health care providers, first responders, anyone who is working in science and developing vaccines or tests or medications that are going to be used for COVID are women.
UCHE BLACKSTOCK: They are the higher risk group. And so what we have to think about is any inadvertent pregnancies that may happen in that group that will receive the vaccine. And we have to know what are the effects of this vaccine on that group?
It's very important that we involve pregnant people. And the reason why is because we've already seen that it has a very high mortality rate, about 10 times that of the flu. And what we know already is that pregnant women are more likely to be hospitalized than non-pregnant women of the same age.
RUTH FADEN: It is ethically complicated. The state of pregnancy is unlike no other in they sense that you have two entities, both of which matter from a moral point of view, in one body. This makes things complicated. I would not want to suggest otherwise.
But there are ethically acceptable ways to include pregnant women in the evaluations of new vaccines and new drugs. Right now, there's no vaccine for anyone to take. So for people who are contemplating pregnancy or for people who are in the early stages of pregnancy, it's possible that we'll have information available that may inform a decision about whether you should take the vaccine by the time vaccines are broadly available. But we just don't know yet.