More than 210,000 people in the U.S. have died from COVID-19, and tens of thousands are testing positive daily. The best way to defeat the pandemic is with a safe vaccine that can protect a large share of the population, especially people at higher risk of exposure, such as frontline health workers, and those more vulnerable, such as the elderly and, some health experts maintain, pregnant women. The data on whether pregnancy increases the risk for coronavirus infection or leads to more complications is incomplete, but there are preliminary indications that it is a potential risk factor.
By the workings of “herd immunity,” a vaccine wouldn’t even have to be given to everyone; if a large enough portion of the population is protected from infection, the virus won’t be able to keep spreading. The country is nowhere near that point at present.
It is encouraging to know that there are many efforts on a global scale to make and distribute a safe vaccine. According to the World Health Organization, more than 190 COVID-19 vaccine candidates are currently under development. Of these, 42 are in the human trial phase.
But so far, manufacturers and U.S. regulators have held off on including pregnant women in these trials, raising concerns among bioethicists, vaccine experts and maternal health specialists that when a vaccine is approved and ready to be distributed, this important and vulnerable population may not be able to benefit from it.
However, it isn’t unreasonable that they have not been included in trials yet. When most vaccines are being developed, they are usually tested first in healthy adults.
“It’s really important before we consider studies in pregnant women to know that there is a safety record of these vaccines and other populations,” said Dr. Ruth Karron, a pediatrician and professor at Johns Hopkins University. She is one of the co-founders of PREVENT, a collaboration that advocates for the need to include the interests of pregnant women and their offspring in the development of new vaccines.
Testing a vaccine in healthy, nonpregnant adults first can show whether the vaccine triggers an effective immune response, while minimizing the risk of dangerous side effects and complications. But considering the scope of this pandemic and how dangerous this virus can be, some health experts believe pregnant women should be considered high priority and included in vaccine trials as soon as the likely benefits of participating in them outweigh the risks.
Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics and one of the co-leads on the PREVENT project, told Yahoo News, “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’s really serious attention being paid to how quickly we can start to include [them] in the trials.”
The experts’ concerns about the absence of pregnant women in these important vaccine trials are also not unreasonable, considering that there exists a history of excluding this group