Getting the CO
Getting the COVID-19 vaccine makes it incredibly less likely that you’ll contract the novel coronavirus. What if those benefits could be passed on?
That’s among a list of questions researchers are hoping to answer with a clinical trial using Pfizer’s COVID-19 vaccine in pregnant adult women, who are at higher risk for severe COVID-19 infection.
The vaccine is believed to be just as safe for pregnant women as it is for other people, according to the U.S. Centers for Disease Control and Prevention. Two recently published studies also suggest that. One small study, published in early March, found that babies could gain some immunity if their mothers received the vaccine while pregnant. Yet, pregnant women were excluded from the main clinical trials that federal officials reviewed to authorize the vaccines, so conclusive evidence is not yet available.
“The general consensus is the vaccines are safe, and they are able to be given to women that are pregnant,” said Dr. Nikolas Arvis, research director at Clinical Research Prime in Idaho Falls, who oversees his clinic’s participation in the trial. Hard data that controls for outside bias is needed, he said, to know how safe it is for mothers to be and their children.
“The whole hope of that is the baby does better” as well, Arvis said in a phone interview.
To test how effective medications, vaccines or treatments are, the technology usually undergoes rigorous research. In the medical world, the ideal test method is through double-blinded, randomized, controlled trials. Neither the patients nor the doctors treating them know if someone got the real treatment or a placebo. The process is meant to control for both the placebo effect and doctors treating the two groups differently.
Women must be between 24 and 34 weeks pregnant to enlist in the trial, which is transitioning from phase 2 to phase 3. Participants won’t initially be told if they received the actual vaccine or the placebo. And they’ll be compensated for participating and undergo regular medical screenings. Once the participants give birth, they’ll be told if they received the placebo and offered a chance to get the actual COVID-19 vaccine.
Babies in the trial have their health monitored for six months after birth, Arvis said.
Pregnant women who have had COVID-19 or have already received the vaccine are not currently eligible.
Arvis said the trial is soon set to enter phase 3, with more lenient restrictions on who can join. Arvis and Kimberly Lowe, research director at Bingham Memorial Hospital in Blackfoot, another site participating in the trial, said they’ll be recruiting patients for months.
“We have a lot of information” that the vaccine is safe for pregnant women, “but it’s not done in a systematic, controlled way,” Lowe said in a phone interview. “… We need good information to solidify what’s out there already or to give you new information.”
Part of the CDC’s statement that “experts believe (the vaccines) are unlikely to pose a risk for people who are pregnant” was supported by studies in pregnant animals that showed no safety concerns. This trial is the sort of next step that could offer more certainty, said Dr. Carrie Merrill, a Wyoming doctor specializing in obstetrics.
“Human studies would be more reassuring that it is safe and effective in pregnant women,” Merrill said. “Animal studies go a long way to help our understanding but placebo-controlled, double-blinded human trials are the gold standard for all research in medications for vaccines.”
To see if you can participate, visit Clinical Research Prime’s website or call 208-497-0600. For Bingham Memorial Hospital, call 208-782-3731.
Reporter Kyle Pfannenstiel can be reached at 208-542-6754. Follow him on Twitter: @pfannyyy. He is a corps member with Report for America, a national service program that places journalists into local newsrooms.