Pfizer and BioNTech are having trouble finding enough participants to enroll in a study of COVID-19 vaccines in expectant mothers.
The slow enrollment has led to a delay that could otherwise inform physicians about how pregnant women are affected by the vaccine. News of the delay was reported by The Wall Street Journal.
The news comes after other studies have confirmed pregnant women are at higher risk of severe illness and preterm pregnancies if they contract the virus.
The drugmakers closed enrollment at many study sites with lower-than-anticipated enrollment numbers. Part of the problem is that many expectant women are already vaccinated, after physician and government groups both recommended the vaccine for this group.
“It’s hard to enthusiastically recommend the study when you’ve got a vaccine out there,” Andrew Wagner, MD, an obstetrician-gynecologist, told the WSJ. “The scientist hat I wear says you want those patients, but obviously the clinician in me says, ‘You’ve got to get your vaccine.’ ”
Wagner’s Saginaw, Michigan-based practice had fewer than a dozen enrollees in the spring for its study before the vaccine was widely available.
Despite the low enrollment, Pfizer still plans to complete the trials and share the results. However, the drugmaker has missed target dates to share results so far. Instead of sharing the results by the end of this year, Pfizer expects results early next year, according to the WSJ.
Pfizer and BioNTech are also conducting clinical trials for usage of the vaccine among children 5-11.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."