Pfizer and BioNTech have launched a large-scale clinical trial to determine the safety and efficacy of their COVID-19 vaccine in pregnant recipients, the drugmakers announced Feb. 18.
The global trial aims to enroll about 4,000 pregnant women ages 18 and older vaccinated during 24 to 34 weeks of gestation.
Prior to conducting the trial, regulatory authorities required Pfizer and BioNTech to complete a developmental and reproductive toxicity study with their COVID-19 vaccines. The drugmakers said the studies showed no evidence of fertility or reproductive toxicity in animals.
The trial announcement comes a week after National Institutes of Health researchers urged drugmakers developing COVID-19 vaccines to conduct more research on the vaccines' safety and efficacy in pregnant recipients.
"Pregnant and lactating persons should not be protected from participating in research, but rather should be protected through research," they wrote in an article published Feb. 10 in JAMA.
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