COVID-19 Vaccine: Clinical Trials Started in Pregnant Women
Submitted to What's On Your Mind?
Pfizer and BioNTech announced this week that they have begun a large scale clinical trial of their COVID-19 vaccine in pregnant women.
According to a statement from the companies, they enrolled approximately 4,000 pregnant women who are 18 years of age or older and between 24 and 34 weeks of gestation in the trial.
The trial will include participants from the United States, as well as those from Argentina, Brazil, Canada, Chile, Mozambique, South Africa, Spain, and the United Kingdom.
Participants in the study will receive two doses at 21 days apart, and each individual will be followed for a minimum of 7 to 10 months so that the health of the mother and child can be assessed.
The drug companies expect to start additional studies in children between the ages of 5 and 11 over the next couple of months, and in children younger than 5 later in 2021. Trails in subjects 12 to 15 years of age are already being evaluated in the global Phase 3 study and the relevant data will be submitted to regulatory authorities in the second quarter of 2021. Further studies are being planned to evaluate the vaccine in people with compromised immune systems.
Check out the COVID-19 in Pregnancy Decision Aids resource, and further discussion in the Should I Get Vaccinated if I am Pregnant or Going to be Blog.