Moderna said it will establish a "pregnancy registry" to track pregnancies during clinical trials for its Covid-19 vaccine.
The company told US Food and Drug Administration vaccine advisers about plans to keep track of people who get vaccinated while pregnant.
"With respect to safety in the event of vaccine exposure during pregnancy, a developmental and reproductive study was completed in December 2020, with no adverse findings," Dr. David Martin, vice president of pharmacovigilance at Moderna, told FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
In documents released earlier this week ahead of the VRBPAC meeting, Moderna said 13 pregnancies were reported through Dec. 2. Six of the pregnancies were in the vaccine arm and seven were in the placebo arm.
"Given the limited human exposure to date in the phase three trial, we will establish a pregnancy registry that includes a cohort recruited from the general population," he said.
0 Comments