Large U.S. COVID-19 vaccine trials will exclude pregnant women for now - (National Post via NewsPoints Desk)

  • Moderna and Pfizer's COVID-19 vaccines, which are entering large-scale US trials, will not be tested in pregnant women this year, as reported National Post on Friday.

  • Meanwhile, Johnson & Johnson chief scientific officer Paul Stoffels said the company would decide in the next few weeks whether it will include pregnant women in its large Phase III trial for a COVID-19 vaccine due to start in September.

  • Pfizer expects to start toxicology studies in pregnant animals shortly, with data ready for review by the FDA in the first quarter of 2021, with Bill Gruber, Pfizer's senior vice president of vaccine clinical R&D, noting that "we continue to explore potential ways to shorten the time to studies in pregnant women."

  • Based on past experiences in such trials, Gruber said he expects about 1% of women in Pfizer's Phase III trial, or about 150 women, will become pregnant, and those women and their babies will be followed closely.

  • Moderna said that it launched its safety study in pregnant animals at the end of June and expects results by the end of this year, with a company spokesman suggesting that "once we have generated additional safety data for our vaccine, and importantly demonstrated that it is efficacious, we intend to conduct additional studies in this important population."

  • Sanofi is undertaking reproductive toxicology in animals and may establish a pregnancy registry after the vaccine is approved to track outcomes in pregnant women.

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