CHICAGO (Reuters) – Pfizer Inc and BioNTech SE have initiated an international study with 4,000 volunteers to evaluate the safety and effectiveness of their COVID-19 vaccine in pregnant women, the companies said Thursday.
Pregnant women are at higher risk of developing severe COVID-19, and many public health officials have recommended that some women in high-risk professions take coronavirus vaccines even without confirmation of their presence. safe for them.
Last week, the U.S. National Institutes of Health called for greater inclusion of pregnant or lactating women in COVID-19 vaccine research.
Biologists, vaccines and maternal health experts have argued for years that pregnant women should be introduced early in trials of pandemic vaccines so that they do not have to wait until long after a successful man emerges.
Nonetheless, pregnant women were excluded from major US trials used to obtain emergency use clearance of COVID-19 vaccines.
Drug dealers have said they must first make sure the vaccines are generally safe and effective. In the United States, regulators are urging drug dealers to perform a safety check in pregnant animals before testing on vaccines in pregnant women to make sure they do not harm the fetus or that they will give birth prematurely. The companies said these inspections did not reveal new risks.
Pregnant women in the United States have already received their first doses, the companies said.
The new study will test pregnant women aged 18 and over in the United States, Canada, Argentina, Brazil, Chile, Mozambique, South Africa, the UK and Spain.
Women receive the vaccine at 24-34 weeks of gestation, receiving two strokes 21 days apart – the same regimen used in the larger clinical trial.
Shortly after giving birth, participants who received a placebo in the trial will have the opportunity to get their own vaccine, as long as they remain part of the study, the companies said.
Reporting by Julie Steenhuysen; Edited by Bill Berkrot