In its emergency authorization of the Pfizer-BioNTech vaccine on Friday night, the Food and Drug Administration took an unexpected step, leaving open the possibility that pregnant and breastfeeding women may opt for immunization against the coronavirus. The agency authorized the vaccine for anyone 16 and older, and asked Pfizer to file regular reports on the safety of the vaccine, including its use in pregnant women. There had been no guarantee that the agency would take this route. The vaccine was not tested in pregnant women or in those who were breastfeeding. Regulators in the United Kingdom recommended against these women receiving the shots even while acknowledging that the evidence so far “raises no concerns for safety in pregnancy.”The Centers for Disease Control and Prevention has not yet endorsed the vaccine for pregnant women, but an advisory committee to the agency is expected to meet this weekend to make further recommendations.
Source: New York Times December 12, 2020 04:14 UTC