FDA admits no safety data for Spikevax use among pregnant women

Beyond the legal questions raised by the FDA’s approval this week of Spikevax, the approval also raises safety questions.

For instance, the FDA admitted Spikevax was insufficiently tested on pregnant women, stating that “[a]vailable data on SPIKEVAX administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

Furthermore, Spikevax was approved without having been tested for its ability to provide protection against the Omicron variant, which is reported to account for 99.9% of current U.S. COVID cases — it was approved only for providing protection against mutations that are no longer circulating.

And yet, the FDA cited the Omicron variant as the reason behind its decision to pull its EUA for monoclonal antibody products. The FDA claims that these products have not been shown to provide protection against the Omicron variant.