Less than a year after identification of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes coronavirus disease 2019 (COVID-19), safe and effective vaccines are beginning to be distributed across the United States, with the hope of bringing the COVID-19 pandemic to an end. Here we summarize what is currently known about COVID-19 vaccines and their use during pregnancy.
COVID-19 VACCINES AND THE VACCINE APPROVAL PROCESS IN THE UNITED STATES
Six leading vaccine candidates have received some form of federal government support through Operation Warp Speed, the partnership between the U.S. government and the pharmaceutical industry of these, two are messenger RNA (mRNA)–based vaccine candidates, two are based on viral vectors, and two are recombinant proteins manufactured in a baculoviral (DNA virus that infects insect cells) system that are co-formulated with adjuvants (substances that are added to vaccines to boost the immune response). As of December 13, 2020, applications for Emergency Use Authorization (EUA) have been submitted to the U.S. Food and Drug Administration (FDA) for the two mRNA-based vaccine candidates; the other vaccines have not yet completed the clinical trial process. Emergency Use Authorization is an authority provided to the FDA to allow unapproved medical products to be used in a public health emergency to diagnose, treat, or prevent serious or life-threatening conditions when there are no adequate, approved, and available alternatives.
Although the process of EUA is usually considered to be less rigorous than full FDA approval through a Biologics License Application, the FDA issued guidance in October 2020 that set a higher standard for COVID-19 vaccines, given that they would be used on large populations of healthy people. In their guidance, the FDA recommended that, for issuance of an EUA, the evidence would need to be similar to that for full approval: benefits of the vaccine would need to outweigh its risks based on data from at least one well-designed phase 3 clinical trial (a trial in which participants are randomized to receive a new product or a placebo) that demonstrated the vaccine’s safety and efficacy in a clear and compelling manner.