FDA investigating impact of Omicron on available mitigation strategies


The US Food and Drug Administration (FDA) is currently investigating whether the new COVID-19 variant will evade current mitigation strategies and diagnostic tools.

Over the holiday weekend, a new variant of COVID-19 was reported and dubbed Omicron by the World Health Organization. As with previous variants, questions regarding the efficacy of available mitigation strategies, particularly available vaccines, quickly arose.

The US Food and Drug Administration (FDA) issued a statement that it is currently working with other federal agencies as well as international partners and pharmaceutical companies to understand how the new variant may impact the available diagnostic tools, therapeutic agencies, and vaccines.1 The acting FDA commissioner Janet Woodcock, MD, cautioned that it will take time to collect genetic information on the variant as well as patient samples, but most of the work should be carried out over the next several weeks. As more is understood, the agency will provide information to the public.

With the current information, it’s anticipated that high-volume polymerase chain reaction and antigen rapid tests will not be negatively impacted and remain effective diagnostic tools. Furthermore, Woodcock stressed that vaccination continues to be highly efficacious at preventing serious outcomes such as hospitalization or death, and the recently expanded booster will provide further protection. If a modification is required to maintain effectiveness, the FDA and companies are pledged to rapidly develop and test any necessary changes.

Woodcock closed the statement by saying, “getting vaccinated or receiving a booster with one of the currently available vaccines is the best thing that you can do right now (in addition to standard precautions like wearing a mask) to help protect yourself, your family and friends.”


1. Woodcock J. Coronavirus (COVID-19) update: FDA actively working to investigate, address potential impacts of omicron variant; urges vaccination and boosters. Published November 30, 2021. Accessed November 30, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-actively-working-investigate-address-potential-impacts-omicron

Recent Videos
cUTI Roundtable: Discussing and diagnosing these difficult infections
Courtney Nelson, MD
Tina Tan, MD, FAAP, FIDSA, FPIDS, editor in chief, Contemporary Pediatrics, professor of pediatrics, Feinberg School of Medicine, Northwestern University, pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago
Related Content
© 2024 MJH Life Sciences

All rights reserved.