Janet Woodcock, MD, acting commissioner of the Food and Drug Administration (FDA), says that as it has with previous emerging COVID-19 variants, the agency is "actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. We are closely monitoring the situation and are committed to communicating with the public as we learn more."
Woodcock noted that historically, the work to obtain the genetic information and patient samples for variants and then perform the testing needed to evaluate their impact takes time, however the agency expects the vast majority of this work to be completed in the coming weeks.
"The FDA has been actively monitoring for the possible emergence of SARS-CoV-2 variants since early in the pandemic and has worked with medical product developers when a new variant (or mutation) emerges that could impact product performance," she says. "With industry guidance laid out in February and contingency plans already in place, we are well-positioned and committed to working with companies to evaluate and expeditiously address the potential impact of emerging and future viral mutations on COVID-19 tests, therapeutics and vaccines. We’ve taken a number of steps to adapt to emerging variants thus far in the pandemic, such as requiring companies to actively monitor for and evaluate the impact of variants on their products as a condition of authorization, and quickly taking appropriate action. The agency has previously limited the scope of use of certain monoclonal antibodies depending on variants circulating in certain areas, updated fact sheets for healthcare providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations."
Woodcock continues, "We anticipate having more information from the ongoing evaluation regarding if and how well the current vaccines work against this variant in the next few weeks. If a modification to the current vaccines is needed, the FDA and companies will work together to develop and test such a modification quickly. On preliminary review, we believe high-volume polymerase chain reaction (PCR) and antigen (rapid) tests widely used in the U.S. show low likelihood of being impacted and continue to work. However, the FDA will continue to closely review and adjust course as needed. The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts, to arm ourselves with the best available diagnostics, and life-saving therapeutics and vaccines to fight this virus."