Coronavirus (COVID-19) Update: FDA Actively Working to Investigate, Address Potential Impacts of Omicron Variant; Urges Vaccination and Boosters

FDA Statement

• For Immediate Release: November 30, 2021
• Statement From: Janet Woodcock, M.D.

As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration 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. 

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, we expect 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. 

• 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 health care providers with information about how known variants impact certain therapeutics, and communicated with the public about tests affected by viral mutations. 
• 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.

At this time, the current vaccines remain highly effective at preventing COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. Additionally, currently available data from our international partners and vaccine manufacturers that has been evaluated by the FDA, suggests that an additional booster shot following the completion of a primary vaccination (six months for Pfizer-BioNTech and Moderna and two months for Janssen (Johnson & Johnson)) provides further protection against a COVID-19 infection.

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.