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

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FDA Statement

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. 
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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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