FDA STATEMENT Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
For Immediate Release: January 24, 2022
Statement From: Patrizia Cavazzoni, M.D.
Director - Center for Drug Evaluation and Research
As we have throughout the COVID-19 pandemic, the U.S. Food and Drug Administration has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency.
In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.
Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. And like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in certain treatments not working against certain variants such as omicron. This is the case with these two treatments for which we’re making changes today.
Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.
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“Globally, as of 7:15pm CET, 2 February 2022, there have been 380,321,615 confirmed cases of COVID-19, including 5,680,741 deaths, reported to WHO. As of 2 February 2022, a total of 10,040,766,359 vaccine doses have been administered.”
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Globally, during the week of 31 January to 6 February 2022, the number of new COVID-19 cases decreased by 17% as compared to the number reported during the previous week, while the number of new deaths increased by 7%. Across the six WHO regions, over 19 million new cases and just under 68 000 new deaths were reported. As of 6 February 2022, over 392 million confirmed cases and over 5.7 million deaths have been reported globally.
In this edition, we provide updates on the geographic distribution of circulating SARS-CoV-2 variants of concern (VOCs), including the spread and prevalence of the Omicron variant. We also provide updates on vaccine effectiveness for the Delta and Omicron variants.
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