FDA Monoclonal Antibody Guideline Changes

Jan 25

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The covidCAREgroup strives to keep followers informed on new developments about COVID-19. There is a lot of information coming out about COVID-19 management and prevention, and it can be confusing.

As of 1/24/2022, the U.S. Food and Drug Administration 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. The FDA made this decision based on the available science to ensure that healthcare providers on the frontlines have the best tools available to treat patients is a top priority for the agency.

Data show the monoclonal antibody treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States. The monoclonal antibody 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.

What does this mean?

This means that some of the structures of the COVID-19 Omicron variant have changed, so the antibody therapy is not as effective against it.

Prior variants are still a risk, so vaccination and antibodies remain an important part of prevention and control. Antibodies we developed from prior infections and vaccination still give our immune systems the information they need to respond to the core virus.

We do not want the old virus strains resurfacing and possibly mutating in a different direction, so it is important not to let your guard down.

Continue protecting yourself with social distancing, hand washing, hand sanitizing, avoiding crowds in poorly ventilated areas, and vaccination.
Get tested if you don't feel well.