FDA Updates Recommendation Around AstraZeneca’s Evusheld

February 28, 2022

The FDA has revised its emergency use authorization for AstraZeneca’s Evusheld, which has been recommended for immunocompromised persons 12 years of age and older. Due to emerging data, it has been observed that the original 150mg dose of each monoclonal antibody may be less likely to prevent infection than originally indicated. Thus, the FDA has authorized an double dose of each monoclonal antibody. “Patients who have already received the previously authorized dose (150mg of tixagevimab and 150mg of cilgavimab) should receive an additional dose of 150mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.”

According to the FDA website, “The duration of protection provided by Evusheld against symptomatic SARS-CoV-2 infection may not be as long as was shown in the clinical trial supporting the initial authorization because the clinical trial data came from a time period before the emergence of the BA.1 and BA.1.1 subvariants. However, it is not known whether BA.1 and BA1.1 will still be circulating in the coming months or whether another Omicron subvariant, BA.2, for which Evusheld is expected to have greater neutralizing activity, will become dominant. Because it is unclear which SARS-CoV-2 variant or Omicron subvariant will become dominant in the United States over the next few months, the recommended timing for repeat dosing cannot be provided at this time.”

Dosing and timing between doses should be determined with a health care provider.

You can read more about various monoclonal antibody treatments, including AstraZeneca’s Evusheld, and their efficacy against the Omicron variant, in this study published in Nature.





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