FDA: Evusheld may lack efficacy against upcoming COVID-19 subvariants
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Evusheld demonstrates reduced protection against the omicron subvariant BA.4.6, resulting in an increased risk for infection in those exposed to that COVID-19 strain, according to an updated FDA fact sheet.
In the revised fact sheet, the FDA warned that providers should be aware of an increased risk for developing COVID-19 when exposed to certain COVID-19 variants that are not neutralized by tixagevimab packaged with cilgavimab (Evusheld, AstraZeneca).
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“Health care professionals should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive,” the FDA said in a statement released on Oct. 3.
Specifically, the fact sheet references the omicron subvariant BA.4.6, which, according to the FDA, has shown greater than 1,000-fold reduction in susceptibility to tixagevimab/cilgavimab, which is authorized for emergency use for pre-exposure prophylaxis of COVID-19
Currently, omicron BA.4.6 accounts for 6.8% of new COVID-19 cases in the United States, as of the week ending Oct. 1, according to the CDC.
The FDA suggests that medical providers discuss the risks for developing a COVID-19 infection following the administration of Evusheld, the statement said. Additionally, options such as Paxlovid (nirmatrelvir/ritonavir, Pfizer) are available.
“Use of Evusheld is not a substitute for COVID-19 vaccination, and individuals for whom COVID-19 vaccination is recommended should get vaccinated,” the FDA statement said. “Individuals who received Evusheld but who develop COVID-19 remain eligible for use of any of the available treatments for COVID-19 if the criteria for use are met.”
According to Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, the RJ Fasenmyer chair of clinical immunology at the Cleveland Clinic, and chief medical editor of Healio Rheumatology, future COVID-19 variants pose a “continuous challenge” to physicians. However, he added that he is still optimistic.
“Evolving variants will pose a continuous challenge to monoclonal antibody prevention and therapy,” Calabrese told Healio. “We have been fortunate thus far in having agents that still should be efficacious for the vast majority of immunocompromised infected patients. New antibodies are already undergoing in vitro and clinical evaluation and I remain optimistic.”
References:
Monitoring variant proportions. https://covid.cdc.gov/covid-data-tracker/#variant-proportions. Accessed Oct. 4, 2022.
Editor's note: On Oct. 4, 2022, this article was updated to accurately reflect the share of new cases attributed to BA.4.6.
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