FDA doubles initial Evusheld dosing regimen to enhance prevention of COVID-19 variants
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The FDA has revised its emergency use authorization for the monoclonal antibody cocktail Evusheld, doubling its initial dosing for COVID-19 prevention in light of data suggesting it may be less active against certain omicron subvariants.
The authorized initial dose for Evusheld (tixagevimab plus cilgavimab, AstraZeneca) is now 300 mg of tixagevimab and 300 mg of cilgavimab, increased from the previous authorization of 150 mg for each.
Patients who have already received the previously authorized dose should receive an additional 150 mg dose of tixagevimab and cilgavimab each “as soon as possible,” to increase their monoclonal antibody levels, according to the FDA. Any subsequent repeat dosing will be timed from the date of this additional Evusheld dose, the agency added.
“Health care professionals should contact patients who received the previously authorized Evusheld dose to return for an additional 150 mg tixagevimab and 150 mg cilgavimab dose as soon as possible,” an FDA press release noted.
According to the press release, the volume of each injection for the new, higher dose will also be larger — 3 mL instead of 1.5 mL. This means that the injections should be limited to large muscles on the body that can accommodate this volume, such as the gluteal muscles, the FDA said.
The EUA revision is based on recent data that suggest a higher dose of Evusheld may be more likely to prevent infection by the COVID-19 omicron subvariants BA.1 and BA.1.1, compared with the original authorized doses, according to the FDA.
“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,” read the press release. “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.”
As it remains unclear which COVID-19 variant or omicron subvariant will become dominant in the United States over the next few months, the FDA said it cannot provide any timing recommendations for repeat dosing at this time.
“We will continue to monitor the situation closely and will provide updates with redosing recommendations in the near future when more data are available to determine the appropriate timing of redosing (eg, 3 months or 6 months after the prior dose),” according to the release.
Evusheld is authorized for the emergency use as pre-exposure prophylaxis for COVID-19 prevention in certain adults and pediatric patients aged 12 years or older and weighing at least 40 kg. According to the FDA, health care providers should only administer the cocktail to patients who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to anyone with COVID-19.
Eligible patients include those who have moderate-to-severe immune compromise due to a medical condition or who have received immunosuppressive therapy, and may not mount an adequate immune response to COVID-19 vaccination. Individuals may also receive Evusheld if vaccination with any available approved or authorized COVID-19 vaccine is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine and/or COVID-19 vaccine components.
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