February 25, 2022
2 min read
The FDA has revised its emergency use approval for the Evusheld monoclonal antibody cocktail and doubled its initial dosage for COVID-19 prevention in light of data suggesting that it may be less active against certain omicron subvariants.
The approved starting dose for Evusheld (tixagevimab plus cilgavimab, AstraZeneca) is now 300 mg tixagevimab and 300 mg cilgavimab, increased from the previous approval of 150 mg each.
Patients who have already received the previously approved dose should receive an additional dose of 150 mg of tixagevimab and cilgavimab each “as soon as possible”, in order to increase their monoclonal antibody levels, according to the FDA. Any subsequent repeated dosing will be timed from the date of this additional dose of Evusheld, the agency added.
“Healthcare professionals should contact patients who have received the previously approved dose of Evusheld to return for an additional 150 mg of tixagevimab and 150 mg of cilgavimab 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 greater – 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 suggesting that a higher dose of Evusheld may be more likely to prevent infection with COVID-19 omicron subvariants BA.1 and BA.1.1 compared to the original approved doses according to the FDA.
“The duration of protection provided by Evusheld against symptomatic SARS-CoV-2 infection may not be as long as shown in the clinical trial supporting the original authorization, because the clinical trial data came from a period before the emergence of BA.1 and BA.1.1 sub-variants, “the press release read.” However, it is not known whether BA.1 and BA1.1 will still be circulating in the coming months, or whether another omicron sub-variant, BA.2 , for which Evusheld is expected to have greater neutralizing activity, will become dominant. “
As it is still unclear which COVID-19 variant or omicron subvariant will become dominant in the United States over the next few months, the FDA said it can not provide any timing recommendations for repeated dosing at this time.
We will continue to monitor the situation closely and will provide updates with re-dosing recommendations in the near future when more data are available to determine the appropriate timing of re-dosing (eg 3 months or 6 months after the previous dose) , “according to release.
Evusheld is approved for emergency use as pre-exposure prophylaxis of COVID-19 prevention in certain adult and pediatric patients aged 12 years or older and weighing at least 40 kg. According to the FDA, healthcare 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 disorders due to a medical condition, or who have received immunosuppressive therapy, and who may not have adequate immune response to COVID-19 vaccination. Individuals may also receive Evusheld if vaccination with an available approved or approved COVID-19 vaccine is not recommended due to a history of serious adverse reactions to a COVID-19 vaccine and / or COVID-19 vaccine components.