By IDSE News Staff
Tixagevimab co-packaged with cilgavimab (TIX+CIL; Evusheld, AstraZeneca) may not be effective against COVID-19 variants, according to the FDA.
The agency updated the authorized Fact Sheet for TIX+CIL to include the information about an increased risk for developing COVID-19 with exposure to variants that are not neutralized by TIX+CIL.
TIX+CIL may not be as effective against the various omicron variants—especially BA. 4.6, which the CDC estimates now makes up nearly 13% of cases in the United States. Detailed neutralization data can be found in the recently revised FDA authorized Fact Sheet for Healthcare Providers.
The FDA is advising all healthcare professionals to inform their patients of the risk and advise those who develop symptoms of COVID-19 to test for an infection and promptly seek medical attention if testing yields a positive result.
There are several other treatments—nirmatrelvir/ritonavir (Paxlovid, Pfizer), remdesivir (Veklury, Gilead), bebtelovimab (Lilly) and molnupiravir (Lageviro, Merck and Ridgeback Biotherapeutics)—that the FDA said are expected to retain activity against currently circulating variants, and are also authorized or approved to treat patients with mild to moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.
To date, TIX+CIL is the only pre-exposure prophylaxis (PrEP) option for COVID-19 and is authorized under an emergency use authorization in immunocompromised individuals who may not mount an adequate immune response to COVID-19 vaccination, and for people who are not recommended to receive a COVID-19 vaccination due to a history of a severe adverse reaction. It is to be administered every six months and is not intended as a substitution for COVID-19 vaccination, the agency said.
Despite this new information, the FDA continues to recommend TIX+CIL as an appropriate option for PrEP to prevent COVID-19 with other recommended preventive measures (i.e., vaccination and boosters), adding that TIX+CIL still offers protection against many of the currently circulating variants and may offer protection against future variants.
—From FDA press materials.
