The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
“The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2,” read the statement issued by FDA.
According to the FDA, the authorization also requires that individuals either have:
- moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for health care providers) or;
- a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
The authorization came after a clinical trial under which 3,441 people were given the drug while 1,731 received a placebo. It was then concluded that the Evusheld recipients saw a 77% reduced risk of developing Covid-19 compared to those who received a placebo.
Additional analyses showed the reduction in risk of developing COVID-19 was maintained for Evusheld recipients through six months, according to the FDA.
The safety and effectiveness of Evusheld for use in the pre-exposure prevention of COVID-19 continue to be evaluated, the statement read.
Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a press release by FDA, said, “Vaccines have proven to be the best defense available against COVID-19. However, there are certain immune-compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option.”
This is the first time that the FDA has given emergency authorization for purely preventative treatment.
According to the FDA, possible side effects of Evusheld include: hypersensitivity reactions (including anaphylaxis), bleeding at the injection site, headache, fatigue, and cough.
Few trial participants also suffered from serious cardiac adverse events after receiving Evusheld. All of these participants had risk factors for cardiac disease or a history of cardiovascular disease before participating in the clinical trial. However, it is not yet clear if Evusheld caused these.
(With inputs from agencies)
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