Covid: In a first, FDA authorises AstraZeneca's Evusheld as a purely preventative treatment
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The authorisation came after a clinical trial under which 3,500 people were given the drug while 1,700 received a placebo
The US Food and Drug Administration has now issued an emergency use authorisation for AstraZeneca's Evusheld to prevent people from the deadly coronavirus. Evusheld comprises two types of synthetic antibodies - tixagevimab and cilgavimab. It is given as two intramuscular injections.
"The product is only authorised 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.
It can only be used if the person has required prerequisites, including moderate to severely compromised immune systems because of a particular medical condition. Also, when there is a history of severe adverse reactions to a Covid vaccine.
The authorisation came after a clinical trial under which 3,500 people were given the drug while 1,700 received a placebo. It was then concluded that the treatment cut the risk of developing Covid by 77 per cent.
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 ddefence 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 authorisation for purely preventative treatment.
Side effects of Evusheld range from hypersensitivity reactions, 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)