The United States Food and Drug Administration has authorized an AstraZeneca preventative antibody combination that has demonstrated significant efficacy in decreasing the risk of developing symptoms of COVID-19.
The FDA clearance is a first-of-its-kind option for a subset of persons for whom immunizations are deemed ineffective.
Evusheld, an AstraZeneca antibody cocktail, was developed to prevent COVID-19 infections in persons with weakened immune systems or a history of severe coronavirus vaccination side effects.
"Vaccines have been shown to be the most effective defense against COVID-19. However, certain individuals with impaired immune systems may be unable to produce an appropriate immunological response to COVID-19 vaccination," Patrizia Cavazzoni, head of the FDA's Center for Drug Evaluation and Research, said.
The approval of the medication, which consists of two monoclonal antibodies called tixagevimab and cilgavimab, represents a big step forward for AstraZeneca, whose widely used COVID-19 vaccine is still awaiting approval by U.S. authorities.
AstraZeneca agreed last month to offer the U.S. government with 700,000 doses of Evusheld, which had previously been demonstrated in a late-stage trial to reduce the likelihood of acquiring any COVID-19 symptoms by more than 70%.
While vaccinations rely on an undamaged immune system to create specific antibodies and infection-fighting cells, Evusheld contains laboratory-made antibodies that are designed to remain in the body for months in the event of an infection.
AstraZeneca's therapy is intended to last many months to a year and is administered in two successive injections.
According to the FDA, pre-exposure prevention with Evusheld is not a substitute for vaccination in persons who should get COVID-19 vaccine.
Monoclonal antibodies are designed to halt the progression of COVID-19 in its early, milder phases. Similar medicines are manufactured by Regeneron, Eli Lilly, and GlaxoSmithKline in collaboration with Vir.
A single dose of Evusheld provided as two successive intramuscular injections (one injection per monoclonal antibody, given in rapid succession) may be effective for six months as a pre-exposure preventive measure.
Evusheld is not approved for the treatment of COVID-19 or for post-exposure prevention of COVID-19 in persons. Patients should consult their health care practitioner to evaluate if Evusheld is an appropriate option for pre-exposure prevention.
An emergency use approval (EUA) is not the same as an FDA approval. The FDA considers all available scientific information when deciding whether to issue an EUA and carefully weighs any known or possible dangers against any known or potential benefits of the vaccine product.
