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(CNN) -
The US Food and Drug Administration (FDA) said Wednesday that it authorized a combination of monoclonal antibodies made by AstraZeneca to prevent covid-19 in people who cannot. be vaccinated or are unlikely to get a sufficient immune response from a vaccine.
Evushield is a combination of two monoclonal antibodies, which are immune system proteins designed to boost the body's immune response.
It is not authorized for use in the treatment of covid-19.
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"The product is only licensed for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to a person infected with SARS-CoV-2," the FDA said in a statement.
“The authorization also requires that people have a moderately to severely compromised immune system due to a medical condition or due to taking immunosuppressive medications or treatments and may not generate an adequate immune response to the COVID-19 vaccine or a history of serious adverse reactions to a COVID-19 vaccine and / or component (s) of those vaccines, (and) therefore vaccination with an available COVID-19 vaccine is not recommended, according to the approved schedule or licensed, ”the FDA said.
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“Vaccines have proven to be the best defense available against covid-19.
However, there are certain immunosuppressed people who may not have an adequate immune response to the COVID-19 vaccine, or those who have a history of serious adverse reactions to a COVID-19 vaccine and therefore cannot receive one and they need an alternative prevention option, ”Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"Today's action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing covid-19 in these people."
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An AstraZeneca spokeswoman said in a statement that the therapy, given in two consecutive injections, neutralizes "all previous variants of SARS-CoV-2," and said the company is investigating whether it can also neutralize the omicron variant.
"Evusheld, which is expected to be available in a few weeks, has the potential to provide much-needed protection to the 7 million Americans who are immunosuppressed," the statement read.
The FDA said the treatment can be effective for up to six months.
"Pre-exposure prevention with Evusheld is not a substitute for vaccination in people for whom the COVID-19 vaccine is recommended," the agency said.
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