Before being exposed to the coronavirus, the Food and Drug Administration approved the first injectable monoclonal antibody cocktail for long-term prevention of Covid-19 in persons with impaired immune systems.
The FDA granted AstraZeneca’s Evusheld antibody cocktail an emergency use permission on Wednesday for what is called as pre-exposure prophylaxis, or PrEP, against Covid-19.
To yet, laboratory-produced antibodies have only been approved for early Covid-19 treatment or as preventative therapy for high-risk patients who have had close contact with someone who has tested positive.
People aged 12 and up who are moderately to severely immunocompromised and may not acquire appropriate immune responses from the Covid vaccination can use Evusheld as PrEP. The therapy is also an option for those who have had significant adverse responses to a Covid vaccination or one of its components in the past.
Preventive injections as often as every six months are part of the AstraZeneca treatment. The combo is around 83 percent effective at preventing symptomatic disease during such a period, according to a big placebo-controlled clinical experiment.
It’s unknown how the highly modified omicron coronavirus — which has spread to 57 nations, including the United States — would affect the monoclonal antibody therapy’s efficacy.
According to Ruud Dobber, executive vice president and president of AstraZeneca’s BioPharmaceuticals Business Unit, scientists are testing Evusheld against the new type. Because both of the antibodies in the cocktail, tixagevimab and cilgavimab, target the virus’s spike protein in different and complementary ways, they are confident about its efficacy against the omicron form.
Data is due in the following weeks, according to Dobber.
Still, the long-awaited news that antibody PrEP has been cleared should bring great relief to many of the estimated 3% of individuals in the United States who are immunocompromised.
Dr. Alfred Kim, a rheumatologist at Washington University in St. Louis, said, “This new FDA authorization is a very important development for those with immunosuppression.”
“provides a healthy load of antibodies for the 40 percent to 80 percent of the immunosuppressed who have very poor antibody responses following SARS-CoV-2 vaccination,” Evusheld stated.
Immunosuppression is linked to a significantly increased incidence of breakthrough coronavirus infections and severe Covid. Many people, including transplant recipients and those being treated with cancer or autoimmune diseases, have had to remain under solitary lockdowns even after being vaccinated against Covid.
Janet Handal, 70, a transplant recipient from New York City, runs a roughly 900-member Facebook patient advocacy group for other immunocompromised patients. PrEP, according to Handal, will be revolutionary for her group’s members if Evusheld proves effective against the omicron version.
“We can rejoin life. We can rejoin our families. We can hug someone without fear,” she said.
Evusheld as PrEP can provide an additional layer of protection for the vaccinated and vulnerable, according to Lucy Horton, an infectious disease specialist at the University of California, San Diego, but it “should not be viewed as an alternative to or replacement of vaccine.”
Candidates for PrEP must be free of the coronavirus. They couldn’t have been exposed to infectious people recently, either.
Nearly 5,200 initially unvaccinated volunteers in the United States and Western Europe were randomised 2-to-1 to receive a single injection of Evusheld or a placebo in a large clinical trial of Evusheld as PrEP that has not yet been peer-reviewed. According to AstraZeneca, the antibody injection reduced the risk of symptomatic Covid-19 by 83 percent compared to the placebo during a median six-month follow-up.
There have been no severe Covid-19 instances or deaths among patients who had the antibody injection, compared to five severe cases and two deaths in the placebo group.
The study’s participants will be followed for 15 months.
Seventy-five percent of those who took part had health problems that put them at risk for severe Covid, such as diabetes or obesity. Despite the fact that just 3% of the participants were immunocompromised, experts believe that using Evusheld as PrEP should be safe and effective.
The federal government has reached an arrangement with AstraZeneca to purchase 700,000 Evusheld dosages at no cost to qualified patients. The initial doses should be accessible “very soon,” with the rest of the doses arriving in a few months, according to Dobber.
While the medicine is free to consumers, health care providers may charge for its administration, so users may still have to pay out of pocket.