SAN DIEGO (KGTV) – Cancer patients and others with compromised immune systems have high hopes for a newly authorized drug from AstraZeneca, the first medicine designed to prevent COVID in people who mount weak responses to vaccines.
The Food and Drug Administration on Wednesday authorized Evusheld (pronounced "ev-yoo-shelled," according to the company). The two-drug antibody cocktail was 77 to 83 percent effective at preventing symptomatic COVID in a clinical trial.
“I am thrilled,” said Brian Koffman, a retired physician living with chronic lymphocytic leukemia who volunteered in the trial. “This is a way for us to get back into the world.”
About 7 million Americans have a compromised immune system that blunts their response to vaccination. Some mount no protection at all.
“The immunocompromised community sat on its hands, watching the rest of the world get back to eating out, going to movies, visiting friends, attending sporting events,” said Koffman, the co-founder of the CLL Society. “We felt increasingly frustrated and isolated.”
For them, Evusheld may be the next best thing to a vaccine.
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Vaccines train several types of defensive cells, including the B cells that make antibodies, offering multiple lines of long-lasting protection. For that reason, vaccines remain the best defense for individuals with normal immune systems, the FDA said.
Evusheld skips the training step and provides a cocktail of pre-made antibodies cloned in a lab.
These monoclonal antibodies are similar to offerings from Eli Lilly and Regeneron, which doctors use to treat the sick, with some notable differences.
AstraZeneca engineered its antibodies to be particularly long-lasting, offering protection for six months. They are given as a shot, not a lengthy IV infusion. And they’re the first monoclonals authorized for prevention without a documented exposure, what doctors call “pre-exposure prophylaxis.”
“We’ve been waiting to have that similar kind of protection that others get through vaccinations, and this will offer that,” Koffman said.
Evusheld has been battle-tested for efficacy against Delta, but AstraZeneca is racing to study how well it protects against Omicron.
Early studies on the monoclonals from Regeneron and Eli Lilly suggest those drugs will be less effective against Omicron. However, AstraZeneca’s antibodies stick to different locations on the virus. Outside scientists say there are theoretical reasons to think Evusheld may fare better than the others.
“Do we know what its activity against Omicron is? We don’t. But we’re excited that this gives us an opportunity to weigh our risks,” Dr. Koffman said.
Koffman said he’s hopeful the drug will offer at least some immunity against Omicron. And some protection is better than none.
The federal government has already agreed to buy 700,000 doses of Evusheld. It plans to start shipping the drug in the next few weeks.
To qualify for Evusheld, an individual must have a moderate or severely compromised immune system from a medical condition or a drug. Evusheld is also available to people with a documented allergy to the COVID-19 vaccines. Individuals must be aged 12 or older.