The Food and Drug Administration this week allowed two of the most commonly used monoclonal antibodies to treat COVID-19, leaving doctors with fewer opportunities to help their patients escape from the hospital.
Why did the FDA close them?
Because drug manufacturers Regeneron and Eli Lilly are not currently working against the omicron variant, which causes more than 99% of COVID-19 infections in the United States.
“All the data show that these old antibodies are ineffective against omicron,” said Dr. Daniel Kuritzkes, head of infectious diseases at Brigham and Women’s Hospital in Boston.
For patients with omicron infections, it was clear that monoclonals “do nothing,” said Dr. Eric Topol, founder and director of the Skripps Research Translation Institute in La Jolla, California.
“There is very strong evidence that monoclonals cannot bind to the omicron,” he said.
So what now? .
How common is the use of remdesivir, other monoclonal antibodies?
In November, the government nearly doubled orders for a third monoclonal antibody sotrovimab produced by GlaxoSmithKline and Vir Biotechnology. The U.S. has now spent $ 1 billion to buy the drug, which reduces the risk of hospitalization by more than a day by 79 percent, according to a previous study by Omicron.
In mid-December, the government said it was preparing to ship 55,000 doses of sotrovimab nationwide.
Doctors said it would help, but the number of high-risk patients with COVID-19 who could benefit from the drug was much higher than the delivery. For example, there are only 228 doses in the entire state of Louisiana.
OMICRON’S NEW VARIANT DAUGHTER, BA.2, CAME TO US: But don’t panic, experts say
About 40% of Americans are at high risk of developing a serious illness due to age or health.
The FDA also allowed the administration of remdesivir, a drug used only in hospitalized patients, to those at risk of hospitalization at the onset of the disease.
The drug is effective for outpatients and reduces the risk of hospitalization and death by 87% compared with placebo. It can be difficult to deliver because it has to be given by infusion for three days in a row, but it can be especially helpful for people in a nursing home or otherwise can easily access medical care for three days in a row.
It can also be used in high-risk children 12 and older who weigh at least 88 pounds.
What are monoclonals and how do they work against COVID-19?
Monoclonal antibodies are engineering proteins initially derived from patients who have overcome the disease.
They target and bind specific areas of the virus, preventing it from entering human cells.
But when these spots in the virus change with new variants, the monoclonals no longer work. Regeneron and Lilly monoclonals each consist of two monoclonals, which have attempted to overcome this problem, but there are differences in the areas intended by both in the omicron.
“That doesn’t mean they’re dead forever,” Topol said. “They could have come back with the next option, but we don’t know what’s ahead.”
All monoclonal antibodies to COVID-19 are approved for emergency use, so the FDA may revoke their use permit at any time if they are safe or ineffective. Medications that are allowed for emergency use should cross fewer barriers than fully licensed medications, but they should still be shown to be safe and effective.
Can monoclonal antibodies replace COVID vaccines?
No. For several reasons.
First, vaccines are designed to prevent infection, while monoclonals and other treatments are aimed at people who are already infected.
The chances of preventing a serious infection are much better with a vaccine than with trying to treat it “after the horse is out of the stable,” Topol said. “It’s a roll of dice, one of those treatments that’s hard to achieve that actually works.”
SPECIAL OMICRON VACCINE? Pfizer and BioNTech are announcing testing plans for adult testing
According to him, even the most effective treatment, Paxlovid, prevents 90 percent of serious infections and deaths, while vaccines prevent close to 99 percent.
Time is also important for treatments that need to be given and require a prescription within about 5 days after symptoms appear.
While vaccines can help prevent the spread of the virus that causes COVID-19, treatments do not reduce the spread.
In addition, monoclonals are about 50 times more expensive. Although both are provided free of charge by the federal government, vaccines cost less than $ 20 and monoclonals less than $ 1,200, not to mention the need to set up an infusion center to provide antibodies.
What can doctors do to prevent COVID-19 patients from being hospitalized?
Although no one has been able to diagnose COVID-19 malignancy, the vaccines have been proven to be very effective in preventing serious illness, hospitalization, and death.
A monoclonal antibody called Evusheld from AstraZeneca has been shown to prevent serious diseases in people with weakened immune systems who are not fully protected from vaccines. It provides long-term protection, but with the 700,000 doses ordered by the federal government, it won’t help most of the 7 million immunocompromised Americans who might benefit from it.
“tired, burnt, frustrated”:With the expiration of the vaccine mandate, there has been an increase in Omicron in nursing homes
There are also two new promising antiviral medications available that come as a five-day course of pills that can be taken at home. But allowed at the end of last year, they will continue to be in short supply for much of this year.
Both have strengths and weaknesses.
Paxlovid, developed by Pfizer, research shows that it prevents almost 90 percent of COVID-19 infections from becoming severe. The combination of antiviral and HIV drug, which makes it work more effectively, Paxlovid may interact with a number of other drugs, they may need to be stopped during 5 days of treatment.
Molnupiravir, produced by Merck and Ridgeback Therapeutics, should be the second choice, the federal advisory committee decided in December, although it could be wider than Pahlovid, at least in the next few months. Studies show that it is less effective and should not be taken during pregnancy.
Not allowed for use in children.
What comes next in the supply chain?
More monoclonal antibodies undergo an FDA approval process, which ultimately increases delivery.
As the virus continues to evolve, it may even take new ones to target new options.
Contact Karen Weintraub at kweintraub@usatoday.com
Health and patient safety coverage is partly funded by a grant from the Masimo Health Ethics, Innovation and Competition Foundation. The Masimo Foundation does not provide editorial information.
