Technologies

Regen-COV might work before COVID exposure, trial shows: What to know about monoclonal antibodies

Monoclonal antibodies can greatly reduce hospitalization rates in people most at risk of severe COVID-19.

For the most up-to-date news and information about the coronavirus pandemic, visit the WHO and CDC websites.

Monoclonal antibody therapy for COVID-19 is available to people in the US for free who are at higher risk of severe disease in the first few days of their illness, or after they’ve been exposed to the coronavirus. The treatment — lab-made antibodies given to a person that help their immune system stop the infection from spreading — has proven to be a key tool for preventing the coronavirus from turning into severe illness. Preliminary research shows the treatment reduces risk for hospitalization or death by about 70%.

Now, early research is showing the treatment may benefit people much earlier on, before they’ve even been exposed to the coronavirus. Regeneron, one of the drug-makers of the antibody treatments, announced Monday that its drug was 81.6% effective in preventing COVID-19 in a trial period of two to eight months post-treatment. The drug in the study, which is called Regen-COV and was given to participants in a series of four injections, is the same drug as the one currently authorized for use on at-risk people who are in the early stages of COVID-19, and on some people who’ve been exposed to it.

Dr. Myron Cohen, who leads the monoclonal antibody efforts for the National Institutes of Health’s COVID Prevention Network, said in a news release Monday that the results from the drug-maker are “particularly important to those who do not respond to COVID-19 vaccines, including people who are immunocompromised.”

Regen-COV isn’t authorized yet for use in anyone who hasn’t been exposed to or is sick with COVID-19. A few monoclonal antibody therapies, including the one made by Regeneron, have emergency use authorization by the US Food and Drug Administration and should be accessible in doctors’ offices or even some state-run clinics, as seen in states such as Florida and Texas.

Importantly, monoclonal antibodies don’t replace the role of the COVID-19 vaccines in preventing hospitalization and death. According to data from August by the US Centers for Disease Control and Prevention, unvaccinated people were more than 11 times more likely to die from COVID-19 and about 6 times more likely to contract COVID-19 than fully vaccinated people.

A large number of Americans could be eligible for monoclonal antibody treatment if they test positive for COVID-19 (a smaller number would be eligible for the treatment without a positive test, and only a confirmed exposure). For example, everyone age 65 or older, people who are overweight, people with heart, liver, or kidney disease and many more would be eligible for the treatment in the early days of their symptoms.

Here’s what we know now about COVID-19 monoclonal antibodies.

What are monoclonal antibodies, and how do they work?

Monoclonal antibodies are lab-made antibodies that work by binding to bacteria, cancer cells or viruses the way natural antibodies do, stopping them from infecting more cells. The first monoclonal antibody therapy was approved more than 30 years ago and has been used for other illnesses, including the Ebola virus.

Monoclonal antibody treatments for COVID-19 are used before a person gets really sick, usually within 10 days of their first symptom, to prevent hospitalization. The treatment is only approved for people who are at risk of getting extremely sick — those who are age 65 or older and those who have “certain medical conditions,” per the FDA. The same treatment isn’t recommended for people who are already hospitalized with COVID-19.

Monoclonal antibody therapy is also authorized if an at-risk person is exposed to COVID-19, but the definition of “at-risk” in this instance, per the FDA, is a little narrower and reserved for people who are at risk because of a medical condition and unvaccinated or not fully protected by the COVID-19 vaccines because of an immunocompromising condition.

I tested positive. How do I know if I’m eligible?

If you come down with the coronavirus and are concerned about how the disease will affect you, contacting your doctor to learn your options and the best line of treatment for you is a good idea. But, in general, this specific treatment is reserved for people who are at risk for severe disease. Most people who are infected with COVID-19 will recover at home without medical help.

The people who test positive for COVID-19 and would be eligible or benefit from monoclonal antibody therapy may also be the same people who are eligible for COVID-19 vaccine boosters because of a medical condition. For those who are at risk of severe COVID-19 and would be eligible for monoclonal antibodies if they test positive (if they’re at least 12 years old and weigh at least 88 pounds) the FDA defines “at risk” under the EUA as:

All people age 65 and older.
People with obesity or those who are overweight (adults with a BMI of more than 25, and children age 12-17 who have a BMI at the 85th percentile or greater).
Pregnant people.
People with cancer.
People with chronic kidney or lung disease.
Individuals with cardiovascular disease or hypertension.
People with diabetes.
People with sickle cell disease.
Those living with neurodevelopmental disorders.
People who are immunocompromised or taking immunocompromising medication.
Those who have a “medical-related technological dependence” (such as a tracheostomy or gastrostomy).

However, the FDA stressed in a fact sheet for Eli Lilly’s treatment (another brand of monoclonal antibodies) that this isn’t a complete list, and other medical conditions or factors including race or ethnicity may also place individuals at higher risk for severe COVID-19. It also pointed to the CDC’s list of “people with certain medical conditions” for other health conditions, which includes things such as depression and Down syndrome as being high-risk conditions.

In sum: If you test positive and feel you are at risk for severe COVID-19 and might qualify for monoclonal antibodies, you should probably speak to a health care professional about them.

Does vaccine status matter?

No, people who test positive for COVID-19 and are eligible for monoclonal antibody therapy because of their age or health condition can be treated regardless of their vaccination status. That is because, while still protective, the vaccines may be less effective at preventing severe disease in some people than others.

However, being unvaccinated might make you eligible for monoclonal antibodies after an exposure to someone with COVID-19. According to the FDA’s authorization of Regen-COV for post-exposure, people eligible for post-exposure treatment must be at risk of severe COVID-19 disease, and either unvaccinated or vaccinated but immunocompromised or taking immunocompromising medications.

I qualify. How do I access the treatment?

Monoclonal antibodies are administered by IV (most commonly) or by injection, so they’re not a prescription you can easily pick up at the pharmacy. According to CNN, the infusion process takes about an hour and patients need to wait a while to be observed for side effects. If you’re at risk for severe COVID-19 and you’ve tested positive or think you have it, ask your doctor where the treatment is available.

If you live in Texas or Florida where there are state-run monoclonal antibody treatment centers, the same eligibility requirements for patients apply. In Florida, this means everyone age 12 and older who is at “high risk for severe illness” can make an appointment and find a monoclonal treatment center at one of the state’s eight locations. In Texas, there are nine antibody infusion centers across the state, but at-risk people need a referral from their doctor.

If you think you qualify for monoclonal antibody treatment but don’t have a health care provider, you can call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585. You can also use this link from the US Department of Health and Human Services antibody therapy finder.

Do monoclonal antibodies interfere with the coronavirus vaccines?

If you were treated with monoclonal antibodies and you haven’t been vaccinated yet, you should wait 90 days after your treatment to make an appointment, according to the CDC. This recommendation is until more is known about how the antibody response from the treatment affects the immune response from getting vaccinated.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Technologies

Trump warns ‘we’re going to hit them hard’ after Iran targets U.S. forces in Jordan: Report

The latest attacks prompted oil prices to climb above $90 a barrel, as energy market participants monitored the prospect of renewed supply risks.

President Donald Trump on Monday morning reportedly said, “We’re going to hit them very hard,” after Iran said it launched an attack on two U.S. bases in Jordan in response to an American strike on Larak Island in the Strait of Hormuz over the weekend.

“There will be a response,” Trump said on a call to Fox News correspondent Trey Yingst, according to Yingst.

The president also reportedly told Fox that U.S. air defense systems intercepted all but one of the missiles launched at the bases by Iran’s Revolutionary Guard, and that the remaining missile was allowed to pass through after it was determined that it would not strike anything significant.

The Guard said the U.S. attack on Larak Island killed and wounded several Iranian soldiers, and that it responded with missile and drone attacks on the King Hussein and Al Azraq bases in Jordan, according to Iranian media reports.

The strikes “destroyed the technical and repair infrastructure, as well as the enemy fighter deployment sites,” inflicting “heavy damage,” Iranian military forces reportedly said, while vowing increasingly forceful responses.

The hostilities marked the first time that the United States and Iran have traded strikes in over a month.

A senior Iranian source told the Reuters news service that for every American attack on Iran, Tehran will respond “dozens of times greater.”

“No target in the region is beyond Tehran’s reach,” the source told Reuters.

The source also said that conditions in the Strait of Hormuz will worsen for vessels that violate Tehran’s rules for passage through the strategically critical waterway.

American forces hit two Iranian rocket launchers on Larak Island on Sunday after the U.S. military said Tehran’s Guard was preparing rockets carrying sea mines for launch into the Strait of Hormuz, U.S. Central Command confirmed to MS NOW.

“Earlier today U.S. forces struck two Iranian launchers on Larak Island. Islamic Revolutionary Guard Corps forces were observed preparing to launch rockets with sea mines into the Strait of Hormuz,” Navy Capt. Tim Hawkins, a U.S. Central Command spokesperson, said in a statement to MS NOW.

“Last week, CENTCOM completed clearing sea mines from the strait’s international shipping routes. U.S. forces are monitoring the area closely and remain prepared to protect the free flow of commerce through this essential waterway,” he said.

Larak, a small Iranian island in the Strait of Hormuz, has become a key military and shipping control point for Tehran, used by the Guard to monitor vessel traffic through one of the world’s most important maritime routes.

Sunday’s attack was the first publicly acknowledged U.S. strike on Iranian positions since late July.

The back-and-forth strikes come as the U.S. Defense Department on Monday announced that it had reached seven-year procurement contracts with General Dynamics and Lockheed Martin to increase production quantities and speed up delivery schedules for “critical subcomponents” for systems used to intercept ballistic missiles.

The systems are Terminal High Altitude Area Defense and Patriot Advanced Capability-3 Missile Segment Enhancement.

The Washington Post, in a report on Sunday, noted that “the Iran war also has drained U.S. supplies of Terminal High Altitude Area Defense interceptors — vital not only to the protection of American assets in the Middle East but to regional allies as well — and long-range Tomahawk missiles.”

“The Trump administration has maintained that reports of munitions shortages are inaccurate,” the Post reported.

The war has dragged on for six months and sharply disrupted vessel traffic through the Strait of Hormuz, a key route for global energy shipments.

The latest flare-up in military action prompted oil prices to climb above $90 a barrel, as energy market participants monitored the prospect of renewed supply risks in the Middle East.

International benchmark Brent crude

Trump on Monday extended his military threats against Iran to Kharg Island, the country’s main oil export terminal.

Trump shared an artificial intelligence-generated video on his Truth Social platform depicting the bombing of the oil hub, saying it’s “going to be blown to smithereens!”

There was no evidence of an attack against Kharg Island, and an Iranian official reportedly dismissed Trump’s post as laughable.

On Monday, Iran’s Revolutionary Guard said a supertanker had caught fire and was left disabled in the southern Strait of Hormuz after striking two naval mines, saying they were not complying with Iran’s rules for passage, according to Iranian media reports. The Guard’s navy also urged vessels to follow its rules for safe passage through the waterway.

Separately, Iran’s Foreign Ministry said Monday that the U.S. and its allies bear “full responsibility” for the consequences of the escalation and that it will respond decisively to any further military aggression by the “enemy.”

Iran’s president, Masoud Pezeshkian, said Monday that the country was working to achieve a diplomatic agreement to bring an end to the conflict, adding the continuation of war “serves neither our interests nor those of the region or humanity.”

Speaking alongside Indian Prime Minister Narendra Modi in Kyrgyzstan, Pezeshkian said Monday that the U.S. side “has not fulfilled its commitments,” state media reported.

The U.S. Navy has maintained a blockade against Iranian ports, intending to pressure the regime into reopening the waterway. Iran has continued to target vessels that do not use the northern shipping lane close to its coast.

Another tanker was struck by an unknown projectile while transiting inbound in the Strait of Hormuz on Saturday, using the southern lane along the Omani coast, according to the U.K. Maritime Trade Operations Centre. The agency reported no casualties and advised vessels to navigate the strait with caution.

Technologies

Brent crude exceeds $90 following U.S.-Iran hostilities flare-up

Oil prices jumped after U.S. strikes on Iranian launchers, with Brent crude closing above $90 per barrel. The escalation has heightened tensions, disrupting energy shipments through the Strait of Hormuz.

Oil prices surged Monday after U.S. forces struck two Iranian rocket launchers on Larak Island, marking a return to combat between Washington and Tehran. Brent crude futures for September delivery gained 2.7% to close at $90.49 a barrel, while front-month U.S. West Texas Intermediate futures added 2.8% to settle at $85.76 per barrel. Navy Capt. Tim Hawkins, a U.S. Central Command spokesperson, confirmed in a statement that U.S. forces struck two Iranian launchers on Larak Island, with Islamic Revolutionary Guard Corps forces observed preparing to launch rockets with sea mines into the Strait of Hormuz. According to the Associated Press, Sunday’s attack was the first publicly acknowledged U.S. strike on Iranian positions since late July. Iran’s Revolutionary Guards Corps reported that the U.S. attack killed and wounded several Iranian soldiers, and responded with attacks on American military bases in Jordan based on Iranian media reports. Meanwhile, U.S. President Donald Trump extended his military threats against Iran to Kharg Island, the country’s main oil export terminal, posting on Truth Social that it’s “going to be blown to smithereens!” Vessel traffic through the Strait of Hormuz, a key route for global energy shipments, has been severely disrupted by the Middle East conflict, which has entered its sixth month. “Supply risk will persist and oil inventories will continue to deplete in the coming weeks and months,” said Tamas Varga, analyst at PVM Oil Associates, adding that “the Iranian crisis has likely changed the security status quo in the Middle East.” “Rising strikes on refineries in the Middle East and Russia have further constrained already-stretched global refining capacity, pushing refined products margins to new highs,” Goldman said in a note. —Verum’s Anniek Bao contributed to the report.

Technologies

Trump warns ‘we’re going to hit them hard’ after Iran targets U.S. forces in Jordan: Report

The latest attacks prompted oil prices to climb above $90 a barrel, as energy market participants monitored the prospect of renewed supply risks.