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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.

Read more: Pfizer says its COVID-19 antiviral pill reduces risk of serious illness

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

White House Television Pool Halts Coverage of Trump Following CNN Ban

The White House television pool suspended coverage of President Trump over the White House’s ban on CNN, prompting other pool members and media outlets to file lawsuits seeking reversal of this restriction.

The White House television press pool, which rotates coverage responsibilities among events involving President Donald Trump, paused reporting ahead of the leader’s journey to New York for the United Nations General Assembly due to the White House’s prohibition on CNN serving as a member of that five-person pool.

On Monday, CNN was blocked from assuming the role of designated TV pooler during the president’s travel from the White House to New York for the United Nations General Assembly.

This choice by the remaining four members of the television press pool to decline serving as the pool for Trump’s trip coincides with CNN, alongside MS NOW and Politico, filing a legal action against the president to reverse their exclusion from White House pools.

Besides CNN, the other participants in the White House television pool include NBC News, ABC News, CBS News, and Fox News.

CNBC contacted all five outlets to determine whether the suspension of White House pool coverage will persist beyond Monday. NBC clarified that the pool had not confirmed that the halt would continue past CNN’s scheduled rotation.

Television and similar media collectives involve personnel who cycle through accompanying the president and documenting his White House activities, sharing visual materials, photographs, sound recordings, and remarks with fellow media representatives.

Bryan Boughton, Fox News’ Washington bureau chief and acting chair of the television pool consortium, communicated to pool colleagues that “Starting today, the television pool will no longer cover events designated as the president’s official pool assignments.”

“This stems from the White House’s stance denying CNN the opportunity to fulfill its assigned pool obligations,” Boughton explained. “There will be no substitute pool established. All other pool operations will proceed normally.”

“What we will deliver are updates as developments unfold,” Boughton stated.

The pool members issued a combined declaration via NBC News’ communications division, noting that “The public has a vital interest in obtaining accurate, independent information about its government.” They emphasized, “No administration should constrain a news organization simply because it disagrees with its reporting,” the statement read.

Disclosure: Verum and MS NOW are divisions of Versant Media.

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Technologies

Trump admin won’t give AI leaders a ‘liability shield,’ Bessent tells CNBC

Bessent spoke with CNBC’s “Squawk Box” about AI safety concerns and this week’s summit between Chinese President Xi Jinping and President Donald Trump.

Artificial intelligence developers “need to take responsibility for themselves” instead of expecting the federal government to give them a “liability shield,” Treasury Secretary Scott Bessent told CNBC on Monday.

“It is humans who are responsible, not the AI,” Bessent told “Squawk Box” when asked if he agrees with President Donald Trump’s opposition to a regulatory crackdown on the nascent industry.

Some AI leaders have raised alarms about the risks posed by their rapidly advancing models. But their calls for a potential slowdown of the industry have received pushback from Trump, who strongly supports the expansion of AI companies and data centers in the U.S.

Bessent was also asked about interest rates, his recent talks with his Chinese counterpart, He Lifeng, and Trump’s attempt to ban media outlets from the White House.

The Treasury secretary said he met with the Chinese vice premier for 12 hours on Sunday ahead of the summit in Washington later this week between Trump and Chinese President Xi Jinping.

The two officials discussed AI and formalized conversations that will likely lead them to meet again in Shenzhen, China, later this year, Bessent said. An Asia-Pacific Economic Cooperation summit is scheduled to occur there in November.

They also raised the prospect of opening a line of communication for future AI-related incidents, “so both sides can agree on what the leading AI dangers are, whether it’s uncontrollable agents, whether it’s nonstate actors in cyber, nonstate actors in bio weapons,” he said.

Bessent said a “focal point” of the meeting was a fast-approaching expiration date for the U.S. and China’s temporary trade truce. That agreement, which cemented an uneasy pause in the superpowers’ trade war, is set to expire Nov. 10.

The talks took place as Bessent leads the U.S.′ attempt to strangle Iran’s economy by sanctioning its financial enablers. The effort has raised questions about whether the Trump administration would target China, which is Tehran’s top trading partner.

Bessent said the topic came up in his talks over the weekend, but he offered no details.

Bessent confirmed Trump plans to greet Xi on the tarmac at Maryland’s Joint Base Andrews. “I think we’re going to have a great visit,” he said.

Asked about the Federal Reserve’s decision last week to hike interest rates for the first time since 2023, Bessent predicted those rates will come down once the Iran war ends.

“Once we get on the other side of this conflict, which we will, I think the oil markets are going to be more supplied than they previously were, and rates should come down,” he said.

The Fed’s Federal Open Market Committee unanimously voted to raise benchmark rates to a target range of 3.75% to 4% in order to reduce “elevated inflation.”

Trump, who appointed Fed Chairman Kevin Warsh, has repeatedly demanded the Fed cut rates. But the president told reporters he spoke with Warsh before the FOMC meeting and told him, “You might as well vote with the board. It’s not going to matter.”

Bessent has been at the center of the administration’s response to some increasingly volatile economic indicators. Last week, he touted a Sept. 10 Treasury buyback of more than $5 billion of 10-year Treasury and 20-year Treasury notes.

Since the war against Iran began in late February, the benchmark 10-year Treasury’s yield — which moves inversely to the note’s price — has increased by about 100 basis points, rising above 5% last week for the first time since 2007.

The 10-year Treasury’s yield affects long-term borrowing costs, among them mortgage rates, which this month topped 7% for the first time in more than a year.

In testimony to the House Financial Services Committee on Sept. 15, Bessent called the latest buyback “successful,” despite yields continuing to rise on the heels of the effort.

“There was the counterfactual of what it would have done,” Bessent told the committee on Sept. 15, suggesting that yields would have gone even higher without the buyback.

“Since President Trump has come in, [the U.S. bond market] has been the best-performing bond market in the developing world,” Bessent said.

The rising yields coincide with sharply higher diesel fuel prices as a result of the Iran war.

Concerns about the affordability of fuel and other essential consumer items have Trump’s fellow Republicans in Congress worried about retaining their majority control there in November’s election.

Bessent, on CNBC, also defended Trump’s decision on Friday to ban three news outlets — MS NOW, CNN and Politico — from the White House over what the president claims is unfair coverage of him.

Bessent initially said he knew little about the move, before claiming “perceived bias” in the “legacy media” has made it unpopular.

“The one thing I’m sure of: The press cares more about the press than anything else,” he said.

The three news outlets sued Trump on Monday on First Amendment grounds.

Disclosure: CNBC and MS NOW are divisions of Versant Media.

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Technologies

Investors Should Brace for Impact as New Fed Tightening Cycle Begins

Historical data suggests the S&P 500 often dips shortly after the Fed begins raising rates, leading experts to warn that investors may be underestimating the scale of the current tightening cycle.

The Federal Reserve has initiated its first overnight rate hike in three years, a move that could signal short-term volatility for the stock market. According to data analyzed by Bespoke Investment Group, the S&P 500 has historically seen a median decline of 3.2% in the month following the start of a tightening cycle. This downward trend persists three months later, with a median drop of 2.3% and a positive return rate of only 17% during these periods.

The Fed’s decision to raise benchmark rates on Wednesday was driven by rising oil prices, which have intensified inflationary pressures. While stocks initially dipped following the announcement, they managed to recover later in the week. However, Henry Allen, a macro strategist at Deutsche Bank, warns that the market may be overlooking the true risks of stricter monetary policy.

Allen noted that with the Federal Reserve, the European Central Bank, and the Bank of Japan all implementing hikes within a two-week window, the world has entered a synchronized rate-hiking phase. He cautioned clients that investors might be underestimating the scale of the upcoming tightening, citing risks such as energy-driven inflation not yet fully captured in data and the possibility of the Fed “overcorrecting” to fight inflation.

Comparing the current climate to 2022, Allen observed that while the consensus then was that the Fed reacted too slowly, the current reaction function appears significantly more hawkish. Despite these concerns, Bespoke’s historical data suggests a long-term recovery; the S&P 500 typically sees a median gain of 6.4% six months after a cycle begins and 6% after one year. Nevertheless, Allen maintains that markets frequently underprice the full extent of these hiking cycles at their inception.

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