All the weak points of American health care — testing delays, communication breakdowns, inequity — are working against this potential treatment.
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Tag Archives: antibodies
How an Ill-Fated Fishing Voyage Helped Us Understand Covid-19
The threat posed by the virus makes randomized controlled trials extremely difficult. That means “real-life experiments” are especially important.
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FDA approves first treatment for Ebola, a Regeneron antibody cocktail
Enlarge / Staff from South Sudan’s Health Ministry pose with protective suits during a drill for Ebola preparedness conducted by the World Health Organization (WHO). (credit: Getty | Patrick Meinhardt)
The Food and Drug Administration on Tuesday issued the first-ever approval for a therapy against Ebola virus disease.
Though the Ebola vaccine, Ervebo, earned approval late last year and proved 97.5 percent effective in preliminary trials, the newly approved therapy may be useful in addressing an ongoing outbreak in Democratic Republic of Congo, which began in June. The FDA’s approval may also boost the outlook for similar therapies being developed for COVID-19, which may become available before a vaccine.
The newly approved Ebola treatment, called Inmazeb (aka REGN-EB3), is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. The antibodies target the only protein on the outside of Ebola virus particles, the glycoprotein. Ebola uses its glycoprotein to attach to and enter human cells, sparking infection. The cocktail of antibodies glom on to the protein, keeping it from invading cells.
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Trump May Be Immune to the Coronavirus. But for How Long?
A unique treatment course may have blunted his body’s production of antibodies, scientists warn.
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For How Long Will President Trump Be Immune to the Coronavirus?
A unique treatment course may have blunted his body’s production of antibodies, scientists warn.
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The Race for a Super-Antibody Against the Coronavirus
A network of scientists is chasing the pandemic’s holy grail: an antibody that protects against not just the virus, but also related pathogens that may threaten humans.
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Trump’s Covid Treatments Were Tested in Cells Derived From Fetal Tissue
The “cell lines” used to develop monoclonal antibodies, as well as remdesivir and vaccines, began with fetal tissue decades ago.
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With ‘Cure’ Comment, Trump Exaggerates Known Benefits of Another Covid-19 Therapy
An experimental antibody cocktail taken by the president has not yet been proven effective against the illness caused by the coronavirus.
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Trump’s Covid Treatments Suggest a Serious Condition
Outside experts pointed to the therapies as signs that the president’s health may not be as good as his doctors said. His age, weight and gender put him at high risk.
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Will President Trump Get Antibody Treatments for Covid-19?
Regeneron and Eli Lilly wouldn’t say whether Mr. Trump would receive their experimental antibody drugs. Regeneron’s C.E.O. has known the president for years.
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Pandemic Is Far From Over, Experts Say, Despite Trump Allies’ Claims
The C.D.C. and leading experts have concluded, using different scientific methods, that as many as 90 percent of Americans are still vulnerable to infection.
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Eli Lilly Claims Experimental Drug Protects Covid-19 Patients
A so-called monoclonal antibody lowered levels of the coronavirus and prevented hospitalizations. The research has not yet been vetted by independent experts.
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Russians Publish Early Coronavirus Vaccine Results
The first batch of public data from the “Sputnik V” vaccine showed that it was safe and produced an immune response. No one knows yet whether it prevents coronavirus infections.
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National Institutes of Health disses FDA on plasma as COVID treatment
Enlarge / Francis Collins, director of the U.S. National Institutes of Health, reportedly objected to the FDA’s decision to grant an Emergency Use Authorization to plasma treatments. (credit: Bloomberg / Getty Images)
Last week, the FDA announced that it was issuing an emergency use authorization for the treatment of COVID-19: the blood plasma of people who have recovered from a COVID-19 infection. But controversy quickly engulfed that announcement after it became clear that the head of the FDA had exaggerated the effectiveness of the treatment when explaining why it was being approved.
The FDA’s salesmanship of blood plasma—which is a treatment of unknown efficacy—was taken as evidence that the emergency use authorization was the product of political pressure exerted by a Trump administration anxious to have some good news to promote its reelection campaign. Additionally, health experts at the National Institute of Health (NIH) didn’t agree with the decision and had tried to block it a week ago. Now, the NIH may be striking back, releasing a document that basically says it’s looked at the evidence and is not convinced.
Not so fast
While the CDC and FDA have led some aspects of the coronavirus response, the NIH is the employer of Anthony Fauci and the largest biomedical research organization in the world. So it certainly has things to say about how to handle the pandemic, and it maintains a COVID-19 Treatment Guidelines Panel. This, as its name implies, maintains guidelines on different aspects of care for the disease. So, given that the FDA has just given an Emergency Use Authorization to a treatment, it essentially forced the NIH to respond in some way.
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These Scientists Are Giving Themselves D.I.Y. Coronavirus Vaccines
Impatient for a coronavirus vaccine, dozens of scientists around the world are giving themselves — and sometimes, friends and family — their own unproven versions.
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Another COVID-19 reinfection: This time second infection was more severe
Enlarge / A nurse practitioner administers COVID-19 tests in the parking lot at Brockton High School in Brockton, MA under a tent during the coronavirus pandemic on Aug. 13, 2020. (credit: Getty | Boston Globe)
A 25-year-old resident of Reno, Nevada was infected with the pandemic coronavirus, SARS-CoV-2, two times, about 48-days apart, with the second infection causing a more severe case of COVID-19 than the first and requiring hospitalization and oxygen support.
That’s according to a draft study, led by researchers at the University of Nevada and posted online. The study has not been published by a scientific journal and has not been peer-reviewed. Still, it drew quick attention from researchers, who have been examining data from the first confirmed case of a SARS-CoV-2 reinfection, reported earlier this week.
Reinfections with SARS-CoV-2 are not surprising—or even necessarily concerning. From person to person, immune responses to an infection develop along a spectrum, with some people mounting robust, protective responses and others being left with weaker responses. Amid the more than 24.5 million cases worldwide, it is completely expected to find some recovered patients who are not completely protected by their immune responses and are thus vulnerable to reinfection.
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What if the First Coronavirus Vaccines Aren’t the Best?
Dozens of research groups around the world are playing the long game, convinced that their experimental vaccines will be cheaper and more powerful than the ones leading the race today.
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More of Your Coronavirus Testing Questions, Answered
Our readers sent in smart questions about this thorny issue.
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FDA’s promotion of post-COVID plasma treatment was as bad as it appeared
Enlarge / FDA Commissioner Stephen Hahn, speaking at the press conference in which he badly mangled statistics. (credit: Pete Marovich/Getty Image)
After several days of rumors with ever-growing hype, the Trump administration announced on Sunday that the Food and Drug Administration was granting an Emergency Use Authorization (EUA) for a COVID-19 treatment. The move was controversial from the start, with reports indicating that the EUA was opposed by a number of health experts, including Francis Collins and Anthony Fauci. The press conference didn’t settle matters, with a growing chorus of scientists saying that the data presented in support of the EUA had been misrepresented.
On Monday night, FDA commissioner Stephen Hahn acknowledged that he had made a significant error in presenting the benefits of the treatment, and he followed that with an apology on Tuesday. But Hahn pushed back on indications that the approval of the treatment on the eve of the Republican National Convention was motivated by political pressure.
Wrong kind of risk
The treatment at issue involves taking the antibody-containing plasma from those who have recovered from a SARS-CoV-2 infection (convalescent plasma) and giving it to those currently suffering from COVID-19 symptoms. At Sunday’s press conference, the principle justification for allowing this treatment under an EUA was a 35 percent drop in mortality for those receiving plasma in the first three days of treatment—specifically, Hahn said 35 of 100 people “would have been saved” by this treatment.
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First Documented Coronavirus Reinfection Reported in Hong Kong
The patient did mount an immune response to the new infection, however, and did not experience symptoms.
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Where We Stand on the Pandemic
As summer draws to a close, four new developments in the treatment and understanding of the coronavirus have arisen in the United States and abroad.
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Healthy 33-yr-old man first to have confirmed reinfection with SARS-CoV-2
Enlarge / Medical staff wearing personal protective equipment (PPE) as a precautionary measure against the COVID-19 coronavirus approach Lei Muk Shue care home in Hong Kong on August 23, 2020. (credit: Getty | May James)
A healthy, 33-year-old man in Hong Kong is now the first person in the world confirmed to have been reinfected by the pandemic coronavirus, SARS-CoV-2—which has currently infected more than 23 million people worldwide.
The man’s first infection was in late March. He reported having a cough with sputum, fever, sore throat, and a headache for three days before testing positive for the virus on March 26. Though his symptoms subsided days later, he was hospitalized on March 29 and remained in the hospital until April 14, when he tested negative for SARS-CoV-2 in two tests taken 24-hours apart.
About 4.5 months later, the man tested positive for the virus again. This time, his infection was caught during entry screening at a Hong Kong airport, as he returned from a trip to Spain, via the United Kingdom, on August 15. Though he had no symptoms, he was again hospitalized. Clinical data showed he had signs of an acute infection, but he remained asymptomatic throughout his time in the hospital.
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Trump announces a COVID-19 Emergency Use Authorization for blood plasma
Enlarge / Donald Trump gestures to Stephen Hahn, head of the FDA, at an earlier press conference. (credit: Drew Angerer)
Today, President Trump held a news conference to announce that the FDA has granted an Emergency Use Authorization for the treatment of COVID-19 cases using blood plasma from those formerly infected. The move comes despite significant uncertainty regarding just how effective this treatment is, and comes just days after Trump attacked the FDA for delaying its work as part of a plot to sabotage his re-election.
In the blood
Plasma is the liquid portion of the blood, which (among other things) contains antibodies. It has been used to treat other infections, as some antibodies can be capable of neutralizing the infecting pathogen—binding to the bacteria or virus in a way that prevents it from entering cells. Early studies have indicated that it’s relatively common for those who have had a SARS-CoV-2 infection to generate antibodies that can neutralize the virus in lab tests, although the antibody response to the virus is also highly variable.
In the absence of any effective treatments, people started testing this “convalescent plasma” as early as March, and testing has been expanded as the pool of post-infected individuals has continued to grow. But so far, the evidence has been mixed. One of the largest studies, led by researchers at the Mayo Clinic and including over 35,000 patients, did see an effect, but it was a very mild one: mortality dropped from 11.9 percent in people who received plasma four days or more after starting treatment, compared with 8.7 percent if treatment was started earlier than that. But, critically, the study lacked a control group, leaving its authors talking about “signatures of efficacy,” rather than actual evidence of efficacy.
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Hint of COVID-19 immunity: 3 sailors with antibodies spared in outbreak at sea
Enlarge / Fishing vessels in Seattle. (credit: Getty | Art Seitz)
Hints of protective immunity against the pandemic coronavirus have surfaced in the wake of a recent COVID-19 outbreak that flooded the crew of a fishing vessel.
The coronavirus, SARS-CoV-2, infected 104 of the 122 people on board, about 85 percent, during a short voyage. But trawling through data collected before and after the ship set sail, researchers noted that the 18 spared from infection just happened to include the only three people on board that had potent, pre-existing immune responses against SARS-CoV-2. Specifically, the three sailors were the only ones found to have SARS-CoV-2 neutralizing antibodies, which are proteins that circulate in the blood and completely sink the infectious virus.
The numbers are small and the finding is not definitive. Additionally, the study appeared this month on a pre-print server, meaning it has not been published by a scientific journal or gone through peer review. Still, experts say the study was well done and significant for netting data that hint that potent, pre-existing immune responses from a past infection can indeed protect someone from catching the virus again.
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Why Antibody Tests Won’t Help You Much
Most antibody tests are useful only for large population surveys, diagnosis in certain children or when initial diagnostic testing fails, according to an expert panel.
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An ‘Unprecedented’ Effort to Stop the Coronavirus in Nursing Homes
Researchers are testing an experimental drug to halt sudden outbreaks. The trial may bring a new type of treatment for the virus.
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What Antibody Test Results Show Us
The data from 1.5 million tests confirms how deeply the coronavirus affected lower-income communities.
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Covid-19 Antibody Tests Show What Parts of N.Y.C. Were Hit Hardest
The data from the city is on a far larger scale than previously released information, and includes all antibody test results reported to the city’s Department of Health.
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Covid-19: What if ‘Herd Immunity’ Is Closer Than Scientists Thought?
In what may be the world’s most important math puzzle, researchers are trying to figure out how many people in a community must be immune before the coronavirus fades.
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Scientists See Signs of Lasting Immunity to Covid-19, Even After Mild Infections
New research indicates that human immune system cells are storing information about the coronavirus so they can fight it off again.
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Scared That Covid-19 Immunity Won’t Last? Don’t Be
Dropping antibody counts aren’t a sign that our immune system is failing against the coronavirus, nor an omen that we can’t develop a viable vaccine.
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The Coronavirus Could Dodge Some Treatments, Study Suggests
A laboratory experiment hints at some of the ways the virus might elude antibody treatments. Combining therapies could help, experts said.
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Your Coronavirus Antibodies Are Disappearing. Should You Care?
Declining antibody levels do not mean less immunity, experts say. Besides, two widely used tests may detect the wrong antibodies.
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Can You Become Reinfected With Covid? It’s Very Unlikely, Experts Say
Reports of reinfection instead may be cases of drawn-out illness. A decline in antibodies is normal after a few weeks, and people are protected from the coronavirus in other ways.
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CDC finds lots of undetected coronavirus cases in the US
Enlarge / A nurse at the Miami Beach Convention Center Community Based Testing Site conducts a COVID-19 antibody test. The Florida Guard is providing support at the Miami Beach hybrid CBTS and Hard Rock Stadium CBTS to allow the state and local partners to conduct antibody testing for first responders at both facilities. (US Army photo by Sgt. Leia Tascarini) (credit: Army Sgt. Leia Tascarini)
It’s been clear from quite early in the COVID-19 pandemic that a substantial number of people who get infected by SARS-CoV-2 don’t experience significant symptoms. This simple fact has enormous public health consequences, as these asymptomatic individuals can still pass the infection on to others. That means that even if we were able to get everyone with symptoms to self-isolate, we may still be unable to check the spread of the pandemic. It also makes it much harder to find out the true spread of the virus, since many people won’t bother to get tested if they aren’t feeling unwell.
Most of the data on the spread of the pandemic within the US comes from tests that pick up the presence of the virus’ genome, which indicates the presence of an active infection. But you have to catch the person while the infection is happening for this to work. The alternative is to look for an indication of a past infection: the presence of antibodies against SARS-CoV-2. While the immune response to the virus is complex and isn’t present immediately after an infection, most people have at least some antibodies a few weeks after the virus is cleared.
This allows widespread antibody testing to provide a clearer picture of the virus’ past spread through a population. On Tuesday, the CDC started releasing lots of data from past antibody testing. While it was from a period where the virus was relatively rare in the US, the data provides a sharp contrast to the RNA-based tests from the same time, showing that lots of infections have gone undetected.
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Nannies Wanted: Covid-19 Antibodies Preferred
During the pandemic, caregivers are being asked to do more than ever, from cleaning and cooking to teaching algebra.
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Study of Coronavirus in Pregnant Women Finds Striking Racial Differences
About 10 percent of Black, Hispanic and Latino participants in a Philadelphia study of pregnant women had been exposed to the coronavirus, compared with 2 percent of white participants.
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Regeneron Scientists Raced To Find Antibodies To Fight Covid-19. Then The Coronavirus Found Them.
This spring, researchers at Regeneron’s Westchester headquarters found themselves in one of the country’s first coronavirus hot spots.
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68% Have Antibodies in This Neighborhood. Can It Hold Off a Next Wave?
The data emerging from those tested at a storefront medical office in Queens is leading to a deeper understanding of the scope of the coronavirus outbreak in New York.
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In Early February, the Coronavirus Was Moving Through New York
Antibodies appeared in blood samples taken later in the month, a new study finds.
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Coronavirus Was Moving Through NY in Early February
Antibodies appeared in blood samples taken later in the month, a new study finds.
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You May Have Antibodies After Coronavirus Infection. But Not for Long.
Antibodies to the virus faded quickly in asymptomatic people, scientists reported. That does not mean immunity disappears.
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Black and Latino Churches Offer Prayers, Hope and Coronavirus Testing
A public health program takes free tests and fellowship to communities in New York that have been devastated by Covid-19.
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Antibody testing suggests immune response post-COVID is very variable
Enlarge / Melissa Cruz elevates her arm after donating COVID-19 convalescent plasma as phlebotomist Jenee Wilson shuts down a machine. (credit: Karen Ducey / Getty Images)
How much of an immune response does a SARS-CoV-2 infection produce? It’s a critical question for all sorts of reasons. To begin with, long-lasting immunity, either through an infection or a vaccine, is critical for any hope of returning the world to something that resembles its pre-pandemic state. It’s also essential to understanding how safe people who have recovered from infections are and how they can behave in the face of continued outbreaks and spread.
But there are also more subtle public policy issues. Since testing wasn’t generally available at the time of many outbreaks, we’ll need antibody tests to figure out who was actually exposed. And the accuracy of those tests—which has been called into question—can have a big influence on studies of the pandemic’s progression.
A bunch of recent draft papers have looked at the sort of immune response we’re seeing in patients who have cleared the virus after testing positive for it. And the results suggest that it’s very variable—as is the quality of the tests that detect it. (We’ll remind you that pre-publication documents carry some quality risks.)
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