Fact Sheet for Patients And Parents/Caregivers
Emergency Use Authorization (EUA) Of Veklury® (remdesivir) For Coronavirus Disease 2019
You are being given a medicine called Veklury (remdesivir) for the treatment of coronavirus disease 2019
(COVID-19). This Fact Sheet contains information to help you understand the potential risks and potential benefits
of taking Veklury, which you have received or may receive.
There is no U.S. Food and Drug Administration (FDA) approved product available to treat COVID-19. Receiving
Veklury may benefit certain people in the hospital with COVID-19. Read this Fact Sheet for information about
Veklury. Talk to your healthcare provider if you have questions. It is your choice to receive Veklury or stop it at
What is COVID-19?
COVID-19 is caused by a virus called a coronavirus. This type of coronavirus has not been seen before.
You can get COVID-19 through contact with another person who has the virus.
COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including
illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can
happen and may cause some of your other medical conditions to become worse. Older people and people of all
ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for
example, seem to be at higher risk of being hospitalized for COVID-19.
What are the symptoms of COVID-19?
The symptoms of COVID-19 are fever, cough, and shortness of breath, which may appear 2 to 14 days after
exposure. Serious illness including breathing problems can occur and may cause your other medical conditions to
What is Veklury (remdesivir)?
Veklury is an investigational antiviral medicine used for the treatment of certain people in the hospital with COVID19. Veklury is investigational because it is still being studied. There is limited information known about the safety
and effectiveness of using Veklury to treat people in the hospital with COVID-19. Veklury was shown in a clinical
trial to shorten the time to recovery in some people. There are no medicines approved by the FDA as safe and
effective to treat people in the hospital who have COVID-19. Therefore, the FDA has authorized the emergency
use of Veklury for the treatment of COVID-19 under an Emergency Use Authorization (EUA). For more information
on EUA, see the “What is an Emergency Use Authorization (EUA)?” section at the end of this Fact Sheet.
What should I tell my healthcare provider before I receive Veklury (remdesivir)?
Tell your healthcare provider about all of your medical conditions, including if you:
• Have any allergies
• Have kidney or liver problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Have any serious illnesses
• Are taking any medicines (prescription, over-the-counter, vitamins, or herbal products). Veklury may affect the
way other medicines work, and other medicines may affect how Veklury works.
o Especially tell your healthcare provider if you are taking the medicines chloroquine phosphate or
How will I receive Veklury (remdesivir)?
Veklury is given to you through a vein (intravenous or IV) one time each day for up to 10 days depending on what
your healthcare provider thinks is best for you. Veklury may help decrease the amount of the coronavirus in your
body. This may help you to get better faster.
What are the important possible side effects of Veklury (remdesivir)?
Possible side effects of Veklury are:
• Allergic reactions. Veklury can cause allergic reactions, including serious reactions, during and after infusion.
Tell your healthcare provider or nurse, or get medical help right away if you get any of the following signs and
symptoms of allergic reactions: low blood pressure, changes in your heartbeat, shortness of breath, wheezing,
swelling of your lips, face, or throat, rash, nausea, vomiting, sweating, or shivering.
• Increases in levels of liver enzymes. Increases in levels of liver enzymes have been seen in people who have
received Veklury, which may be a sign of inflammation or damage to cells in the liver. Your healthcare
provider will do blood tests to check your liver before you receive Veklury and daily while receiving Veklury.
These are not all the possible side effects of Veklury. Veklury is still being studied so it is possible that all of the
risks are not known at this time.
Not a lot of people have taken Veklury. Serious and unexpected side effects may happen. The side effects of
getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and
possible infection at the injection site.
What other treatment choices are there?
Like Veklury, FDA may allow for the emergency use of other medicines to treat people in the hospital with COVID19. Go to https://www.covid19treatmentguidelines.nih.gov/ for information on the emergency use of other
medicines that are not approved by FDA to treat people in the hospital with COVID-19. Your healthcare provider
may talk with you about clinical trials you may be eligible for.
It is your choice to be treated or not to be treated with Veklury. Should you decide not to receive it or stop it at any
time, it will not change your standard medical care.
What if I am pregnant or breastfeeding?
There is limited experience giving Veklury to pregnant women or breastfeeding mothers. For a mother and
unborn baby, the benefit of receiving Veklury may be greater than the risk from the treatment. If you are
pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.
How do I report side effects with Veklury (remdesivir)?
Tell your healthcare provider right away if you have any side effect that bothers you or does not go away.
Report side effects to FDA MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088.
How can I learn more?
• Ask your healthcare provider.
• Visit https://www.covid19treatmentguidelines.nih.gov/
• Contact your local or state public health department.
What is an Emergency Use Authorization (EUA)?
The United States FDA has made Veklury available under an emergency access mechanism called an EUA.
The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist
to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
Veklury has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an
EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives.
In addition, the FDA decision is based on the totality of scientific evidence available showing that it is
reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be
effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for
the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for Veklury (remdesivir) is in effect for the duration of the COVID-19 declaration justifying emergency
use of these products, unless terminated or revoked (after which the products may no longer be used).
© 2020 Gilead Sciences, Inc. All rights reserved.
As we all navigate uncharted territory during this COVID-19 epidemic, La Jolla Institute for Immunology is committed to updating the community on its related research efforts underway as well as resources for additional information. Click below to learn more.RESEARCH EFFORTS UNDERWAYACCELERATE DISCOVERIESVIDEOSSTAFF SUPPORT AND RESOURCESCOVID-19 STUDY
RESEARCH EFFORTS UNDERWAY
LA JOLLA INSTITUTE FOR IMMUNOLOGY CORONAVIRUS TASK FORCE
La Jolla Institute, one of the leading global organizations dedicated to studying the immune system, is stepping up to provide much needed information and real solutions for the COVID-19 outbreak and to improve how we respond to future emerging infectious diseases. We have launched a multi-lab Coronavirus Taskforce that capitalizes on our competitive advantages of unique skill in infectious disease research, state-of-the-art technology, and highly collaborative organization.
Members of the LJI Coronavirus Taskforce are contributing their unique expertise and perspective in the following ways:
Validating a novel, point-of-need diagnostic test
In collaboration with diagnostic company Mologic, Dr. Sujan Shresta is validating a quick diagnostic test that can detect current or past infections with SARS-CoV-2 in the field.
Understanding why and how COVID-19 spreads and kills
Dr. Alessandro Sette, a world leader in analyzing T cells responses, is establishing a global network to comprehensively map the T cell response to SARS-CoV-2. The work will provide an atlas to guide vaccine evaluation, establish the relative value of various viral targets and vaccine designs, and project the impact of viral variants that may be developing throughout the pandemic.
Dr. Pandurangan Vijayanand, a widely recognized expert in analyzing how genes influence immune responses, will carry out genetic analysis of single T cells from groups of patients to quickly reveal what’s wrong with immune cells in blood and lungs of patients with severe disease.
The lab of Dr. Shane Crotty is an acknowledged groundbreaker on devising ways to stimulate protective B cells responses to HIV and other viruses. He will lead the effort to analyze the helper T cells, focused on understanding how they help B cells make antibodies against SARS-CoV-2 in mild and severe disease manifestations, as this is likely important for knowing what will constitute a desirable immune response in the context of a vaccine.
Together with her international network of collaborators, Dr. Sujan Shresta is initiating epidemiological studies in Nepal, Thailand, and Vietnam to create a biorepository of Asian viral isolates and human samples. The samples will be used by several labs at LJI to provide fundamental insights into the virus itself, the role of the host immune system in disease severity as well as the development of long-term immunity to help guide the development of vaccines and antivirals.
The lungs of many COVID-19 patients are filled with hundreds of microclots, while others suffer sudden strokes or heart attacks when errant blood clots break off and block blood vessels in the brain or heart. Dr. Lynn Hedrick’s team studies whether the observed cardiovascular complications of COVID-19 may be influenced by an overactive innate immune system—the body’s first line of defense against pathogens. Dr. Hedrick is using mass cytometry (CyTOF) to analyze innate immune cells known as neutrophils and monocytes from patients with modest and severe manifestations of COVID-19 to determine whether the innate immune system contributes to vascular inflammation and abnormal blood clotting in the lung and other organs.
A mysterious illness, which has been dubbed Pediatric Multisystem Inflammatory Syndrome or PMIS, is afflicting children in areas hit hard by COVID-19. The serious and potentially deadly condition has been linked to coronavirus infections and is similar to Kawasaki disease and another rare pediatric inflammatory condition, DADA2 vasculitis, which lead to massive inflammation of small and medium blood vessels. Dr. Sonia Sharma, who recently uncovered the immune-related metabolic trigger of inflammation in DADA2 vasculitis, has already collected 500 plasma and blood samples from COVID-19 positive and negative individuals (children and adults) in the greater Los Angeles area, with 20,000 more samples on the way, ~4% of which are estimated to be COVID-19 positive. She and her team are using these samples to examine whether the same immune-related metabolic mechanisms underlie multi-organ inflammation and vasculitis in children with PMIS.
Testing therapies and vaccines
Therapeutic antibodies can be launched even before approved vaccines to be administered to protect frontline workers and case contacts from infection. Molecular characterization of potential therapeutic antibodies is essential, and because of her extraordinary talents, Dr. Erica Ollmann Saphire has been funded by Gates foundation to take on a leadership role in this effort. For more information visit covic.lji.org.
Relying on years of experience of modeling viral infections in vitro and in vivo, Dr. Sujan Shresta’s lab is developing experimental systems to assess the efficacy of therapeutic antibodies and vaccines in living cells and animals.
FROM THE LAB
AUG 8, 2020 // THE WASHINGTON POST
Forty percent of people with coronavirus infections have no symptoms. Might they be the key to ending the pandemic?
New research suggests that some of us may be partially protected due to past encounters with common cold coronavirusesCrotty LabSette LabCOVID-19Center For Infectious Disease and Vaccine ResearchCOVID-19In the NewsREAD MOREAUG 7, 2020 // NATIONAL GEOGRAPHIC
Why antibodies may not be the key to beating coronavirus
Worries over waning antibodies may be overblown, as growing evidence shows a role for T cells in the coronavirus immune response.Sette LabCOVID-19Center For Infectious Disease and Vaccine ResearchIn the News
PUBLISHED AUGUST 7, 2020
WINTER BREAK HAD arrived in Stockholm in late February, and Soo Aleman watched as her fellow Swedes departed the capital city for ski vacations across Europe. Aleman’s colleagues at the Karolinska University Hospital, where she works as a researcher and physician, returned relaxed and invigorated, with stories to tell about their days on the slopes. But a few of the city’s residents also brought back a most unwelcome souvenir: the SARS-CoV-2 coronavirus.
Like much of the rest of the world, Sweden soon found itself in the grips of an outbreak. As Aleman pivoted from her work on the hepatitis B and C viruses to study COVID-19, she began screening patients for the novel infection and for signs of the body’s immune response. And that’s when things got weird.
The body should produce both protective antibodies, which keep the virus from invading, and killer T cells, which tell virus-infected human cells to destroy themselves to keep the virus from spreading. Normally, these immune responses appear in tandem. But in a subset of those who tested positive for COVID-19, Aleman found T cells but no antibodies.
Other scientists around the world also had similar findings. Much of this work is still preliminary, and scientists don’t know what it means in terms of assessing how well a vaccine will work or how well people are protected from severe forms of the disease. But one thing is becoming clear: antibodies might not be telling the whole story when it comes to COVID-19 immunity. “We shouldn’t just look blindly at antibody tests,” Aleman says.
“I don’t know another virus like this,” adds Rory de Vries, a virologist at the Erasmus Medical Center in the Netherlands. “We are living in special times with a special virus.”
The Bs and Ts of immune cells
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Wellness gurus may exhort us to treat our bodies like temples, but when it comes to fighting off pathogens, the body is more like a castle under siege. Like any fortress, the body has several lines of defenses to protect it from infectious microbes.
The innate immune system is the first line, and it sets out to discourage any potential intruder by making the body as inhospitable for them as possible by raising the body’s temperature with a fever and assaulting pathogens with toxic chemicals. It acts like an overzealous security guard and reacts against any sign that a cell or protein is not the body’s own.
Even these security forces can be overwhelmed and outmaneuvered by pathogens that have evolved stealth to evade the immune system and counter inflammatory responses dedicated to stopping germs. When that happens, the adaptive immune system kicks in—and that’s when we see things like antibodies and T cells. These defenses emerge after a pathogen has invaded, and the body has learned the type of threat it poses.
B cells produce antibodies, small proteins that recognize certain pieces of a pathogen known as epitopes. If enough antibodies bind to a virus, it can’t enter the body’s cells to make copies of itself, and thus cannot make you sick. Likewise, killer T cells recognize epitopes displayed by virus-infected cells and tell the cells to self-destruct.
It’s a process that has evolved over hundreds of millions of years, and all the different arms of the immune system generally work together seamlessly.
When the body is actively fighting off a pathogen, it mobilizes large numbers of antibodies and T cells. In the following weeks and months, those numbers can slowly decline. That’s normal and even beneficial, said Nicolas Vabret, an immunologist at the Mount Sinai School of Medicine in New York.
“If antibodies didn’t decline, over time, there would only be antibodies in the blood with no room for anything else,” he says.
But the defenses haven’t completely evaporated after this initial siege. A portion of the B cells and T cells form memories of past invaders, while a low level of antibodies keep circulating in the blood. For months or even years, these forces continue to patrol the bloodstream, the spleen, bone marrow, and lymph nodes embedded in various organs long after the infection is over, so if the body ever sees the same pathogen again, it can respond faster.
Sometimes, a reinfected person won’t even have symptoms. Other times, the disease may be very mild. The amount and type of antibodies and T cells present after an infection can tell scientists how well a vaccine might protect people.
More than waning antibodies
Historically during epidemics, scientists have focused on antibody responses rather than T cells, because antibodies are easier to measure in the lab. Antibodies can be detected directly from a blood sample, explains Daniela Weiskopf, an immunologist at the La Jolla Institute for Immunology in California.
When Weiskopf wants to spot a T cell response, however, she has to reenact the series of steps the T cells use to identify a pathogen. First, she synthesizes a library of all the possible tiny epitopes the T cells can recognize. Then she needs to isolate the T cells from the blood and test them against all the different protein epitopes, to see which ones interact with the cells.
For most viruses, antibody and T cell responses usually match up in terms of timing and strength of response, so scientists generally rely on antibody tests alone because they are quicker, cheaper, and easier to administer. Some antibody test kits can provide results in minutes to hours, whereas T cell tests need to be sent to a specialized lab.
“It’s just not practical to test for T cell response in large samples,” says Weiskopf.
It kind of looks like T cells could be really useful to you in this infection.
ADRIAN HAYDAY, IMMUNOLOGIST, KING’S COLLEGE LONDON
But when Aleman and other virologists and immunologists began turning their attention to COVID-19, a different story started emerging. Aleman and her colleagues began to study how immunity developed in people who had tested positive for SARS-CoV-2, as well as their close contacts, some of whom were presumably exposed to the virus, even if they didn’t get sick. As expected, hospitalized individuals developed strong antibody and T cell responses to SARS-CoV-2. But two-thirds of the close contacts who were asymptomatic showed a subsequent T cell response, even though tests didn’t detect any antibodies.
“It was very strange and very surprising,” Aleman says. The study results, released June 29 without peer review via the medical pre-print service medRxiv, didn’t reveal whether these individuals never developed antibodies or whether they rapidly declined to undetectable levels. Regardless, the report immediately raised concerns about a vaccine, since stimulating antibody production is a key strategy by which immunizations protect against disease.
This apparent decline in antibodies was reported again on July 21, in 34 individuals with mild COVID-19 infections. If some people infected with SARS-CoV-2 don’t produce antibodies, it could mean they might not respond to a vaccine.
T cells to the rescue?
Immunologist Adrian Hayday at King’s College London is less worried. Even though T cells are harder to measure and may not prevent a second infection, they play a major role in the body’s ability to remember past infections and protect someone from severe disease.
“It kind of looks like T cells could be really useful to you in this infection,” Hayday says, pointing to several new papers on SARS-CoV-2 and other coronaviruses as proof.
SARS-CoV-2 is one of seven known coronaviruses that can infect humans. The original SARS virus vanished after creating large outbreaks in 2003, and the Middle Eastern Respiratory Syndrome (MERS) virus has only infected a small number of people in the Middle East and North Africa. Four other coronaviruses circulate widely and cause the common cold.
Immunity to the common cold coronaviruses only lasts a year or two, which is why sniffles and stuffiness remain a pervasive part of life. However, patients infected with the original SARS virus still possessed memory T cells that responded to the virus’ proteins 17 years later, immunologist Antonio Bertoletti at Duke-NUS Medical School in Singapore recently reported in Nature. These same memory T cells also reacted to SARS-CoV-2. It’s something Bertoletti says bodes well for COVID-19.
Even if the T cells don’t prevent a second infection, you might not get as sick.
ANTONIO BERTOLETTI, IMMUNOLOGIST, DUKE-NUS MEDICAL SCHOOL
“Even if the T cells don’t prevent a second infection, you might not get as sick,” he says.
Likewise, Leif Erik Sander, an infectious disease physician at Charité University Hospital in Berlin, found that 83 percent of 25 COVID-19 patients in Germany produced helper T cells, a cousin of the killer variety so named for their ability to help stimulate antibody production. These cells were able to mount a response to the spike protein that coats SARS-CoV-2. Sander and colleagues also found that a third of the 68 people who had never been exposed to the novel coronavirus also had these helper T cells. Although Sander can’t yet say for sure, he suspects that these T cells were originally produced to protect against a common cold coronavirus.
A Science paper published August 4 by Weiskopf and colleagues supports this hypothesis and hints that preexisting immunity to these common cold coronaviruses may help explain why some people have no symptoms. Since COVID-19 has some similarity to these viruses, some T cells may respond to both pathogens. However, it’s still early days for this idea.
“We really don’t know how T cells relate to disease severity,” he says.
Weiskopf, fellow La Jolla Institute immunologist Alessandro Sette, and de Vries also conducted an in-depth analysis of the immune response from 20 adults who had recovered from COVID-19. They found that although antibodies developed primarily to the spike protein that coated the virus, T cells could respond to epitopes from inside and outside of the virus. Their results were published in Cell.
That’s good news for a vaccine, de Vries says, because it means that even if the outer spike proteins mutate over time, T cells will still be able to provide some protection, since they recognize other parts of the virus that are less prone to change.
What no one can say yet is what these T cell responses mean in terms of preventing and infection, or how long they might last. Potential preexisting T cell responses may yet affect how well a vaccine protects people, Sander says.