An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
Mike Segar | Reuters
A key monoclonal antibody used to treat people with weak immune systems who catch Covid is no longer authorized for use in the U.S. because it is not effective against emerging omicron subvariants.
The FDA, in a notice Wednesday, said bebtelovimab is not approved for use because it is not expected to neutralize the omicron BQ.1 and BQ.1.1 subvariants. They are causing 57% of new infections nationally and make up a majority of cases in every U.S. region except one.
The Health and Human Services Department is putting on hold pending requests for bebtelovimab, and the manufacturer Eli Lilliy has also halted commercial distribution of the antibody treatment until further notice, according to the FDA notice.
But bebtelovimab stocks should be kept on hand in the event that Covid variants which the antibody can neutralize become dominant again in the future, according to FDA.
Bebtelovimab is a single-dose injection administered to people who catch Covid and are at high risk of developing severe disease, but cannot take any other FDA-approved treatments such as the oral antiviral Paxlovid. Many people with weak immune systems, such as organ transplant patients, cannot take Paxlovid with other medications they need.
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U.S. health officials have warned that people with weak immune systems face a heightened risk from Covid this winter, because more immune evasive omicron subvariants threaten to knock out antibody treatments they rely on to stay safe from Covid.
Dr. Ashish Jha, the White House Covid coordinator, said in October that the failure of Congress to pass additional Covid funding means treatments will dwindle as new variants render them ineffective.
“We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters. “Because of lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
President Joe Biden has called on people with weak immune systems to consult with their physicians about what extra precautions they should take this winter to stay safe.
Deaths from drug and alcohol use are rising among America’s seniors.
Drug overdose deaths more than tripled among people age 65 and older during the past two decades while deaths from alcohol abuse increased more than 18% from 2019 to 2020, according to data published Wednesday by the National Center for Health Statistics.
More than 800,000 seniors suffered from drug addiction and 2.7 million suffered from alcohol addiction in 2020, according to separate data from the Health and Human Services Department.
In total, more than 5,000 seniors died of drug overdoses in 2020 and more than 11,600 succumbed to alcohol, according to the NCHS data. Though drug overdose death rates are lower for seniors than other age groups, they have increased substantially from 2.4 per 100,000 in 2000 to 8.8 per 100,000 in 2020.
“We’ve got a public health problem coming at our door — these trends have been increasing for a long time now,” said Alexis Kuerbis, a professor at the Silberman School of Social Work and an expert on substance use among older adults.
Seniors today are baby boomers, a generation that had a much more open attitude toward drugs and alcohol than their parents, Kuerbis said. Some baby boomers have carried alcohol and drug habits from their youth and middle age into their later years when their bodies are no longer able to tolerate them, she said.
“Baby boomers obviously are very different generation than the silent generation or the World War II generation,” Kuerbis said. “Baby boomers were far more open to using alcohol and drugs during their younger years but also through their middle-aged years and now they are older adults,” she said.
Deaths from fentanyl and other synthetic opioids increased 53% among seniors from 2019 to 2020, according to the data. Kuerbis said there’s some evidence to suggest people who were prescribed opioids in their middle age for an injury later switched to fentanyl once it became harder to get a prescription.
If you are having suicidal thoughts or are in distress, contact the Suicide & Crisis Lifeline at 988 for support and assistance from a trained counselor.
While some drug deaths among seniors are from accidental misuse of drugs, many are suicides from overdosing on opioids, Kuerbis said. Although seniors tend to be happier than younger adults, they also have a higher prevalence of chronic pain, terminal illness and dementia, she said.
Some older adults also use drugs or alcohol to cope with major life changes such as retirement, grief and loss, or a change in their living situation, according to the National Institute of Drug Abuse.
Drug overdose deaths were highest among Black seniors. The death rate from drugs among Black men ages 65 to 74 was more than four times higher than Hispanic or white men in that age group, according to the data. Black women ages 65 to 74 died more often from drug overdoses than white and Hispanic women. White women older than 75 had a higher death rate from drugs than Black and Hispanic women.
Alcohol deaths were highest among American Indian seniors followed by Hispanics, white Americans, Black Americans and Asian Americans, according to the data.
A sign advertising flu shots is displayed at a Walgreens pharmacy on January 22, 2018 in San Francisco, California. A strong strain of H3N2 influenza has claimed the lives of 74 Californians under the age of 65 since the flu season began in October of last year.
Justin Sullivan | Getty Images
A variant of the flu that hits kids and seniors worse than other strains of the virus is dominant in the U.S. right now, setting the country up for a potentially bad flu season.
Public health labs have detected influenza A(H3N2) in 76% of the more than 3,500 respiratory samples that have tested positive for the flu and were analyzed for the virus subtype, according to a surveillance report published Friday by the Centers for Disease Control and Prevention.
The H3N2 variant has been associated with more severe flu seasons for children and the elderly in the past, according to Dr. Jose Romero, director the CDC’s National Center for Immunization and Respiratory Disease.
“There are also early signs of influenza causing severe illness in precisely these two groups of individuals this season,” Romero told reporters on a call earlier this month.
The flu hospitalization rate has surged to a decade high this season. Overall, about 8 people per 100,000 are being hospitalized with the flu right now but seniors and the youngest children are much harder hit than other age groups, according to CDC data.
The hospitalization rate for seniors is more than double the general population at 18 per 100,000. For kids younger than age five, the hospitalization rate is about 13 per 100,000.
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At least 4.4 million people have fallen ill with the flu, 38,000 have been hospitalized, and 2,100 have died since the season started. Seven kids have died from the flu so far this season.
“When we have more H3N2, we usually have a more severe flu season — so longer duration, more children affected, more children with severe disease,” said Dr. Andi Shane, a pediatrician and infectious disease expert at Children’s Healthcare Atlanta.
The other influenza A variant, H1N1, is generally associated with less severe seasons compared with H3N2, Shane said. H1N1 makes up about 22% of sample that have tested positive for flu and were analyzed for a subtype, according to CDC.
The percentage of patients reporting symptoms similar to the flu, a fever of 100 degrees or greater plus a sore throat or cough, is the highest in Virginia, Tennessee, South Carolina, Alabama and Washington D.C right now, according to CDC.
Respiratory illnesses are also very high in Arkansas, Colorado, Georgia, Kentucky, New Jersey, Maryland, Mississippi, New Mexico, North Carolina and Texas, according to CDC.
The CDC recommends that everyone 6 months or older get a flu shot. Children younger than age 8 who are receiving the vaccine for the first time should get two doses for the best protection.
The flu vaccine is normally 40% to 60% effective at preventing illness, but people who do still get sick are less likely to end up in the hospital or die, according to the CDC.
Public health officials are also encouraging people to stay home when they are sick, cover coughs and sneezes and wash hands frequently. Those who want to take extra precautions can consider wearing a facemask indoors in public.
Flu hospitalizations have surged to a decade high in the U.S. with the Southeast the hardest region right now.
Five out every 100,000 people in the U.S. were hospitalized with the flu during the week ending Nov. 5, according to data from the Centers for Disease Control and Prevention. That’s the highest hospitalization rate this early in the flu season since 2010, more than 10 years ago.
But the percentage of patients reporting symptoms similar to the flu, a fever of 100 degrees or greater plus a sore throat or cough, is the highest in Alabama, Georgia, Mississippi, North Carolina, South Carolina, Tennessee, Virginia and Washington D.C., according to CDC data.
Flu activity is also very high in Arkansas, Louisiana, Maryland, New Mexico, New Jersey, New York City and Texas, according to the CDC.
More than 6,400 people were admitted to the hospital with the flu during the week ending Nov. 5, according to data from the Health and Human Services Department. About 54% of these patients were hospitalized in the Southeast and South-Central portion of the U.S.
Just over 2,000 people were hospitalized with the flu in the region that includes Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, and Tennessee. More than 1,400 were admitted to the hospital in Arkansas, Louisiana, New Mexico, Oklahoma and Texas.
In the Southeast, the influenza A H3N2 strain appears to be the most common right now, according to Dr. Jose Romero, director of the CDC’s National Center for Immunization and Respiratory Diseases. This strain is associated with more severe illness in the elderly and young children, Romero said.
“There are also early signs of influenza causing severe illness in precisely these two groups of individuals this season,” Romero told reporters during a call earlier this month.
Nearly 11 out of every 100,000 seniors were hospitalized with the flu during the week ending Nov. 5 while about 10 out every 100,000 kids younger than age 5 were admitted to the hospital, according to CDC data. The hospitalization rate for these age groups is about double the national rate.
So far this season, at least 2.8 million people have fallen ill with the flu, 23,000 have been hospitalized, and 1,300 people have died from the virus, according to CDC.
Hospitals across the U.S. are getting slammed with a surge of patients, particularly kids, sick with the flu or respiratory syncytial virus. Romero said these viruses are probably surging because immunity declined as pandemic-era public health measures crushed transmission of these viruses. May kids, as a consequence, are getting infected for the first time.
Public health officials are also expecting another wave of Covid infection this winter. The CDC, the Food and Drug Administration and the White House have called for everyone whose eligible to receive a flu shot and Covid booster ahead of the holidays.
Even healthy infants face a considerable risk of hospitalization from respiratory syncytial virus, according to a large European study published Thursday.
Dutch and British scientists, in a study published in Lancet Respiratory Medicine, found that 1.8% of healthy infants are hospitalized with RSV before their first birthday. This means about 1 in 56 healthy infants are hospitalized with the virus annually.
Dr. Louis Bont, one of the authors of the study, stressed that the incidence of RSV hospitalization in healthy infants was about twice as high as the researchers had expected.
The scientists found that a majority of the infants hospitalized with RSV were younger than 3 months. About 1 in 18 infants hospitalized with RSV required treatment in the intensive care unit.
RSV is a common respiratory virus that normally results in mild symptoms similar to the common cold. But for infants younger than 6 months, it can cause lung infections that result in hospitalization and in some cases require assisted breathing.
The scientists followed more than 9,000 healthy newborns to at least their first birthday across five sites in Spain, Finland, England, Scotland and the Netherlands.
They found that 145 of the healthy babies were hospitalized with RSV, eight of whom required treatment in the intensive care unit, about 5%, and three of whom needed mechanical ventilation, or 2%.
Bont said the findings highlight the importance of bringing vaccines to market that can significantly lower the amount of disease in infants and relieve pressure on pediatric hospitals.
The European Medicines Agency this month approved an antibody called nirsevimab, developed by AstraZeneca and Sanofi, to prevent lower respiratory tract disease from RSV in newborns and infants.
Pfizer is developing a single-dose vaccine given to pregnant mothers to protect their newborns against severe disease from RSV. Clinical trials found the shot was about 81% effective at preventing severe lower respiratory tract illnesses in the first 90 days of the baby’s life.
Pfizer plans to submit an application to the Food and Drug Administration by the end of 2022 for the vaccine’s approval in the U.S.
The U.S. is facing a significant increase in RSV cases among kids in almost every region of the country, according to the Centers for Disease Control and Prevention. About 77% of pediatric hospital beds are occupied as RSV and the flu surge, according to data from the Health and Human Services Department.
The CDC is encouraging parents to seek immediate medical attention for their children if they show any of the following warning signs: Trouble breathing, blueish lips or face, chest or muscle pain, dehydration (dry mouth, crying without tears, or not urinating for hours), or not being alert or interactive when awake.
RSV symptoms include runny nose, loss of appetite, and a cough that can progress to wheezing. Infants almost always show symptoms, but for babies younger than 6 months these symptoms can be more subtle, according to the CDC. RSV does not always result in a fever.
Irritability, decreased activity and appetite, as well as pausing while breathing, are all signs that an infant might have RSV, according to the CDC.
If it seems like everyone around you is getting sick, you’re not imagining it. The flu season is hitting the United States unusually early and much harder than it usually does.
“I’m scared about what’s going to happen this flu season because I don’t think we’ve ever seen a coalition of multiple viruses kind of manifesting in this way before,” said Dr. Elizabeth Clayborne, an emergency medicine doctor and associate professor at the University of Maryland School of Medicine.
Clayborne family
Carlos Waters | CNBC
Covid precautions did lead to lower rates of flu-like illnesses compared to normal, pre-pandemic times. But now that much of America has abandoned preventive measures such as masking, more people are getting sick with seasonal illnesses.
“All of the patterns of intermingling and transmission of different viruses really slowed down from that shutdown,” said Dr. Andrea Berry, associate professor of pediatrics and medicine at University of Maryland School of Medicine. “As the world has opened up, the usual patterns are not quite the same.”
One of those flu-like illnesses is respiratory syncytial virus, or RSV, which is most severe in young children, the elderly and immune-compromised individuals.
There have been more reported cases of RSV in each week of October this year than any other week in the past two years, and doctors around the country are raising the alarm about hospitals being overwhelmed this season.
Just like RSV, cases of flu started surging earlier this year, with the Centers for Disease Control and Prevention reporting at least 1,600,000 cases, 13,000 hospitalizations and 730 deaths as of Oct. 29, which is high for this early in a typical flu season.
Clayborne’s 2-year-old and 4-year-old children both had RSV in late September, and her older daughter had to be taken to the emergency room for treatment.
Clayborne family
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“I know that [the flu and RSV are] common and it seems like a lot of kids get them,” Clayborne said. “But we see kids die all the time, and usually it’s from respiratory complications.”
There is currently no federally approved vaccine for treating RSV, but Pfizer reported in early November that its RSV vaccine candidate in its phase 3 trial, which was given to mothers during pregnancy, was nearly 70% effective at protecting severe symptoms in infants less than 6 months old.
Watch the video above to learn more about why this flu season is starting off with a surge and what we can do about it.
Mindfulness meditation is as effective at reducing anxiety as a commonly prescribed antidepressant, according to a study published in a major journal on Wednesday.
The study, led by researchers at Georgetown University Medical Center, is the first randomized clinical trial to compare the effectiveness of mindfulness meditation with the antidepressant escitalopram. The results were published in JAMA Psychiatry, a peer-reviewed journal.
The adult participants in the mindfulness group practiced 45-minute daily meditations using a few different techniques they learned at weekly classes. They also went on daylong weekend retreats.
The meditation techniques included breath awareness; body scanning, in which attention is directed to one body part at a time; and mindful movement, in which stretching and movements bring attention to the body.
Participants in the antidepressant group received 10mg of escitalopram daily the first week, and then took 20mg daily for the rest of the study if the pill was well tolerated. There were 102 patients in the mindfulness group and 106 in the antidepressant group. Escitalopram is sold under the brand names Lexapro and Cipralex, among others.
After monitoring the two groups for eight weeks, researchers found that people using mindfulness meditation saw their anxiety improve nearly as much as people who were taking the antidepressant.
Dr. Elizabeth Hoge, lead author on the study, said the findings support physicians recommending mindfulness meditation as an alternative to antidepressants for some patients. Many people worry that antidepressants will interfere with their daily lives and others start taking medications but stop.
Hoge, who is director of Georgetown University’s Anxiety Disorders Research Program, said the study also provides evidence for insurers to cover mindfulness meditation as a treatment for anxiety.
Anxiety disorders are the most common type of mental illness, affecting about 301 million people around the world, according to a February study published in Lancet Psychiatry.
Two omicron subvariants that are resistant to key antibody treatments are on the rise in the U.S., according to data from the Centers for Disease Control and Prevention.
The subvariants BQ.1 and BQ.1.1 now represent 27% of infections in the U.S., a significant jump from the week prior when they made up about 16% of new cases, according to CDC data published Friday.
Omicron BA.5, though still the dominant variant, is diminishing every week. It now represents about 50% of infections in the U.S., down from 60% the week prior, according to the data.
President Joe Biden this week warned people with compromised immune systems that they were particularly at risk this winter because antibody treatments are not effective against emerging subvariants.
BQ.1 and BQ.1.1 are likely resistant to Evusheld and bebtelovimab, according to the National Institutes of Health.
Evusheld is an antibody cocktail administered as two injections that people ages 12 and older with moderately or severely compromised immune systems take to prevent Covid-19. Bebtelovimab is a monoclonal antibody taken to treat Covid after an infection.
Biden urged people with weak immune systems to consult their physicians on what precautions to take. Dr. Ashish Jha, head of the White House Covid task force, said the U.S. is running out of options to treat the vulnerable because Congress failed to pass more money for the nation’s Covid response.
“We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters this week. “Because of lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
It’s unclear how well the new boosters will protect against variants such as BQ.1 and BQ.1.1. Jha has said the boosters should offer better protection than the old shots because these subvariants are descended from BA.5, which is contained in the updated vaccines.
Two independent studies from Columbia and Harvard this week found that the omicron boosters did not perform much better than the old shots against BA.5. The Food and Drug Administration said the studies were too small to draw any definitive conclusions.
The CDC, the FDA and the White House Covid taskforce believe the new shots will prove more effective because they are better matched to the circulating variants than the first generation vaccines.
“It is reasonable to expect based on what we know about immunology and the science of this virus that these new vaccines will provide better protection against infection, better protection against transmission and ongoing and better protection against serious illness,” Jha told reporters in September.
Jha called for all eligible Americans to get the omicron booster and their flu shot by Halloween so that they are protected when families start gathering for the holidays.
Emerging omicron subvariants are resistant to key antibody treatments for HIV patients, kidney transplant recipients and other immunocompromised people, making them particularly vulnerable to Covid this winter, the White House warned this week.
“With some of the new subvariants that are emerging, some of the main tools we’ve had to protect the immunocompromised like Evusheld may not work moving forward. And that’s a huge challenge,” Dr. Ashish Jha, head of the White House Covid task force, told reporters on Tuesday.
President Joe Biden on Tuesday cautioned the estimated 7 million adults in the U.S. who have compromised immune systems that they are particularly at risk, but he could offer little in the way of reassurance other than telling them to consult their physician about what precautions to take.
“New variants may make some existing protections ineffective for the immunocompromised,” the president said before getting his booster Tuesday. “Sadly, this means you may be at a special risk this winter. I urge you to consult your doctors on the right steps to protect yourself, take extra precautions.”
The message clashes with repeated White House assurances that the U.S. has all the vaccines and treatments it needs to fight Covid this winter as public health officials are expecting another surge.
While this may be true for the general population, it is not the case for people with weak immune systems. They include those with cancer, those who have had organ transplants, people living with HIV and individuals who are taking medicine for autoimmune diseases.
Evusheld is an antibody cocktail authorized by the Food and Drug Administration to prevent Covid in people ages 12 and older who have moderately or severely compromised immune systems. The drug is administered as two injections, prior to infection, every six months.
Evusheld, made by AstraZeneca, has helped fill a gap in protection for those with weak immune systems who cannot mount a strong response to the vaccines. The drug, plus several rounds of vaccination, has led to significant declines in hospitalization among this cohort over the past several months, according Camille Kotton, an infectious disease expert who specializes in treating people with weak immune systems.
“We’ve been in a sweet spot for maybe several months now as far as immunocompromised patients having good protection and then good treatment options,” said Kotton, a physician at Massachusetts General Hospital and a member of the Centers for Disease Control and Prevention’s independent vaccine advisory committee.
But more immune evasive omicron subvariants such as BA.4.6, BA.2.75.2, BF.7, BQ.1 and BQ.1.1 are resistant to Evusheld, according to the National Institutes of Health. Scientists at Columbia University, for example, found Evusheld had completely lost its effectiveness against BA.4.6.
And BQ.1 and BQ.1.1 are likely resistant to bebtelovimab, the monoclonal antibody developed by Eli Lily to prevent people with compromised immune systems who catch Covid from developing severe disease, according to NIH.
That leaves people with compromised immune systems increasingly vulnerable as these subvariants increase in circulation in the U.S. As omicron BA.5 declines, this swarm of newer subvariants collectively make up about 38% of infections in the U.S., according to CDC data.
Although Pfizer’s antiviral Paxlovid remains effective against the omicron subvariants, people who have had organ transplants often can’t take the pill because of the way it interacts with other drugs they need, Kotton said.
“I’m concerned that the near future will be a challenging time for immunocompromised patients,” said Kotton. “The monoclonal antibodies in Evusheld are going to provide less protection and bebtelovimab is going to provide ineffective treatment for several of the emerging variants.”
And help is not on the way at the moment. Kotton said she’s not aware of any monoclonal antibodies that are ready to replace the ones the subvariants are chipping away at. Jha acknowledged at the White House on Tuesday that the U.S. has dwindling treatment and prevention options for people with weak immune systems as Covid evolves. He blamed Congress for failing to pass $22.5 billion in funding for the nation’s Covid response due to Republican opposition.
“We had hoped that over time as the pandemic went along, as our fight against this virus went along, we would be expanding our medicine cabinet,” Jha told reporters. “Because of lack of congressional funding that medicine cabinet has actually shrunk and that does put vulnerable people at risk.”
Andrew Pekosz, a virologist at Johns Hopkins University, said finding ways to protect people with compromised immune systems is the most critical issue of the pandemic right now and it needs to be addressed quickly.
“What we need to really work on is getting new antibody treatments out of the lab and into clinics,” Pekosz said. “In the lab, scientists know what next-generation monoclonal antibodies look like.”
Kotton said people with compromised immune systems should stay up to date on their vaccines, which means getting the new booster that targets omicron BA.5. Those who have stayed up to date throughout the pandemic have received six shots by now.
Those starting from scratch would receive a three-dose primary series of Moderna or Pfizer with the older generation shots and then a new booster that targets omicron, according to CDC guidelines.
People with compromised immune systems should continue to exercise caution this winter, because the immune-resistant omicron subvariants could pick up in circulation as people gather for the holidays, Kotton said. But she noted that the group has been more diligent in wearing masks and practicing mitigation measures to avoid the virus than the rest of the population.
The bigger problem is that the general population has largely moved on and is no longer taking basic precautions that could reduce transmissions and protect the vulnerable — such as wearing masks, Kotton said.
“If we all were to mask more in public venues that would enhance the safety for them and allow them to have a higher likelihood of a safer return to many activities,” she said.
Jha was asked by NBC News on Tuesday whether Biden telling people with weak immune systems to consult their physicians about precautions is an indication that the burden of responsibility has shifted to the individuals instead of the broader community.
“As a society — as a caring society, we care about all Americans, particularly the most vulnerable Americans,” Jha said. “So it remains, I think, a collective responsibility for all of us to care about our fellow Americans who are immunocompromised.”
The CDC recommends that people in communities where the Covid risk level is moderate to self test and wear a high-quality mask before meeting indoors with someone who is at high risk of getting sick. Those who are at high risk should wear a high-quality mask when indoors in public.
When the Covid level is high, people in general should consider wearing high-quality masks and the vulnerable should consider avoiding indoor activities in public that aren’t essential, according to CDC. You can check your county’s Covid level at the CDC’s website.
A patient receives a coronavirus disease (COVID-19) test at Sparrow Laboratories Drive-Thru Services in Lansing, Michigan, December 27, 2021.
Emily Elconin | Reuters
People who caught mild cases of Covid-19 during the first year of the pandemic had a higher risk of developing blood clots than those who were not infected, according to a large study published by British scientists this week.
Patients with mild Covid, defined as those not hospitalized, were 2.7 times more likely to develop blood clots, according to the study published in the British Medical Journal’s Heart on Monday. They were also 10 times more likely to die than people who did not have Covid.
Scientists affiliated with Queen Mary University of London followed 18,000 people who caught Covid during the first year of the pandemic and compared their health outcomes with nearly 34,000 people who didn’t contract the virus.
Participants were tracked until they developed cardiovascular disease, died or until the study ended in March 2021. Most of the study was conducted before the vaccines rolled out in the Britain in December 2020.
While people with mild Covid had an increased risk of blood clots, patients hospitalized with the virus had a significantly higher risk of cardiovascular disease in general. The risk of cardiovascular disease for mild and severe cases was highest in the first 30 days after infection but continued later.
In addition, patients hospitalized with Covid were 28 times more likely to develop blood clots, 22 times more likely to suffer heart failure and17 times more likely to have a stroke, according to the study. Overall, they were over 100 times more likely to die than people who didn’t have Covid.
The scientists said their findings highlight the importance of monitoring even people who had mild Covid for cardiovascular disease over the long term.
“Our findings highlight the increased cardiovascular risk of individuals with past infection, which are likely to be greater in countries with limited access to vaccination and thus greater population exposure to COVID-19,” the authors of the study wrote.