Category: Covid-19 Vaccine

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Study: Before vaccines, 44% of COVID-19 patients in ICU died – University of Minnesota Twin Cities

May 17, 2024

A new analysis of pre-vaccine data from scientists at the Centers for Disease Control and Prevention (CDC) shows that 18% of hospitalized patients and 44% of those admitted to an intensive care unit (ICU) for COVID-19 died, with wide variations among different groups.

The study was published yesterday in Emerging Infectious Diseases and is based on 2,479,423 cases from 21 jurisdictions with hospitalization information reported to the CDC from May 1, 2020, to December 1, 2020, to create a hospitalization dataset. The authors also analyzed 4,708,444 cases from 22 jurisdictions for a death dataset during the same time frame. The case-hospitalization dataset covers 25.5% of the US population, and the case-fatality dataset covers 43.7% of the US population, the authors said.

Before the mid-December 2020 introduction of COVID-19 vaccines, the pandemic caused approximately 480,000 hospitalizations, and 350,000 deaths in the United States.

"Few precise estimates of hospitalization and mortality rates exist in the COVID-19naive population in the United States, especially among demographic and clinical subgroups," the authors said.

The overall case-hospitalization rate among patients was 5.7%, and the rate by sex was 6.2% for male and 5.2% for female. Hospitalization rates were lowest for children ages 5 to 14 (0.6%), and highest in case-patients 75 years and older (25.9%).

When looking at racial and ethnic demographics, the highest case-hospitalization rates were among African American or Black (14.0%) and Asian or Pacific Islander (11.2%) patients. White patients had the lowest rate (6.8%).

Few precise estimates of hospitalization and mortality rates exist in the COVID-19naive population in the United States.

In the deaths dataset, the overall case-fatality rate was 1.7%. The lowest death rates were seen in infants and young children (0.05% for infants and 0.01% for children 1 to 14 years of age). Ten infants died in the study period.

Case-fatality rates increased steadily with age. The rate was 4.7% in patients 65 to 74 years old, 12.0% in those 75 to 84, and 23.6% in people 85 and older.

Case-fatality rates for female patients were lower than or equal to those for male patients in every age-group except infants, the authors said.

Asian or Pacific Islanders had the highest crude mortality rate (3.0%), followed by Black and African Americans (2.8%).

The fatality rate was 0.6% in people who were not hospitalized. The rate was 17.6% among all people who were hospitalized and 44.2% in those admitted to an ICU.

"Age was a primary driver of SARS-CoV-2 hospitalization and death; rates had a U-shaped curve, being higher in infants, lowest in children 5 to 14 years of age, and highest among persons >65 years of age, confirming previous reports, " the authors concluded.

The analysis confirmed prior studies that have shown a nearly 50% mortality rate for ICU patients early in the pandemic. Moreover, the authors said, the findings present a baseline of data for future comparisons.

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Study: Before vaccines, 44% of COVID-19 patients in ICU died - University of Minnesota Twin Cities

What is VITT, the other blood clotting condition linked to AstraZeneca’s COVID-19 vaccine? – Firstpost

May 17, 2024

AstraZeneca's COVID-19 vaccine has been linked to Vaccine-induced Immune Thrombotic Thrombocytopenia, a rare but potentially fatal condition. Reuters File Photo

British-Swedish pharma giant AstraZeneca has remained in the headlines after reports surfaced that it admitted its COVID-19 vaccine can cause a rare side effect of blood clotting. Now, Australian researchers have found a link between vaccine-induced immune thrombocytopenia and thrombosis (VITT), a rare complication associated with AstraZenecas COVID-19 jabs, and an uncommon but potentially fatal blood disease contracted by some who had a cold.

According to Adelaides Flinders University, the antibodies from VITT and an adenovirus VITT-like disorder share nearly identical molecular signatures or fingerprints.

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These findings, using a completely new approach for targeting blood antibodies developed at Flinders University, indicate a common triggering factor on virus and vaccine structures that initiates the pathological PF4 antibodies, the universitys Professor Tom Gordon was quoted as saying by 9news.com.au.

Researchers said these findings will have implications for vaccine development and safety.

What is VITT? Is it different from TTS? How is it linked to AstraZeneca s COVID-19 vaccine? Lets take a closer look.

What is VITT?

VITT is a rare condition found in some people who got adenoviral vector COVID-19 vaccines such as AstraZenecas Vaxzevria and the Johnson & Johnsons Janssen shots.

The adverse effect led to blood clots and low platelet count in healthy young adults.

VITT is marked by venous or arterial thrombosis, particularly at unusual sites including cerebral sinus venous thrombosis (CSVT)/splanchnic thrombosis; mild to severe thrombocytopenia (low platelet count); and positive PF4-heparin ELISA (HIT ELISA), according to American Society of Hematology.

HIT stands for Heparin-induced thrombocytopenia which is an immune complication that can occur in patients exposed to heparin products.

Thrombosis refers to a blood clot within blood vessels that restricts the flow of the red-hued body fluid.

The symptoms of VITT include persistent headaches, shortness of breath, abdominal pain, easy bruising or bleeding, nausea and vomiting.

People who have VITT, their immune response gets compromised and they make antibodies that can stick to one of the bodys own proteins called platelet factor 4 (PF4), as per The Conversation.

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TTS and VITT

AstraZeneca has accepted in court documents in the United Kingdom that its COVID-19 vaccine, in rare cases, can cause Thrombosis with Thrombocytopenia Syndrome (TTS).

TTS is a broader category that can be triggered by vaccine or it can be non-immune mediated. As per ScienceDirect, VITT can be considered as one of several entities that fall under the umbrella of immune-mediated TTS.

A 2022 study in Lancet Global Health revealed that AstraZeneca had reported rates of 8.1 TTS cases per million who got the first dose of its COVID-19 vaccine and 2.3 cases per million after people got the second jab. The highest number of these cases were found in Nordic countries 17.6 per million doses and the lowest in Asian nations 0.2 per million doses.

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In India, at least one young woman is believed to have died from VITT after taking Covishield .

Rithaika Sri Omtri, 18, got the first dose of Covishield in May 2021 in Hyderabad. As per a Scroll report, within five days of being vaccinated, she experienced a prickling sensation in her fingers and, later, a high fever.

As her fever did not subside for a few days, a doctor suggested her a blood test which revealed her platelets had dropped to a dangerous low of 40,000 per cubic millimetre, compared to a normal range between 1.5 lakh and 4 lakh.

Over 10 days later, Rithaika started vomiting and could not walk. An MRI scan of her brain showed that she had multiple blood clots and a haemorrhage in the right frontal region, Scroll reported.

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Despite efforts to save her, she was declared brain dead, two weeks after her vaccination.

Rithaika had suffered a vaccine-induced (immune) thrombotic thrombocytopenia, Scroll reported.

AstraZeneca under scanner

The pharma giant has been under scrutiny since its admission came to light. People who took its COVID-19 vaccine started questioning its safety. However, experts said the side effects appeared within the first few weeks of taking the vaccine and there was no need to worry now.

Recently, AstraZeneca said its COVID-19 vaccine, which was manufactured by the Serum Institute of India (SII) and sold as Covishield in India, has been removed from the markets for commercial reasons.

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With inputs from agencies

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What is VITT, the other blood clotting condition linked to AstraZeneca's COVID-19 vaccine? - Firstpost

Former American teacher part of Covid-19 vaccine trial sues AstraZeneca, claims permanent disability – The Indian Express

May 17, 2024

Weeks after pharmaceutical giant AstraZeneca admitted to rare side effects from its Covid-19 vaccine, an American woman, who had taken part in the clinical trials of the coronavirus shot, has sued the English pharmaceutical giant claiming that it had left her permanently disabled.

According to a report by The Telegraph,Brianne Dressen, a 42 year-old former American teacher from Utah, is first from the US to file a lawsuit against the company. In the UK, more than 50 people have filed a case against the corporation as multiple cases of rare and serious conditions were registered post taking the jab.

Last week, AstraZeneca voluntarily withdrew from the marketing authorisation of the COVID vaccine in EU. This came in action after the giant accepted that the vaccine can cause rare side effects to the human body in the court documents.

Ms Dressen mentioned that post the trial in 2020 she came down with a severe neurological condition which left her experiencing pricking pain all over her body.

Express Opinion | Side effects of AstraZeneca vaccine: Medicine is clear now to the courts

Speaking to Telegraph she stated that she was diagnosed with peripheral neuropathy and the her condition was considered as a "post-vaccine neuropathy".

This thing took me out of my job Im still permanently disabled,, she exclaimed.

I still have that horrific nightmare of the pins and needles sensation coursing through my body, head to toe, 24 hours a day, seven days a week.

Her complaint in the court further described that she had become "a shadow of her former self: unable to work, unable to do any athletic activity, unable to parent the way she had, and unable to drive more than a few blocks at a time"

In a chat thread on X(formerly twitter), Dressen shed light on what her current medication prevailed and how her 11 year-old son helped her set it up.

She mentioned that the conglomerate had signed an agreement with her stating they will "pay the costs of medical treatment for research injuries, provided that the costs are reasonable, and you did not cause the injury yourself". However, the case comes to light after the court papers were filed on May 12 where the company did not adhere to the promises made.

From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects, stated an AstraZeneca spokesperson through an email communication on May 13.

Current Neurology and Neuroscience Reports journal in 2023 published a finding greater than expected occurrence of severe neurological adverse events following different kinds of Covid-19 vaccination. However, they said that the evidence was not too strong for the withdrawal of the vaccine.

Express Opinon | Covishields rare side-effects: In election season, dangers of politicising the vaccine

Ms Dressen has filed the case in Utah court which allows the complainant to incur amount for breach and damages. While she hasn't specified any amount, she holds the legally binding bills of tens of thousands of dollars for medical care that she had to take care of. Ms Dressen in a X (formerly twitter) post mentioned that the company offered $1200 as a settlement.

In addition, Dressen mentioned that the biggest impact of this condition was on her children who are aged nine and eleven.

They dont remember who I was before, already, she added.

Apart from the breach of contract she is also suing the company for emotional distress, legal fees and lost income.

Hindsight is 20:20, but at the time, I really genuinely believed that this would be like our generations moment to show how we can overcome adversity. I really did. she exclaimed.

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Former American teacher part of Covid-19 vaccine trial sues AstraZeneca, claims permanent disability - The Indian Express

Now, AstraZeneca’s Covid vaccine linked to VITT blood clotting disorder: Report – The Week

May 17, 2024

AstraZeneca coronavirus vaccine, which was sold in India as Covishield, is linked to a rare blood clotting disorder called Vaccine-Induced Immune Thrombocytopenia and Thrombosis (VITT), researchers have found.

Pharmaceutical company AstraZeneca earlier this month had announced the worldwide withdrawal of its Covid-19 vaccines. Although "surplus of available updated vaccines" that target new variants of the virus was cited as the reason for the withdrawal, the decision came days after the company acknowledged in court papers that the vaccine carried serious side effects, known as thrombosis with thrombocytopenia, or TTS, in some people. This also follows the AstraZeneca's decision to withdraw its European Union marketing authorisation. On May 6, Monday, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.

It was scientists of South Australia's Flinders University that revealed in a study VITT emerged in 2021 during the Covid-19 pandemic, particularly after the use of the Oxford-AstraZeneca vaccine. The jab was based on adenovirus vectors, India Today said in a report.

ALSO READ | Why AstraZeneca decided to withdraw Covid-19 vaccine globally

According to the researchers, VITT is caused by a harmful blood autoantibody targeting a protein called platelet factor 4 (PF4), the report said. Another research last year had revealed a similar fatal disorder linked to natural adenovirus infections involving the same PF4 antibody.

PF4 antibodies in vaccine-related VITT and natural adenovirus infections reportedly share identical molecular signatures.

Understanding "autoantibody"

US-based National Cancer Institute describes "autoantibody" as an antibody produced by the immune system that attacks the body's own proteins. Autoantibodies can directly destroy cells that have substances on them or can make it easier for other white blood cells to destroy them.

This can cause to autoimmune diseases, where the immune system harms healthy cells and tissues. Affected people are likely to develop blood clots in unusual places including the brain, India Today said. The patients may also have high levels of a substance called D-dimer in their blood, the report said.

The new study reportedly found that a common factor in viruses and vaccines triggers these harmful antibodies.

However, VITT is likely to occur four to forty-two days after taking the vaccine. As people are no longer taking the vaccine, the study offers vaccinated people no reason to bother, the report added.

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Now, AstraZeneca's Covid vaccine linked to VITT blood clotting disorder: Report - The Week

Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Covid-19 vaccines: scientists report to journal | Mint – Mint

May 17, 2024

Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Plcs Covid-19 vaccines were caused by an autoimmune reaction that some people are predisposed to, researchers have found. This discovery is expected to influence the development of future vaccines, Bloomberg reported.

Adenovirus-based vaccines, like the J&J and AstraZeneca shots that were later pulled from the market, contain a component that can trigger blood clots in genetically susceptible individuals, scientists reported Wednesday in a letter to the New England Journal of Medicine. Researchers are now aiming to identify the specific component and attempt to remove it through genetic engineering, the report said.

Its not known how many people may be susceptible to the complication," said Tom Gordon, head of immunology at Flinders University in South Australia, whose molecular investigation led to the finding. The immune reaction linked to the shot is a new disease," he stated in an interview. I think as haematologists and intensive care specialists become more familiar with these conditions, more cases will be described," the scientists Bloomberg.

Out of more than 18 million people who received the single-dose J&J vaccine, 60 cases of the clotting disorder were reported, resulting in nine deaths, according to the Yale School of Medicine, Bloomberg reported.

A small number of clot-related deaths linked to the AstraZeneca vaccine led to its withdrawal or restriction in Denmark, Norway, and other countries in 2021. The complication occurred in about 2-3 people per 100,000 vaccinated with the AstraZeneca shot under age 60 in Australia, where it hasnt been available since March 2023. The European Commission withdrew the marketing authorization for the vaccine in March 2024, the Bloomberg report said.

AstraZeneca welcomes any further examination of the possible underlying mechanism of thrombosis with thrombocytopenia syndrome (TTS), given that, despite extensive investigation, we do not yet understand the mechanism that can in very rare cases be a trigger for TTS," a spokesperson for the company said, as per the report.

J&J also expressed support for research that helps guide the development of safe and effective vaccines. More data are needed to fully understand potential factors that may be associated with this rare event, including its potential relationship with adeno- and other viruses, to draw appropriate conclusions about the underlying pathogenesis," the company said in an email.

Both vaccines played a crucial role in early pandemic vaccine programmes. An analysis found the AstraZeneca vaccine saved an estimated 6.3 million lives in 2021.

The mRNA vaccines made by the Pfizer Inc.-BioNTech SE partnership and Moderna Inc. were later found to be more effective at protecting against Covid and have been updated to tackle more recent virus variants.

(With Inputs from Bloomberg)

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Rare but deadly blood clots tied to Johnson & Johnson and AstraZeneca Covid-19 vaccines: scientists report to journal | Mint - Mint

Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim – WION

May 17, 2024

Researchers discovered that the rare but deadly blood clots associated with Johnson & Johnson and AstraZeneca Plc's COVID-19 vaccines were triggered by an autoimmune response that some people may have a genetic predisposition to. This finding is expected to influence the development of future vaccines.

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According to scientists who wrote a letter to the New England Journal of Medicine on Wednesday (May 15), said that adenovirus-based vaccines such as the J&J and AstraZeneca shots, which were withdrawn from the market, include a component capable of inducing blood clots in people with a genetic vulnerability. Researchers said they will try to narrow down the component and then try to eliminate it through genetic modification, as reported by Bloomberg.

Tom Gordon, head of immunology at Flinders University in South Australia, whose investigative work led to the discovery, said that the extent of susceptibility to this complication remains unknown. He described the immune reaction associated with the vaccine as "a new disease" stressing on the likelihood of more cases being documented as hematologists and intensive care specialists become more used to these conditions.

According to the Yale School of Medicine, out of over 18 million recipients of the single-dose J&J vaccine, there were 60 reported cases of the clotting disorder, resulting in nine deaths.

Also read | Plea filed inIndiastop court seeking investigation into Covid vaccine Covishield's sideeffects

Following a small number of clot-related deaths associated with the AstraZeneca vaccine, it was withdrawn or restricted in Denmark, Norway, and other nations in 2021. In Australia, where the AstraZeneca shot has not been available since March 2023, the complication occurred in approximately 2-3 people per 100,000 vaccinated individuals under the age of 60. The European Commission revoked the marketing authorisation for this vaccine in March 2024.

AstraZeneca welcomes any further examination of the possible underlying mechanism of thrombosis with thrombocytopenia syndrome (TTS), given that, despite extensive investigation, we do not yet understand the mechanism that can in very rare cases be a trigger for TTS, a spokesperson for the company told Bloomberg.

J&J also said that it is open to research that helps in the development of safe and effective vaccines.

More data are needed to fully understand potential factors that may be associated with this rare event, including its potential relationship with adeno- and other viruses, to draw appropriate conclusions about the underlying pathogenesis, the company said in an email sent to Bloomberg.

Also read | AstraZeneca Covid vaccine: Court case, rare side effects, admission of guilt, and more. All you need to know

Both vaccines were crucial in vaccine campaigns in the initial phases of the pandemic. An assessment indicated that the AstraZeneca vaccine potentially saved around 6.3 million lives in 2021. However, the mRNA vaccines produced by Pfizer Inc.-BioNTech SE and Moderna Inc. were subsequently discovered to offer higher effectiveness against Covid and have been modified to address more recent virus variants.

(With inputs from agencies)

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Genetics linked to rare blood clots from J&J and AstraZeneca Covid vaccines, researchers claim - WION

Novavax stock jumps 50% as Sanofi deal kicks off turning point for struggling vaccine maker – CNBC

May 15, 2024

A vial labeled "Novavax V Covid-19 Vaccine" is seen in this photo taken Jan. 16, 2022.

Dado Ruvic | Reuters

Shares of Novavax closed nearly 50% higher on Monday as Wall Street cheered the company's new multibillion-dollar deal with French drugmaker Sanofi that sparked a dramatic turnaround for the struggling vaccine maker.

Novavax's stock almost doubled on Friday after it announced the licensing agreement with Sanofi. Novavax on Friday said the deal allows the company to remove its "going concern" warning, which it first issued in February 2023 due to major doubts about its ability to stay afloat.

"It really does help our business. It keeps us well capitalized, it takes the going concern off, it gives us the chance to pivot our strategy more toward what we're best at to bring additional value to all of our stakeholders, including our shareholders," Novavax CEO John Jacobs told CNBC in an interview.

Under the agreement, Sanofi will take a less than 5% stake in Novavax. The deal also entitles Novavax to an upfront cash payment of $500 million and future payments contingent on certain milestones, as well as royalties.

Sanofi, one of the world's largest vaccine makers, will co-market Novavax's Covid vaccine in most countries starting in 2025. The deal also allows Sanofi to use Novavax's Covid shot and flagship vaccine technology, Matrix-M adjuvant, to develop new vaccine products. The shots include combination jabs targeting Covid and the flu.

A logo on the Sanofi exhibition space at the Viva Technology conference dedicated to innovation and startups at Porte de Versailles exhibition center in Paris, France, on June 15, 2022.

Benoit Tessier | Reuters

In a note Sunday, Jefferies analyst Roger Song said the deal will provide significant capital to Novavax and support the company's growth.

"Economically, the deal is highly lucrative and impactful," Song wrote.

He said the upfront payment helps remove investor worry about Novavax's going concern warning, and that milestone payments are "significant and relatively near-term" for the company since they are not tied to sales. Meanwhile, royalties will provide a steady revenue stream each year, Song said.

He added that the deal "validates" the company's protein-based vaccine platform.

Novavax's shot is the first Covid vaccine to use protein technology, a decades-old method for fighting viruses used in routine shots against Hepatitis B and shingles. Health officials view the vaccine as a valuable alternative for people who do not want to take messenger RNA jabs from Pfizer and Moderna.

In a note on Sunday, Leerink Partners analyst David Risinger said he is interested to see how effective Sanofi is at raising consumer awareness about how the side effects of Novavax's Covid vaccine are easier for patients to tolerate compared to competing shots from Pfizer and Moderna.

Risinger noted that consumer hesitancy around Covid boosters has come in part from fears about the fatigue and discomfort associated with Pfizer's and Moderna's shots.

The firm expects Sanofi "to drive greater commercial success of [Novavax's] vaccine starting in 2025, due to its commercial scale and contracting abilities, but it is difficult to predict the magnitude of impact," Risinger wrote.

He added that there could be "further upside" for Sanofi and Novavax if they develop a combination Covid and flu vaccine that has advantages over the mRNA combo shots being developed by Pfizer and Moderna.

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Novavax stock jumps 50% as Sanofi deal kicks off turning point for struggling vaccine maker - CNBC

Data: Heart-failure patients have 82% better odds of living longer if vaccinated against COVID – University of Minnesota Twin Cities

May 15, 2024

The first study of COVID-19 vaccine effectiveness in a large population of adult heart-failure patients suggests that vaccinated participants are 82% more likely to live longer than their unvaccinated peers, according to ananalysis presented over the weekend at the Heart Failure 2024 scientific congress of the European Society of Cardiology (ESC) in Lisbon, Portugal.

Researchers from theNational Health Insurance Service Ilsan Hospital in Goyang, South Korea,analyzed information on vaccinations and clinical outcomes among 147,118 heart-failure patients from the Korean National Health Insurance Service database, which covers nearly all Koreans.

To control for potential confounding factors, vaccinated patients (who received at least two COVID-19 vaccine doses) were matched in a 1:1 ratio to their unvaccinated counterparts (those who received one or no dose), for a total of 73,559 participants each. Participants were followed for a median of 6 months. The average patient age was 69.5 years, and half were women.

Worldwide, more than 64 million people have been diagnosed as having heart failure, a life-threatening syndrome. Previous studies have shown that COVID-19 vaccination is safe in patients with cardiovascular diseases such as heart failureand that COVID-19 outcomes tend to be more severe in patients with the condition.

Relative to one or no vaccination, COVID-19 vaccination was tied to an 82% lower risk of death from any cause,a47% lower risk of hospitalization for heart failure,and a 13% reduced risk of infection over 6 months. Vaccination was also linked to significantly lower risks of stroke, heart attack, myocarditis/pericarditis, and venous thromboembolism.

"This was the first analysis of COVID-19 vaccine effectiveness in a large population of heart failure patients, and the first to show a clear benefit from vaccination," study coauthor Kyeong-Hyeon Chun, MD, said in the ESC news release.

"The study provides strong evidence to support vaccination in patients with heart failure," he added. "However, this evidence may not be applicable to all patients with heart failure, and the risks of vaccination should be considered in patients with unstable conditions."

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Data: Heart-failure patients have 82% better odds of living longer if vaccinated against COVID - University of Minnesota Twin Cities

New COVID-19 Variant FLiRT: What to Know – AARP

May 15, 2024

With national levels of respiratory illness declining and warmer weather on the horizon, COVID-19 may no longer be top of mind. But dont let it slip too far, health experts warn.

COVID is down, but it has not gone away. I would say its continuing to smolder out there, says infectious disease expert William Schaffner, M.D., a professor of medicine at Vanderbilt University School of Medicine in Nashville, Tennessee.

Unlike influenza, which Schaffner says virtually disappears during the summer months, COVID-19 keeps circulating. In fact, federal data shows that historically, COVID-19 cases and hospitalizations spike some during the summer months.

One thing that could fuel another surge this summer: a new variant, one that is better able to escape our immune defenses from vaccines and previous infections. Right now, all eyes in the U.S. are on two variants KP.2 and KP.1.1 from a group known as the FLiRT variants. Together these two variants make up about one-third of infections in the U.S.

No doubt weve seen some strange nicknames for variants throughout the COVID-19 pandemic Arcturus, Pirola and Eris, to name a few. According to an explainer posted by the Infectious Diseases Society of America, FLiRT is an acronym for some of the variants spike protein mutations.

The FLiRT variants, which are still in the omicron family, appear to be highly transmissible, meaning they spread easily. However so far, they do not appear to cause more severe disease, Schaffner says.

The slight caution about the FLiRT variants, Schaffner says, is that from a genetic perspective, they are a little more distant from their parents. That means immunity from previous infections and vaccines may not protect perfectly against an infection with a FLiRT variant, he notes.

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New COVID-19 Variant FLiRT: What to Know - AARP

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