The U.S. Food and Drug Administration (FDA) has recommended that COVID vaccine manufacturers update their formulas for fall doses, in an attempt to target the KP.2 strain of the JN.1 variant.

The Thursday announcement came just a week after the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend a “monovalent JN.1-lineage vaccine” at its June 5 meeting.

As of the end of March 2024, the KP.2 variant was responsible for just 4% of infections in the U.S., according to the COVID Data Tracker from the Centers for Disease Control and Prevention (CDC).

CDC WARNS OF ‘DUAL MUTANT’ FLU STRAIN THAT COULD EVADE ANTIVIRAL DRUGS: ‘NEED TO CLOSELY MONITOR’

Meanwhile, over 50% of infections at that time were attributed to its parental strain, JN.1.

Just a few weeks later, KP.2 is now the cause of around 28% of infections, while the JN.1 variants have largely dropped in prevalence, the tracker shows.

Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, recently spoke with Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration, about the new vaccine formulations.

“It makes sense to target the KP.2 strain because it is becoming the predominant strain — it is surging in California and will spread across the country,” Siegel told Fox News Digital.

KP.2 is now the cause of around 28% of infections, while the JN.1 variants have largely dropped in prevalence, CDC Tracker data shows. (iStock)

The KP.2 strain is “highly immunoevasive,” the doctor warned — which means that immunity from previous variants and subvariants don’t offer much protection.

COVID-FLU COMBO VACCINE SHOWS ‘POSITIVE’ RESULTS IN PHASE 3 TRIALS, MODERNA SAYS: A ‘TWO-FOR’ OPTION

“On the other hand, the vaccine will cause a production of immune cells and antibodies that will continue to protect you against previous variants and subvariants,” Siegel added.

The updated vaccine is especially important for high-risk groups, those who have chronic illnesses, the elderly and anyone who comes in contact with them, according to doctors. (iStock)

It is especially important for high-risk groups, those who have chronic illnesses, the elderly and anyone who comes in contact with them, according to the doctor.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

In a statement to Fox News Digital, vaccine maker Novavax — which makes protein-based vaccines — said the company “just filed” its application for a JN.1 COVID vaccine. 

A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George’s University hospital in London, on Oct. 7, 2020. (AP Photo/Alastair Grant, File)

“Novavax’s updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3,” the company said in a press release.

“The submission is in line with guidance from the U.S. FDA, European Medicines Agency (EMA) and the World Health Organization (WHO) to target the JN.1 lineage this fall.”

For more Health articles, visit www.foxnews/health. 

Fox News Digital reached out to Pfizer and Moderna — both of which produce mRNA-based vaccines — requesting comment on their plans for fall formulations.

Heart disease has been the world’s No. 1 killer for over a century, and experts predict that it will become even more prevalent in the coming decades.

A report this month from the American Heart Association (AHA) predicts that at least six in 10 U.S. adults could experience cardiovascular disease within the next 30 years.

The rate of hypertension (high blood pressure) — which is one of the key risk factors for heart disease — is expected to increase from 51.2% in 2020 to 61.0% in 2050.

HEART ATTACKS MORE LIKELY DURING PRESIDENTIAL ELECTIONS AND OTHER STRESSFUL TIMES, STUDY SHOWS

Diabetes, another major risk factor, is also expected to rise (16.3% to 26.8%), along with obesity (43.1% to 60.6%), according to the study, which was published in the AHA journal Circulation.

As a result, total cardiovascular disease is predicted to rise from 11.3% to 15.0% between 2020 and 2050.

“The landscape of cardiovascular disease in the U.S. is seeing the arrival of a near-perfect storm,” Dr. Dhruv S. Kazi, vice chair of the advisory writing group and a Boston cardiologist, said in a press release.

ANGER CAN INCREASE HEART ATTACK RISK, STUDY FINDS

“The last decade has seen a surge of cardiovascular risk factors, such as uncontrolled high blood pressure, diabetes and obesity, each of which raises the risks of developing heart disease and stroke,” he continued. 

“It is not surprising that an enormous increase in cardiovascular risk factors and diseases will produce a substantial economic burden.”

As a result of the risk factors identified in the study, total cardiovascular disease is predicted to rise from 11.3% to 15.0% between 2020 and 2050. (iStock)

On a positive note, the researchers determined that hypercholesterolemia (high levels of LDL, or “bad cholesterol”), will decline (45.8% to 24.0%).

They also predicted that diet, exercise and smoking habits will improve, although sleep quality is expected to worsen.

ASK A DOCTOR: ‘WHY AM I HEARING MY HEARTBEAT IN MY EARS?’

The researchers analyzed data from the 2015 to March 2020 National Health and Nutrition Examination Survey and the 2015 to 2019 Medical Expenditure Panel Survey.

“We projected through 2050, overall and by age and race and ethnicity, accounting for changes in disease prevalence and demographics,” they wrote.

“[The] most adverse trends are projected to be worse among people identifying as American Indian/Alaska Native or multiracial, Black or Hispanic.”

Life’s Essential 8 consists of the following eight lifestyle behaviors for optimal heart health, according to the American Heart Association. (iStock/American Heart Association)

The study looked for trends in cardiovascular risk factors based on adverse levels of Life’s Essential 8 and clinical cardiovascular disease and stroke. 

WANT TO LIVE LONGER? FOLLOW 8 HEART-HEALTHY HABITS, SAYS THE AMERICAN HEART ASSOCIATION

Life’s Essential 8 consists of the following eight lifestyle behaviors for optimal heart health, according to the AHA:

1. Following a healthy sleep schedule
2. Not smoking
3. Getting regular physical activity
4. Adhering to a healthy diet
5. Maintaining a healthy body weight
6. Maintaining healthy blood glucose levels
7. Maintaining healthy cholesterol levels
8. Maintaining healthy blood pressure

Overall, the report predicts that clinical cardiovascular disease (affecting the heart or blood vessels) will affect 45 million adults by 2050, and clinical cardiovascular disease (including hypertension) will affect more than 184 million adults.

Overall, the report predicts that clinical cardiovascular disease (affecting the heart or blood vessels) will affect 45 million adults by 2050, and clinical cardiovascular disease (including hypertension) will affect more than 184 million adults. (iStock)

“The prevalence of many cardiovascular risk factors and most established diseases will increase over the next 30 years,” the researchers stated.

Renato Apolito, M.D., the medical director of the Cardiac Catheterization Laboratory at Hackensack Meridian Jersey Shore University Medical Center, was not involved in the AHA study but shared his insights on the findings.

“We are all under a lot of pressure and stress to work more to make ends meet.”

One of the key factors is the projected increase in obesity in the coming decades, Apolito said in an interview with Fox News Digital. 

“Obesity is very commonly associated as a driver of hypertension, diabetes, sleep apnea and hypertriglyceridemia,” he said. 

Some of the greater causes of obesity are lack of exercise and a heavy reliance on processed and fast food, he noted.

Some of the greater causes of obesity are lack of exercise and a heavy reliance on processed and fast food, a cardiologist said. (iStock)

“I suspect that as our standard of living goes up, our reliance on processed and pre-prepared food — in addition to lack of exercise and lack of sleep from our hectic work lives — will drive up obesity as the common denominator leading to all the other risk factors mentioned,” Apolito predicted.

“All of those factors put together would lead to an increase in coronary artery disease, heart failure and stroke.”

Reducing the risk

“Clinical and public health interventions are needed to effectively manage, stem and even reverse these adverse trends,” the researchers advised.

Apolito agreed that change is needed.

“We are all under a lot of pressure and stress to work more to make ends meet,” he said. 

“This typically leads to the bad lifestyle habits mentioned above.”

The doctor recommends starting small, setting aside just 10 to 20 minutes per day to do some form of exercise and to make conscious decisions to avoid processed and fast foods.

A cardiologist recommends starting small, setting aside just 10 to 20 minutes per day to do some form of exercise and to make conscious decisions to avoid processed and fast foods. (iStock)

“You would maintain a healthier weight, which would mitigate your risk of hypertension, diabetes, sleep apnea, dyslipidemia and, ultimately, cardiovascular disease,” he said.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

Apolito also pointed out that the study is speculative, using predictive models on data from the past and present to predict the future — “which is never easy to do.”

For more Health articles, visit www.foxnews/health. 

“Hopefully, with increased public education, we can turn the tide and improve overall health in the coming decades by making healthy choices in lifestyle,” he added.

The Food and Drug Administration (FDA) is warning consumers about a mushroom-infused chocolate bar that has reportedly sent some people to the hospital.

The FDA released an advisory message about Diamond Shruumz “microdosing” chocolate bars on June 7. The chocolate bars contain a “proprietary nootropics blend” that is said to give a “relaxed euphoric experience without psilocybin,” according to its website.

“The FDA and CDC, in collaboration with America’s Poison Centers and state and local partners, are investigating a series of illnesses associated with eating Diamond Shruumz-brand Microdosing Chocolate Bars,” the FDA’s website reads.

“Do not eat, sell, or serve Diamond Shruumz-Brand Microdosing Chocolate Bars,” the site warns. “FDA’s investigation is ongoing.”

STUDY FINDS EVIDENCE OF MICROPLASTICS IN BRAINS AND OTHER ORGANS

“Microdosing” is a practice where one takes a very small amount of psychedelic drugs with the intent of increasing productivity, inspiring creativity and boosting mood. According to Diamond Shruumz’s website, the brand said its products help achieve “a subtle, sumptuous experience and a more creative state of mind.”

“We’re talkin’ confections with a kick,” the brand said. “So if you like mushroom chocolate bars and want to mingle with some microdosing, check us out. We just might change how you see the world.”

But government officials warn that the products have caused seizures in some consumers and vomiting in others.

“People who became ill after eating Diamond Shruumz-brand Microdosing Chocolate Bars reported a variety of severe symptoms including seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting,” the FDA reported. 

WOMAN LEFT WITH KIDNEY DAMAGE AFTER VISITING HAIR SALON

Six people reportedly experienced such severe reactions that they sought medical care.

At least eight people have suffered a variety of medical symptoms from the chocolates, including nausea. (iStock)

“All eight people have reported seeking medical care; six have been hospitalized,” the FDA’s press release said. “No deaths have been reported.”

Diamond Shruumz says on its website that its products are not necessarily psychedelic. Although the chocolate is marketed as promising a psilocybin-like experience, there is no psilocybin in it.

“There is no presence of psilocybin, amanita or any scheduled drugs, ensuring a safe and enjoyable experience,” the website claims. “Rest assured, our treats are not only free from psychedelic substances but our carefully crafted ingredients still offer an experience.”

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

“This allows you to indulge in a uniquely crafted blend designed for your pleasure and peace of mind.”

Officials warn consumers to keep the products out of the reach of minors, as kids and teens may be tempted to eat the chocolate bars.

The chocolate bars are marketed as products that boost mood and creativity. (iStock)

“This product may appeal to children and teenagers as it is marketed as a candy,” the FDA advises. “Parents and caregivers should consider discussing the information in this advisory with their children and take extra care to avoid this product being consumed by younger people.”

The FDA and CDC are actively investigating the products.

Fox News Digital reached out to Diamond Shruumz for comment, but did not hear back.

For more Health articles, visit www.foxnews.com/health.