Tag: strokes (medical)

Up to 60% of stroke survivors may develop cognitive decline within a year | CNN

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CNN
 — 

Up to 60% of all stroke survivors develop memory and thinking problems within a year, and one-third go on to develop dementia within five years, according to a new American Stroke Association scientific statement.

“The numbers are staggering, right?” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health in Denver.

“This is a call to action to up our game and focus on prevention,” said Freeman, who was not part of the scientific committee who prepared the statement.

An estimated 9.4 million American adults — about 3.6% of the US adult population — report having had a stroke, according to 2023 statistics from the American Heart Association.

“Cognitive impairment is an often under-reported and under-diagnosed but yet very common condition stroke survivors frequently deal with,” said Dr. Nada El Husseini, an associate professor of neurology at Duke University Medical Center in Durham, North Carolina, in a statement.

About 40% of the survivors of stroke have mild cognitive impairment that does not meet the diagnostic criteria for dementia. Mild or not, the mental difficulties can seriously affect quality of life, said El Husseini, who chaired the writing committee for the statement.

“Cognitive impairment after stroke ranges from mild impairment to dementia and may affect many aspects of life, such as remembering, thinking, planning, language and attention, as well as a person’s ability to work, drive or live independently,” El Husseini said.

Cognitive impairment is most common within the first two weeks after a stroke, the statement said. Mental decline may go hand in hand with other conditions associated with a stroke such as behavioral and personality changes, depression, physical disability and disruption in sleep, all of which can contribute to a lower quality of life.

The American Stroke Association’s statement did offer some good news: About 20% of people who experience mild cognitive impairment after a stroke fully recover their cognitive function, typically within the first six months.

People are at higher risk for strokes if they have atrial fibrillation, an irregular heartbeat that sufferers often describe as a quiver, flutter or flip-flop of the heart in the chest. Those with uncontrolled high cholesterol or high blood pressure are also at high risk, as are people who smoke or use drugs or alcohol. Being diabetic or obese can be risk factors, too.

Ischemic strokes, caused by a clot in the blood vessels that feed blood to the brain, account for 87% of all strokes, according to the statement. Brain bleeds caused by a rupture of a weak vessel in the brain, called hemorrhagic strokes, are much less common, accounting for some 13% of all strokes.

The following are signs of a stroke, according to the National Institute of Neurological Disorders and Stroke:

  • Sudden numbness or weakness in the face, arm or leg, especially on one side of the body.
  • Sudden confusion, trouble speaking or difficulty understanding speech.
  • Sudden trouble seeing in one or both eyes.
  • Sudden trouble walking, dizziness, loss of balance or lack of coordination.
  • Sudden severe headache with no known cause.

Other, less commons symptoms include dizziness, disorientation, nausea, memory loss or vomiting.

Any of the warning signs may last only a few moments and then disappear, which could mean the person is having a minor stroke or a transient ischemic attack, or TIA. Any symptom should not be ignored, experts say, as it can signal a more serious stroke to come.

“One might call a TIA a ‘lucky stroke’ because it’s less serious, but it really is a sentinel event,” Freeman said.

It’s never too late for prevention, but serious effort is needed after even mild stroke to “extinguish the fire if you will, with aggressive change and aggressive medication therapy when appropriate,” Freeman added.

“It should push people to make very drastic lifestyle changes: Eat better, exercise more, go on the appropriate statins or aspirins or whatever their doctor suggests are appropriate so that their risk is as low as possible,” he said.

Damage to the brain occurs when some cells stop getting oxygen and die, while other brain cells may die due to bleeding in the brain. As a result, permanent brain damage can occur within minutes to hours, according to the institute. “Some brain cells die quickly but many linger in a compromised or weakened state for several hours,” it said.

Immediate medical attention is key to lessening the impact of a stroke. Learning the symptoms of a stroke using the acronym FAST can help identify the signs quickly, according to the US Centers for Disease Control and Prevention.

  • F — Face: Ask the person to smile. Does one side of the face droop?
  • A — Arms: Ask the person to raise both arms. Does one arm drift downward?
  • S — Speech: Ask the person to repeat a simple phrase. Is the speech slurred or strange?
  • T — Time: If you see any of these signs, call 911 right away.

Be sure to capture the time when any symptom first appears, the CDC advises, to help medical personnel determine the best course of treatment.

Additional strokes only worsen potential cognitive decline, the scientific statement said, so prevention is key. Stroke risk factors, such as hypertension, high cholesterol and type 2 diabetes, should be treated, as should atrial fibrillation.

Keeping high blood pressure under control has been linked to a reduction in risk for additional strokes as well as mild cognitive impairment, the statement said.

“Stroke survivors should be systematically evaluated for cognitive impairment so that treatment may begin as soon as possible after signs appear,” El Husseini said.

“Perhaps the most pressing need, however, is the development of effective and culturally relevant treatments for post-stroke cognitive impairment,” she said. “We hope to see big enough clinical trials that assess various techniques, medications and lifestyle changes in diverse groups of patients that may help improve cognitive function.”

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Senator John Fetterman’s hospitalization for depression has raised awareness of the condition. Our medical analyst explains what it is and how it’s treated | CNN

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Editor’s Note: If you or someone you know is struggling with suicidal thoughts or mental health matters, please call the 988 Suicide and Crisis Lifeline, or visit the hotline’s website.



CNN
 — 

Sen. John Fetterman of Pennsylvania is continuing to receive treatment for depression at Walter Reed Medical Center in Bethesda, Maryland, after checking himself into the hospital on February 15. His office has said he has experienced depression “off and on” during his life, but that his condition “only became severe in recent weeks,” necessitating inpatient care.

Fetterman’s disclosure, widely praised by mental health advocates, has prompted many people to ask questions about the often misunderstood illness: What is depression and what are the symptoms? What are its risk factors? How can one distinguish clinical depression from feeling sad? How common is major depressive disorder? What treatments are available and when is hospitalization needed? And how can someone who needs help find assistance?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she served as Baltimore’s health commissioner and chaired the board of Behavioral Health System Baltimore, a nonprofit organization that oversaw mental health services in the city.

CNN: What is depression, and what are its symptoms?

Dr. Leana Wen: Major depressive disorder, colloquially referred to as depression or clinical depression, is a common illness. It is a serious mental health condition characterized by a persistently low or depressed mood and a loss of interest in activities that previously brought a person joy. Other symptoms include a lack of energy, feelings of guilt or worthlessness, an inability to concentrate, appetite changes, sleep disturbances or suicidal thoughts. These symptoms often affect someone’s ability to function at work, at home, and in social interactions.

CNN: How can one distinguish clinical depression from feeling sad? How is a diagnosis made?

Wen: It’s very common to feel down from time to time; many people experience periods of sadness, especially when facing challenging life situations. But this is different from major depressive disorder, for which there are specific diagnostic criteria including depressed mood or lack of interest in normal activities causing social or occupational impairment, and other specified symptoms such as problems with sleep, eating, concentration, energy or self-worth. These symptoms must persist for at least two weeks for a diagnosis of major depressive disorder to be made.

Screening for major depressive disorder generally begins with a physical examination by a health care provider. Often, laboratory tests are done to rule out other ailments, such as hypothyroidism and vitamin deficiency. There are questionnaires that can help screen for depression and aid your physician or other provider with the diagnosis.

CNN: How common is major depressive disorder?

Wen: An estimated 21 million adults in the United States had at least one major depressive disorder episode lasting at least two weeks in 2020, according to the US Substance Abuse and Mental Health Services Administration. This is about 8.4% of all US adults. The prevalence is higher among girls and women compared to boys and men (10.5% compared to 6.2%). The age group with the highest prevalence is young adults 18-25 years old (17%).

The lifetime prevalence of major depressive disorder is even higher; some studies estimate it affects on average 12% of people in the US, but that it could be as high as 17%. That’s 1 in every 6 people.

CNN: What are risk factors for depression?

Wen: There are several different types of risk factors. One is a recent change in life circumstances. The death of a loved one, getting a divorce, losing a home or a job and other major upheavals can increase risk. Other behavioral health conditions, such as anxiety and substance use disorders, are also associated with depression.

A recent illness can increase the risk of major depressive disorder, too. Serious chronic conditions such as heart disease, cancer, multiple sclerosis and dementia are associated with higher rates of depression.

Senator John Fetterman on Capitol Hill in Washington, D.C., on February 14, 2023.

There is a link, too, between stroke and depression; about a third of people who have had a stroke suffer some depressive symptoms.

Senator Fetterman suffered a stroke in May 2022, during his Senate campaign. That could have increased his risk for a depressive episode, especially as, according to his office, he has had episodes of depression in the past.

CNN: What treatments are available, and when is hospitalization needed?

Wen: It’s very important to note that effective treatments are available for major depressive disorder. Initial treatment includes anti-depressant medications and psychotherapy. Sometimes, lifestyle modifications and social supports can also help.

Most patients can be managed effectively with outpatient treatment, meaning that they do not need to be hospitalized. But there are circumstances under which someone may need inpatient treatment in the hospital. A patient could have worsening symptoms and may be suicidal, for instance. They could also have several other medical conditions and may need medication adjustments that are best provided in a hospital setting.

(These refer generally to patients who require hospitalization for major depressive disorder, and not specifically to Senator Fetterman, for whom such detailed medical information is not known and should not be presumed.)

Other individuals can be treated well on an outpatient basis and still from time to time, require inpatient care. This is not dissimilar to how we manage other medical conditions. Patients with diabetes, for example, may be doing well with oral medication then need to switch to insulin. Sometimes, they may have complications that require hospitalization. I think it’s important for us to think about major depressive disorder and other mental health conditions the same as we would physical health conditions.

CNN: How can someone who needs help find assistance?

Wen: For those with a trusted health care provider, a good place to start is to speak with that person. Your physician or other provider can help with the initial assessment, often can make the diagnosis and either begin treatment or refer to someone else who can.

If your primary care provider is delayed in making a referral to a mental health specialist or treating you themselves, you should follow up and emphasize the importance of getting care. Many workplaces and universities offer resources, and there are online telehealth services that could provide some care while you are pursuing referrals through your physician. Local and state health departments often provide some treatment options as well.

In addition, the federal government last year launched the 988 hotline that provides 24/7, free and confidential support for people experiencing emotional distress. The 988 hotline is a network of local and regional hotlines that can refer people and help them get information about where to seek treatment in their area. People can — and should — call or text this number if they are experiencing a mental health crisis.

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Stem cell therapy may reduce risk of heart attack and stroke in certain heart failure patients, study shows | CNN

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CNN
 — 

Cell therapy, involving adult stem cells from bone marrow, has been shown to reduce the risk of heart attack and stroke in severe heart failure patients, according to a new study.

A single administration of adult stem cells directly into an inflamed heart, through a catheter, could result in a long-term 58% reduced risk of heart attack or stroke among heart failure patients with reduced ejection fraction, meaning they have a weakened heart muscle, suggests the study, published Monday in the Journal of the American College of Cardiology.

The study is being called the largest clinical trial of cell therapy to date in patients with heart failure, a serious condition that occurs when the heart can’t pump enough blood to meet the body’s needs.

“We followed these patients during several years – three years – and what we found was that their hearts got stronger. We found a very significant reduction in heart attack and stroke, especially in the patient that we measured in their blood that they had more inflammation going on,” said the study’s lead author Dr. Emerson Perin, a practicing cardiologist and medical director at The Texas Heart Institute in Houston.

“That effect, it was there across everyone, but for the patient that had inflammation, it was even more significant,” Perin said. “And there also is evidence that we had a reduction in cardiovascular deaths.”

The therapy involves injecting mesenchymal precursor cells into the heart. These particular stem cells have anti-inflammatory properties, which could improve outcomes in heart failure patients since elevated inflammation is a hallmark feature of chronic heart failure.

More than 6 million adults in the United States have chronic heart failure, and most are treated with drugs that address the symptoms of the condition. The patients included in the new study were all taking medications for heart failure, and the new research suggests that cell therapy can be beneficial when used in conjunction with heart failure drugs.

“You can imagine, we keep everybody going and doing better with the medicine. And now we have a treatment that actually addresses the cause and quiets everything down. So, this line of investigation really has a great future and I can see that, with a confirmatory trial, we can bring this kind of treatment into the mainstream,” Perin said.

“We can treat heart failure differently,” he said. “We have a new weapon against heart failure and this study really opens the door and leads the way for us to be able to get there.”

The new study – sponsored by Australian biotechnology company Mesoblast – included 565 heart failure patients with a weakened heart muscle, ages 18 to 80. The patients were screened between 2014 and 2019 and randomly assigned to either receive the cell therapy or a placebo procedure at 51 study sites across North America.

The patients who received the cell therapy were delivered about 150 million stem cells to the heart through a catheter. The cells came from the bone marrow of three healthy young adult donors.

The researchers, from The Texas Heart Institute and other various institutions in the United States, Canada and Australia, then monitored each patient for heart-related events or life-threatening arrhythmias.

Compared with the patients who received a sham procedure, those treated with the stem cell therapy showed a small but statistically significant strengthening of the muscle of the heart’s left pumping chamber within a year.

The researchers also found that the cell therapy decreased the risk of heart attack or stroke by 58% overall.

“This is a long-term effect, lasting an average of 30 months. So that’s why we’re so excited about it,” Perin said.

Among patients with high inflammation in their bodies, the combined reduced risk of heart attack or stroke was even greater, at 75%, the researchers found.

“These cells directly address inflammation,” Perin said.

“They have little receptors for these inflammatory substances – some of them are called interleukins, and there’s other kinds,” he said. “When you put them into an inflamed heart, it activates the cells and the cells go, ‘Wow, we need to respond. This house is on fire. We need to put out the fire.’ And so they then secrete various anti-inflammatories.”

The researchers wrote in their study that their findings should be considered as “hypothesis generating,” in that they show this cell therapy concept could work, but clinical trials would be needed to specifically confirm the effects of these stem cells on heart attack, stroke and other events. It is still unclear for how long the effects of the stem cell therapy last beyond 30 months and whether patients will need more stem cell injections in the future.

Overall, there were no major differences between the adverse events reported among the patients who received the cell therapy compared with those in the control group, and the researchers reported no major safety concerns.

“We’ve made an enormous step to be able to harness the real power of adult stem cells to treating the heart,” Perin said. “This trial really is a signal of a new era.”

For more than a decade, scientists have been studying potential stem cell therapies for heart failure patients – but more research is needed to determine whether this treatment approach could reduce the amount of hospitalizations, urgent care events or complications among patients with heart failure.

The new study didn’t find that, said cardiologist Dr. Nieca Goldberg, medical director of Atria New York City and clinical associate professor of medicine at NYU Grossman School of Medicine, who was not involved in the latest study.

What the new study did find is that “there may be a population of people that could benefit from the stem cell therapy, particularly people who have inflammation,” Goldberg said.

“It’s actually an interesting therapy, an interesting thing to consider, once more research substantiates its benefit. Because in heart failure, there’s multiple things going on and, particularly for the inflammatory component, this could be an interesting treatment,” she said. “It might have some role in heart failure patients with inflammation.”

The therapy’s effects on heart attack or stroke risks “were positive,” Dr. Brett Victor, a cardiologist at the Cardiology Consultants of Philadelphia, who was not involved in the study, said in an email.

“Specifically, patients who received the stem cell therapy were less likely to have a heart attack or stroke over the next 2.5 years, especially among those who were found to have a high degree of systemic inflammation as measured by a laboratory test,” Victor said in the email, adding that this represents how heart failure has a significant inflammatory component.

Those “positive signals” likely will be evaluated more in subsequent studies, Victor said.

“Current therapies for heart failure including lifestyle modifications, a growing list of excellent medications, and device therapies will continue to be the standard of care for treatment in the near-term,” he said. “I suspect that this trial will continue to move the field forward in studying cardiac cell therapy as we continue to look for ways to not just treat, but actually find a cure for this disease.”

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Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN

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CNN
 — 

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN

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CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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