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Tuesday, August 31, 2021

Japan finds another Moderna vial suspected to contain foreign substance

  Japan’s Kanagawa prefecture said it has found another vial of Moderna Inc’s COVID-19 vaccine suspected of containing a foreign substance and has put the rest of the lot on hold.

In a statement on Tuesday, prefectural authorities said a pharmacist found several black particles in one vial upon checking for foreign substances before the vaccine’s use.

Japan suspended the use of 1.63 million doses of Moderna shots last week after being notified of contamination in some of the supply. Moderna and Spanish pharma company Rovi, which bottles Moderna vaccines, have said the cause could be a manufacturing issue, and European safety regulators have launched an investigation.

Moderna has said no safety or efficacy issues had been identified from the issue.

Kanagawa prefecture said the vaccine’s domestic distributor, Takeda Pharmaceutical Co Ltd , had collected the vial with the suspected contaminant, and that about 3,790 people had already received shots from the same lot.

More Moderna shots were temporarily halted in two regions of Japan this week for what appears to be a separate issue of bits of the vials’ rubber stopper breaking off when needles are incorrectly inserted.

Texas 6-week abortion ban takes effect, with high court mum

 A Texas law banning most abortions in the state took effect at midnight, but the Supreme Court has yet to act on an emergency appeal to put the law on hold.

If allowed to remain in force, the law would be the most dramatic restriction on abortion rights in the United States since the high court’s landmark Roe v. Wade decision legalized abortion across the country in 1973.

The Texas law, signed by Republican Gov. Greg Abbott in May, would prohibit abortions once a fetal heartbeat can be detected, usually around six weeks and before most women even know they’re pregnant.

Abortion providers who are asking the Supreme Court to step in said the law would rule out 85% of abortions in Texas and force many clinics to close. Planned Parenthood is among the abortion providers that have stopped scheduling abortions beyond six weeks from conception.

At least 12 other states have enacted bans on abortion early in pregnancy, but all have been blocked from going into effect.

What makes the Texas law different is its unusual enforcement scheme. Rather than have officials responsible for enforcing the law, private citizens are authorized to sue abortion providers and anyone involved in facilitating abortions. Among other situations, that would include anyone who drives a woman to a clinic to get an abortion. Under the law, anyone who successfully sues another person would be entitled to at least $10,000.

Abortion opponents who wrote the law also made it difficult to challenge the law in court, in part because it’s hard to know whom to sue.

Texas has long had some of the nation’s toughest abortion restrictions, including a sweeping law passed in 2013 that the Supreme Court eventually struck down but not before more than half of the state’s 40-plus abortion clinics closed.

Lawmakers also are moving forward in an ongoing special session in Texas with proposed new restrictions on medication abortion, a method using pills that accounts for roughly 40% of abortions in the U.S.

Novartis to Provide Cholesterol-Fighting Drug Leqvio in UK

 Novartis AG has reached a deal to provide its cholesterol-lowering medicine Leqvio to patients via the U.K.'s National Health Service, the Swiss pharmaceutical company said Wednesday.

Over the course of three years, around 300,000 patients should be treated with Leqvio (inclisiran), Novartis said. The patients targeted are those at high risk of having a second cardiovascular event.

The treatment is part of a population health-management approach and aims to reduce patients' long-term elevated LDL cholesterol, a key modifiable risk factor in cardiovascular disease, the company said.

The collaboration with the NHS follows final recommendation for Leqvio from the U.K.'s medicines regulator, NICE.

Florida changed its COVID-19 data, creating an ‘artificial decline’ in recent deaths

 As the delta variant spreads through Florida, data published by the Centers for Disease Control and Prevention suggest this could be the most serious and deadly surge in COVID-19 infections since the beginning of the pandemic.

As cases ballooned in August, however, the Florida Department of Health changed the way it reported death data to the CDC, giving the appearance of a pandemic in decline, an analysis of Florida data by the Miami Herald and el Nuevo Herald found.

On Monday, Florida death data would have shown an average of 262 daily deaths reported to the CDC over the previous week had the health department used its former reporting system, the Herald analysis showed. Instead, the Monday update from Florida showed just 46 “new deaths” per day over the previous seven days.

The dramatic difference is due to a small change in the fine print. Until three weeks ago, data collected by DOH and published on the CDC website counted deaths by the date they were recorded — a common method for producing daily stats used by most states. On Aug. 10, Florida switched its methodology and, along with just a handful of other states, began to tally new deaths by the date the person died.

If you chart deaths by Florida’s new method, based on date of death, it will generally appear — even during a spike like the present — that deaths are on a recent downslope. That’s because it takes time for deaths to be evaluated and death certificates processed. When those deaths finally are tallied, they are assigned to the actual date of death — creating a spike where there once existed a downslope and moving the downslope forward in time.

Shivani Patel, a social epidemiologist and assistant professor at Emory University called the move “extremely problematic,” especially since it came without warning or explanation during a rise in cases.

Patel said Florida death data now show an “artificial decline” in recent deaths and without an explanation or context, and “it would look like we are doing better than we are.”

The change came the day after the state health department’s official Twitter account posted a series of late-night tweets accusing the CDC of publishing incorrect numbers, but offering little explanation

“As a result of data discrepancies that have occurred, this week, FDOH worked quickly and efficiently with CDC to ensure accurate display of data on their website the same day,” DOH spokesperson Weesam Khoury told the Herald in a statement at the time. “To proactively ensure accurate data is consistently displayed, the Department will begin daily submission of a complete renewed set of case data to CDC, including retrospective COVID-19 cases.”

The health department did not acknowledge the subsequent change in the data structure or its abrupt onset, leaving the public scrambling for answers as more than a year’s worth of data changed from one day to the next.

“It shouldn’t be left to the public, to scientists, national policy makers or the media to guess as to what these numbers are,” Patel said. “We know from the beginning that dates matter and that they tell us different things.”

Jason Salemi, an epidemiologist at the University of South Florida who has been tracking the state’s COVID data, said reporting by date of death is better for long-term studies of the disease.

“Deaths by date of death curve is the most accurate you can get,” Salemi said. “You know exactly when people died, you know how to construct the curve and exactly when we were experiencing surges in terms of deaths.”

But Florida’s new data structure is less useful for understanding the pandemic in real time, he warned.

“When you have big surges in deaths, the deaths by date reported will always show an increase while deaths by date occurred will go down,” Salemi said.

“Someone could have died yesterday and we may not know about it for a week, or two weeks,” Salemi said. As a result, new death trends as reported by the Florida health department are significantly lower when data are first reported and don’t immediately reflect the actual number of people who died that day.

During surges of cases and deaths, averaging seven days of deaths by report date provides an important early indicator of how many people have recently died of the disease — a number that will eventually be reflected in the data by date of death, Salemi said.

Although deaths by date the person died are not currently reflecting record numbers, trends based on newly reported deaths are currently almost 31% higher than previous peaks in summer of 2020 and over the holidays, the Herald analysis showed. Of the record deaths reported to the CDC between Saturday and Monday, the Herald found that the vast majority of the 902 victims died within the past two weeks.

The Herald also found that during the last two surges the trend lines using date of death showed peaks 25% and 8% higher respectively than the corresponding peaks by report date.


The Florida health department has made several, unannounced changes to its data methodology over the span of the pandemic, abruptly switching between including and disregarding non-resident deaths in its total counts, for example. Salemi said such frequent variations make it difficult to report numbers in a consistent and transparent manner that’s easily understood by the public.

Florida hasn’t always depended on the CDC to be the exclusive publishing house for its daily numbers. Until June 4, the department published its own data, available in daily PDF reports and also provided to view and download through an online dashboard.

The downloadable data sets on cases and deaths included the report date as well as the date a person died or got sick, allowing journalists and independent researchers to select the best metric for their purposes. The daily reports showed additional cases and deaths added from one day to the next.

In June, as case numbers dropped and vaccination rates continued to rise, the health department discontinued the dashboard and changed to a weekly report. The only near-daily data was submitted by the health department to the CDC and published on the CDC Trend Tracker website.

At first, the data on the CDC website was updated in a largely predictable manner, similar to the way that the DOH had reported daily changes throughout the pandemic. Then on Aug. 10, without warning or any explanation from the health department or the CDC, the data for nearly every day of the previous year changed. Neither agency immediately explained the changes.

The CDC eventually confirmed what experts had hypothesized after comparing the new data to previous reports — that the Florida Department of Health had begun to report deaths by date of death. The change was also reflected in data about new cases, which went from being counted by date of report to “the date of specimen collection, confirmed COVID-19 laboratory test result, or clinical diagnosis,” according to the CDC website. The case data show less of a dramatic shift than death data because case data are reported more quickly than deaths.

The CDC website listed Florida as one of just 12 jurisdictions — 11 states and New York City — reporting new deaths by date of death as of the end of August. The choice of how to report is determined by each jurisdiction, according to the website.

Florida’s weekly report, published on Fridays, also shows a decline in deaths in recent weeks even as the number of total dead across the state spikes. Last Friday, the DOH report showed 389 COVID-19 deaths for the previous week. But a comparison of cumulative deaths from the report the week before showed that 1,727 additional deaths were logged by the health department over that seven-day period. The DOH chart of deaths shows a decline over the past two weeks.


The DOH weekly report notes “death counts include individuals who meet a standardized national surveillance case definition” but includes no descriptions of how the health department presents the numbers.

“Due to inherent delays in deaths being reported to the [Health] Department, the previous 14 days may be incomplete and are updated over time,” said Khoury, the health department spokesperson, in an Aug. 30 statement to the Herald. “The Department reports deaths by date of death to the CDC upon notification to the Department.”

The Florida health department does not provide that explanation on its website or anywhere in its weekly reports.

In consultation with epidemiologists the Herald continued to report additional cases and deaths added to the total each day in daily updates rather than relying on the number of “new cases” and “new deaths” DOH data attribute to the previous day. However, data still appear inconsistent, as deaths backfill in large semi-weekly batches, rather than in all weekday updates.

“The CDC has started displaying the Department’s submitted retrospective file twice a week on Mondays and Thursdays, which updates previous day deaths that were subsequently reported to the Department,” Khoury explained for the first time in Monday’s statement. The difference can be an addition of eight deaths one day, and 901 the following day, as happened in the middle of last week.

Without context about how data are reported, when recent numbers are low due to reporting lags, “people will think there’s nothing going on,” said Mary Jo Trepka, an infectious disease epidemiologist and professor at Florida International University.

Economist Tim Harford, author of “The Data Detective,” who spoke generally about how data can be manipulated, said that changes in data definitions are unlikely to have long-term negative effects on scientists, but could easily confuse or mislead the layperson.

“When numbers are presented in a flattering light, an expert will generally be able to see through the dazzle quite quickly,” Harford said. “That said, I still think the truthful-yet-deceptive framing of numbers is a serious problem.”

When data are subtly distorted or presented differently than expected — something Harford called “statistical sleight of hand” — it can prompt dangerous levels of general mistrust and cynicism, he said.

“COVID is a matter of life and death and people deserve to have information that is both accurate and understandable without having to decode it,” he said.


Current data from Florida also show that cases and hospitalizations are at record levels, although trends seem to have plateaued over the past week.

“What we’re seeing is an active rise in cases where we can’t keep up, an active rise in deaths that, because of using actual date of deaths, has been shifted back in time and we have no idea where we really are,” said Patel, the epidemiologist from Emory University.

This plateau, she said, might not reflect reality.

“It just looks like Florida is unable to count and report its cases fast enough,” she said.

Patel said data indicate the worst has yet to come for Florida, and it’s likely that deaths will surpass past records. But it’s still too soon to know with certainty, she said.

“Ultimately, having a lot of people in the hospital at the same time decreases our overall survival,” Marty said.

The more patients there are in the hospital at the same time, the harder it is for medical staff to give quality care for those patients, Marty said. As the number of patients hospitalized keeps going up, hospitals often start running out of supplies, staff and beds she said.

“The end result is that someone who, if they were the only patient they’d survive, and now might not,” she said.

“We won’t know the true magnitude of the loss of life from this summer’s surge until the fall,” said Trepka.


Tennessee underreported COVID-19 hospitalizations by about 5,100

 The coronavirus hospitalized about 5,100 more Tennesseans than previously reported over the past 14 months — an increase of more than 20% over prior totals — according to newly backfilled data from the state department of health.

Hospitalizations were underreported by anywhere from one patient to dozens on nearly every day since the start of last summer, according to the new data. The largest share of the unreported hospitalizations occurred during the winter surge.

Tennessee's revised hospitalization total, including the backfilled data, is 29,694.

Sarah Tanksley, a spokesperson for the health department, said the unreported hospitalizations were now revealed because the agency incorporated a new data source from the Tennessee Hospital Association into its COVID-19 tracking efforts.

The hospital association receives patient-level virus data from hospitals, which is more detailed than the facility-level data hospitals provide to the state government, Tanksley said. The health department only recently figured out how to combine the two sources of information, allowing for a more complete accounting of the virus' impact, she said.

Tanksley said a more complete picture of COVID-19 hospitalizations is "helpful in assessing disease severity, impact of vaccination status, demographics of hospitalized patients."

As of Tuesday, Tennessee was reporting an average of about 7,000 infections and 39 deaths from the virus per day. Nearly 3,300 people were hospitalized with the virus, including 79 children. The state is on pace to set a new record for hospitalizations by the end of the week.

Texas school system closes after 2 teachers die of COVID-19

 A Texas school district announced Monday evening it would close all campuses until Sept. 7 after a second teacher passed away of COVID-19 complications.

Natalia Chansler and David “Andy” McCormick both taught social studies at Connally Independent School District’s junior high school.

“Although they were in the same content area, they were at two different grade levels in two different portions… of the building,” said Assistant Superintendent Jill Bottelberghe. All staff identified as “close contacts” with a known COVID-19 case are asked to get tested every other day, Bottelberghe said.

All of the district’s campuses are set to be closed for a week and students will do remote learning. Buildings will be deep cleaned and sanitized.

The district will also offer testing for the families of the students who might have been in contact with Mr. McCormick and Ms. Chansler.

The district released a statement to all parents and guardians saying, “We know the hardship this may present to families, but we want to do everything we can to ensure the health and safety of our students and team.” For now, the district is asking parents to monitor children for symptoms and alert the school nurse if a child tests positive.

Repurpose Beta-Blocker for Severe COVID?

 Intravenous metoprolol for severely ill COVID-19 patients on intensive mechanical ventilation was associated with less lung inflammation and better oxygenation, a randomized pilot study in Spain found.

Among 20 patients on ventilation for COVID-related acute respiratory distress syndrome (ARDS), those assigned to 3 days of metoprolol saw lower neutrophil counts in bronchoalveolar lavage at day 4 compared with those who did not receive the beta-blocker (median 14 vs 397 neutrophils/μl, respectively; P=0.016), reported Borja Ibanez, MD, PhD, of the National Center of Cardiovascular Research in Madrid, and colleagues.

Compared with baseline, oxygenation (PaO2:FiO2) improved for patients on IV metoprolol (median 130 to 267; P=0.003), while no change was seen without the treatment, the authors wrote in the Journal of the American College of Cardiology.

"Repurposing metoprolol for COVID-19-associated ARDS appears to be a safe and inexpensive strategy that can alleviate the burden of the COVID-19 pandemic," the authors said.

Metoprolol also decreased neutrophil extracellular traps content and other markers of lung inflammation, such as IL-8, versus baseline, and the intervention group spent fewer days on mechanical ventilation, though this did not reach statistical significance (15.5 vs 21.9 days, P=0.17).

"There is a growing body of literature regarding the role of beta-blockers in a wide variety of critically ill patients with sepsis and before major surgery, acute respiratory distress syndrome, and traumatic brain injury," noted Mourad Senussi, MD, MS, of Baylor St. Luke's Medical Center in Houston, in an accompanying editorial.

"Although a small-sized, single-center study amid a multitude of others exploring potential treatment modalities for COVID-19 -- this study uses a readily available, safe, and inexpensive medication; has a simple study design; and, most importantly, shows biological plausibility," Senussi wrote.

He also noted the selection bias in the study, as "only those patients who are hemodynamically stable enough can receive beta-blockers."

Anywhere from 6% to 18% of COVID cases result in ARDS, requiring intensive care unit (ICU) admission and use of intensive mechanical ventilation, Ibanez and colleagues explained. As the virus rapidly replicates, ARDS develops from activated neutrophils that infiltrate the alveolar space of the lungs. Metoprolol can reduce inflammation, thereby lowering the risk of cardiovascular events.

"Administration of IV beta-blockers has largely been proven to be safe except for patients with acute pump failure," they noted.

From October 2020 to January 2021, the MADRID-COVID trial (Intravenous Metoprolol in Respiratory Distress Due to COVID-19) randomized patients with COVID-19-associated ARDS to IV metoprolol (n=12; 15 mg daily for 3 days) or no metoprolol (n=8). One patient in the intervention arm only received 2 days of metoprolol due to bradycardia.

The cohort included adults up to age 80 (median 60) with SARS-CoV-2 infection confirmed by RT-PCR, systolic blood pressure ≥120 mm Hg, and a minimum heart rate of 60 bpm. Patients were required to be on mechanical ventilation for fewer than 3 days.

The study's main outcomes were metoprolol's effect on lung inflammation and respiratory function. Before and after randomization, patients in both groups underwent bronchoalveolar lavage. ICU patients were given anticoagulants, corticosteroids, acetylcysteine, and melatonin.

Baseline patient characteristics did not significantly differ between groups. For comorbidities, hypertension (30%) and dyslipidemia (30%) were most common. One-fourth of patients were previously taking renin-angiotensin system inhibitors.

At baseline, there were no between-group differences in neutrophil count. No side effects were reported from the use of metoprolol. While most were discharged, one patient from each group died.

Other limitations of the study included the open-label treatment administration, the authors acknowledged.


Funding for the study was provided by the Spanish government.

Ibanez reported support from the European Commission and one co-author reported support from a Madrid governmental program as well. No additional conflicts were reported.

Senussi did not report any conflicts of interest.

CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses

 A risk-based booster dose strategy for COVID-19 vaccines could target populations at risk of severe disease and those critical to the public health infrastructure, CDC staff said at a meeting of CDC's Advisory Committee on Immunization Practices (ACIP) on Monday.

Though FDA has yet to review data on booster doses for COVID-19 vaccines among the general population, CDC staff presented a preliminary framework to determine those who might need it most, including older adults, long-term care facility residents, and healthcare workers.

CDC staff presented limited data that showed that vaccines remain effective at preventing hospitalization and severe disease, but could be less effective at preventing infection or milder symptomatic illness.

That would be fine for most populations, except as Sara Oliver, MD, of the CDC, pointed out, healthcare professionals who develop even mild illness are forced to call out sick for COVID-19, which strains the healthcare infrastructure. While limited data on vaccine effectiveness among frontline workers -- including healthcare professionals -- showed declines against the Delta variant, differences were not significant compared with a pre-Delta period.

However, recent data showed lower vaccine effectiveness against infection among long-term care facility residents since the Delta variant gained prominence in the U.S. Preliminary vaccine effectiveness estimates found that among adults ages 65 and older, vaccine effectiveness decreased against hospitalization, but remained high.

ACIP members disagreed about the need for booster doses, with some arguing that ensuring the unvaccinated receive the primary vaccination series should be the highest priority.

"We've got lots of vaccine. At the moment we don't have a lot of evidence of reduced vaccine effectiveness ... based on the current data," said ACIP committee member, Beth Bell, MD, of the University of Washington in Seattle.

ACIP chair, Grace Lee, MD, of Stanford University in California, argued that it didn't necessarily have to be an "either/or situation."

"Where we are in the pandemic, it makes sense to prevent severe disease, hospitalization, and death," and that would be achieved both by vaccinating those who were unvaccinated, as well as booster doses in populations vulnerable to severe illness and death.

Currently, third doses of vaccine are only authorized for certain immunocompromised populations, and CDC staff warned clinicians that any off-label use of vaccine for booster doses meant they would not be covered under the PREP Act, which provides immunity from liability to COVID-19 vaccinators.

ACIP member, Helen Keipp Talbot, MD, of Vanderbilt University in Nashville, said that the Biden administration had confused the issue by saying they would make boosters available by September 20, which many providers took as a tacit approval of booster doses, despite no authorization from the FDA.

She added that because they believed the White House had given its blessing, "many, many, many hospitals" started giving a third dose both to providers and patients, and stressed the need for these recommendations to come through "normal" regulatory avenues.

Pfizer Vaccine Approval Hailed as 'Miraculous Accomplishment'

In what was merely a formality, the ACIP voted unanimously to recommend the Pfizer/BioNTech COVID-19 vaccine for individuals ages 16 and older under the terms of an FDA biologics license application (BLA). The 14-0 vote replaces the interim recommendation for the vaccine made when it was still under emergency use authorization (EUA) for this age group.

Several members took the time after the vote to reiterate how impressed they were by the work done by the FDA and CDC over the past 18 months, and the fact that there is now an approved COVID-19 vaccine was a testament to that hard work.

Kathleen Dooling, MD, of the CDC, emphasized the mountain of available evidence supporting the vaccine's safety and efficacy. Whereas the EUA only had one phase II/III clinical trial with a median of 2 months of follow-up data, the BLA featured at least 6 months of data from these trials, plus "a plethora of observational studies" and "extremely high-quality, real-world evidence" from around the world.

"I can't think of a vaccine where we've had more efficacy and effectiveness and adverse event data," said ACIP committee member, Sarah Long, MD, of Drexel University in Philadelphia. "This vaccine is worthy of recommendation for what it does today and worthy of the trust of the American people."

While there is an association between the vaccine and myocarditis in younger men, CDC staff put it into perspective with a benefits/risk chart projected out to a year, showing for every million doses of vaccine, there would be an estimated 73 myocarditis cases in boys ages 16-17 compared to 1,540 COVID-19 hospitalizations prevented.

Amanda Cohn, MD, of the CDC, also put in that outcomes of "this apparent vaccine-associated myocarditis are substantially better than myocarditis caused by other types of infections or vaccines." CDC staff still said they will continue to evaluate the data for long-term outcomes.

ACIP members also emphasized the need to get the message out that the vaccine is safe and effective, and the need for other strategies to encourage vaccine uptake in underserved populations, such as employers giving time off for employees to get vaccinated.

What are researchers doing to stop dementia?

 They are words nobody wants to hear: Alzheimer's disease and dementia. As the population ages, a growing number of older adults gradually lose cherished memories and the ability to think and, ultimately, to perform even the most basic functions of daily living.

Researchers say dementias are so varied and complex, there remain more questions than answers when it comes to how to thwart them.

"This is a condition with multiple pathologies," said Cynthia Lemere, immediate past chair of the medical and scientific advisory group of the Alzheimer's Association. "There's a lot of research going on right now."

While there are many causes of dementias, much of the research revolves around Alzheimer's, which accounts for 60%–70% of all cases. According to the Alzheimer's Association, more than 6.2 million people are living with Alzheimer's , a number expected to double by 2050.

The federal government spends about $3.1 billion annually on Alzheimer's research. Another $250 million comes from the Alzheimer's Association, and last year the American Heart Association announced a joint brain health research project with Bill Gates, as well as support for a global networking effort among research centers to accelerate early detection and treatment of Alzheimer's and related dementias.

Many drugs are being tested. Some work by going after what is considered one of the hallmarks of the disease—beta-amyloid protein. When this protein builds up in the brain, it clumps together to form plaques that stick in between nerve cells, interfering with the cells' ability to communicate.

Lemere, an associate professor of neurology in the Ann Romney Center for Neurologic Diseases at Brigham and Women's Hospital and Harvard Medical School in Boston, has spent the past two decades working on an Alzheimer's vaccine and antibodies that would attack .

While trials have shown some potential, it has been difficult to get sufficient amounts of antibodies to cross the , she said. Nonetheless, "there are three or four drugs in this class coming down the pipeline that look promising." A drug that targets amyloid plaque received conditional approval from the Food and Drug Administration this summer and requires further testing to verify its benefits.

A newer area of investigation focuses on drugs to stop the spread of a protein called tau, needed to stabilize the structure of nerve cells. In the brains of people with Alzheimer's disease, tau changes its structure and aggregates inside the cells, causing tangles to form. The tangles block nutrients and any communication from moving through the cells, which eventually die. That's when symptoms appear.

"Alzheimer's disease doesn't start when you begin to see memory loss. It starts 15–25 years earlier, when these plaques and tangles are forming," Lemere said. "When you have them both for a long period of time, neurodegeneration starts."

So far, researchers have seen the best results with patients who are in the earliest stages of Alzheimer's, Lemere said. "Previous clinical trials have shown that these drugs do not work well for people with moderate to severe Alzheimer's disease. If someone has already lost 40% of their hippocampal neurons, clearing plaque won't bring those back. That's why we still need to continue to find ways to help those in later stages of the disease."

What's causing beta-amyloid to accumulate in the first place remains unclear. Some believe it may be an  to , such as herpes, and may even be linked to the bacteria in gum disease.

"It turns out that amyloid plays a role in protecting the brain from infection," said Dr. Mitchell Elkind, immediate past president of the American Heart Association. He is a professor of neurology and epidemiology at Columbia University Irving Medical Center in New York City.

When an infection attacks the brain, beta-amyloid may be overproduced as part of an immune response, he said. One avenue of investigation hypothesizes that anti-viral agents could therefore prevent Alzheimer's or slow progression of the disease based on the theory that "if we eliminate the inciting insult of the infection, perhaps we can decrease the amount of amyloid. That's an exciting possibility."

Studying COVID-19 may help, Elkind said. "For those of us interested in the concept that infections may worsen dementia, COVID provides a great model because there is so much of it around. It can help us answer the question of whether a virus can cause long-term cognitive decline. We don't know yet."

When viruses and bacteria activate the immune system, they also produce inflammation, which researchers believe contributes to plaque development.

"Inflammation is a hot button now for Alzheimer's disease research," Elkind said. Investigators are exploring whether anti-inflammatory agents can be used to ward off symptoms.

Lemere said she believes the most promising approach may be combinations of drugs that help the immune cells in the brain do their job while tamping down inflammation.

"That is going to be the wave of the future," she said. "Maybe an anti-inflammatory agent with a tau antibody to prevent the downstream neurodegeneration."

But even if researchers succeed in developing drugs that clear the brain of amyloid plaques and tau tangles, it won't stop other forms of dementia, said Dr. Mary Sano, director of the Alzheimer's Disease Research Center at Mount Sinai Health System in New York City.

About 10% of dementias are vascular—they're linked to strokes or issues with poor blood flow to the brain. Others have mixed dementia, which can be a combination of Alzheimer's, vascular and other less common types of dementia.

Sano's center works with people who often develop dementias related to Type 2 diabetes and heart disease risk factors, such as , and these "have a very different profile of cognitive deficits." For example, people with diabetes begin with greater problems with executive functions, such as the ability to plan and organize. Memory may be less impaired.

Lifestyle behaviors remain an important avenue for preventing vascular dementia, she said. Controlling blood pressure, cholesterol and blood sugar levels and making other , such as quitting smoking, exercising, eating a nutritious diet and losing weight—metrics the AHA has dubbed Life's Simple 7—all have been shown to help maintain good brain health as people age.

This has to start early, Elkind said. "It's not your blood pressure in your 70s and 80s that causes dementia, but what it was in your 40s and 50s."

One of the best things people can do is exercise, Lemere said. "It promotes cardiovascular health, which is related to brain health. It's anti-inflammatory and it promotes better sleep. Lack of sleep is a risk factor for Alzheimer's disease, and exercise is one of the biggest ways people can stave off or reduce their risk for ."

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Ireland to drop almost all COVID restrictions in October

 Ireland, which had one of Europe’s longest COVID-19 lockdowns, will drop almost all pandemic restrictions in October after one of the continent’s most successful vaccine rollouts, Prime Minister Micheal Martin said on Tuesday.

From Oct. 22, the requirement for vaccine certificates in bars and restaurants will be dropped, as will all restrictions on the numbers attending indoor and outdoor events.

As part of a phased easing of restrictions, the government is recommending the reopening of theaters and cinemas at 60% capacity next week and a return of non-essential workers to offices from Sept. 20.

“Because of the effort of our vaccination team and because you have stepped up to the mark and taken the vaccine when it was offered, we are now entering a whole new phase of the pandemic,” Martin said in a televised address.

Almost 90% of adults in Ireland are fully vaccinated as are 80% of over those over 12 years old.

Indoor dining in cafes, bars and restaurants was banned in Ireland for much of the 16 months to July, when the government opened the sector to people with vaccine certificates.

The Irish government in recent weeks has been heavily criticized by the live-events sector as large concerts took place in the United Kingdom, which dropped most restrictions on July 19 but has a lower level of vaccinations.

Martin struck a note of caution, however, warning of an increase in case numbers in the coming weeks before an expected decline.

“We are very unlikely to ever be able to be rid of the virus completely,” he said.

About 14 million in U.S. get first COVID-19 shot in August, up from July

 Around 14 million people in the United States received their first dose of a COVID-19 vaccine in August, about 4 million more than in July, officials said on Tuesday as the government pushes inoculation amid rising infections.

The United States’ vaccination rate still lags that of other developed countries. Only around 52% of U.S. residents are fully vaccinated, including about 63% of adults, according to data from the Centers for Disease Control.

Meanwhile, the European Commission said on Tuesday that 70% of the European Union’s adult population had been fully vaccinated against COVID-19.

President Joe Biden has urged businesses to mandate vaccinations for their staff in a bid to drive up vaccination rates.

The White House also plans to begin vaccinating Americans with a third booster shot in September, but an advisory group to the CDC said on Monday there is limited evidence to support boosters.

The advisory group “did not review international data that actually has led us to be more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease and death,” CDC director Rochelle Walensky said on a call with journalists.

Average daily coronavirus infections in the United States are around 130,000, up from lows of fewer than 12,000 in late June, mainly due to the delta variant of the virus.

Deaths have also been rising. The seven-day average of daily deaths is up to nearly 900, higher than in the previous week, Walensky said.

Brazilian viper venom may become tool in fight against coronavirus: study

 Brazilian researchers have found that a molecule in the venom of a type of snake inhibited coronavirus reproduction in monkey cells, a possible first step toward a drug to combat the virus causing COVID-19.

A study published in the scientific journal Molecules this month found that the molecule produced by the jararacussu pit viper inhibited the virus’s ability to multiply in monkey cells by 75%.

“We were able to show this component of snake venom was able to inhibit a very important protein from the virus,” said Rafael Guido, a University of Sao Paulo professor and an author of the study.

The molecule is a peptide, or chain of amino acids, that can connect to an enzyme of the coronavirus called PLPro, which is vital to reproduction of the virus, without hurting other cells.

Already known for its antibacterial qualities, the peptide can be synthesized in the laboratory, Guido said in an interview, making the capture or raising of the snakes unnecessary.

“We’re wary about people going out to hunt the jararacussu around Brazil, thinking they’re going to save the world … That’s not it!” said Giuseppe Puorto, a herpetologist running the Butantan Institute’s biological collection in Sao Paulo. “It’s not the venom itself that will cure the coronavirus.”

Researchers will next evaluate the efficiency of different doses of the molecule and whether it is able to prevent the virus from entering cells in the first place, according to a statement from the State University of Sao Paulo (Unesp), which was also involved in the research.

They hope to test the substance in human cells but gave no timeline.

The jararacussu is one of the largest snakes in Brazil, measuring up to 6 feet (2 meters) long. It lives in the coastal Atlantic Forest and is also found in Bolivia, Paraguay, and Argentina.