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.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94293

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 disease, 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 amyloid plaques.

While trials have shown some potential, it has been difficult to get sufficient amounts of antibodies to cross the blood-brain barrier, 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 immune system response to viral infections, 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 high blood pressure, 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 lifestyle changes, 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 dementia."

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https://medicalxpress.com/news/2021-08-dementia.html

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.

https://www.eastbaytimes.com/2021/08/31/ireland-to-drop-almost-all-covid-restrictions-in-october/

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.

https://www.newsnationnow.com/health/coronavirus/vaccine/about-14-million-in-us-get-first-covid-19-shot-in-august-up-from-july/

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.

https://wtvbam.com/2021/08/31/brazilian-viper-venom-may-become-tool-in-fight-against-coronavirus-study-shows/

South Korea to begin offering COVID-19 vaccine booster shots in October

 South Korea plans to begin giving out COVID-19 booster shots from October, joining several countries that have approved such doses amid resurgent infections and concern that vaccine protection wanes over time.

The plan will kick in once an October target for full vaccination of 70% of the population is achieved, as authorities aim to boost the rate above 80% with coverage for pregnant women and minors aged between 12 and 17 in the fourth quarter.

Initial booster doses will go to those with weakened immune systems or deemed to be at high risk. Others will receive them six months after full vaccination, the Korea Disease Control and Prevention Agency said.

"We will start with booster shots for high-risk groups such as the elderly and virus-prevention, medical personnel and gradually expand inoculation in line with expert recommendation and decisions by health authorities," President Moon Jae-in told his top aides on Monday.

Although the World Health Organization has repeatedly urged a delay in booster doses, arguing that the world's most vulnerable people should be fully vaccinated first, several countries have approved them, citing data on waning protection.

Vaccine booster doses will be made widely available to Americans in September, while nations from France and Germany to Israel have decided to offer them to older adults and those with weak immunity.

Evidence is growing that protection from COVID-19 vaccines ebbs after six months or more, especially in older people with underlying health conditions.

In June, South Korea said it planned to secure more mRNA vaccines https://www.reuters.com/world/asia-pacific/skorea-secure-more-mrna-vaccines-covid-19-booster-shot-2021-06-29 for booster doses next year for the entire population, on top of its already agreed 106 million doses from Pfizer/BioNTech / and Moderna.

South Korea has struggled to rein in daily COVID-19 cases as it battles its worst wave of infections since early July.

Monday's 1,372 new cases take its tally of infections to 251,421, with a death toll of 2,285.

By Monday, at least 56.5% of the population of 52 million had received at least one vaccine dose, while 29.6% had completed the inoculation

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-South-Korea-to-begin-offering-COVID-19-vaccine-booster-shots-in-October-36282156/

ANI Pharmaceuticals : FDA Accepts Application for Cortrophin Gel Revival

 ANI Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration has accepted its application to reintroduce its Cortrophin Gel treatment for patients with chronic auto-immune disorders.

The Baudette, Minn., pharmaceutical company said the agency set a target action date of Oct. 29 for the potential competitor to Mallinckrodt PLC's Acthar Gel.

The FDA originally approved Cortrophin Gel in 1954, but it was last used in patients in the 1980s. The product has more than 54 indications on its previously approved label, including the treatment of acute exacerbations of multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

ANI, which acquired Cortrophin Gel from Merck in early 2016 and spent more than $100 million to re-establish the product, last year filed for FDA approval to reintroduce it to the U.S. market.

However, the agency turned the application away, citing concerns related to chemistry, manufacturing and controls section. ANI resubmitted the application in June.

https://www.marketscreener.com/quote/stock/ANI-PHARMACEUTICALS-INC-13658425/news/ANI-Pharmaceuticals-FDA-Accepts-Application-for-Cortrophin-Gel-Revival-36286343/