Tampa's Oragenics Explores Nasal, Needle-Free COVID Vaccine

 A Tampa-based laboratory is working on a needle-free option for the COVID-19 vaccine.

The group, Oragenics, is working on a nasal spray as an alternative. 

It's still in its research stage, but scientists say the aim is for the mist to last years in the immune system, and fight the virus faster if someone becomes infected. 

“We are trying to stimulate the immune system…specifically the nasal cavity where the virus is going to come in first,” says Alan Joslyn, CEO of Oragenics. 

So far, they have raised $33 million for the project.

“We want to make this as simple as possible for people to get the vaccine…and reach individuals in areas and countries who can’t get the vaccine,” says Joslyn. 

The group plans to start their clinical trials by the end of the year. 

If the FDA approves the vaccine, it may be available by 2023. 

https://www.baynews9.com/fl/tampa/coronavirus/2021/03/26/tampa-laboratory-explores-nasal--needle-free-covid-vaccine

Vax alone 'won't have major impact' on 4th wave of virus in Tokyo: Sim study

 It’s hoped that COVID-19 vaccines will be the silver bullet that eventually allows society to return to normal. But even an accelerated inoculation campaign is unlikely to have a major impact on what appears to be a growing fourth wave of infections in Tokyo, according to research by a Tsukuba University professor.

Setsuya Kurahashi, a professor of systems management, conducted a simulation using artificial intelligence that looked at how the vaccine rollout would help prevent the spread of the coronavirus in Tokyo if new infections rise at the same pace as during the second wave last summer.

Even if 70,000 vaccinations per day, or 0.5% of the capital’s 14 million people, were given to Tokyoites — with priority given to people age 60 and over — the capital would still see a fourth wave of infections peaking at 1,610 new cases on May 14, the study showed. The study also showed a fifth wave is expected to peak at 640 cases on Aug. 31.

“The effect of the vaccine inoculations will be observed from July onward, so it’s presumed that it’s dangerous to place too much hope on the effect of the vaccinations for the fourth wave,” Kurahashi wrote.

In addition to the vaccinations, a mechanism that automatically triggers stricter measures if daily new cases exceed a certain threshold, which the study calls a “circuit breaker,” would help curb a fourth wave of infections. Such a system would work as a tool for policymakers to impose a wide-ranging set of measures, similar to those seen in a state of emergency, to restrict people’s contact with one another, such as by shortening business hours, limiting the number of attendees and participants at certain events, increasing the prevalence of telecommuting and asking people to refrain from nonessential outings.

The capital’s outlook could be much more severe if COVID-19 variants begin to spread widely.

Kurahashi last week released a separate simulation study on how variants would likely spread in Tokyo assuming 10 of the roughly 260 new cases confirmed on March 21 were of the U.K. variant. The variant, called B.1.1.7 and first detected last September in the southeast of the U.K., has been raising concerns as it is said to be up to 70% more contagious, and deadlier, than other versions of the virus.

Assuming no circuit breaker measures are taken, but with vaccines given to 70,000 Tokyoites daily, the simulation projected a fifth wave in the capital would peak at an eye-popping 229,300 new cases of the variant on Oct. 20. If the mechanism for tighter measures is put in place once daily numbers exceed 500 cases, however, infections in a fifth wave would peak at 1,700 new cases on the same day.

The study also pointed to a potential benefit of not giving vaccination priority exclusively to older people. According to the research, it is about five times more likely that people age 59 and under infect people age 60 and over rather than the opposite.

For example, if 30% of the 70,000 shots given daily were given to people age 59 and under with the rest administered to older people, that would help reduce daily infections to a peak of 700 cases on Aug. 30, the study said.

Accelerating the vaccination rollout alone won’t be able to prevent a fifth wave of infections, but an effective use of a circuit breaker in addition to adding people under 60 to at least 10% of the priority vaccination lists would prove useful for preventing the spread of the virus, it added.

https://www.japantimes.co.jp/news/2021/04/03/national/vaccination-impact-fourth-wave/

Veterans, families may need to get COVID vaccine boosters later this year

 Veterans Affairs officials still have millions of coronavirus vaccine doses they hope to deliver in coming months, but they’re already looking ahead to the possibility of booster shots for vaccinated veterans this fall.

That’s because VA medical experts — along with other health professionals worldwide — are planning for the next potential wave of pandemic problems, as COVID-19 variants emerge and researchers develop a better understanding of how effective current vaccines can be against them.

“Right now, it appears that we’ll be able to publish in the next few weeks the evidence that between seven and nine months we can feel comfortable that [vaccinated] individuals are still protected,” acting VA Under Secretary for Health Richard Stone told reporters at a department press conference Friday.

“The next question you ask is if this is an endemic disease — which hundreds of researchers and public health leaders believe, and I am one of those — how do we reduce mortality and hospitalization because of it? Clearly, it’s going to be the ability to deliver more immunizations.”

Department medical staff have been working alongside officials from the Centers for Disease Control and Prevention in recent months on coronavirus antibody research.

Based on those findings so far, Stone said, VA officials have begun taking steps to treat the current pandemic as an annual problem, similar to influenza, with “recurrent immunizations” for veterans and their families.

That work is taking place as VA officials are working to rapidly increase the pace of vaccinations in their existing medical system, in response to new legislation from Congress dramatically expanding the population eligible to receive shots at VA medical centers.

Until earlier this week, only veterans who qualified for VA health care — less than half of the estimated 19 million veterans in America today — were eligible to receive vaccine doses through VA, along with a small number of caregivers.

Now, under the new rules, all veterans, their spouses and caregivers are eligible. VA’s potential pool of individuals to vaccinate jumped from about 7 million to more than 30 million with the change.

VA Secretary Denis McDonough said the department has set a goal of May 1 for all of those individuals to be able to sign up for vaccine waiting lists.

“I take great pride in the fact that Congress and the President voted their confidence in VA’s capacity here,” he told reporters. “And that’s by virtue of how the team has run the vaccination program to date.”

Department officials have administered more than 3.3 million vaccine doses since mid-December, and fully vaccinated more than 1.6 million veterans and about 33,000 non-VA federal employees through arrangements with other agencies.

Stone said he expects the department’s weekly allotment of vaccines to rise from about 200,000 to 250,000 over the next month, and believes VA staff could deliver as much at 300,000 each week if supplies allow.

Those supplies will be the determining factor on when most veterans can actually visit VA to receive vaccinations. Stone said that department leaders have approved pilot programs in areas where local authorities believe they have vaccinated most of the previously eligible population, to start widening the number of veterans helped.

“So areas up in the northeast and down in the mid- and southwest have volunteered to be pilots,” he said. “We also began working yesterday with officials down in Florida on expansion.”

McDonough said part of the challenge is finding ways to quickly enter potentially millions more individuals into VA’s medical records system, to ensure vaccines and medical issues are being tracked.

For federal partners receiving doses, the process has taken up to 15 minutes of paperwork and data entry per individual. McDonough said he hopes to streamline that in coming weeks.

VA officials are encouraging veterans interested in the vaccine to contact local officials and ask about eligibility timelines.

Department leaders also have planned for April more than 30 missions by mobile-health unit teams to rural areas across the country, in an effort to ensure veterans in hard-to-reach locations are helped. That’s on top of more than 300 missions already run since December, which have vaccinated more than 86,000 people.

At least 240,000 VA patients have tested positive for coronavirus in the last year, with more than 11,200 dying from complications related to the illness. Nationwide, nearly 30 million individuals have contracted coronavirus, and nearly 544,000 have died.

https://www.navytimes.com/veterans/2021/03/26/veterans-families-may-need-to-get-covid-vaccine-boosters-later-this-year/

Health Canada issues advisory over masks containing graphene, urges recall

 Health Canada issued an advisory and asked distributors to recall face masks that contain graphene or biographene, citing potential inhalation risks.

In an advisory released Friday, the agency said there is a “potential that wearers could inhale graphene particles from some masks, which may pose health risks.”

Health Canada said graphene is a novel nanomaterial — a material made of tiny particles — that is reported to have antiviral and antibacterial properties.

“Health Canada conducted a preliminary scientific assessment after being made aware that masks containing graphene have been sold with COVID-19 claims and used by adults and children in schools and daycares,” the advisory reads.

Masks containing graphene may have also been distributed in health-care settings, the agency said.

Health Canada said its “preliminary assessment” found that graphene particles had “some potential to cause early lung toxicity in animals.”

“However, the potential for people to inhale graphene particles from face masks and the related health risks are not yet known, and may vary based on mask design,” the advisory reads. “The health risk to people of any age is not clear.”

Health Canada says it has requested data from the manufacturers to “assess the potential health risks related to their masks that contain graphene,” and has directed all known distributors, importers and manufacturers to stop selling the recalled products.

In an email to Global News, Health Canada said the department is currently reviewing data from two manufacturers of graphene-coated face masks.

The agency said while it has received a report “indicating concerns” related to the use of masks coated in graphene, “no incidents involving serious harm have been reported to date.”

Health Canada said it will complete a “thorough scientific assessment” to establish the safety and effectiveness of face masks containing graphene.

Canada’s provinces and territories have also been notified and were advised to stop the distribution of graphene masks in their region.

“The department will continue to take appropriate action to stop the import and sale of graphene face masks,” Health Canada said.

https://globalnews.ca/news/7736862/mask-recall-graphene/

Brazil hopes veterinary facilities can help increase COVID-19 vaccine output

 Brazil hopes to use veterinary facilities to increase COVID-19 vaccine output, authorities said on Saturday, as the country accounts for the world’s worst daily death tolls and its vaccination efforts lag.

Brazil already makes or finishes coronavirus vaccines at its two main public health institutes, although those efforts have not been enough to supply Latin America’s largest nation.

Marcelo Queiroga, Brazil’s fourth health minister since the pandemic began, said he hoped to include veterinary facilities that make vaccines for pets.

“This is not just to supply the internal market and increase our capacity but also for Brazil, as a leader in Latin America, can offer its vaccines to other countries,” Queiroga told reporters.

Brazil’s President Jair Bolsonaro has been widely criticized for his handling of the pandemic, for downplaying the severity of the virus, to undermining social distancing efforts and lockdowns. As Brazil has come to have the world’s worst daily COVID-19 death tolls, Bolsonaro is making a bigger push to secure vaccines, including asking the United States for spare doses.

Brazil’s Fiocruz Institute has a partnership with AstraZeneca Plc to manufacture its vaccine, while the Butantan Institute has a similar partnership with China’s Sinovac Biotech to make CoronaVac.

Butantan has also separately developed a vaccine of its own that is going through early-stage studies.

Queiroga did not get into specifics, such as the capacity of veterinary facilities and whether any initiative would require pharma companies to waive intellectual property rights.

On Saturday, Brazil registered 1,987 new COVID-19 deaths, the health ministry said, bringing the total to 330,193. Deaths now total 330,193. Cases rose by 43,515, the ministry said, and now total 12,953,597.

https://www.reuters.com/article/health-coronavirus-brazil/update-1-brazil-hopes-veterinary-facilities-can-help-increase-covid-19-vaccine-output-idUSL1N2LW0FM

New Decoy Protein Treatment Fools Coronavirus, Rendering It Impotent

 A novel decoy protein designed by Northwestern Medicine scientists fools SARS-Cov-2  by intercepting the spike of the coronavirus and rendering it impotent.

The novel protein significantly reduced lung damage and resulted in only mild symptoms in mice infected with SARS-Cov-2, while untreated animals in this model all succumbed to the infection.

“We envision this soluble ACE2 protein will attenuate the entry of coronavirus into cells in the body mainly in the respiratory system and, consequently, the serious symptoms seen in severe COVID 19,” said lead investigator Dr. Daniel Batlle, a professor of medicine at Northwestern University Feinberg School of Medicine and a Northwestern Medicine physician. “We have converted a lethal disease to a milder lung disease that is fully reversible. The protein could be complimentary to other potential treatments or effective alone.”

The protein is a variant of ACE2 (angiotensin converting enzyme-2), the receptor the coronavirus uses to enter and infect human cells. The modified protein intercepts the S spike of the coronavirus and fools it into binding to it rather than the real ACE2 receptor in cell membranes.

The study is the first proof of concept that a soluble human ACE2 protein is effective in vivo in a preclinical study using an appropriate animal model. The soluble ACE2 protein variant developed by Batlle and colleagues binds well to the coronavirus and has been enhanced so it’s effective for days. 

“While widespread vaccination is the best way to combat the COVID-19 pandemic, there will always be a need for treatment of people who were not vaccinated or for whom the vaccine was not fully effective,” Batlle said.

The study is a pre-print, which means the findings should be considered preliminary until it is published in a peer-reviewed journal. 

Investigators tested the protein in a genetically modified mouse model, because normal rodents are resistant to infection by the coronavirus causing COVID-19. Mouse ACE2 does not bind the coronavirus. But the transgenic mouse can be infected by the coronavirus, because in addition to its own mouse ACE2 it also has human ACE2 in its tissue.

Batlle’s lab has studied ACE2 for many years as part of a potential treatment for kidney disease. Batlle and study co-author Dr. Jan Wysocki, research assistant professor of medicine at Feinberg, have bioengineered novel ACE2 variants licensed to Northwestern University. They believe the variants can be adapted for COVID-19 therapy by intercepting the coronavirus and preventing it from attaching to the natural ACE2 receptor in the membrane of the cell.

The next steps involve the planning of safety studies needed before applying for Investigational New Drug approval for future studies in patients with COVID-19.

The study was supported in part by the Joseph and Bessie Feinberg Foundation, a gift from the state of Dr. Frank Krumlowsky and the George M. O’Brien Kidney Research Core Center (NU GoKidney) supported by the award P30 DK114857 (National Institute of Diabetes and Digestive and Kidney Diseases). Dr. Batlle received unrelated support from grant RO1DK104785 from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

https://scitechdaily.com/new-decoy-protein-treatment-fools-coronavirus-rendering-it-impotent/

340B Drug Discount Program Should Be on GAO’s High-Risk-for-Abuse List

 When a new Congress begins, the Government Accountability Office (GAO) releases its updated “High-Risk List” of programs and operations that are ‘high risk’ due to their vulnerabilities to fraud, waste, abuse, and mismanagement, or that need transformation. The 2021 version has 36 risk areas, including Department of Defense (DOD) Weapons Systems Acquisition, Medicare and Medicaid, and the National Flood Insurance Program.

While improvements were seen in seven areas, the only program removed was the DOD Support on Infrastructure Management, which had been on the list since 1997. Overall, the ratings for 20 of the 36 areas remained unchanged, with five areas that regressed. The GAO added Small Business Administration Emergency Loans and the Federal Response to Illegal Drug Use to the list. However, the 340B Drug Discount Program, which has been the subject of several critical GAO reports, should also have been added to the list. 

GAO reports on 340B include “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals,” which was published in 2015 and found that on average Part B spending at 340B disproportionate share hospitals (DSH) was higher than non-340B hospitals, likely because more drugs were prescribed or more expensive drugs were dispensed. A 2018 report found insufficient oversight by the Health Resources and Services Administration (HRSA) with regard to contract pharmacies’ accountability to ensure compliance with the program, like verifying prohibited duplicate discounts were not being provided for Medicaid beneficiaries. The House Energy and Commerce Committee issued a report in January 2018 that laid out several recommendations to improve the program, like clarifying its intent, promoting more transparency for all stakeholders, requiring independent audits of program compliance, and establishing a mechanism to monitor levels of charity care.

Congress created 340B under the 1992 Veterans Health Care Act to fix a problem it had created when the Medicaid Drug Rebate program was established in 1990. The rebates were based on the average manufacturer price (AMP) or the difference between the AMP and the lowest price charged to any entity in the U.S. Although members of Congress were made aware of a problem related to discounts in hearings on the legislation, the bill that was enacted into law did not factor in the substantial voluntary discounts many pharmaceutical companies had given the VA and non-profit entities that were serving indigent and uninsured patients. As a result, their generous discounts disappeared. The 1992 law created two new price control programs, the VA Federal Ceiling Price program and the 340B Drug Discount Program and excluded their prices from the Medicaid rebate calculus.

The Patient Protection and Affordable Care Act (PPACA) expanded eligibility to more hospitals, like sole community and critical access hospitals, along with expanded Medicaid eligibility.

This was one of several reasons why the 340B has grown wildly out of control with an increase of 464 percent since 2010. It has also been subject to significant waste, abuse, and mismanagement. In addition to the PPACA expansion, HRSA allowed covered entities to have unlimited for-profit contract pharmacies, including chain drug stores, to participate in the program even though the law is silent on the use of contract pharmacies. Because there is no requirement to pass along the savings to the patient, hospitals and their contract pharmacies can pocket the difference between the 340B discounted price and what insurance pays.

In 2018, the New England Journal of Medicine found that there are no direct incentives for 340B DSH hospitals to follow the intent of the program and use the savings to improve care for low-income patients who need it most. The 340B program has been associated with “hospital-physician consolidation in hematology-oncology” that has led to more “hospital-based administration of parenteral drugs” like cancer drugs, but the financial gains for hospitals “have not been associated with clear evidence of expanded care or lower mortality among low-income patients.”

Despite these findings and recommendations, nothing has been done to reform 340B and stop hospitals and for-profit pharmacies from enriching themselves. Establishing a clear definition for a 340B patient by focusing on indigent individuals with no health insurance would go a long way in solving many of the problems in the program. It is long past due to be put on the 340B program on the GAO High Risk List and for Congress to return it to its original mission.

Elizabeth Wright is the Health and Science Director at Citizens Against Government Waste

https://www.realclearhealth.com/articles/2021/04/02/340b_drug_discount_program_should_be_on_gaos_high-risk_list_111186.html