Biomerica Rolls Out Fast 15-Minute Easy to Use COVID-19 Antigen Test

 

• Less invasive nasal swab taken from front opening of the nose is more comfortable for patients
• Test can be performed by doctors, school and company nurses, and medical assistants, in any location without specialized equipment

Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, announced that its new COVID-19 Antigen Rapid Test can now be performed with a simple less invasive nasal swab. This simple nasal swab, which takes the sample from the front opening of the nose, is less invasive and more comfortable for patients than the deep anterior nasal swab which is typically used. The test is highly portable, cost effective and provides visual results negating the need for any equipment to perform or read the test. The test also provides results in 15 minutes versus lab-run PCR tests which can take up to three days for results, thereby potentially expediting the process of identifying infectious people and preventing further spread of the virus.

https://www.globenewswire.com/news-release/2021/05/11/2227212/0/en/Biomerica-s-Fast-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Now-Available-With-Simple-Nasal-Swab.html

Takeda: May double imports of Moderna shots to accelerate Japan vaccination

 Takeda Pharmaceutical Co on Tuesday said it may double imports of Moderna Inc's COVID-19 vaccine to help Japan speed up COVID-19 inoculation efforts that have trailed most wealthy countries.

Japan's biggest drugmaker is handling the imports, and discussions are underway with the government to double shipments to 100 million, Takeda CEO Christophe Weber said.

"Japan is behind. So our goal now is to really support an acceleration of the vaccination," Weber said in a conference call after the company released full-year earnings results.

The company had reported positive interim results from a domestic trial of the Moderna shot, and Weber said he expected approval to come "very soon".

The COVID-19 pandemic has defined much of Takeda's activities in the past 12 months. This time last year, the company was promoting a plasma treatment for the disease, which ultimately failed in clinical trials.

Takeda is also handling domestic approval and production of 250 million doses of Novavax Inc's vaccine candidate. The Japanese government wants to use 150 million, with the remainder being dispatched elsewhere, Weber said.

For the year ended on March 31, Takeda reported a five-fold increase in operating profit versus the previous year, driven by sales of its Entyvio colitis treatment and other mainstay drugs.

Operating profit was 509 billion yen ($4.68 billion), compared with earlier guidance of 434 billion yen and a consensus estimate of 567 billion yen from a Refinitiv poll of 14 analysts.

Takeda also exceeded its goal for asset sales this year to reduce debt following a $59 billion purchase of Shire Plc in 2019. It has off-loaded about $12.9 billion in assets so far, mostly in over-the-counter and consumer goods, as part of a renewed focus on prescription drugs.

Among the biggest divestitures was Takeda's 227.7 billion yen sale of its Japanese consumer healthcare company to funds controlled by the Blackstone Group Inc.

https://finance.yahoo.com/news/takeda-says-may-double-imports-094616988.html

Estimation of total mortality due to COVID-19

 New analysis from IHME highlights the true toll of the pandemic.

SEATTLE—Globally, COVID-19 has caused approximately 6.9 million deaths, more than double what official numbers show, according to a new analysis by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington School of Medicine. IHME found that COVID-19 deaths are significantly underreported in almost every country. The updated analysis shows that the United States has had more COVID-19 deaths to-date than any other country, a total of more than 905,000. By region, Latin America and the Caribbean and Central Europe, Eastern Europe and Central Asia were hardest hit in terms of total deaths. This figure only includes deaths caused directly by the SARS-CoV-2 virus, not deaths caused by the pandemic’s disruption to health care systems and communities.

Read more about the methodology here.

“As terrible as the COVID-19 pandemic appears, this analysis shows that the actual toll is significantly worse,” said Dr. Chris Murray, IHME’s director. “Understanding the true number of COVID-19 deaths not only helps us appreciate the magnitude of this global crisis, but also provides valuable information to policymakers developing response and recovery plans.”

The 20 countries with the highest number of total COVID-19 deaths, March 2020­–May 2021 

Country	Total COVID-19 deaths	Reported COVID-19 deaths
United States of America	905,289	574,043
India	654,395	221,181
Mexico	617,127	217,694
Brazil	595,903	408,680
Russian Federation	593,610	109,334
United Kingdom	209,661	150,519
Italy	175,832	121,257
Iran	174,177	72,906
Egypt	170,041	13,529
South Africa	160,452	54,390
Poland	149,855	68,237
Peru	147,765	62,739
Ukraine	138,507	46,737
France	132,680	105,506
Spain	123,786	85,365
Germany	120,729	83,256
Indonesia	115,743	45,938
Japan	108,320	10,390
Romania	87,649	28,382
Kazakhstan	81,696	5,620

 

Many deaths from COVID-19 go unreported because countries only report deaths that occur in hospitals or in patients with a confirmed infection. In many places, weak health reporting systems and low access to health care magnify this challenge.

IHME’s analysis found that the largest number of unreported deaths occurred in countries that have had the largest epidemics to-date. However, some countries with relatively smaller epidemics saw a large increase in the death rate when accounting for unreported deaths. This analysis shows that they may be at greater risk for a wider epidemic than previously thought.

“Many countries have devoted exceptional effort to measuring the pandemic’s toll, but our analysis shows how difficult it is to accurately track a new and rapidly spreading infectious disease,” Murray said. “We hope that today’s report will encourage governments to identify and address gaps in their COVID-19 mortality reporting, so that they can more accurately direct pandemic resources.” Moving forward, IHME’s COVID-19 modeling, which forecasts the potential course of the pandemic over the next several months, will be based on these estimates of total COVID-19 deaths. IHME’s modeling is updated weekly and can be accessed at covid19.healthdata.org.

Cumulative total COVID-19 death rate by May 3, 2021

Methodology

These estimates are based on IHME’s long-standing methodology for measuring the burden of diseases on a global scale. Since 1990, the Global Burden of Disease study has measured the total human cost of diseases.

IHME estimated total COVID-19 deaths by comparing anticipated deaths from all causes based on pre-pandemic trends with the actual number of all-cause deaths during the pandemic. This “excess mortality” figure was then adjusted to remove deaths indirectly attributable to the pandemic (for example, due to people with non-COVID conditions avoiding health care facilities) as well as deaths averted by the pandemic (for example, declines in traffic deaths due to lower mobility). The resulting adjusted estimates include only deaths directly due to the SARS-CoV-2 virus, which causes COVID-19. A detailed write-up on methodology is available here.

http://www.healthdata.org/news-release/covid-19-has-caused-69-million-deaths-globally-more-double-what-official-reports-show

INOVIO: Positive Data from Phase 2 Trial Evaluating COVID-19 DNA Vaccine

 INO-4800 was shown to be safe, well-tolerated and immunogenic in all age groups

Phase 2 results informed INOVIO's selection of 2.0 mg dose for the Phase 3 segment of the trial
Data published as a preprint in MedRxiv

PLYMOUTH MEETING, Pa., May 10, 2021 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced positive safety, tolerability and immunogenicity data from its placebo-controlled and blinded Phase 2 segment of its Phase 2/3 clinical trial in the U.S., called INNOVATE (INOVIO INO-4800 Vaccine Trial for Efficacy), evaluating INO-4800, its DNA vaccine candidate for COVID-19. Preliminary results show in a larger population that INO-4800 was generally safe, well-tolerated and immunogenic in all studied age groups.

Findings from the Phase 2 Clinical Trial:

• The Phase 2 segment of the trial enrolled approximately 400 participants, 18 years of age or older, at 16 U.S. sites.
• Participants received either INO-4800 (1.0 mg or 2.0 mg dose) or placebo at 0 and 4 weeks (randomized 3:3:1:1). Each dose was administered by intradermal injection followed by electroporation using INOVIO's CELLECTRA^®, its proprietary smart device.
• Safety endpoints included systemic and local administration site reactions through 8 weeks post-dose one (or 4 weeks post-dose 2). Immunology endpoints included antigen-specific binding antibody titers, neutralization titers, and antigen-specific interferon-gamma (IFN-γ) cellular immune responses after two doses of the vaccine.
• Vaccine administration was generally safe and well-tolerated. The majority of adverse events (AEs) were Grade 1 and Grade 2 in severity and did not appear to increase in frequency with the second dose. The number of participants experiencing each of the most common AEs did not differ between the two dosing groups.
• The geometric mean fold rise (GMFR) of binding and neutralizing antibody levels were statistically significantly greater in the 2.0 mg dose group versus the 1.0 mg dose group.
• The T cell immune responses measured by the ELISpot assay were also higher in the 2.0 mg dose group compared to the 1.0 mg dose group.
• ClinicalTrials.gov identifier: NCT04642638

INOVIO plans to file preliminary Phase 2 results and device data with the U.S. Food and Drug Administration (FDA). Following the submission and FDA concurrence to proceed, the company plans to conduct a global Phase 3 clinical trial for INO-4800. The company recognizes the growing and unmet global demand for both initial as well as boosting doses of COVID-19 vaccines and looks forward to supporting the rollout of much needed additional vaccines to prevent the spread of COVID-19 – including both current and future variants – around the world.

https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Announces-Positive-Data-from-Phase-2-Segment-of-Clinical-Trial-Evaluating-INO-4800-its-COVID-19-DNA-Vaccine/default.aspx

Integration Into the Human Genome?

By Derek Lowe

I’ve had several requests for comment on this recent PNAS paper, which talks about integration of SARS-CoV-2 sequences into the DNA of human cells. I’m glad to do it, but right off I have to note that a lot of the attention that it’s getting seems (sadly) to be coming from anti-vaccine activists, who are trying to whip up fear that getting the vaccine somehow means that you will be Permanently Corona-ed. This is nonsense, as you’ll see below (skip to the end for this part!)

Here’s a good writeup on the paper itself, and I recommend it for background. The first thing to keep in mind is that the coronavirus is an RNA virus, so there’s a big barrier to getting that integrated into the DNA genome of a cell. You need a reverse transcriptase enzyme, one that runs the usual tape backwards and makes DNA out of an RNA sequence instead. We humans don’t do that ourselves, but there are plenty of viruses that do. And over the untold millennia, we have been infected by many of these, and a good amount of the stuff that they jammed into our genome is still there. This information freaks some people out when they first learn it, but it’s true: somewhere around 5 to 20% of our genomic DNA appears to be detritus from ancient retroviruses. Somehow the “Intelligent Design” folks seem to skip over this – go figure. Now, it’s not all in good shape, because many of these things happened a long time ago. But some of it may be involved in human disease, in some cases possibly through continued expression of pieces of viral proteins.

You can see evidence of this in retrotransposons, which likely have a retroviral origin and can at any rate act like built-in retroviruses. We have a lot of those in our DNA, because they just keep on copying themselves. A particularly well-studied case is the LINE1 sequences. There are a lot of these in the genome, and most of them have deteriorated to the point that they are inactive. But every human still has a few dozen of them that can be expressed into active proteins, among them a reverse transcriptase that then turns around and makes LINE1 DNA and inserts it back into the genome. In mammals, these sequences seem to have undergone evolution inside our cells, showing the history of a long-term “arms race”.

So our cells don’t have any need for a reverse transcriptase themselves, but we have one running around thanks to LINE1. And the PNAS paper under discussion presents evidence that under some conditions, this enzyme can pick up coronavirus RNA during an infection, make DNA off that sequence, and insert it back into the genome of a cell. In the paper, though, those conditions include modifying the cell lines so that they have even more LINE1 than usual, and this is one of the reasons that the extension of these results to real-world infections has been challenged. An earlier version of the paper also took incoming fire because the human/virus chimeric sequences they detected can also be produced artifactually, but this latest version seems to have addressed many of those concerns.

And it’s worth noting that viral infection might actually de-repress LINE1 activity, so this mechanism can’t be ruled out yet (nor does it apply only to the current coronavirus – it could take place with other RNA viruses as well). If it does happen, it could lead (perhaps) to autoimmune consequences through production of these mixed human/viral protein fragments, and it could also confound diagnostic tests if they’re pointed towards viral sequences that have “turned endogenous”. All this remains to be seen, and I think it’s worth investigating in general. But as of yet, we have no hard evidence that this process is taking place in coronavirus-infected human patients at all.

It’s also important to note that even under the cell-culture conditions used here, the authors are just seeing some variable-length insertions from one end (the 3′ one) of the viral genome. This process does not produce infectious virus. And it’s also important to note that authors themselves say that these results in no way imply that the mRNA vaccines cause integration of Spike protein into a cell’s DNA, either. The mRNA in the vaccines does not look like the 3′ end of the viral genome – they have completely different “untranslated regions” (UTRs), and for what it’s worth, the Spike protein itself is nowhere near the 3′ end of the actual viral genome. A vaccination is enough to set off your immune system for future action, but it’s really not like being infected with the virus, either in the scale of it all or in the many details.

I sympathize with the researchers who are frustrated with the way that this work has been picked up by the anti-vaccine folks. That stuff drives me crazy, too. At the same time, I think it’s a hypothesis that’s worth investigating for viral infections in general – unlikely, but worth a look – and I think it’s a shame in general that there are people who will seize on anything they can for the anti-vaccination crusade. If not for this paper, they’d be going on about something else. . .

https://blogs.sciencemag.org/pipeline/archives/2021/05/10/integration-into-the-human-genome

Social Security Sees Slowdown in Retiree Rolls Amid Covid Deaths

 The rate of growth in retired Americans who collect Social Security has slowed down sharply, and the drop may be due in part to the disproportionate number of deaths from Covid-19 among the elderly.

The number of people who received retirement benefits from the Social Security Administration rose 900,000 to 46.4 million in March, the smallest year-over-year gain since April 2009.

While the Office of the Chief Actuary at the government agency said it is still too early to assess the impact from Covid-19, the year-over-year change appears to reflect excess deaths. About 447,000 people who died from the virus were 65 or older, according to data from the Centers for Disease Control and Prevention, or about 80% of total deaths.

The number of Social Security beneficiaries has risen in the past decade as baby boomers -- the large cohort born between 1946 and 1964 -- started to reach retirement age. Usually, during economic downturns, many are forced into retirement due to job losses, which adds to the retiree pool.

Other factors can have an impact on the numbers. In the early 2000s, the bump in beneficiaries was likely tied to the Senior Citizens’ Freedom to Work Act signed into law in April 2000, according to Teresa Ghilarducci, an economics professor at the New School for Social Research in New York. The law reduced penalties for beneficiaries who continued to work. The monthly data show 300,000 people claiming Social Security in May 2000.

The pandemic created a unique situation in 2020. While surveys show that many are retiring or planning to retire earlier than they once thought, deaths are removing hundreds of thousands of beneficiaries from Social Security rolls.

U.S. life expectancy plunged by a full year in the first half of 2020, the biggest drop since World War II, to 77.8 years from 78.8 in 2019, according to provisional data from the National Center for Health Statistics.

https://www.bloomberg.com/news/articles/2021-05-03/social-security-sees-slowdown-in-retiree-rolls-amid-covid-deaths

Newsom eyes new $600 stimulus payments for millions more Californians in recovery plan

 Armed with a projected $75.7 billion budget surplus, Gov. Gavin Newsom on Monday unveiled an economic recovery plan that would send new direct payments to millions more Californians and additional relief for renters.

If approved, the proposed plan would expand the Golden State Stimulus program, providing billions in tax rebates to residents, the governor announced during a news conference.

Two-thirds of Californians will benefit from $600 direct payments sent to those who make up to $75,000 annually. Families with dependents, including undocumented residents, will be eligible for an additional $500.

“Direct stimulus checks, going into people’s pockets,” Newsom said. “That direct relief, that’s meaningful.”

About 5.7 million people were eligible for $600 direct payments under the Golden State Stimulus program, but the expansion announced Monday triples California’s previous investment to $11.9 billion, sending payments to residents who didn’t get a check in the first round.

The $100 billion proposal, dubbed the “California Comeback Plan,” would also double the rental assistance in the state, putting in a proposed $5.2 billion to help low-income Californians directly impacted by the pandemic pay back 100% of their back rent, according to Newsom.

The governor also announced $2 billion of relief to help Californians pay overdue utility expenses like water, gas and electricity.

“California is not just back. California is roaring back,” the governor said as he introduced the plan while facing a recall election.

Oakland Mayor Libby Schaaf joined Newsom Monday, saying her city was hit hard by the pandemic. She commended the governor for his plan and urged residents to file their taxes. 

“For much of the aid that is available in this unprecedented state budget, you must file your taxes,” the mayor said.

On Mother’s Day, the governor announced in a video that he’s also asking the Legislature to add 100,000 slots in child care across the state, and millions more in state funds to support child care providers and families.

Newsom will present his economic plan to lawmakers on Friday, and they will begin negotiations as a June 15 deadline to pass the budget nears.

The state is boasting a massive budget surplus a year after predicting a $55 billion budget shortfall. Officials said the surplus comes from taxes paid by wealthy residents.

Signaling support for the plan, Senate Budget Chair and State Senator Nancy Skinner, attended Monday’s news conference.

“Because of California’s very progressive tax structure, and because most of our revenue comes from the wealthiest … we have money,” she said. “Now, unlike other states, we are using that money to support the many Californians who’ve been hurt during this pandemic.”

“We are in the position now to be able to provide more,” the state senator said.

https://ktla.com/news/california/gov-newsom-to-announce-economic-recovery-plan-with-new-cash-payments-for-millions-of-californians/