Government
Covid-19 roundup: Arcturus launches Phase II vaccine trial, but analysts are skeptical; Germany hits snags in Pfizer/BioNTech vaccine distribution
As Arcturus Therapeutics charges full speed into a Phase II trial for its single-dose Covid-19 vaccine in Singapore, some analysts say weak Phase I/II data point to an uncertain path ahead.
US-based Arcturus got cleared on Monday by the Singapore Health..
As Arcturus Therapeutics charges full speed into a Phase II trial for its single-dose Covid-19 vaccine in Singapore, some analysts say weak Phase I/II data point to an uncertain path ahead.
US-based Arcturus got cleared on Monday by the Singapore Health Sciences Authority to launch a Phase II trial of its candidate, ARCT-021, developed with Duke-NUS Medical School in Singapore. The trial will enroll up to 600 participants, and determine an optimal regimen to head into Phase III, according to the company. The Phase II will evaluate both single and “prime-boost” dosing regimens.
Baird analysts, though, called the Phase I/II results “lackluster,” and wrote in a note to investors that they are “skeptical of the path for this mRNA vaccine in COVID-19.”
Arcturus’ stock $ARCT was down 54.04% on Tuesday morning, at $42.48 per share.
The reason for their concern is that ARCT-021 achieved “modest” neutralizing antibody induction across doses and ages, coming in at the lower end of the range of healthy convalescent sera. Pfizer/BioNTech’s jab, for example, achieved two- to four-fold nAb induction above healthy convalescent sera. According to Arcturus, nAb titers in convalescent sera ranged from 12 to 1818 in the Phase I/II study.
“We see little mechanistic basis by which a mRNA vaccine that achieves lesser nAb induction than peers would somehow show comparable protection from COVID-19 driven entirely by T-cell induction, given how much nAb and T-cell induction should be driven by similar means of mRNA translation/antigen presentation within transduced cells,” Baird’s Madhu Kumar and Robert Palermo wrote.
Arcturus called the Phase I/II results favorable, and said it’s planning a global Phase III launch in Q2 2021.
“The Phase 1/2 study results, together with recently generated preclinical data, indicate that ARCT-021 leads to a potent immune response to SARS-CoV-2, and demonstrates a differentiated biological profile whereby the immune response increases in the weeks following vaccination,” Eng Eong Ooi, a Duke-NUS professor and member of Arcturus’ Vaccine Platform Scientific Advisory Board, said in a statement.
Arcturus’ vaccine push is being led by Joseph Payne, who was ousted from the company over two years ago by what he called a “dysfunctional board.” Last month, he bagged a $45 million limited recourse loan from Singapore’s Economic Development Board, and inked an agreement with the country for up to $175 million in dose purchases. If the candidate is approved, Arcturus will repay Singapore’s EDB through sales royalties. If it isn’t approved, the board is willing to forgive the loan.
Germany hits snags in Pfizer/BioNTech vaccine distrubution
In the rush to get jabs in arms, Germany is experiencing some distribution pains.
According to a Reuters report, some Bavarian districts are sending back 1,000 doses of Pfizer and BioNTech’s vaccine candidate following doubts they were properly refrigerated. A spokesman for the Lichtenfels district said the doses may have become too warm in their delivery cool boxes, per Reuters.
Pfizer/BioNTech’s mRNA candidate must be kept at about -70 degrees Celsius temperatures — colder than Antarctica — to remain stable. They’re being shipped in specialized boxes with dry ice, and must be kept at 2 to 8 degrees Celsius after they’re taken out of freezer storage to remain viable for up to five days.
Upon arrival in Lictenfels and other northern Bavarian districts, temperature loggers showed some interim temperatures of up to 15 degrees Celsius, Reuters reported.
“BioNTech commented and said that the vaccine was probably okay, but probably okay is not enough,” Lichtenfels District Administrator Christian Meissner told Reuters TV.
Authorities have expressed concern over Pfizer/BioNTech’s cold chain requirements, and some countries have said they can’t afford the infrastructure that would be necessary to distribute the vaccine. Moderna announced last month that their vaccine can be stored at 36 degrees to 46 degrees Fahrenheit for up to 30 days, and should be stable for 12 hours at room temperature.
Meanwhile, in the Vorpommern-Rügen district, 8 workers in an elderly care home mistakenly received five times the recommended dose of Pfizer’s vaccine, four of whom have since been hospitalized for flu-like symptoms, according to Reuters.
Pfizer and BioNTech inked a deal to double the US’ dose order last week, promising a full 200 million doses to Operation Warp Speed by July 31, 2021.
Brazil VP Hamilton Mourao takes unproven Covid-19 treatment hydroxychloroquine
Months after the FDA yanked its emergency use authorization for President Donald Trump’s so-called “miracle” Covid-19 treatment hydroxychloroquine, Brazilian Vice President Hamilton Mourao is reportedly taking the unproven drug.
According to Reuters, Mourao is in “good” condition and is self-isolating at home after testing positive on Sunday.
The FDA issued an EUA for hydroxychloroquine in March, which became part of routine care for Covid-19 patients at hospitals nationwide. But by June, the NIH had stopped a larger study because interim results showed the drug didn’t improve patient outcomes. The FDA revoked its EUA, citing a lack of both benefits and risks.
“We hope this clear result will help practitioners make informed treatment decisions and researchers continue their efforts pursuing other possible safe and effective treatments for patients suffering with this disease,” James Kiley of the NIH’s National Heart, Lung, and Blood Institute said in a statement at the time.
Brazil has the third-highest amount of Covid-19 cases in the world, behind only the US and India, at 7.48 million cumulative cases. In the last 24 hours, the country has reported 18,479 new cases.
For a look at all Endpoints News coronavirus stories, check out our special news channel.
emergency use authorization trump coronavirus covid-19 vaccine treatment testing fda preclinical hydroxychloroquine new cases singapore india brazil germanyGovernment
Survey Shows Declining Concerns Among Americans About COVID-19
Survey Shows Declining Concerns Among Americans About COVID-19
A new survey reveals that only 20% of Americans view covid-19 as "a major threat"…
A new survey reveals that only 20% of Americans view covid-19 as "a major threat" to the health of the US population - a sharp decline from a high of 67% in July 2020.
What's more, the Pew Research Center survey conducted from Feb. 7 to Feb. 11 showed that just 10% of Americans are concerned that they will catch the disease and require hospitalization.
"This data represents a low ebb of public concern about the virus that reached its height in the summer and fall of 2020, when as many as two-thirds of Americans viewed COVID-19 as a major threat to public health," reads the report, which was published March 7.
According to the survey, half of the participants understand the significance of researchers and healthcare providers in understanding and treating long COVID - however 27% of participants consider this issue less important, while 22% of Americans are unaware of long COVID.
What's more, while Democrats were far more worried than Republicans in the past, that gap has narrowed significantly.
"In the pandemic’s first year, Democrats were routinely about 40 points more likely than Republicans to view the coronavirus as a major threat to the health of the U.S. population. This gap has waned as overall levels of concern have fallen," reads the report.
More via the Epoch Times;
The survey found that three in ten Democrats under 50 have received an updated COVID-19 vaccine, compared with 66 percent of Democrats ages 65 and older.
Moreover, 66 percent of Democrats ages 65 and older have received the updated COVID-19 vaccine, while only 24 percent of Republicans ages 65 and older have done so.
“This 42-point partisan gap is much wider now than at other points since the start of the outbreak. For instance, in August 2021, 93 percent of older Democrats and 78 percent of older Republicans said they had received all the shots needed to be fully vaccinated (a 15-point gap),” it noted.
COVID-19 No Longer an Emergency
The U.S. Centers for Disease Control and Prevention (CDC) recently issued its updated recommendations for the virus, which no longer require people to stay home for five days after testing positive for COVID-19.
The updated guidance recommends that people who contracted a respiratory virus stay home, and they can resume normal activities when their symptoms improve overall and their fever subsides for 24 hours without medication.
“We still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses, this includes vaccination, treatment, and staying home when we get sick,” CDC director Dr. Mandy Cohen said in a statement.
The CDC said that while the virus remains a threat, it is now less likely to cause severe illness because of widespread immunity and improved tools to prevent and treat the disease.
“Importantly, states and countries that have already adjusted recommended isolation times have not seen increased hospitalizations or deaths related to COVID-19,” it stated.
The federal government suspended its free at-home COVID-19 test program on March 8, according to a website set up by the government, following a decrease in COVID-19-related hospitalizations.
According to the CDC, hospitalization rates for COVID-19 and influenza diseases remain “elevated” but are decreasing in some parts of the United States.
International
Rand Paul Teases Senate GOP Leader Run – Musk Says “I Would Support”
Rand Paul Teases Senate GOP Leader Run – Musk Says "I Would Support"
Republican Kentucky Senator Rand Paul on Friday hinted that he may jump…
Republican Kentucky Senator Rand Paul on Friday hinted that he may jump into the race to become the next Senate GOP leader, and Elon Musk was quick to support the idea. Republicans must find a successor for periodically malfunctioning Mitch McConnell, who recently announced he'll step down in November, though intending to keep his Senate seat until his term ends in January 2027, when he'd be within weeks of turning 86.
So far, the announced field consists of two quintessential establishment types: John Cornyn of Texas and John Thune of South Dakota. While John Barrasso's name had been thrown around as one of "The Three Johns" considered top contenders, the Wyoming senator on Tuesday said he'll instead seek the number two slot as party whip.
Paul used X to tease his potential bid for the position which -- if the GOP takes back the upper chamber in November -- could graduate from Minority Leader to Majority Leader. He started by telling his 5.1 million followers he'd had lots of people asking him about his interest in running...
Thousands of people have been asking if I'd run for Senate leadership...
— Rand Paul (@RandPaul) March 8, 2024
...then followed up with a poll in which he predictably annihilated Cornyn and Thune, taking a 96% share as of Friday night, with the other two below 2% each.
????????️VOTE NOW ????️ ???? Who would you like to be the next Senate leader?
— Rand Paul (@RandPaul) March 8, 2024
Elon Musk was quick to back the idea of Paul as GOP leader, while daring Cornyn and Thune to follow Paul's lead by throwing their names out for consideration by the Twitter-verse X-verse.
I would support Rand Paul and suspect that other candidates will not actually run polls out of concern for the results, but let’s see if they will!
— Elon Musk (@elonmusk) March 8, 2024
Paul has been a stalwart opponent of security-state mass surveillance, foreign interventionism -- to include shoveling billions of dollars into the proxy war in Ukraine -- and out-of-control spending in general. He demonstrated the latter passion on the Senate floor this week as he ridiculed the latest kick-the-can spending package:
This bill is an insult to the American people. The earmarks are all the wasteful spending that you could ever hope to see, and it should be defeated. Read more: https://t.co/Jt8K5iucA4 pic.twitter.com/I5okd4QgDg
— Senator Rand Paul (@SenRandPaul) March 8, 2024
In February, Paul used Senate rules to force his colleagues into a grueling Super Bowl weekend of votes, as he worked to derail a $95 billion foreign aid bill. "I think we should stay here as long as it takes,” said Paul. “If it takes a week or a month, I’ll force them to stay here to discuss why they think the border of Ukraine is more important than the US border.”
Don't expect a Majority Leader Paul to ditch the filibuster -- he's been a hardy user of the legislative delay tactic. In 2013, he spoke for 13 hours to fight the nomination of John Brennan as CIA director. In 2015, he orated for 10-and-a-half-hours to oppose extension of the Patriot Act.
Among the general public, Paul is probably best known as Capitol Hill's chief tormentor of Dr. Anthony Fauci, who was director of the National Institute of Allergy and Infectious Disease during the Covid-19 pandemic. Paul says the evidence indicates the virus emerged from China's Wuhan Institute of Virology. He's accused Fauci and other members of the US government public health apparatus of evading questions about their funding of the Chinese lab's "gain of function" research, which takes natural viruses and morphs them into something more dangerous. Paul has pointedly said that Fauci committed perjury in congressional hearings and that he belongs in jail "without question."
Musk is neither the only nor the first noteworthy figure to back Paul for party leader. Just hours after McConnell announced his upcoming step-down from leadership, independent 2024 presidential candidate Robert F. Kennedy, Jr voiced his support:
Mitch McConnell, who has served in the Senate for almost 40 years, announced he'll step down this November.
— Robert F. Kennedy Jr (@RobertKennedyJr) February 28, 2024
Part of public service is about knowing when to usher in a new generation. It’s time to promote leaders in Washington, DC who won’t kowtow to the military contractors or…
In a testament to the extent to which the establishment recoils at the libertarian-minded Paul, mainstream media outlets -- which have been quick to report on other developments in the majority leader race -- pretended not to notice that Paul had signaled his interest in the job. More than 24 hours after Paul's test-the-waters tweet-fest began, not a single major outlet had brought it to the attention of their audience.
That may be his strongest endorsement yet.
Government
The Great Replacement Loophole: Illegal Immigrants Score 5-Year Work Benefit While “Waiting” For Deporation, Asylum
The Great Replacement Loophole: Illegal Immigrants Score 5-Year Work Benefit While "Waiting" For Deporation, Asylum
Over the past several…
Over the past several months we've pointed out that there has been zero job creation for native-born workers since the summer of 2018...
... and that since Joe Biden was sworn into office, most of the post-pandemic job gains the administration continuously brags about have gone foreign-born (read immigrants, mostly illegal ones) workers.
And while the left might find this data almost as verboten as FBI crime statistics - as it directly supports the so-called "great replacement theory" we're not supposed to discuss - it also coincides with record numbers of illegal crossings into the United States under Biden.
In short, the Biden administration opened the floodgates, 10 million illegal immigrants poured into the country, and most of the post-pandemic "jobs recovery" went to foreign-born workers, of which illegal immigrants represent the largest chunk.
'But Tyler, illegal immigrants can't possibly work in the United States whilst awaiting their asylum hearings,' one might hear from the peanut gallery. On the contrary: ever since Biden reversed a key aspect of Trump's labor policies, all illegal immigrants - even those awaiting deportation proceedings - have been given carte blanche to work while awaiting said proceedings for up to five years...
... something which even Elon Musk was shocked to learn.
Wow, learn something new every day https://t.co/8MDtEEZGam
— Elon Musk (@elonmusk) March 10, 2024
Which leads us to another question: recall that the primary concern for the Biden admin for much of 2022 and 2023 was soaring prices, i.e., relentless inflation in general, and rising wages in particular, which in turn prompted even Goldman to admit two years ago that the diabolical wage-price spiral had been unleashed in the US (diabolical, because nothing absent a major economic shock, read recession or depression, can short-circuit it once it is in place).
Well, there is one other thing that can break the wage-price spiral loop: a flood of ultra-cheap illegal immigrant workers. But don't take our word for it: here is Fed Chair Jerome Powell himself during his February 60 Minutes interview:
PELLEY: Why was immigration important?
POWELL: Because, you know, immigrants come in, and they tend to work at a rate that is at or above that for non-immigrants. Immigrants who come to the country tend to be in the workforce at a slightly higher level than native Americans do. But that's largely because of the age difference. They tend to skew younger.
PELLEY: Why is immigration so important to the economy?
POWELL: Well, first of all, immigration policy is not the Fed's job. The immigration policy of the United States is really important and really much under discussion right now, and that's none of our business. We don't set immigration policy. We don't comment on it.
I will say, over time, though, the U.S. economy has benefited from immigration. And, frankly, just in the last, year a big part of the story of the labor market coming back into better balance is immigration returning to levels that were more typical of the pre-pandemic era.
PELLEY: The country needed the workers.
POWELL: It did. And so, that's what's been happening.
Translation: Immigrants work hard, and Americans are lazy. But much more importantly, since illegal immigrants will work for any pay, and since Biden's Department of Homeland Security, via its Citizenship and Immigration Services Agency, has made it so illegal immigrants can work in the US perfectly legally for up to 5 years (if not more), one can argue that the flood of illegals through the southern border has been the primary reason why inflation - or rather mostly wage inflation, that all too critical component of the wage-price spiral - has moderated in in the past year, when the US labor market suddenly found itself flooded with millions of perfectly eligible workers, who just also happen to be illegal immigrants and thus have zero wage bargaining options.
None of this is to suggest that the relentless flood of immigrants into the US is not also driven by voting and census concerns - something Elon Musk has been pounding the table on in recent weeks, and has gone so far to call it "the biggest corruption of American democracy in the 21st century", but in retrospect, one can also argue that the only modest success the Biden admin has had in the past year - namely bringing inflation down from a torrid 9% annual rate to "only" 3% - has also been due to the millions of illegals he's imported into the country.
We would be remiss if we didn't also note that this so often carries catastrophic short-term consequences for the social fabric of the country (the Laken Riley fiasco being only the latest example), not to mention the far more dire long-term consequences for the future of the US - chief among them the trillions of dollars in debt the US will need to incur to pay for all those new illegal immigrants Democrat voters and low-paid workers. This is on top of the labor revolution that will kick in once AI leads to mass layoffs among high-paying, white-collar jobs, after which all those newly laid off native-born workers hoping to trade down to lower paying (if available) jobs will discover that hardened criminals from Honduras or Guatemala have already taken them, all thanks to Joe Biden.
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