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Covid-19 roundup: CEPI injects $20.6M into Gritstone’s push for a next-gen vaccine; Qualigen shelves its Covid-19 candidate after a failed IND

As the Delta variant drives a global surge in Covid-19 cases, the Coalition for Epidemic Preparedness Innovations (CEPI) is investing $20.6 million in Gritstone’s efforts to develop a second-generation vaccine.
The funds will support a Phase I study…

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As the Delta variant drives a global surge in Covid-19 cases, the Coalition for Epidemic Preparedness Innovations (CEPI) is investing $20.6 million in Gritstone’s efforts to develop a second-generation vaccine.

The funds will support a Phase I study for two different constructs of Gritstone’s self-amplifying mRNA vaccine, which is designed to deliver a broad set of viral antigens beyond the spike protein. The trial is expected to launch by the end of this year, according to Gritstone. The company’s stock $GRTS was up more than 10% on Tuesday morning.

“The ongoing mutations in SARS-CoV-2 leading to increased transmissibility and relative immune evasion from most first generation COVID-19 vaccines that primarily target the spike protein, call for alternate approaches aimed at driving CD8+ immunity against spike and more conserved epitopes,” said Shabir Madhi, a member of the WHO Strategic Advisory Group of Experts on Immunization (SAGE).

Gritstone is planning a multi-arm Phase I study with a variety of volunteers, including those who have never been infected with Covid-19, those who have, and HIV-positive patients. The CEPI funds will also go toward pre-clinical studies, as well as scale-up and formulation development.

Compared to other vaccine developers, Gritstone got off to a late start with its Covid-19 program, announcing plans to begin testing an experimental shot in tandem with the NIAID back in January. The company’s big idea is to hit the virus on multiple fronts, which could provide protection against emerging variants and future coronavirus pandemics.

“COVID-19 variants are already rendering some of our vaccines less effective, so it is critical that we don’t let our guard down: we must continue to invest in critical vaccine R&D if we are to stay one step ahead of this deadly virus,” CEPI CEO Richard Hatchett said in a statement.

Qualigen shelves its Covid-19 candidate after a failed IND

A Carlsbad, CA-based biotech is shelving its antiviral for Covid-19 after the FDA barred the company from testing it in humans.

Qualigen Therapeutics announced on Tuesday that regulators have rejected its investigational new drug (IND) application for QN-165, a DNA aptamer researchers were looking to test in hospitalized Covid-19 patients. As a result, the biotech is pivoting to its oncology pipeline, where it believes it has a better shot.

Michael Poirier

“Although the FDA requested that we perform additional pre-clinical toxicity and safety pharmacology studies before proceeding with clinical trials in COVID-19 patients, we believe that, given the time horizon which these suggested studies would require, coupled with the already very crowded COVID-19 vaccine and therapeutic landscape, the best and most prudent strategy for us at this time is to pivot to focusing primarily on our oncology pipeline that includes QN-247 and RAS-F assets for which we have already seen encouraging preclinical data,” CEO Michael Poirier said in a statement.

QN-165 is a piece of synthetic DNA that was designed to bind to the nucleolin protein. Scientists believe viruses like SARS-CoV-2 exploit nucleolin to gain access to a cell and replicate. So by tying up the protein, Qualigen thought it could block the virus’ replication.

Biden administration expected to launch campaign for booster shots — reports

Days after the FDA and CDC told Americans most of them don’t need booster shots just yet, unnamed sources told the Wall Street Journal that the Biden administration is expected to launch a campaign for the extra shots as early as this week.

The administration will likely announce that Americans who’ve been fully vaccinated for Covid-19 should receive a booster dose eight months after receiving their last dose, the WSJ reported.

Last week, the FDA expanded the emergency use authorizations for both the Pfizer/BioNTech and Moderna vaccines, to allow certain immunocompromised individuals to receive an additional dose.

“As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time,” acting FDA commissioner Janet Woodcock said in a statement. “The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future.”

Pfizer and BioNTech submitted Phase I data to regulators yesterday showing a third dose of their current mRNA shot “elicited significantly higher neutralizing antibodies” against the original Covid-19 strain, as well as the Beta and Delta variants. The news comes about a week after a study across multiple states in the US — which has not yet been peer-reviewed — suggested those who received Pfizer’s vaccine are at a two-fold higher risk of breakthrough infection compared to those who got the Moderna vaccine.

Moderna, which is also working on booster shots, announced last week that their two-dose vaccine regimen has been shown to maintain antibodies against variants of concern for six months after the second dose is received.

Stéphane Bancel

“These data support the durable efficacy of 93% seen with the Moderna COVID-19 vaccine through six months,” CEO Stéphane Bancel said in a statement. “We expect that these data and the growing body of real-world evidence will help inform health regulators’ approaches to how and when to administer additional boosting doses.”

The CDC said in a filing that it’s convening its Advisory Committee on Immunization Practices on Aug. 24 for “discussions on additional doses of COVID-19 vaccine, including booster doses.”

Last month, as the leading vaccine players said booster shots would likely be necessary, the FDA and CDC issued a joint statement saying that “Americans who have been vaccinated do not need a booster shot at this time,” and that they should wait for the regulatory officials to thoroughly review the data and make a recommendation.

For a look at all Endpoints News coronavirus stories, check out our special news channel.

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate…

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Low Iron Levels In Blood Could Trigger Long COVID: Study

Authored by Amie Dahnke via The Epoch Times (emphasis ours),

People with inadequate iron levels in their blood due to a COVID-19 infection could be at greater risk of long COVID.

(Shutterstock)

A new study indicates that problems with iron levels in the bloodstream likely trigger chronic inflammation and other conditions associated with the post-COVID phenomenon. The findings, published on March 1 in Nature Immunology, could offer new ways to treat or prevent the condition.

Long COVID Patients Have Low Iron Levels

Researchers at the University of Cambridge pinpointed low iron as a potential link to long-COVID symptoms thanks to a study they initiated shortly after the start of the pandemic. They recruited people who tested positive for the virus to provide blood samples for analysis over a year, which allowed the researchers to look for post-infection changes in the blood. The researchers looked at 214 samples and found that 45 percent of patients reported symptoms of long COVID that lasted between three and 10 months.

In analyzing the blood samples, the research team noticed that people experiencing long COVID had low iron levels, contributing to anemia and low red blood cell production, just two weeks after they were diagnosed with COVID-19. This was true for patients regardless of age, sex, or the initial severity of their infection.

According to one of the study co-authors, the removal of iron from the bloodstream is a natural process and defense mechanism of the body.

But it can jeopardize a person’s recovery.

When the body has an infection, it responds by removing iron from the bloodstream. This protects us from potentially lethal bacteria that capture the iron in the bloodstream and grow rapidly. It’s an evolutionary response that redistributes iron in the body, and the blood plasma becomes an iron desert,” University of Oxford professor Hal Drakesmith said in a press release. “However, if this goes on for a long time, there is less iron for red blood cells, so oxygen is transported less efficiently affecting metabolism and energy production, and for white blood cells, which need iron to work properly. The protective mechanism ends up becoming a problem.”

The research team believes that consistently low iron levels could explain why individuals with long COVID continue to experience fatigue and difficulty exercising. As such, the researchers suggested iron supplementation to help regulate and prevent the often debilitating symptoms associated with long COVID.

It isn’t necessarily the case that individuals don’t have enough iron in their body, it’s just that it’s trapped in the wrong place,” Aimee Hanson, a postdoctoral researcher at the University of Cambridge who worked on the study, said in the press release. “What we need is a way to remobilize the iron and pull it back into the bloodstream, where it becomes more useful to the red blood cells.”

The research team pointed out that iron supplementation isn’t always straightforward. Achieving the right level of iron varies from person to person. Too much iron can cause stomach issues, ranging from constipation, nausea, and abdominal pain to gastritis and gastric lesions.

1 in 5 Still Affected by Long COVID

COVID-19 has affected nearly 40 percent of Americans, with one in five of those still suffering from symptoms of long COVID, according to the U.S. Centers for Disease Control and Prevention (CDC). Long COVID is marked by health issues that continue at least four weeks after an individual was initially diagnosed with COVID-19. Symptoms can last for days, weeks, months, or years and may include fatigue, cough or chest pain, headache, brain fog, depression or anxiety, digestive issues, and joint or muscle pain.

Tyler Durden Sat, 03/09/2024 - 12:50

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Walmart joins Costco in sharing key pricing news

The massive retailers have both shared information that some retailers keep very close to the vest.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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Walmart has really good news for shoppers (and Joe Biden)

The giant retailer joins Costco in making a statement that has political overtones, even if that’s not the intent.

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As we head toward a presidential election, the presumed candidates for both parties will look for issues that rally undecided voters. 

The economy will be a key issue, with Democrats pointing to job creation and lowering prices while Republicans will cite the layoffs at Big Tech companies, high housing prices, and of course, sticky inflation.

The covid pandemic created a perfect storm for inflation and higher prices. It became harder to get many items because people getting sick slowed down, or even stopped, production at some factories.

Related: Popular mall retailer shuts down abruptly after bankruptcy filing

It was also a period where demand increased while shipping, trucking and delivery systems were all strained or thrown out of whack. The combination led to product shortages and higher prices.

You might have gone to the grocery store and not been able to buy your favorite paper towel brand or find toilet paper at all. That happened partly because of the supply chain and partly due to increased demand, but at the end of the day, it led to higher prices, which some consumers blamed on President Joe Biden's administration.

Biden, of course, was blamed for the price increases, but as inflation has dropped and grocery prices have fallen, few companies have been up front about it. That's probably not a political choice in most cases. Instead, some companies have chosen to lower prices more slowly than they raised them.

However, two major retailers, Walmart (WMT) and Costco, have been very honest about inflation. Walmart Chief Executive Doug McMillon's most recent comments validate what Biden's administration has been saying about the state of the economy. And they contrast with the economic picture being painted by Republicans who support their presumptive nominee, Donald Trump.

Walmart has seen inflation drop in many key areas.

Image source: Joe Raedle/Getty Images

Walmart sees lower prices

McMillon does not talk about lower prices to make a political statement. He's communicating with customers and potential customers through the analysts who cover the company's quarterly-earnings calls.

During Walmart's fiscal-fourth-quarter-earnings call, McMillon was clear that prices are going down.

"I'm excited about the omnichannel net promoter score trends the team is driving. Across countries, we continue to see a customer that's resilient but looking for value. As always, we're working hard to deliver that for them, including through our rollbacks on food pricing in Walmart U.S. Those were up significantly in Q4 versus last year, following a big increase in Q3," he said.

He was specific about where the chain has seen prices go down.

"Our general merchandise prices are lower than a year ago and even two years ago in some categories, which means our customers are finding value in areas like apparel and hard lines," he said. "In food, prices are lower than a year ago in places like eggs, apples, and deli snacks, but higher in other places like asparagus and blackberries."

McMillon said that in other areas prices were still up but have been falling.

"Dry grocery and consumables categories like paper goods and cleaning supplies are up mid-single digits versus last year and high teens versus two years ago. Private-brand penetration is up in many of the countries where we operate, including the United States," he said.

Costco sees almost no inflation impact

McMillon avoided the word inflation in his comments. Costco  (COST)  Chief Financial Officer Richard Galanti, who steps down on March 15, has been very transparent on the topic.

The CFO commented on inflation during his company's fiscal-first-quarter-earnings call.

"Most recently, in the last fourth-quarter discussion, we had estimated that year-over-year inflation was in the 1% to 2% range. Our estimate for the quarter just ended, that inflation was in the 0% to 1% range," he said.

Galanti made clear that inflation (and even deflation) varied by category.

"A bigger deflation in some big and bulky items like furniture sets due to lower freight costs year over year, as well as on things like domestics, bulky lower-priced items, again, where the freight cost is significant. Some deflationary items were as much as 20% to 30% and, again, mostly freight-related," he added.

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