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Does the pandemic mark a turning point in vaccine development?

After a period where vaccine development had fallen away, suddenly it is back in the limelight. Investment has
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After a period where vaccine development had fallen away, suddenly it is back in the limelight. Investment has flowed back into the sector and Ben Hargreaves finds how this is changing the infectious disease pipeline, as well as how the industry is seeking to address weaknesses in manufacturing capacity.

There are very few things to be grateful for about the arrival of the pandemic. However, for those individuals working on vaccine development, the pandemic has proven to be a validation of the important work being carried out in the field. The significant investment and importance placed on the creation of vaccines against COVID-19 has spurred numerous breakthroughs, not least with the emergence of the first approved mRNA vaccine.

The funding directed into accelerating the development of COVID-19 vaccines resulted in the successful and rapid creation of solutions that are now being utilised to curtail the worst of the pandemic. More than just providing a lifeline against the current pandemic, however, the investment has also found its way to those companies specialising in broader vaccine development. This has catapulted forward work being done to produce vaccines against various infectious diseases and rejuvenated a field that had previously been struggling for investment within the pharma industry.

The ‘poor relation’

Pfizer reported its full year 2021 results last month and predicted sales of $32 billion for its COVID-19 vaccine in 2022, adding to sales of $36 billion managed in 2021, alongside its partner, BioNTech. Moderna also published its financials last month, predicting 2022 sales of between $17 and $22 billion, after having previously earned $17.7 billion from its vaccine in 2021. With the unprecedented situation of the pandemic, there has arrived unprecedented revenue in the vaccine development space.

However, the financial success that has been delivered to certain companies working on vaccine development has emerged after a long period where investing in the space had become increasingly unpopular among the larger pharma companies. As a spokesperson for CureVac, a vaccine-focused biopharma company with a pipeline targeting various infectious disease, explained to pharmaphorum: “pre-pandemic, vaccine development was viewed almost as the poor relation of pharmaceuticals, despite the obvious success of most vaccines.”

The reason behind this was the lack of return on investment. Figures published by the US government, found that US retail drug spend on vaccines lagged far behind other therapeutic classes in 2009. These figures had increased by 2019, but they still lagged far behind other, more lucrative areas, such as oncology, diabetes, and autoimmune disorders. This has led the proportion of the global pipeline of potential therapies dedicated to oncology to grow from 26.8% in 2010 to 37.5% in 2021, suggested figures published by Citeline. By comparison, IQVIA research showed that treatments targeting infectious disease represented just 6% of the 2019 late-stage active pipeline.

Renewed interest

However, with COVID-19, there has been proof that there is a financial reward to be had if an effective vaccine can be introduced where there is urgent demand. GSK had benefited from this a few years prior, when it received approval for Shingrix, a vaccine used for the prevention of shingles (herpes zoster). Due to its above 90% efficacy at preventing shingles, the vaccine quickly became a blockbuster success for the company, to such a degree that Pfizer and BioNTech are now looking to establish themselves in the same market.

Now, the pipeline for products in infectious diseases is growing once again. According to figures published by Deloitte, the number of infectious disease assets in the pipeline has tripled since 2020 – though this is mostly driven by COVID-19-related assets, there are other candidates being developed amid increased levels of funding available for those working in the space. There have also been lessons learnt during the course of the pandemic, particularly in regard to the emergence of mRNA vaccines as a viable therapeutic solution — currently to protect against COVID-19, but future applications could well be broader.

The spokesperson for CureVac explained, “The herculean efforts to ensure a successful COVID vaccine campaign worldwide produced a great deal of new data and learning. The industry now has an opportunity to capitalize on this and explore new avenues of vaccine and therapeutic development based on mRNA, such as cancer vaccines and treatments for indications where there is a need to express intracellular proteins, inhibitors, or modulators.”

On a more basic level, the pandemic has also highlighted the importance and value of vaccines. “COVID-19 has drastically enhanced the public profile of vaccine development and, in doing so, increased recognition of the full value chain – from lab to clinic”, Dr Juan Carlos Jaramillo, chief medical officer of Valneva, told pharmaphorum.

Valneva has been a beneficiary of this effect, after recently being awarded £20 million in funds from the Scottish government to further develop its COVID-19 vaccine and to support R&D associated with its manufacturing processes for other vaccines. Alongside its vaccine candidate for COVID-19, VLA2001, the company is also progressing VLA1553, a single-shot vaccine candidate against the mosquito-borne viral infection chikungunya.

According to Dr Jaramillo, the investment will support the development of its manufacturing site in Livingston, Scotland, as he identified manufacturing capacity as one of the ‘key challenges’ highlighted by the pandemic.

Manufacturing challenges remain

There is an interesting parallel between the early stages of both the Shingrix and COVID-19 vaccine launches, which was the difficulty in scaling manufacturing in line with demand. The early success of the Shingrix vaccine saw GSK announce in 2019 that it would build out capacity with a new facility, but would see supply constrained until 2024 upon completion of the site. Likewise, in the early stages of the pandemic, much investment was made in vaccine production ahead of any potential approval to try to ensure sufficient capacity. This remains one of the obstacles when preparing for future pandemics and even for scaling manufacture to meet existing global demand for COVID-19 vaccines, as such capacity expansions take time to be completed and for supply issues to be eased.

CureVac is currently working on developing a flexible solution that could address this initial limited capacity, especially if mRNA vaccines go on to receive further approvals, by creating a dedicated manufacturing company for such therapies. The new company, known as CureVac RNA Printer, was announced at the beginning of March, and the spokesperson explained that it will support not only CureVac’s programs but will also work with external partners.

In terms of what the company will offer, the spokesperson said that “The RNA printer is a production system that has been designed to downscale the manufacturing process and automate major manufacturing steps based on a proprietary and advanced manufacturing technology.” As a result, this production process will allow ‘rapid and reproducible’ manufacture of products, including the technology to carry out automated cleaning and sanitisation.

CureVac worked alongside Tesla Automation to create the system and believes that the printer “could be used for a rapid first response in outbreak scenarios or in a hospital to allow for patient access to advanced and personalized mRNA-based therapies in oncology,” the spokesperson added. Though the prospect of a future outbreak akin to COVID-19 is difficult to imagine, the positives are that the pipeline of potential vaccines is growing again and manufacturing capacity is expanding with it. If there is a next time, the pharma industry will be better equipped and the financial incentives, as seen by those companies producing leading vaccines, are there to be had for those quickest to develop solutions.

 

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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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