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Approval of a coronavirus vaccine would be just the beginning – huge production challenges could cause long delays

Approval of a coronavirus vaccine would be just the beginning – huge production challenges could cause long delays

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Billions of people are going to need a coronavirus vaccine and that demand is going to be hard to meet. Francesco Carta fotografo/Moment via Getty Images

The race for a SARS-CoV-2 vaccine is well underway. It’s tempting to assume that once the first vaccine is approved for human use, all the problems of this pandemic will be immediately solved. Unfortunately, that is not exactly the case.

Developing a new vaccine is only the first part of the complex journey that’s supposed to end with a return to some sort of normal life. Producing hundreds of millions of vaccines for the U.S. – and billions for the world as a whole – will be no small feat. There are many technical and economic challenges that will need to be overcome somehow to produce millions of vaccines as fast as possible.

I am a professor of health policy and management at the City University of New York (CUNY) School of Public Health and have been working in and studying the worlds of vaccine development, production and distribution for over two decades. The issues the world is facing today regarding the coronavirus vaccine are not new, but the stakes are perhaps higher than ever before.

There are four main challenges that must be addressed as soon as possible if a vaccine is to be produced quickly and at a large scale.

Existing manufacturing capacity is limited

The shrinking and outsourcing of U.S. manufacturing capacity has reached into all sectors. Vaccines are no exception.

The number of U.S. biotech and pharmaceutical companies involved in vaccines development and production has fallen from 26 in 1967 to just five in 2004. There are many causes – relatively low profit margins, smaller markets compared to those of other medications, corporate mergers, liability risks and the anti-vaccination movement – but the result is that in some years, companies have struggled to meet need even for existing vaccines. Just take a look at the flu vaccine shortages of 2003-2005 and the childhood vaccine shortages of the early 2000s.

When a coronavirus vaccine is approved, production of other vaccines will need to continue as well. With the flu season each year and children being born every day, you can’t simply reallocate all existing vaccine manufacturing capacity to COVID-19 vaccine production. New additional capacity will be needed.

A drawing of a strand of RNA.
Many of the most promising vaccine candidates are using new technology, like RNA vaccines, that would require entirely new manufacturing processes. BSIP/Contributor via Getty Images

The type of vaccine is still unknown

While there are a few frontrunners at the moment, it is still unknown which of the more than 160 vaccines in development will get approval first, and therefore, what kind of manufacturing needs to be put in place. Producing a COVID-19 vaccine will not be the same as adding a new strain to an existing flu vaccine or simply tweaking how other existing vaccine are made.

Most existing vaccines, like those for flu and measles, use either inactivated or weakened forms of those specific viruses to generate immunity, but researchers can’t simply swap the flu virus for SARS-CoV-2. Additionally, a SARS-CoV-2 vaccine may not even use inactivated or weakened virus, but instead could incorporate a protein or genetic material from the coronavirus. Manufacturing such pieces of the virus in large amounts may require new processes that never been tried before, since the Food and Drug Administration hasn’t ever approved any DNA vaccines for human use.

Some companies are developing mRNA or DNA vaccines. Others are working with inactivated SARS-CoV-2 or even other types of viruses like the chimp adenovirus. Then there are those targeting different protein subunits of the virus. Each vaccine may have very different manufacturing requirements and it is impossible to know which of these candidates will reach the market and when.

Governments and other funders face a difficult choice. If they gamble and provide funding to scale up manufacturing for a particular vaccine now, they could save time and thus lives. Picking wrong, though, could end up costing much more in money, suffering and lives. Ultimately, manufacturers will seek financial assurances – like upfront payments or commitments to buy the vaccine when it is available – from governments and funders to make sure that the time, effort and resources dedicated to vaccine development and manufacturing will not be wasted. For example, the U.S. government’s US$2.1 billion deal with Sanofi and GSK will include scaling up of manufacturing capacity and the purchase of 100 million doses of the vaccine.

The size of the problem is unprecedented

As the saying goes, knowing is not the same as doing. Producing a completely new vaccine at such a large scale so quickly is unprecedented.

Numerous delays occurred in the production of the H1N1 flu vaccine in 2009. Consider what may happen with a novel vaccine that could require new reagents, production processes, equipment and containers, among other things. Rollouts of the smallpox and polio vaccines occurred decades ago with less urgency and when populations were significantly smaller. Today, assuming that the herd immunity threshold is at least 70%, manufacturers would need to produce at least 230 million doses to cover the U.S. population and over 5.25 billion doses to cover world’s population. And that’s if only one dose is required. Requiring two doses per person would double the doses needed.

Never before has humanity tried to produce something for every person on Earth as quickly as possible. There are going to be problems.

A man walks out of the Moderna headquarters.
Pharmaceutical companies in the vaccine race, like Moderna, might face a choice between what is best for shareholders and what is best for public health. AP Photo/Bill Sikes

Economic poker game

Ultimately, most potential vaccine manufacturers are businesses, seeking to minimize costs and maximize revenue where possible. They will want incentives to forego other more lucrative opportunities, such as continuing to develop or produce medications that have higher profit margins.

For example, companies may not readily reveal current and potential manufacturing capacity. After all, these can be major bargaining chips in negotiating contracts with governments and other possible funders. Revealing that you have too little capacity right now may jeopardize confidence in your ability to make the vaccine. Revealing that you already have enough capacity can hinder your bargaining for more funding and resources.

During the 2009 H1N1 flu pandemic while I was working within the U.S. Department of Health and Human Services, we had to continuously deal with changing vaccine production schedules as manufacturers continued to renegotiate the terms with the government.

Moreover, the extent of the pandemic brings this poker game to the world stage. Different countries may be negotiating with or even against each other and manufacturers. For example, high-income countries may be angling to get ahead of other countries seeking to receive vaccines.

A plan and a systems approach

Ultimately, vaccine production is only one part of a complex, interconnected system whose ultimate goal is to prevent people from getting a disease.

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The type of vaccine developed, size and location of the initial target populations, the way the vaccine is administered, the number of doses and the storage requirements for the vaccine are all interconnected and just some of the factors that affect the production requirements. For example, work done by my team at the City University of New York has shown that that the number of vaccine doses that you put in a single vial can have a variety of cascading effects on vaccination and disease control programs.

People’s lives, and life as we know it, are on the line. All of the complexities of producing a vaccine need to be addressed through open worldwide discussions and extensive mapping and modeling of these scenarios. Without proper planning and preparation, society may be left in a situation where production cannot meet demand or vaccines are shoddily produced.

And even when enough vaccines are manufactured, there’s still the challenge of actually getting them into hundreds of millions of people in the U.S. and billions around the world. There are worries that there won’t be enough glass vials to store the vaccines or syringes to administer them, as well as concerns about the temperature controlled supply chain.

These challenges of production and distribution, though large, are not insurmountable. The more planning governments and businesses do now, the better they will be able to deliver the vaccines the world so desperately needs.

Bruce Y. Lee receives funding from the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the U.S. Agency for International Development (USAID). He has also received funding from the Bill and Melinda Gates Foundation, the Centers for Disease Control and Prevention (CDC), the United Nations Children's Fund (UNICEF), and various vaccine manufacturers to use computational modeling to find ways to improve vaccine development, production, delivery, implementation, and administration.

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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.

Read More

Continue Reading

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