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FDA authorizes about 10M J&J vaccine doses, trashes 60M more from troubled Emergent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.
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The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Peter Marks, FDA

“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said CBER director Peter Marks.

Emergent previously ruined 15 million doses of J&J’s Covid-19 vaccine in March due to the cross-contamination with the AstraZeneca vaccine, which was previously made at the same Baltimore site. In April, Emergent slammed the brakes on all production there, at the FDA’s behest, and J&J took control of the plant.

Now, the 10 million doses that are OK to be used may also be exported, but the FDA said Friday that will come with conditions. For instance, for any export of these two batches OKed for use, or of vaccine manufactured from these batches, J&J and Emergent agreed that the FDA may share relevant information, under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.

Additional batches are still under review, FDA said, but the agency declined to say how many or even how many doses are in one batch. The New York Times first reported on Friday that the FDA would not allow the use of the 60 million doses. J&J did not respond to a request for comment.

The European Medicines Agency also released a statement on Friday, saying that based on available information, batches of the vaccine released in the EU are not affected by the cross-contamination that occurred at the Emergent facility.

“However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities [the medicines authorities in Belgium and the Netherlands who are responsible for batch release in the EU] have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred,” the EMA said.

Additionally, the FDA has extended the expiration dating for the refrigerated J&J doses, after reviewing information and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months, instead of 3 months.

More than 10 million people in the US have now received the J&J vaccine, all of whom received vaccines made at the company’s plant in the Netherlands. Another 10 million more doses have been delivered across the country but not administered yet, according to the CDC.

As of the end of May, 2 million doses of the J&J vaccine have been administered in the EU, EMA said.

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Spread & Containment

This Thanksgiving, Supplies Of Turkey, Eggs, & Butter Will Be Extremely Tight In The US

This Thanksgiving, Supplies Of Turkey, Eggs, & Butter Will Be Extremely Tight In The US

Authored by Michael Snyder via The Economic Collapse…

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This Thanksgiving, Supplies Of Turkey, Eggs, & Butter Will Be Extremely Tight In The US

Authored by Michael Snyder via The Economic Collapse blog,

If you love to cook, this upcoming Thanksgiving may be a real challenge for you.  Thanks to a resurgence of the bird flu, supplies of turkey are getting tighter and tighter.  Sadly, the same thing is true for eggs.  And as you will see below, reduced milk production is sending the price of butter into the stratosphere.  Thanks to soaring prices, a traditional Thanksgiving dinner will be out of reach for millions of American families this year, and that is extremely unfortunate.  Of course all of this is happening in the context of a horrific global food crisis that is getting worse with each passing day.  Yes, things are bad now, but they will be significantly worse this time next year.

The bird flu pandemic that has killed tens of millions of our chickens and turkeys was supposed to go away during the hot summer months, but that didn’t happen.  And now that the weather is starting to get colder again, there has been a resurgence of the bird flu and this is “devastating egg and turkey operations in the heartland of the country”

Turkeys are selling for record high prices ahead of the Thanksgiving holiday as a resurgence of bird flu wipes out supplies across the US.

Avian influenza is devastating egg and turkey operations in the heartland of the country. If just one bird gets it, the entire flock is culled in order to stop the spread. Millions of hens and turkeys have been killed in recent weeks. As a result, prices for turkey hens are nearly 30% higher than a year ago and 80% above pre-pandemic costs. Just as concerning are inventories of whole turkeys, which are the lowest going into the US winter holiday season since 2006. That means there will be little relief from inflation for Thanksgiving dinner.

In the months ahead, we could see tens of millions more chickens and turkeys get wiped out.

Egg prices have already tripled in 2022 and the price of turkey meat is up 60 percent.  Unfortunately, this is likely just the beginning

Turkey hens are $1.82 a pound this week, according to Urner Barry, compared to $1.42 last year and $1.01 before the pandemic. Meanwhile, wholesale egg prices are at $3.62 a dozen as of Wednesday, the highest ever, up from a previous record of $3.45 a dozen set earlier this year, said John Brunnquell, chief executive officer of Egg Innovations, one of the biggest US producers of free-range eggs. Consumers have seen prices for eggs at grocery stores triple this year, while turkey meat rose a record-setting 60%, according to a Cobank report.

Meanwhile, supplies of butter are steadily getting tighter as well

Lower milk production on U.S. dairy farms and labor shortages for processing plants have weighed on butter output for months, leaving the amount of butter in U.S. cold storage facilities at the end of July the lowest since 2017, according to the Agriculture Department.

Tight supplies have sent butter prices soaring at U.S. supermarkets, surpassing most other foods in the past year. U.S. grocery prices in August rose 13.5% during the past 12 months, the largest annual increase since 1979, according to the Labor Department. Butter outstripped those gains, rising 24.6% over the same period.

The trends that are driving up the price of butter aren’t going away any time soon, and so we are being warned to brace ourselves for “elevated” prices for the foreseeable future…

The forces at work in butter highlight the challenge of curtailing inflation. Economic pressures fueling high prices for livestock feed, labor shortages and other factors could persist, keeping prices for the kitchen staple elevated longer term.

To me, slathering a piece of warm bread with a huge chunk of butter is one of the best things about Thanksgiving.

And most of us will continue to buy butter no matter how high it goes.

But the truth is that rapidly rising food prices are forcing vast numbers of Americans to adjust their shopping habits.  Here is one example

For Carol Ehrman, cooking is a joyful experience.

“I love to cook, it’s my favorite thing to do,” she said. She especially likes to cook Indian and Thai food, but stocking the spices and ingredients she needs for those dishes is no longer feasible. “When every ingredient has gone up, that adds up on the total bill,” she said.

“What used to cost us $250 to $300 … is now $400.” Ehrman, 60, and her husband, 65, rely on his social security income, and the increase was stretching their budget. “We just couldn’t do that.”

The global food crisis is starting to hit home for many ordinary Americans, and we need to understand that this crisis is still only in the very early chapters.

David Beasley is the head of the UN World Food Program, and he is actually using the word “hell” to describe what is potentially coming in 2023

“It’s a perfect storm on top of a perfect storm,” Beasley said. “And with the fertilizer crisis we’re facing right now, with droughts, we’re facing a food pricing problem in 2022. This created havoc around the world.”

“If we don’t get on top of this quickly — and I don’t mean next year, I mean this year — you will have a food availability problem in 2023,” he said. “And that’s gonna be hell.”

The World Food Program keeps sounding the alarm, but very few of us in the western world seem to be taking those warnings very seriously.

People are literally dropping dead from starvation in some areas of the globe right now, and a new report that the WFP just released says that there are 19 “hotspots” where we could see a “huge loss of life” between October and January…

World Food Programme (WFP) and the Food and Agriculture Organization of the United Nations (FAO) are out with a new report outlining countries that “are either already starving or on the brink of disaster.”

WFP and FAO found 19 hunger hotspots worldwide, with most countries in Africa, the Middle East, and even some in Central America. They call for urgent humanitarian action between October 2022 and January 2023 to avoid “huge loss of life.”

Afghanistan, Ethiopia, South Sudan, Somalia, Nigeria, Yemen, and Haiti are labeled “hotspots of highest concern,” facing catastrophic hunger levels.

The sort of famines that we were warned about are already starting to happen right in front of our eyes, but most people simply will not care as long as they are not going hungry themselves.

What those people do not realize is that this global food crisis is going to continue to spread.

As supplies of food get tighter and tighter, prices will continue to soar and shortages will become more common.

We truly are in unprecedented territory, and the pain that is ahead will greatly shock all of the lemmings that just kept assuming that everything would work out just fine somehow.

*  *  *

It is finally here! Michael’s new book entitled “7 Year Apocalypse” is now available in paperback and for the Kindle on Amazon.

Tyler Durden Thu, 09/29/2022 - 21:40

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Government

“Historic Levels Of Fraud”: US Watchdog Estimates $45.6 Billion Bilked From Pandemic Unemployment Program

"Historic Levels Of Fraud": US Watchdog Estimates $45.6 Billion Bilked From Pandemic Unemployment Program

A federal watchdog has found that…

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"Historic Levels Of Fraud": US Watchdog Estimates $45.6 Billion Bilked From Pandemic Unemployment Program

A federal watchdog has found that $45.6 billion may have been scammed out of the nation's unemployment program during the pandemic, as fraudsters used a variety of methods to commit fraud - including using the Social Security numbers of dead people, hard-to-trace emails, and the identities of prisoners who were ineligible for aid.

According to the Washington Post, a Thursday report by the inspector general for the Labor Department reveals that the program - which helped some 57 million families in the first five months of the crisis - became an easy target for criminals.

To siphon away funds, scammers allegedly filed billions of dollars in unemployment claims in multiple states simultaneously and relied on suspicious, hard-to-trace emails. In some cases, they used more than 205,000 Social Security numbers that belonged to dead people. Other suspected criminals obtained benefits using the identities of prisoners who were ineligible for aid.

But officials at the watchdog office warned their accounting still may be incomplete: They said they were not able to access more updated federal prisoner data from the Justice Department, and acknowledged that they only focused their report on “high risk” areas for fraud. The two factors raised the prospect that they could uncover billions of dollars in additional theft in the months to come. -WaPo

At least 1,000 individuals have been charged with unemployment fraud and related crimes, according to a Thursday announcement. DOJ director of covid-related enforcement, Kevin Chambers, described the situation as "unprecedented fraud," while the IG's office says it's opened roughly 190,000 related investigative matters since the beginning of the pandemic.

The new report highlights challenges faced by government watchdogs and regulators, two years after what became roughly $5 trillion in (inflationary) pandemic aid was printed in response to the worst economic crisis since the Great Depression.

Last week, federal prosecutors  charged 47 individuals from the Minnesota Somali community for allegedly bilking $250 million in Covid-19 federal funds meant for a child nutrition program, in what the DOJ described as the largest single fraud case related to pandemic aid to date.

Twitter via @LouRaguse

Meanwhile, federal investigators are looking into roughly $1 trillion in loans an grants designed to help small businesses.

"Hundreds of billions in pandemic funds attracted fraudsters seeking to exploit the UI program — resulting in historic levels of fraud and other improper payments," said Labor Department inspector general, Larry Turner.

Turner's office found that between March and October 2020, there were roughly $16 billion in potential fraud in key high-risk areas.

One lawmaker actually who's actually pursuing the fraud is Sen. Ron Wyden (D-OR), who chairs the Senate Finance Committee. Wyden praised the "strong effort to identify criminals," but stressed the need to overhaul the jobless benefits system.

"I’ve long said we need a national set of technology and security standards for state systems to better prevent this kind of fraud, and we’re going to keep working to get our reforms passed," he added.

Tyler Durden Thu, 09/29/2022 - 18:00

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International

Scientists find link between fast-melting Arctic ice and ocean acidification

An international team of researchers have sounded new alarm bells about the changing chemistry of the western region of the Arctic Ocean after discovering acidity…

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An international team of researchers have sounded new alarm bells about the changing chemistry of the western region of the Arctic Ocean after discovering acidity levels increasing three to four times faster than ocean waters elsewhere.

Credit: Photos courtesy of Zhangxian Ouyang, Wei-Jun Cai and Liza Wright-Fairbanks/ University of Delaware

An international team of researchers have sounded new alarm bells about the changing chemistry of the western region of the Arctic Ocean after discovering acidity levels increasing three to four times faster than ocean waters elsewhere.

The team, which includes University of Delaware marine chemistry expert Wei-Jun Cai, also identified a strong correlation between the accelerated rate of melting ice in the region and the rate of ocean acidification, a perilous combination that threatens the survival of plants, shellfish, coral reefs and other marine life and biological processes throughout the planet’s ecosystem.

The new study, published on Thursday, Sept. 30 in Science, the flagship journal of the American Association for the Advancement of Science, is the first analysis of Arctic acidification that includes data from more than two decades, spanning the period from 1994 to 2020.

Scientists have predicted that by 2050 — if not sooner — Arctic sea ice in this region will no longer survive the increasingly warm summer seasons. As a result of this sea-ice retreat each summer, the ocean’s chemistry will grow more acidic, with no persistent ice cover to slow or otherwise mitigate the advance.

That creates life-threatening problems for the enormously diverse population of sea creatures, plants and other living things that depend on a healthy ocean for survival. Crabs, for example, live in a crusty shell built from the calcium carbonate prevalent in ocean water. Polar bears rely on healthy fish populations for food, fish and sea birds rely on plankton and plants, and seafood is a key element of many humans’ diets.

That makes acidification of these distant waters a big deal for many of the planet’s inhabitants.

First, a quick refresher course on pH levels, which indicate how acidic or alkaline a given liquid is. Any liquid that contains water can be characterized by its pH level, which ranges from 0 to 14, with pure water considered neutral with a pH of 7. All levels lower than 7 are acidic, all levels greater than 7 are basic or alkaline, with each full step representing a tenfold difference in the hydrogen ion concentration. Examples on the acidic side include battery acid, which checks in at 0 pH, gastric acid (1), black coffee (5) and milk (6.5). Tilting toward basic are blood (7.4), baking soda (9.5), ammonia (11) and drain cleaner (14). Seawater is normally alkaline, with a pH value of around 8.1.

Cai, the Mary A.S. Lighthipe Professor in the School of Marine Science and Policy in UD’s College of Earth, Ocean and Environment, has published significant research on the changing chemistry of the planet’s oceans and this month completed a cruise from Nova Scotia to Florida, serving as chief scientist among 27 aboard the research vessel. The work, supported by the National Oceanic and Atmospheric Administration (NOAA), includes four areas of study: The East Coast, the Gulf of Mexico, the Pacific Coast and the Alaska/Arctic region.

The new study in Science included UD postdoctoral researcher Zhangxian Ouyang, who participated in a recent voyage to collect data in the Chukchi Sea and Canada Basin in the Arctic Ocean.

The first author on the publication was Di Qi, who works with Chinese research institutes in Xiamen and Qingdao. Also collaborating on this publication were scientists from Seattle, Sweden, Russia and six other Chinese research sites.

“You can’t just go by yourself,” Cai said. “This international collaboration is very important for collecting long-term data over a large area in the remote ocean. In recent years, we have also collaborated with Japanese scientists as accessing the Arctic water was even harder in the past three years due to COVID-19. And we always have European scientists participating.”

Cai said he and Qi both were baffled when they first reviewed the Arctic data together during a conference in Shanghai. The acidity of the water was increasing three to four times faster than ocean waters elsewhere.

That was stunning indeed. But why was it happening?

Cai soon identified a prime suspect: the increased melt of sea ice during the Arctic’s summer season.

Historically, the Arctic’s sea ice has melted in shallow marginal regions during the  summer seasons. That started to change in the 1980s, Cai said, but waxed and waned periodically. In the past 15 years, the ice melt has accelerated, advancing into the deep basin in the north.

For a while, scientists thought the melting ice could provide a promising “carbon sink,” where carbon dioxide from the atmosphere would be sucked into the cold, carbon-hungry waters that had been hidden under the ice. That cold water would hold more carbon dioxide than warmer waters could and might help to offset the effects of increased carbon dioxide elsewhere in the atmosphere.

When Cai first studied the Arctic Ocean in 2008, he saw that the ice had melted beyond the Chukchi Sea in the northwest corner of the region, all the way to the Canada Basin — far beyond its typical range. He and his collaborators found that the fresh meltwater did not mix into deeper waters, which would have diluted the carbon dioxide. Instead, the surface water soaked up the carbon dioxide until it reached about the same levels as in the atmosphere and then stopped collecting it. They reported this result in a paper in Science in 2010.

That would also change the pH level of the Arctic waters, they knew, reducing the alkaline levels of the seawater and reducing its ability to resist acidification. But how much? And how soon? It took them another decade to collect enough data to derive a sound conclusion on the long-term acidification trend.

Analyzing data gathered from 1994 to 2020 – the first time such a long-term perspective was possible — Cai, Qi and their collaborators found an extraordinary increase in acidification and a strong correlation with the increasing rate of melting ice.

They point to sea-ice melt as the key mechanism to explain this rapid pH decrease, because it changes the physics and chemistry of the surface water in three primary ways:

  • The water under the sea ice, which had a deficit of carbon dioxide, now is exposed to the atmospheric carbon dioxide and can take up carbon dioxide freely.

  • The seawater mixed with meltwater is light and cannot mix easily into deeper waters, which means the carbon dioxide taken from the atmosphere is concentrated at the surface.

  • The meltwater dilutes the carbonate ion concentration in the seawater, weakening its ability to neutralize the carbon dioxide into bicarbonate and rapidly decreasing ocean pH.

Cai said more research is required to further refine the above mechanism and better predict future changes, but the data so far show again the far-reaching ripple effects of climate change.

“If all of the multiple-year ice is replaced by first-year ice, then there will be lower alkalinity and lower buffer capacity and acidification continues,” he said. “By 2050, we think all of the ice will be gone in the summer. Some papers predict that will happen by 2030. And if we follow the current trend for 20 more years, the summer acidification will be really, really strong.”

No one knows exactly what that will do to the creatures and plants and other living things that depend on healthy ocean waters.

“How will this affect the biology there?” Cai asked. “That is why this is important.”


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