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Military Official Predicted mRNA COVID-19 Vaccines Might Be Paused Over Heart Inflammation

Military Official Predicted mRNA COVID-19 Vaccines Might Be Paused Over Heart Inflammation

Authored by Zachary Stieber via The Epoch Times…

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Military Official Predicted mRNA COVID-19 Vaccines Might Be Paused Over Heart Inflammation

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

A U.S. military official predicted a pause in the administration of the Moderna and Pfizer COVID-19 vaccines could happen if more cases of post-vaccination heart inflammation were detected, according to newly obtained emails.

A nurse prepares a Pfizer-BioNTech COVID-19 vaccine in Hartford, Conn., on Jan. 6, 2022. (Joseph Prezioso/AFP via Getty Images)

Harry Chang, a U.S. Army lieutenant colonel, made the prediction on April 27, 2021—the same day the director of the U.S. Centers for Disease Control and Prevention (CDC) said the agency was not seeing a safety signal when it came to heart inflammation experienced after getting a COVID-19 vaccine.

Chang noted the pause in the administration of the Johnson & Johnson vaccine over blood clots and said an increased number of heart inflammation issues could trigger a similar action.

A pause of the Pfizer/Moderna administration (much like the J&J blood clot pause) will have an adverse impact on US/CA vaccination rates; assessed as unlikely due to causes of myocarditis can come from multiple sources (eg. COVID, other conditions, other vaccines/prescriptions, etc),” Chang wrote in an email.

Myocarditis is a type of heart inflammation.

However, increased reported #s & media attention is likely to trigger a safety review pause by ACIP/FDA,” he added, referring to the Advisory Committee on Immunization Practices, which advises the CDC on vaccines, and the U.S. Food and Drug Administration (FDA), which decides whether to clear immunizations.

Chang was talking to Tricia Blocher, an official at the California Department of Public Health, and other California and military officials. He was reacting to a story about the U.S. Department of Defense detecting a higher-than-expected number of cases of heart inflammation in troops following COVID-19 vaccination.”

The email was one of 19 pages of messages obtained by The Epoch Times through a Freedom of Information Act request.

Members of ACIP’s COVID-19 Vaccine Safety Technical Work Group (VaST) were sent the Pentagon story, as were some CDC officials, the emails show.

Among them was Dr. Tom Shimabukuro, a leader of the Vaccine Safety Team, part of the CDC’s COVID-19 Vaccine Task Force.

Shimabukuro almost immediately asked colleagues for data from the Vaccine Safety Datalink, a tracking system co-run by the CDC and nine health care organizations to monitor vaccine safety. Eric Weintraub, the project leader for the datalink, found that 24 cases of myocarditis had been automatically detected in the tracking system.

The email chain ended there, with no indication that the officials probed further to see if there was a possible link between the vaccines and heart inflammation.

Weintraub did not respond to a request for comment, nor did Chang, who assessed that the discovery of heart issues was “likely to add to further concerns by general public over vaccine safety and make the ‘vaccine wall’ more challenging to overcome.”

The emails “reveal there was an early red flag with post-mRNA COVID vaccine-related myocarditis reports in the U.S. and Israel” but that officials were concerned that acknowledging the risk “would have a negative effect on public perception of COVID vaccine safety and uptake,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.

The historic reluctance of public health officials to acknowledge that vaccines carry serious risks, which are greater for some people, is one of the biggest impediments to improving the safety of the mass vaccination system,” she added.

Both the Moderna and Pfizer shots are built on messenger RNA, or mRNA, technology.

On the same day as the emails, Dr. Rochelle Walensky, the CDC’s director, told reporters during a virtual briefing that after learning of the Pentagon’s discovery, the CDC examined its data and did not see an elevated rate.

“We have not seen a signal, and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given,” she said.

It’s not clear what data Walensky was relying upon. She did not respond to an inquiry.

Shimabukuro, asked if he had advised Walensky on whether a pause should be imposed, referred comment to the CDC. A spokeswoman for the agency told The Epoch Times in an email, “Vaccination policy is the purview of CDC’s Advisory Committee on Immunization Practices (ACIP) and it would be best to contact the CDC ACIP staff with questions concerning pausing vaccination.”

The CDC sets vaccination policy, but often consults with the ACIP before doing so.

The ACIP did not return emailed questions.

To think that Walensky said she had reviewed the data and wasn’t convinced of the causal nature of this—really, really perplexing,” Dr. Anish Koka, a cardiologist based in Philadelphia, told The Epoch Times in a Twitter message.

Myocarditis and a similar condition, pericarditis, are serious issues that often force people to stop exercising and undertaking other physical activities for a period of time. In some cases, the conditions may lead to death. Most cases detected following vaccination require hospitalization. Some people are suffering long-term effects.

“I understand that the public health authorities are using a very different risk/benefit calculus because the disease in question is infectious, but there were certainly other options to consider rather than take a one note approach of 2 vaccines for every young healthy male 20 some days apart,” Koka said.

Both the Moderna and Pfizer vaccines are administered in 2-dose primary series. Boosters are now recommended because the vaccines aren’t as effective as previously claimed.

Neither the CDC nor ACIP released reports on post-vaccination heart inflammation for weeks after the Pentagon detection went public.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, answers questions during a Senate committee hearing in Washington on Jan. 11, 2022. (Greg Nash/Pool/AFP via Getty Images)

The first report from ACIP, a summary of presentations given behind closed doors, said that myocarditis rates after vaccination did not differ from expected rates, which are established using baselines based on the regular occurrence of the condition in the general population.

A few weeks later, however, the panel acknowledged that there were higher than expected rates of post-vaccination heart inflammation, detailing the numbers in a report dated May 24, 2021.

Shimabukuro presented data on the higher-than-expected rates during public meetings the following month. He revealed that myocarditis and pericarditis were being reported at much higher rates than expected in males aged 12 to 29, but claimed it was too soon to indicate a link between the issues and the vaccines. He and others soon said data points “suggest an association with immunization,” and VaST said the data suggested a “likely association.”

Around the same time, the FDA added warnings about heart inflammation to fact sheets that are distributed to vaccine recipients, caregivers of recipients, and medical professionals who administer the shots, and military doctors reported more cases than expected among troops who received one of the vaccines.

Approximately 341 cases of myocarditis or pericarditis following vaccination had been reported to the Vaccine Adverse Event Reporting System (VAERS), a passive system managed by the CDC and the FDA, by the end of April 2021.

As of June 8, over 5,000 cases have been reported.

Some reports have been deleted, potentially skewing the numbers. Additionally, studies indicate reports to VAERS are an undercount.

Based on the reports that have been made, rates of myocarditis are higher than expected in males as young as 5 and as old as 49 after the second dose, according to data Shimabukuro shared at an FDA meeting on June 7. The highest rate is among 16- and 17-year-old males, with 76 reports per one million second doses and 24 cases per one million third doses.

“The current evidence supports a causal association between mRNA COVID-19 vaccination and myocarditis and pericarditis,” Shimabukuro said.

The CDC in February advised some people to wait longer between the first and second shots to try to minimize the risk of heart inflammation.

But some experts say the rates mean that healthy, young people should not get any of the doses, since COVID-19 primarily presents severe problems to the elderly and those with underlying conditions such as kidney disease.

Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits,” Dr. Joseph Ladapo, Florida’s surgeon general, said earlier this year.

Multiple countries have paused the Moderna vaccine for youth, due to the heart inflammation.

Other experts say at least one dose is recommended, while still others, and the CDC, continue to recommend vaccination for virtually all Americans 5 and older.

The pause on Johnson & Johnson’s vaccine over blood clots was eventually lifted, but the FDA in May restricted its use. There was never a pause on the Moderna or Pfizer vaccines in the United States.

Tyler Durden Sat, 06/11/2022 - 23:30

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Spread & Containment

War, peace and security: The pandemic’s impact on women and girls in Nepal and Sri Lanka

The impacts of COVID-19 must be incorporated into women, peace and security planning in order to improve the lives of women and girls in postwar countries…

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Nepalese girls rest for observation after receiving the Moderna vaccine for COVID-19 in Kathmandu, Nepal. (AP Photo/Niranjan Shrestha)

Attention to the pandemic’s impacts on women has largely focused on the Global North, ignoring countries like Nepal and Sri Lanka, which continue to deal with prolonged effects of war. While the Nepalese Civil War concluded in 2006 and the Sri Lankan Civil War concluded in 2009, internal conflicts continue.

As scholars of gender and war, our work focuses on the United Nations Security Council Resolution 1325 on women, peace and security. And our recently published paper examines COVID-19’s impacts on women and girls in Nepal and Sri Lanka, looking at policy responses and their repercussions on the women, peace and security agenda.

COVID-19 has disproportionately and negatively impacted women in part because most are the primary family caregivers and the pandemic has increased women’s caring duties.

This pattern is even more pronounced in war-affected countries where the compounding factors of war and the pandemic leave women generally more vulnerable. These nations exist at the margins of the international system and suffer from what the World Bank terms “fragility, conflict and violence.”

Women, labour and gender-based violence

Gendered labour precarity is not new to Nepal or Sri Lanka and the pandemic has only eroded women’s already poor economic prospects.

Prior to COVID-19, Tharshani (pseudonym), a Sri Lankan mother of three and head of her household, was able to make ends meet. But when the pandemic hit, lockdowns prevented Tharshani from selling the chickens she raises for market. She was forced to take loans from her neighbours and her family had to skip meals.

Some 1.7 million women in Sri Lanka work in the informal sector, where no state employment protections exist and not working means no wages. COVID-19 is exacerbating women’s struggles with poverty and forcing them to take on debilitating debts.

Although Sri Lankan men also face increased labour precarity, due to gender discrimination and sexism in the job market, women are forced into the informal sector — the jobs hardest hit by the pandemic.

Two women sit in chairs, wearing face masks
Sri Lankan women chat after getting inoculated against the coronavirus in Colombo, Sri Lanka, in August 2021. (AP Photo/Eranga Jayawardena)

The pandemic has also led to women and girls facing increased gender-based violence.

In Nepal, between March 2020 and June 2021, there was an increase in cases of gender-based violence. Over 1,750 incidents were reported in the media, of which rape and sexual assault represented 82 per cent. Pandemic lockdowns also led to new vulnerabilities for women who sought out quarantine shelters — in Lamkichuha, Nepal, a woman was allegedly gang-raped at a quarantine facility.

Gender-based violence is more prevalent among women and girls of low caste in Nepal and the pandemic has made it worse. The Samata Foundation reported 90 cases of gender-based violence faced by women and girls of low caste within the first six months of the pandemic.

What’s next?

While COVID-19 recovery efforts are generally focused on preparing for future pandemics and economic recovery, the women, peace and security agenda can also address the needs of some of those most marginalized when it comes to COVID-19 recovery.

The women, peace and security agenda promotes women’s participation in peace and security matters with a focus on helping women facing violent conflict. By incorporating women’s perspectives, issues and concerns in the context of COVID-19 recovery, policies and activities can help address issues that disproportionately impact most women in war-affected countries.

These issues are: precarious gendered labor market, a surge in care work, the rising feminization of poverty and increased gender-based violence.

A girl in a face mask stares out a window
The women, peace and security agenda can help address the needs of some of those most marginalized. (AP Photo/Niranjan Shrestha)

Policies could include efforts to create living-wage jobs for women that come with state benefits, emergency funding for women heads of household (so they can avoid taking out predatory loans) and increasing the number of resources (like shelters and legal services) for women experiencing domestic gender-based violence.

The impacts of COVID-19 must be incorporated into women, peace and security planning in order to achieve the agenda’s aims of improving the lives of women and girls in postwar countries like Nepal and Sri Lanka.

Luna KC is a Postdoctoral Researcher at the Research Network-Women Peace Security, McGill University. This project is funded by the Government of Canada Mobilizing Insights in Defence and Security (MINDS) program.

Crystal Whetstone does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Government

CDC Announces Overhaul After Botching Pandemic

CDC Announces Overhaul After Botching Pandemic

After more than two years of missteps and backpedaling over Covid-19 guidance that had a profound…

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CDC Announces Overhaul After Botching Pandemic

After more than two years of missteps and backpedaling over Covid-19 guidance that had a profound effect on Americans' lives, the Centers for Disease Control (CDC) announced on Wednesday that the agency would undergo a complete overhaul - and will revamp everything from its operations to its culture after failing to meet expectations during the pandemic, Bloomberg reports.

Director Rochelle Walensky began telling CDC’s staff Wednesday that the changes are aimed at replacing the agency’s insular, academic culture with one that’s quicker to respond to emergencies. That will mean more rapidly turning research into health recommendations, working better with other parts of government and improving how the CDC communicates with the public. -Bloomberg

"For 75 years, CDC and public health have been preparing for Covid-19, and in our big moment, our performance did not reliably meet expectations," said Director Rochelle Walensky. "I want us all to do better and it starts with CDC leading the way.  My goal is a new, public health action-oriented culture at CDC that emphasizes accountability, collaboration, communication and timeliness."

As Bloomberg further notes, The agency has been faulted for an inadequate testing and surveillance program, for not collecting important data on how the virus was spreading and how vaccines were performing, for being too under the influence of the White House during the Trump administration and for repeated challenges communicating to a politically divided and sometimes skeptical public."

A few examples:

Walensky made the announcement in a Wednesday morning video message to CDC staff, where she said that the US has 'significant work to do' in order to improve the country's public health defenses.

"Prior to this pandemic, our infrastructure within the agency and around the country was too frail to tackle what we confronted with Covid-19," she said. "To be frank, we are responsible for some pretty dramatic, pretty public mistakes — from testing, to data, to communications."

The CDC overhaul comes on the heels of the agency admitting that "unvaccinated people now have the same guidance as vaccinated people" - and that those exposed to COVID-19 are no longer required to quarantine.

Tyler Durden Wed, 08/17/2022 - 12:22

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Economics

Why Is No One at Nike Working This Week?

And will the move gain broader acceptance among American employers?

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And will the move gain broader acceptance among American employers?

You go into an office, pull at the door and find that it doesn't give and nobody's there. 

It may sound like the start of the common rushing-to-the-office-on-a-Saturday nightmare but, more and more, collective time off is being embraced by employees as part of a push for a better work culture.

While professional social media platform LinkedIn  (MSFT) - Get Microsoft Corporation Report and dating app Bumble  (BMBL) - Get Bumble Inc. Report had already experimented with collective time off for workers, the corporate ripples truly began with Nike  (NKE) - Get Nike Inc. Report.

In August 2021, the activewear giant announced that it was giving the 11,000-plus employees at its Oregon headquarters the week off to "power down" and "destress" from stress brought on by the covid-19 pandemic.

"In a year (or two) unlike any other, taking time for rest and recovery is key to performing well and staying sane," Matt Marrazzos, Nike's senior manager of global marketing science, wrote to employees at the time.

Nike Is On Vacation Right Now

The experiment was, not exactly unexpectedly, very well-received — a year later, the company instituted its second annual "Well-Being Week." Both the corporate headquarters in Beaverton, Ore., and three Air Manufacturing design labs with over 1,500 employees are closed for a collective paid vacation from Aug. 15 to 19.

"We knew it would be impactful, but I was blown away by the feedback from our teammates [...]," Nike's Chief Human Resources Officer Monique Matheson wrote in a LinkedIn post.

"Because everyone was away at the same time, teammates said they could unplug – really unplug, without worrying about what was happening back at the office or getting anxiety about the emails piling up."

Shutterstock/TheStreet

Of course, the time off only applies to corporate employees. To keep the stores running and online orders fulfilled but not exacerbate the differences between blue and white collar workers, Nike gave its retail and distribution employees a week's worth of paid days off that they can use as they see fit.

Nike has tied the change to its commitment to prioritize mental health. In the last year, it launched everything from a "marathon of mental health" to a podcast that discusses how exercise can be used to manage anxiety and depression.

Rippling Through the Corporate World?

But as corporations are often criticized for turning mental health into positive PR without actually doing much for employees, the collective week off was perhaps the most significant thing the company did for workers' mental health.

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The practice of set office closures has long been common practice in many European countries. In France, not only corporate offices but even restaurants and retail stores empty out over the month of August for what is culturally considered sacred vacation time. 

But as American work culture prioritizes individual choice and "keeping business going" above all else, the practice has been seen as radical by many corporate heads and particularly small businesses that may find it more difficult to have such a prolonged drop in business. 

But in many ways, the conversations mirror some companies' resistance to remote work despite the fact that one-fourth of white-collar jobs in the U.S. are expected to be fully remote by 2023

"This is the kind of perk that makes employees want to stay," industry analyst Shep Hyken wrote in a comment for RetailWire. "And knowing they can’t completely shut the entire company down, I like the way they are compensating the distribution and retail store employees."

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