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Email Reveals Why CDC Didn’t Issue Alert On COVID Vaccines And Myocarditis

Email Reveals Why CDC Didn’t Issue Alert On COVID Vaccines And Myocarditis

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

The…

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Email Reveals Why CDC Didn’t Issue Alert On COVID Vaccines And Myocarditis

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

The nation’s top public health agency did not send an alert on COVID-19 vaccines and heart inflammation because officials were concerned they would cause panic, according to an email obtained by The Epoch Times.

The U.S. Centers for Disease Control and Prevention (CDC) in 2021 drafted an alert for heart inflammation, or myocarditis, and the Pfizer-BioNTech and Moderna COVID-19 vaccines. Officials prepared to release it to the public, taking steps including having the agency’s director review the language, internal documents show.

The alert would have been sent through the CDC’s Health Alert System (HAN) network, which goes to state and local officials, as well as doctors, across the country.

The alert was never sent.

In the May 25, 2021, email, exclusively obtained by The Epoch Times, a CDC official revealed why some officials were against sending the alert.

The pros and cons of an official HAN are what the main discussion are right now,” Dr. Sara Oliver, the official, wrote in the missive. “I think it’s likely to be a HAN since that is CDC’s primary method of communications to clinicians and public health departments, but people don’t want to appear alarmist either.”

Dr. Oliver was corresponding with an employee of either Pfizer or Moderna. The employee’s name and email were redacted in the copy obtained by The Epoch Times.

Dr. Oliver did not respond to a request for comment. Asked about the email, the CDC did not address Dr. Oliver’s statement.

The “CDC’s apparent decision to not immediately issue a formal alert to clinicians warning them about the increased risk of myocarditis and pericarditis in vaccinated individuals is not only inexcusable, it’s malpractice,” Sen. Ron Johnson (R-Wis.), the top Republican on the Senate Homeland Security and Governmental Affairs Committee’s Permanent Subcommittee on Investigations, told The Epoch Times in an email.

“CDC should never prioritize its own public perception over the public’s health, and those who made the decision to do so must be held fully accountable,” he added.

It remains unclear which official or officials decided not to send the alert at a time when doctors across the country were seeing patients with myocarditis report to emergency rooms with chest pain and other symptoms.

Kim Witczak, a drug safety advocate who helped convince regulators to add a suicide warning to antidepressants, said the CDC’s move to downplay heart inflammation fits into a longstanding pattern of transparency issues with agencies and drug companies.

I can’t even believe that this was even a discussion where they’re like, ‘We don’t want to alarm them.’ We do need to alarm people. We need people to be aware that this is a real potential [problem] that could happen,” Ms. Witzcak told The Epoch Times.

Those kinds of choices have helped erode consumer confidence in public health, she added.

Dr. Tom Frieden, a former CDC director who now serves as president and CEO of the global health project Resolve to Save Lives, also reviewed the messages.

“It is important to carefully weigh the risk of COVID-19 against the risk and benefit of any treatment, including the vaccine. The vaccine safety systems worked—they found a very rare but real signal of myocarditis soon after distributing vaccines that were administered to adolescents,“ Dr. Frieden told The Epoch Times via email. ”When public health officials see a safety signal, they must investigate whether it is ‘true’ or ‘random.’ It is important to consider multiple data angles and gather evidence from partners on the ground, including clinicians. This needs to be done quickly but carefully and thoroughly.”

An internal CDC email. (The Epoch Times)

Moderna, Pfizer Given Heads Up

U.S. authorities identified myocarditis and a related condition, pericarditis, before the vaccines were cleared as events that could be caused by the vaccines. People who received the Moderna and Pfizer vaccines began reporting myocarditis and pericarditis to health authorities and the vaccine manufacturers shortly after the vaccines were rolled out in December 2020.

A signal in the Vaccine Adverse Event Reporting System (VAERS), which the CDC helps manage, triggered in February 2021, the same month Israel warned the CDC and U.S. drug regulators of a “large number” of cases, primarily among young males.

Dr. Rochelle Walensky, the CDC’s director at the time, first addressed the issue publicly in April 2021. She falsely said the agency had seen no reports and that no signal had triggered, while disclosing the CDC was in touch with U.S. military officials on cases among service members.

In reality, hundreds of cases had been reported to the CDC, including some that resulted in death; the CDC either missed or ignored the signal in VAERS; and the CDC helped hide a signal that emerged from a Department of Veterans Affairs system, internal documents and other data reviewed by The Epoch Times show.

The CDC did communicate to certain state officials about myocarditis issues starting in April 2021 and told some doctors in a May 14, 2021, email that the agency was monitoring reports of the inflammation following Pfizer and Moderna vaccination.

Shortly after that missive was sent, the CDC began considering next steps, according to the newly obtained documents.

Dr. Oliver on May 21, 2021, emailed representatives of Moderna and Pfizer to warn them that the CDC was planning to go public with information on the myocarditis cases.

“Wanted to make sure you were aware before anything was made public,” Dr. Oliver wrote in one of the messages, which were obtained by The Epoch Times and are being reported in this story for the first time. “You may be aware, but there have been concerns for myocarditis seen in adolescents and young adults after receipt of the mRNA vaccines. Thankfully, the cases appear relatively mild, but there is concern that we need to make providers aware of this issue. CDC is discussing communication options, and we may have more information tomorrow.”

Cardiologists say there’s no such thing as a mild case of heart inflammation and research has since shown that a number of cases don’t resolve for monthsif at all.

The Moderna and Pfizer vaccines both use modified messenger RNA (mRNA) technology.

Moderna and Pfizer did not respond to requests for comment.

One representative from Pfizer sent information to Dr. Oliver and colleagues ahead of a planned meeting, the emails show. The information was redacted.

Moderna officials met with the CDC on May 22, 2021. The discussion covered how the CDC was considering saying there was a “possible causal relationship,” or that the vaccines might be causing the inflammation, according to the emails.

Moderna asked how government officials thought the myocarditis was being caused, or the mechanism of action.

“My current understanding is that it isn’t necessarily a defined mechanism, but that we’ve seen very similar/consistent findings where mRNA vaccines have been used all occurring within days of receipt of an mRNA vaccine (although it could be that systemic inflammation plays a role),” Dr. Oliver wrote.

A representative with one of the companies then checked in on May 25, 2021, asking if the CDC had decided how to communicate to the public about myocarditis.

“Apologies that there hasn’t been more solid communication on this. Unfortunately, I still don’t have a firm update to share. Things have been changing rapidly here,” Dr. Oliver wrote. In the next email, she wrote that some officials did not want to cause panic.

“I am not trying to be vague on purpose- I really don’t know,” she said. “If I had to guess, I would think it’s likely to be a HAN, but can’t say for sure yet. I anticipate there will be firm decisions within the next 24 hours so I'll let you know.”

Scaled-Down Response

A two-page draft of the alert obtained by The Epoch Times was completely redacted. The Epoch Times is working on acquiring an unredacted copy.

The draft was circulated internally, including to Dr. Walensky, emails show. The messages indicated the CDC chose not to send the alert after consulting with the U.S. Food and Drug Administration (FDA).

The CDC said on its website on May 20, 2021, that a review of post-vaccination myocarditis found “relatively few reports” and that rates of myocarditis “have not differed from expected baseline rates.”

Instead of the alert, the CDC decided to post another webpage called clinical considerations. The page, posted on May 27, 2021, said that “increased cases of myocarditis and pericarditis have been reported in the United States after mRNA COVID-19 vaccination (Pfizer-BioNTech and Moderna)” since April 2021.

The page also said the CDC and the agency’s partners were investigating the issue before recommending COVID-19 vaccination for everyone aged 12 and older.

A draft of the page was shared with Moderna and Pfizer at least several hours before publication, according to the emails.

A CDC spokeswoman said that safety data prompted the CDC to post information on myocarditis online “for public awareness and to provide guidance to clinicians.” She said the clinical considerations reached the same 300,000 provider recipients a HAN alert would have.

A clinical consideration is useful when information needs to be updated as circumstances evolve, and more data is collected and evaluated,” the spokeswoman said.

In a separate email, she said that “CDC’s focus and concern on myocarditis after COVID-19 vaccination is well known and documented.”

An FDA spokesperson declined to detail its influence on the shelved alert.

“The FDA continues to work collaboratively with the CDC to monitor for known safety risks related to vaccines and determine how best to ensure any relevant safety information is conveyed to the public, health care providers and clinicians,” the spokesperson told The Epoch Times in an email. “After thorough assessment and when the potential risk was clear, the FDA updated the fact sheets for the COVID-19 vaccines and communicated with the public in a manner that was determined to be appropriate for the assessed risk.”

Federal rules require the FDA to add a warning about a “a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.”

The FDA on June 25, 2021, added warnings about myocarditis to the labels for the Pfizer and Moderna vaccines.

Tyler Durden Fri, 01/26/2024 - 21:00

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide…

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Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide Black Lives Matter riots in the summer of 2020, some elite colleges and universities shredded testing requirements for admission. Several years later, the test-optional admission has yet to produce the promising results for racial and class-based equity that many woke academic institutions wished.

The failure of test-optional admission policies has forced Dartmouth College to reinstate standardized test scores for admission starting next year. This should never have been eliminated, as merit will always prevail. 

"Nearly four years later, having studied the role of testing in our admissions process as well as its value as a predictor of student success at Dartmouth, we are removing the extended pause and reactivating the standardized testing requirement for undergraduate admission, effective with the Class of 2029," Dartmouth wrote in a press release Monday morning. 

"For Dartmouth, the evidence supporting our reactivation of a required testing policy is clear. Our bottom line is simple: we believe a standardized testing requirement will improve—not detract from—our ability to bring the most promising and diverse students to our campus," the elite college said. 

Who would've thought eliminating standardized tests for admission because a fringe minority said they were instruments of racism and a biased system was ever a good idea? 

Also, it doesn't take a rocket scientist to figure this out. More from Dartmouth, who commissioned the research: 

They also found that test scores represent an especially valuable tool to identify high-achieving applicants from low and middle-income backgrounds; who are first-generation college-bound; as well as students from urban and rural backgrounds.

All the colleges and universities that quickly adopted test-optional admissions in 2020 experienced a surge in applications. Perhaps the push for test-optional was under the guise of woke equality but was nothing more than protecting the bottom line for these institutions. 

A glimpse of sanity returns to woke schools: Admit qualified kids. Next up is corporate America and all tiers of the US government. 

Tyler Durden Mon, 02/05/2024 - 17:20

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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