Tag: coronavirus

Top FDA Officials Accepted Jobs With Moderna After Playing Key Roles In The Licensure Of COVID-19 Vaccines

A new BMJ investigation reveals a “revolving door” between FDA officials tasked with regulating COVID-19 vaccines and the companies who manufacture them.

Two high-level regulatory officials with the U.S. Food and Drug Administration (FDA) involved in vaccine oversight accepted jobs at Moderna just months after signing off on the licensure of the company’s COVID-19 vaccine, according to a British Medical Journal (BMJ) investigation.

The report by Peter Doshi, associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ, reveals a long-standing revolving door between the FDA and pharmaceutical companies whose products it regulates and raises questions about the impartiality and independence of top FDA regulators.

Dr. Doran Fink is a “physician/scientist experienced in regulation and clinical development/licensure of vaccines and related biological products” and was deeply involved with vaccine regulation at the FDA for more than 12 years, according to his LinkedIn profile.

According to the BMJ report, Dr. Fink started his FDA career as a clinical reviewer in 2010 and “worked his way up” to Deputy Director of the Division of Vaccines and Related Product Applications within the FDA’s Office of Vaccines Research and Review, where he led a team of medical officers focused on infectious diseases and related biological projects.

During the COVID-19 pandemic, Dr. Fink was a prominent voice on COVID-19 vaccines and which population groups should receive them. He spoke on behalf of the FDA at numerous meetings held by the agency’s vaccine advisors who met to discuss whether to approve COVID-19 vaccines, change their composition, or authorize boosters.

Dr. Fink also presented at meetings held by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices—a group of health experts that develop recommendations on how to use vaccines—as the FDA’s “principal FDA ex officio representative.”

According to the BMJ report and Dr. Fink’s LinkedIn profile, Fink also served on the senior leadership team for COVID-19 vaccine review and policy activities in response to the COVID-19 public health emergency.

As part of his role, he advised vaccine manufacturers on vaccine development throughout the pandemic and coordinated “expedited review of regulatory submissions,” advised U.S. government stakeholders outside the FDA on COVID-19 vaccine science and development, and contributed to FDA guidance on the development, licensure, and emergency use authorization of COVID-19 vaccines.

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Full Extent of COVID Fraud Will ‘Never Be Known With Certainty’

A couple claiming to run a farm that employed dozens of people used fake employee records to get more than $1 million in COVID-19 relief payments when they actually employed no one on a farm that did not exist.

A social media influencer created fake documents to score more than $400,000 in COVID-19 funds meant to help small businesses, then used the money to buy cryptocurrency and gifts for his girlfriend.

A state employee whose job was to stop unemployment benefits fraud helped other fraudsters navigate around fraud prevention systems so they could steal more than $1 million, including federal tax dollars made available to states during the pandemic.

Only now, nearly four years after the federal government approved an unprecedented amount of emergency spending in response to the COVID-19 pandemic, are investigators getting a full picture of all the ways that schemers and thieves raided programs. Congress approved about $4.6 trillion in COVID-19 emergency spending, and so much of it was stolen that auditors now say we’ll likely never have a full accounting of it all.

“When the federal government provides emergency assistance, the risk of payment errors—including those attributable to fraud—may increase because the need to provide this assistance quickly can lead agencies to relax or forego effective safeguards,” the Government Accountability Office (GAO) explained in a new report summing up efforts to recoup stolen funds. “Because not all fraud will be identified, investigated, and adjudicated through judicial or other systems, the full extent of fraud associated with the COVID-19 relief funds will never be known with certainty.”

As Reason has previously reported, auditors believe that about $200 billion was fraudulently disbursed from two programs run by the Small Business Administration (SBA) during the pandemic. That’s about one-sixth of all spending run through the SBA’s Paycheck Protection Program (PPP) and the Economic Injury Disaster Loan (EIDL) program. Additionally, the GAO believes that between $100 billion and $135 billion in federal unemployment funds—provided to states on a temporary basis during the pandemic—were lost to fraud.

One former U.S. attorney has called it “the biggest fraud in a generation.”

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Billions Of Copies Of Residual DNA In A Single Dose Of COVID-19 mRNA Vaccine: Preprint

A new preprint study up for peer review finds billions of residual DNA fragments in the COVID-19 mRNA vaccine vials.

The lead author of the study, molecular virologist David Speicher, who has a doctorate in virology, told The Epoch Times that their study is “the largest study” on residual DNA in COVID-19 vaccines to date.

“In our study, we measured DNA copies of spike, ori (origin of replication), and SV40 enhancer genes,” he told The Epoch Times. “The loads of SV40 enhancer-promoter, ori, and virus spike in Pfizer are up to 186 billion copies per dose.”

The spike he refers to is the DNA sequence of the SARS-CoV-2 spike protein, which can be transcribed to spike mRNA to be used in the COVID-19 mRNA vaccines to be translated to spike protein. The other two DNAs—SV40 enhancer genes and ori—help facilitate the replication of spike DNA.

However, the final mRNA vaccines should only include RNA and not residual DNA instructions for spike production.

The researchers sequenced the gene material in 27 mRNA vaccine vials from 12 different lots. Nineteen vials were from Moderna, and eight were from Pfizer.

“Further work is needed to investigate if anything in these vaccines is actually integrating into the human genome and what effect that may have,” the lead author wrote.

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White House: Economy ‘Exceptionally’ Good and People Like Their Finances, But Don’t Feel Confident Due to COVID, War

On Monday’s broadcast of CNBC’s “Squawk Box,” White House National Economic Council Director Lael Brainard reacted to negative poll numbers on the economy by stating that “the economy is performing exceptionally well” but “people have been through a very challenging few years between the pandemic, and then the oil price spikes associated with Russia’s war. It’s going to take a while for them to feel really confident,” and most people “feel like their personal finances are better now than they were before.”

Co-host Andrew Ross Sorkin said, “Speak to this, though, because I think there [are] a lot of folks who have been waking up to headlines of poll results over the weekend, as it relates to Bidenomics versus, frankly, Trumponomics and where he stands — the president that is — compared to where…the former president stands in terms of how people are thinking about the economy and how, frankly, unhappy they remain about the economy.”

Brainard responded, “Look, if I look around the world, I don’t think there’s a leader out there who wouldn’t rather have the economic record that President Biden has today. We have been growing, 3% over the past year. We’ve had unemployment down below 4% for 21 months in a row. Real incomes are growing. Wealth — this is remarkable — wealth is up 37% for the median household since before the pandemic. And we’re growing faster and have lower inflation than any other advanced economy in the world. So, the statistics, I think, are very strong. Now, people have been through a very challenging few years between the pandemic, and then the oil price spikes associated with Russia’s war. It’s going to take a while for them to feel really confident, but if you look at surveys, 70% of Americans feel like their personal finances are better now than they were before. We’ve still got to work on kitchen table economics, there are still a lot of Americans sitting around their kitchen tables with costs of medicine, pharmaceuticals that are still too high, and we’re working on that.”

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Covid inquiry hears Matt Hancock wanted to decide who lived and died

Former health secretary Matt Hancock wanted to decide “who should live and die” if the NHS was overwhelmed, the Covid inquiry has heard.

The revelation came to light in evidence presented by Sir Simon Stevens, the former NHS England chief.

In his witness statement, he said Mr Hancock thought he, not doctors or the public, should decide who to prioritise if hospitals became overwhelmed.

Sir Simon said: “Fortunately this horrible dilemma never crystallised.”

He told the inquiry: “The secretary of state for health and social care took the position that in this situation he – rather than, say, the medical profession or the public – should ultimately decide who should live and who should die.”

He added: “I certainly wanted to discourage the idea that an individual secretary of state, other than in the most exceptional circumstances, should be deciding how care would be provided.

“I felt we were well-served by the medical profession, in consultation with patients to the greatest extent possible, in making those decisions.”

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Masks required in certain settings again in California

Beginning on Wednesday, lots of people heading into doctor’s offices or hospitals across the Bay Area will be required to mask up.

In some parts of California, masks will be required in hospitals and skilled nursing facilities in an effort to limit the spread of RSV, the flu and COVID. The mandate will last until the end of flu season in March.

Marin County and Santa Clara counties require everyone who enters medical facilities to mask up.  Alameda, San Mateo, Contra Costa, and Sonoma counties will require health care workers to mask up in patient care areas. 

In California, COVID positivity rates were on the rise starting in July, and peaked in late August. According to the Mercury News, wastewater data shows medium levels of COVID in all of Santa Clara County’s sewer sheds at the end of October, down from high transmission range over the last two months.

Dr. Peter Chin-Hong told KTVU medical professional don’t know what is going to happen during this flu season, so they’re opting to take a precautious approach. 

Though, not everyone in the health care industry agrees. 

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Fauci NIH lab infected bats with Wuhan coronavirus, obtained from zoo near Camp David, report

A15-minute drive from the Camp David presidential retreat, a low-rated zoo gave the National Institutes of Health several bats to infect with a coronavirus from the same Chinese lab that some federal agencies believe is responsible for the SARS-CoV-2 outbreak, according to a new investigation and published research.

The White Coat Waste Project, which fights taxpayer funding of “wasteful government animal experiments,” said Monday it’s using Freedom of Information Act requests to get more details about the taxpayer-funded experiments documented in a 2018 paper in the journal Viruses.

Former National Institutes of Allergy and Infectious Diseases Director Dr. Anthony Fauci oversaw the NIH’s Rocky Mountain Laboratories in Montana when it did the research with bats from Maryland’s Catoctin Wildlife Preserve, whose Director of Animal Health Laurie Hahn is a former NIH “lead veterinary technician” for animal research.

The Viruses paper, authored by Montana lab researchers and Wuhan Institute of Virology collaborator Ralph Baric, of the University of North Carolina, determined that the “SARS-like WIV1-coronavirus” first isolated from Chinese rufous horseshoe bats could not cause a “robust infection” in the 12 Egyptian fruit bats from the zoo. Four were euthanized and tested.

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Getting flu and COVID shot together still reasonable amid safety review of potential stroke risk: Experts

Older adults who received last year’s COVID booster and a high-dose version of the flu vaccine in the same visit may have a potential increased risk of stroke, according to a new FDA-funded study.

Experts urged that the results were preliminary and may be explained by other factors such as the fact that older adults are already at a higher risk for stroke due to their age.

“There is no need for panic, and emphatically no need to stop giving COVID and flu shots at the same time to older adults,” said Dr. Peter Chin-Hong, an infectious diseases specialist at the University of California, San Francisco, while he reiterated that more research is needed.

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How Pfizer Hid Nearly 80% of COVID Vaccine Trial Deaths From Regulators

Pfizer-BioNTech delayed reporting vaccine-associated deaths among BNT162b2 clinical trial participants until after the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the product.

The vaccine makers also failed to account for a large number of subjects who dropped out of the trial.

Together, these strategies kept regulators and the public ignorant of a 3.7-fold increase in cardiac deaths among subjects who received the vaccine, according to analysis in the International Journal of Vaccine Theory, Practice, and Research.

The authors of the paper described it as a “forensic analysis,” defined by the U.S. National Institute for Standards and Technology as “the use of scientific methods or expertise to investigate crimes or examine evidence that might be presented in a court of law.”

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FDA finds potential ‘safety signal’ of seizures in 2-5 yr olds after getting Covid-19 shots

A new preprint study led by the U.S. Food and Drug Administration (FDA) has detected a potential “safety signal” for seizures and convulsions in young children after receiving the monovalent Pfizer or Moderna mRNA Covid-19 vaccines.

Researchers observed the condition in children ages 2-4 for the Pfizer vaccine, and ages 2-5 for the Moderna vaccine.

The total number of cases was 72, with over 50% meeting the definition for febrile seizures.

The median time between vaccination and seizures or convulsions was two days, with 32% occurring the day of or the day after vaccination. All seizures and convulsions took place within seven days of vaccination.

The signal emerged through near real-time surveillance of more than 4 million vaccinated children.

The researchers of the preprint study cautioned that the results “should be interpreted carefully given study limitations.”

The study also identified a myocarditis/pericarditis safety signal in mostly male children 12-17 years old.

However, since each of these conditions were a “known adverse outcome,” according to the researchers, they did not conduct any further follow-up.

Data for the study were collected through health claims records from CVS Health, Optum and Carelon Research, which participate in the FDA’s Center for Biologics Evaluation and Research, and supplemented with data from state and local immunization information systems databases.

The study covered reports through January, February or March of this year — as little as 6 months after the approval of vaccinations for younger children.

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