Friday, May 13, 2022

COVID-19 Vaccine Producer Hid Evidence of Problems: Report

Executives at a company that produced millions of COVID-19 vaccine doses attempted to hide evidence that some of the doses were contaminated, according to a congressional report released on May 10.

Emergent BioSolutions “took repeated steps to conceal its quality failures from the federal government and other third parties by limiting access to Bayview, tampering with drug-substance labels to impede FDA oversight, and strategizing to withhold information from HHS following the cross-contamination event in March 2021,” a report from the House Oversight Committee and the Subcommittee on the Coronavirus Crisis concluded.

The Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS), identified deficiencies in the manufacturing process at Emergent’s Baltimore, Maryland facility—known as Bayview—in 2020.

In early 2021, Johnson & Johnson announced that up to 15 million doses of its COVID-19 vaccine at the facility became contaminated.

Documents obtained by the committees showed that Emergent rejected requests from Johnson & Johnson to visit the site around that time ahead of a follow-up FDA inspection.

One email from a consultant hired by Emergent indicated that employees removed quality-assurance tags from containers of Johnson & Johnson’s vaccine drug substance just before inspectors began their tour and put them back into place after inspectors left. The tags alerted employees that portions of the batches were potentially unable to be used.

Several days later, the consultant said that the tags were removed to “avoid drawing attention” to the potential quality issue.

Internal communications obtained by lawmakers show top executives at Emergent were aware of what happened.

Despite the tag removal, the FDA identified problems during the inspection.

In March 2021, another cross-contamination issue was identified by Johnson & Johnson, but Emergent did not alert AstraZeneca—whose vaccines Emergent was also manufacturing—and HHS for three weeks, according to the new report.

When an HHS agency asked for details, an executive said that no details should be shared with the government until its investigation was over.

“Today’s report shows that Emergent profited from the pandemic while violating the public’s trust. Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House oversight panel, said in a statement.

Approximately 400 million doses of COVID-19 vaccines were destroyed because of the contamination issues.

“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe and that it was unlikely to fulfill the contract recklessly awarded by the Trump administration. Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements,” Rep. Jim Clyburn (D-S.C.), chairman of the subcommittee, said in a statement.

Emergent was operating on a $628 million contract awarded during the Trump administration. The Biden administration canceled the contract in late 2021.

In a statement issued in response to the new report, Emergent said the report contained nothing new. The company also said it did not knowingly mislead the FDA, other government agencies, or private partners.

“During the last few years, the FDA and other international regulatory authorities have visited Emergent facilities dozens of times. On several occasions, Emergent invited FDA personnel to visit Bayview to review our progress, assess our capabilities, and provide feedback on our facilities, processes, and systems when no FDA inspection was required.

Further to that point, the single contaminated batch was brought to the attention of the FDA by Johnson & Johnson and Emergent,” the company said, adding that it has been in “constant communication” with the FDA and its clients as it tried to manufacture the Johnson & Johnson and AstraZeneca vaccines.


All About the Newest COVID Pills – Should You Take Them?

Pfizer’s new antiviral pill Paxlovid is receiving high-profile attention – the vice president even took it when she contracted COVID. But a strange phenomenon is being reported by some of its users, raising the question if it, too, should be avoided.

Story at-a-glance:

* So far, all of the drugs developed against COVID-19 have been disastrous in one way or another. Remdesivir, which to this day is the primary COVID drug approved for use in U.S. hospitals, routinely causes severe organ damage and, often, death

* Despite that, the U.S. Food and Drug Administration has approved remdesivir for in-hospital and outpatient use in children as young as 1 month old

* Another COVID drug, Paxlovid, will in some cases cause the infection to rebound when the medication is withdrawn

* Molnupiravir (sold under the brand name Lagevrio) also has serious safety concerns. Not only might it contribute to cancer and birth defects, it may also supercharge the rate at which the virus mutates inside the patient, resulting in newer and more resistant variants

* The fact that U.S. health authorities have focused on these drugs to the exclusion of all others, including older drugs with high rates of effectiveness and superior safety profiles, sends a very disturbing message. They’ve basically become extensions of the drug industry, protecting the drug industry’s interests at the cost of public health

So far, all of the drugs developed against COVID-19 have been disastrous in one way or another. Remdesivir, for example, which to this day is the primary COVID drug approved for use in U.S. hospitals,1 routinely causes severe organ damage2,3,4,5 and, often, death.

Despite its horrible track record, the U.S. government actually pays hospitals a 20% upcharge for sticking to the remdesivir protocol, plus an additional bonus.6,7,8 Hospitals must also use remdesivir if they want liability protection.

Incentives like these have turned U.S. hospitals into veritable death traps, as more effective and far safer drugs are not allowed, and hospitals are essentially forced to follow the recommendations of the U.S. Centers for Disease Control and Prevention. As reported by Forbes science reporter JV Chamary back in January 2021, in an article titled, “The Strange Story of Remdesivir, a COVID Drug That Doesn’t Work”:9

“Remdesivir is an experimental drug developed by biotech company Gilead Sciences (under the brand name Veklury) in collaboration with the US Centers for Disease Control and Army Medical Research Institute of Infectious Diseases …

The drug proved ineffective against the Ebola virus … yet was still subsequently repurposed for SARS-CoV-2 coronavirus. News media prematurely reported that patients were responding to treatment.

But the published data10 later showed that ‘remdesivir was not associated with statistically significant clinical benefits [and] the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies’ …

What’s weird about remdesivir is that it hasn’t been held to the same standards as other drug candidates. Normally, a drug is only approved for use by a regulatory body like the U.S. Food and Drug Administration if it meets the two criteria for safety and efficacy.

Nonetheless, in October 2020, remdesivir was granted approval by FDA based on promising data from relatively small trials with about 1,000 participants. A large-scale analysis11 by the World Health Organization’s Solidarity trial consortium has cleared-up the confusion.

Based on interim results from studying more than 5,000 participants, the international study concluded that remdesivir ‘had little or no effect on hospitalized patients with COVID-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.’ As a consequence of being mostly ineffective, WHO recommends against the use of remdesivir in COVID-19 patients.”

Shockingly, US Approves Remdesivir for Babies

Curiously, while Big Tech — aided and abetted by the U.S. government — has spent the last two years censoring and banning any information that doesn’t jibe with the opinions of the WHO, the U.S. government has completely ignored the WHO’s recommendation against remdesivir.

In fact, in late April 2022, the FDA approved remdesivir as the first and only COVID-19 treatment for children under 12, including babies as young as 28 days,12 which seems beyond Orwellian and crazy considering it’s the worst of both worlds: It’s ineffective AND has serious side effects.

What’s worse, the drug is also approved for outpatient use in children, which is a first. In an April 30, 2022, blog post,13 Dr. Meryl Nass expressed her concerns about the FDA’s approval of remdesivir for outpatient use in babies, stating:

“Remdesivir received an early EUA (May 1, 2020) and then a very early license (October 22, 2020) despite a paucity of evidence that it actually was helpful in the hospital setting. A variety of problems can arise secondary its use, including liver inflammation, renal insufficiency and renal failure14 …

More here: ***********************************************

Inflation up another 8.3 percent in April as Biden economy teeters on the edge. Has the recession already begun?

By Robert Romano

Consumer inflation increased another 8.3 percent annualized in April, according to the latest data compiled by the Bureau of Labor Statistics (BLS), amid increases in prices for housing, food, airline tickets and new vehicles.

And it is crushing wages, with BLS reporting a 2.6 percent drop in real average hourly earnings, thanks to the inflation.

Inflation has now been north of 5 percent since June 2021, in what is the worst inflation since the late 1970s and early 1980s. It caused recessions then, and it may have already induced another recession now just two years after the 2020 Covid recession.

The U.S. economy already contracted 1.4 percent on an inflation-adjusted basis, according to the Bureau of Economic Analysis. The economy did grow on a nominal basis by almost 6.5 percent annualized, by $382 billion to $24.4 trillion, but because inflation averaged about 8 percent the first quarter, real GDP came in negative.

The same thing could be happening right now. With April’s inflation number on the books, May and June will tell the tale of whether President Joe Biden will preside over a recession in 2022 — or perhaps in 2023 or 2024.

If inflation remains above, say, 7 percent throughout the second quarter, nominal growth appears unlikely to be that high. In just 18 economic quarters out of 127 quarters since 1989, nominal growth annualized was above 7 percent. That is only 14 percent of the time. Meaning, there’s about an 86 percent chance it will be less than 7 percent nominal growth in the second quarter.

But when one considers that there have already been massive nominal gains in GDP following the Covid lockdowns — including a monster 38 percent nominal gain in the third quarter of 2020, and a 14.5 percent nominal gain in the fourth quarter of 2021 — it is hard to imagine another big nominal GDP gain in the current environment with high inflation, the continued supply chain crisis and now the war in Ukraine.

It’s like a flock of black swans flying in a triangle formation. What else could possibly go wrong?

Again, in the first quarter, growth was almost 6.5 percent, which was the lowest reading since 2019. So, the economy is already slowing down. Before that, one has to go back to the second quarter of 2018 to find annualized nominal growth above 7 percent, and the second quarter of 2014 before that. It has not been happening a lot in the past 20 years.

Meaning, the escape route to avoid a recession right now is rapidly narrowing. It is still possible, but politically, President Joe Biden and Congressional Democrats might be better off in the long run if the recession happens right now, which would certainly impact the Congressional midterms in November, but might be far enough away from 2024 to provide ample time for a robust economic recovery.

Ronald Reagan had a massive recession in 1982, but by 1984, the recovery was fully underway and he easily defeated Walter Mondale in a 49-state landslide.

On the other hand, given the ongoing supply chain crisis and no end in sight for Russia’s war in Ukraine, which is further exacerbating oil, natural gas and wheat global supply lines, it is foreseeable that even with a recession right now, inflation could remain elevated for the foreseeable future — which could have the economy overheating once again in 2023 headed in the 2024 presidential election cycle.

The point is that it is never a great time for an administration to have to weather a recession. The American people can be quite forgiving, but in Biden’s case, if the inflation remains a going concern after 2022, their patience may end up running thin.




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