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A Johnson & Johnson (J&J) COVID vaccine manufacturing plant where an ingredient mix-up last month resulted in 15 million doses of J&J vaccine being discarded may have contaminated additional doses, according to a report released Wednesday by the U.S. Food and Drug Administration (FDA).
Article by Megan Redshaw from Children’s Health Defense.
The 13-page report also identified a series of other problems at the Baltimore facility owned by Emergent BioSolutions. Emergent, which in June received $628 million in taxpayer funding through the U.S. Department of Health and Human Services (HHS) to establish the primary U.S. manufacturing facility for J&J’s and AstraZeneca’s COVID vaccines, agreed this week to temporarily shut down operations.
According to the FDA report, “There is no assurance that other batches have not been subject to cross-contamination.” The report also said the plant was “not maintained in a clean and sanitary condition.” Inspectors found peeling paint and unidentified black and brown residue on the floors and walls, as well as a failure to properly decontaminate waste generated during the manufacture of the vaccine.
During an FDA inspection completed Tuesday, the Baltimore plant was found to be too small, poorly designed and dirty. Unsealed bags of medical waste were observed, along with damaged floors and walls that could inhibit proper cleaning, inspectors said.
Emergent also “failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross-contamination of bulk drug substances.”
“I’m shocked — I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel advising the Centers for Disease Control and Prevention that will meet Friday to determine whether to lift the pause on J&J’s vaccine announced last week after reports of blood clots associated with the vaccine. “Inappropriate disinfection, the prevention of contamination — those are significant and serious violations,” Romero said.
In statements Wednesday, the FDA, Emergent and J&J said they were working to resolve the problems at the factory, but gave no indication of how long that would take.
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Emergent’s pattern of errors ignored
Just two weeks after the government handed J&J control over the “error-prone” Emergent plant, the FDA asked Emergent to suspend production of J&J’s COVID vaccine after inspecting the facility.
At the FDA’s request, the company agreed on April 16 not to make any new COVID materials at the Baltimore facility and to quarantine existing materials already manufactured there “pending completion of the inspection and remediation of any resulting findings,” according to an 8-K U.S. Securities and Exchange Commission (SEC) filing.
According to The Washington Post, J&J said it was working to resolve the situation at Emergent and would address any findings at the conclusion of the inspection. The facility was cited for the same quality control problems in April 2020 that led to the COVID vaccine production errors.
According to CNBC, an FDA inspection of the Baltimore plant in April 2020 revealed Emergent lacked necessary personnel to produce a COVID vaccine. Another inspection, in June 2020, determined Emergent’s plan for producing vaccines was inadequate due to poorly trained staff and quality control problems.
A series of confidential audits last year, obtained by The New York Times, warned about risks of viral and bacterial contamination and a lack of proper sanitation at the Baltimore facility.
A top federal manufacturing expert cautioned last June that Emergent would have to be “monitored closely” — raising questions as to why the company did not fix problems earlier and why federal officials who oversaw its lucrative contracts did not demand better performance.
An examination by The Times of manufacturing practices at the Baltimore facility found serious problems, including a corporate culture that ignored or deflected missteps and a government sponsor, the Biomedical Advanced Research and Development Authority, that was not policing the plant.
It was allegedly human error that botched 15 million doses of J&J’s vaccine in March. But Emergent CEO Robert Kramer disputed published reports that the problem stemmed from employees mixing up ingredients from J&J and AstraZeneca vaccines, which are made at the same plant.
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Internal logs showed Emergent also had to discard one batch of AstraZeneca’s vaccine in October 2020 because of suspected contamination, and four more in December. Those four were spoiled by bacterial contamination of equipment, a former company official said.
In November 2020, production of a batch of J&J’s vaccine had to be discarded after workers “hooked up” the wrong gas line and accidentally “suffocated” the cells where the virus for the vaccine is grown, logs show.
In December, records indicated workers making AstraZeneca’s vaccine deviated from manufacturing standards on average more than three times a day. About one-fifth of the deviations were classified as major.
Congress launches investigation, shareholders file lawsuit
Before Emergent received the $628 million from HHS to establish Baltimore operations, the company received billions from the U.S. government to help prepare the nation for biowarfare, The Washington Post reported.
According to a February report by Accountable.US — a nonprofit nonpartisan public advocate and watchdog organization that monitors public corruption — executives at five drug companies, including Emergent, made net profits of more than $250 million by dumping company stocks during the first six months of Operation Warp Speed.
According to SEC filings, from the beginning of September through November 15, 2020, executives and directors at Pfizer, Moderna, Novavax and Emergent, who received government COVID vaccine funding, made stock transactions valued at a net profit of more than $105 million.
Accountable.US sent a letter to Emergent calling for the release of the 10b5 automatic trading plans used by top executives who made millions of dollars dumping company stock, and requested the CEO freeze sales until the SEC could investigate and release updated guidance regarding automatic trading plans for companies receiving taxpayer funding and advance purchase guarantees — resulting in millions in profits for pharmaceutical CEOs.
A congressional investigation was launched Tuesday into Emergent BioSolutions’ federal vaccine contract and shareholders filed a class action lawsuit Monday, alleging Emergent and some of the Gaithersburg-based company’s made false statements about the company’s readiness to mass-produce vaccines.
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The lawsuit alleges “false and misleading” comments by company executives drove up the share price, which substantially dropped when news media outlets exposed a major mistake that forced the company to discard millions of vaccine doses and revealed a history of problems found in inspections.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
‘The Purge’ by Big Tech targets conservatives, including us
Just when we thought the Covid-19 lockdowns were ending and our ability to stay afloat was improving, censorship reared its ugly head.
For the last few months, NOQ Report and the American Conservative Movement have appealed to our readers for assistance in staying afloat through Covid-19 lockdowns. The downturn in the economy has limited our ability to generate proper ad revenue just as our traffic was skyrocketing. We had our first sustained stretch of three months with over a million visitors in November, December, and January, but February saw a dip.
It wasn’t just the shortened month. We expected that. We also expected the continuation of dropping traffic from “woke” Big Tech companies like Google, Facebook, and Twitter, but it has actually been much worse than anticipated. Our Twitter account was banned. Both of our YouTube accounts were banned. Facebook “fact-checks” everything we post. Spotify canceled us. Medium canceled us. Apple canceled us. Why? Because we believe in the truth prevailing, and that means we will continue to discuss “taboo” topics.
The 2020 presidential election was stolen. You can’t say that on Big Tech platforms without risking cancellation, but we’d rather get cancelled for telling the truth rather than staying around to repeat mainstream media’s lies. They have been covering it up since before the election and they’ve convinced the vast majority of conservative news outlets that they will be harmed if they continue to discuss voter fraud. We refuse to back down. The truth is the truth.
The lies associated with Covid-19 are only slightly more prevalent than the suppression of valid scientific information that runs counter to the prescribed narrative. We should be allowed to ask questions about the vaccines, for example, as there is ample evidence for concern. One does not have to be an “anti-vaxxer” in order to want answers about vaccines that are still considered experimental and that have a track record in a short period of time of having side-effects, including death. One of our stories about the Johnson & Johnson “vaccine” causing blood clots was “fact-checked” and removed one day before the government hit the brakes on it. These questions and news items are not allowed on Big Tech which is just another reason we are getting canceled.
There are more topics that they refuse to allow. In turn, we refuse to stop discussing them. This is why we desperately need your help. The best way NOQ Report and ACM readers can help is to donate. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal as well. We are on track to be short by about $4100 per month in order to maintain operations.
The second way to help is to become a partner. We’ve strongly considered seeking angel investors in the past but because we were paying the bills, it didn’t seem necessary. Now, we’re struggling to pay the bills. We had 5,657,724 sessions on our website from November, 2020, through February, 2021. Our intention is to elevate that to higher levels this year by focusing on a strategy that relies on free speech rather than being beholden to progressive Big Tech companies.
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During that four-month stretch, Twitter and Facebook accounted for about 20% of our traffic. We are actively working on operating as if that traffic is zero, replacing it with platforms that operate more freely such as Gab, Parler, and others. While we were never as dependent on Big Tech as most conservative sites, we’d like to be completely free from them. That doesn’t mean we will block them, but we refuse to be beholden to companies that absolutely despise us simply because of our political ideology.
We’re heading in the right direction and we believe we’re ready talk to patriotic investors who want to not only “get in on the action” but more importantly who want to help America hear the truth. Interested investors should contact me directly with the contact button above.
As the world spirals towards radical progressivism, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report going.
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Most “Conservative” News Outlets Are on the Big Tech Teat
Not long ago, conservative media was not beholden to anyone. Today, most sites are stuck on the Big Tech gravy train.
I’ll keep this short. The rise of Pandemic Panic Theater, massive voter fraud, and other “taboo” topics have neutered a majority of conservative news sites. You’ll notice they are very careful about what topics they tackle. Sure, they’ll attack Critical Race Theory, Antifa, and the Biden-Harris regime, but you won’t see them going after George Soros, Bill Gates, the World Economic Forum, or the Deep State, among others.
The reason is simple. They are beholden to Big Tech, and Big Tech doesn’t allow certain topics to be discussed or they’ll cut you off. Far too many conservative news outlets rely on Google, Facebook, and Twitter for the bulk of their traffic. They depend on big checks from Google ads to keep the sites running. I don’t necessarily hold it against them. We all do what we need to do to survive. I just wish more would do like we have, which is to cut out Big Tech altogether.
We don’t get Google checks. We don’t have Facebook or Twitter buttons on our stories. We don’t have a YouTube Channel (banned), an Instagram profile (never made one), or a TikTok (no thanks, CCP). We’re not perfect, but we’re doing everything we can to not owe anything to anyone… other than our readers. We owe YOU the truth. We owe YOU the facts that others won’t reveal about topics that others won’t tackle. And we owe America, this great land that allows us to take hold of these opportunities.
Like I said, I don’t hold other conservative sites under too much scrutiny over their choices. It’s easy for people to point fingers when we’re not the ones paying their bills or supporting their families. I just wish there were more who would make the bold move. Today, only a handful of other major conservative news outlets have broken free from the Big Tech teat. Of course, we need help.
The best way you can help us grow and continue to bring proper news and opinions to the people is by donating. We appreciate everything, whether a dollar or $10,000. Anything brings us closer to a point of stability when we can hire writers, editors, and support staff to make the America First message louder. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal or Bitcoin as well. Bitcoin: 3A1ELVhGgrwrypwTJhPwnaTVGmuqyQrMB8
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We are also building partnerships with great conservative sites like The Liberty Daily and The Epoch Times to advance the message as loudly as possible, and we’re always looking for others with which to partner.
Some of our content is spread across multiple sites. Other pieces of content are unique. We write most of what we post but we also draw from those willing to allow us to share their quality articles, videos, and podcasts. We collect the best content from fellow conservative sites that give us permission to republish them. We’re not ego-driven; I’d much rather post a properly attributed story written by experts like Dr. Joseph Mercola or Natural News than rewrite it like so many outlets like to do. We’re not here to take credit. We’re here to spread the truth.
While donations are the best way to help, you can also support us by buying through our sponsors:
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- MyPatriotSupply: Stock up on long-term food, survival gear, and other things that you’ll need just in case things don’t recover and we keep heading towards apocalypse.
We know we could make a lot more money if we sold out like so many “conservative” publications out there. You won’t find Google ads on our site for a reason. Yes, they’re lucrative, but I don’t like getting paid by minions of Satan (I don’t like Google very much if you couldn’t tell).
Time is short. As the world spirals towards The Great Reset, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report and the other sites in the network going. Our promise is this: We will never sell out America. If that means we’re going to struggle for a while or even indefinitely, so be it. Integrity first. Truth first. America first.
Thank you and God Bless,
JD Rucker
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