A group of 27 clinicians, researchers, and consumer advocates this month filed an urgent <a href="https://downloads.regulations.gov/FDA-2021-P-0521-0001/attachment_1.pdf">Citizen Petition</a> with the Food and Drug Administration (FDA), aimed at preventing the agency from prematurely granting full approval to any COVID-19 vaccine, as both Pfizer and Moderna are currently seeking full approval through Biologics License Applications (BLAs).

The group said there is no legitimate reason to rush an approval. They outlined the "many open, unanswered questions surrounding the efficacy and safety of COVID-19 vaccines," detailing how those data must be collected before the FDA considers granting any vaccine full approval.

Currently, three COVID-19 vaccines are available in the United States under Emergency Use Authorizations (EUAs). The petition explains that, even without full approval, vaccines will remain available for all who want them because EUAs do not carry an expiration date; thus, COVID-19 vaccines may continue to be lawfully provided under EUA even after the SARS-CoV-2 public health emergency no longer exists.

The petition states that premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decision, and risks setting a precedent of lowered standards for future vaccine approvals.

They write: “We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure.”

The petition outlines eight efficacy and safety measures that must be met before serious consideration is given to granting full FDA approval:
<ol>
 <li>Completing at least 2 years of follow-up of participants originally enrolled in pivotal clinical trials, even if the trials were unblinded and now lack a placebo control. All vaccine manufacturer phase 3 trials were already designed with this planned duration.</li>
 <li>Prior to including in the list of populations for which a vaccine is approved, ensuring there is substantial evidence that clinical effectiveness outweighs harms in special populations including: infants, children, and adolescents; those with past SARS-CoV-2 infection; immunocompromised; pregnant women; nursing women; frail older adults; and individuals with cancer, autoimmune
disorders, and hematological conditions.</li>
 <li>Requiring thorough safety assessment of spike proteins being produced insitu by body tissues following vaccine administration, and spike proteins’ full biodistribution, pharmacokinetics, and tissue specific toxicity.</li>
 <li>Completion of vaccine biodistribution studies from administration site and safety implications of mRNA translation in distant tissues.</li>
 <li>Thorough investigation of all severe adverse reactions reported following COVID-19 vaccination, such as deaths, reported in VAERS and other pharmacovigilance systems.</li>
 <li>Assessment of safety in individuals receiving more than two doses.</li>
 <li>Inclusion of gene delivery and therapy experts in the Vaccines and Related Biological Products Advisory Committee (VRBPAC), in recognition of the fact that the novel COVID-19 vaccines work on the premise of gene delivery, in contrast to conventional vaccines.</li>
 <li>Enforcing stringent conflict of interest requirements to ensure individuals involved in data analysis and BLA-related decision making processes have no conflict of interests with vaccine manufacturers.</li>
</ol>
The petition says a COVID-19 vaccine should be fully approved when—and only when—substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population.

The petitioners explain the following are invalid reasons to approve a COVID-19 vaccine:
<ul>
 <li>To ensure vaccines are accessible after the public health emergency has ended. "COVID-19 vaccines with an emergency use authorization (EUA) can be lawfully used after the expiry of the SARS-CoV-2 public health emergency declaration." (This is made clear by the many products for Ebola and Zika viruses which still have active EUAs.)</li>
 <li>To ensure adequate access to vaccines across the population. "Full approval is not necessary to assure access to COVID-19 vaccines. EUAs for COVID-19 vaccines have enabled, and continue to enable, their widespread use."</li>
 <li>To enable vaccine mandates. "Consideration of vaccine mandates is outside of FDA’s purview." Furthermore, "a mandate should only be considered once the evidentiary conditions are met for a BLA," demonstrating that benefits outweigh harms.</li>
 <li>To bolster public confidence. "Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview.”</li>
</ul>
The 20-page petition from Linda Wastila and 26 co-authors can be downloaded here and is open for public comment. When FDA responds, it will be public on the regulations.gov docket (Docket ID: FDA-2021-P-0521).

To comment on the Linda Wastila et al. Citizen Petition, click <a href="https://www.regulations.gov/commenton/FDA-2021-P-0521-0001">here</a>.

To read others' comments on the Linda Wastila et al. Citizen Petition, click <a href="https://www.regulations.gov/document/FDA-2021-P-0521-0001/comment">here</a>.

Main FDA docket for Linda Wastila et al. Citizen Petition: <a href="https://www.regulations.gov/docket/FDA-2021-P-0521/document">Docket ID: FDA-2021-P0521</a>

urgent-petition-by-clinicians-researchers-consumer-advocates-warns-fda-against-premature-covid-vaccine-approval.jpg

Urgent petition by clinicians, researchers, consumer advocates warns FDA against 'premature' COVID vaccine approval

<h2>Move over book burning, hello de-platforming?</h2>Closed out of your Facebook or Instagram account? Maybe your website suddenly disappeared, or your YouTube channel was demonetized or deleted? Perhaps you lost access to thousands of hours of posts and videos you produced, and your years of work were gone in an instant? That's de-platforming; the modern version of book burning, a “punishment” for going against the mainstream narrative. And, the censorship doesn't stop with social media, it includes PayPal accounts and more.<h3>Getting up again</h3>How do individuals who went afoul of the globalists, who didn't keep quiet and let others do their thinking for them, respond when they find themselves de-platformed by social media companies and other services? Here's what London Real's Brian Rose, Americas Frontline Doctor founder Dr. Simone Gold, and independent researcher James Roguski did to pick themselves up and continue their work despite the heavy-handed censorship they experienced.Brian RoseWhen London Real YouTuber Brian Rose publicly began trying to understand COVID-19 and its countermeasures, he soon found his entire life seemingly deleted from the internet by the social media giants.&nbsp;Not only did he lose all his years of work, amounting to thousands of videos which he had uploaded to the internet. He also lost access to his Paypal account, and more, because in his search for the truth about the pandemic; his counter-narrative interviews with David Icke were too dangerous for the globalists to allow. &nbsp;In his below documentary, Rose&nbsp;recounts his experiences and how he ultimately started a channel of his own. He explains that he was wholly unprepared for what happened on May 3, 2020, even though he knew that many would want to stop the interview (@about 3:36):<blockquote>Over the past few weeks, our entire world has been transformed. Everything we took for granted has now been taken away and our freedoms have been replaced with fear. All those rights we fought centuries for have been handed over without a second thought.&nbsp;We all process fear in different ways. I cope by immersing myself in my work and today my job is to ask questions. One million people will be watching and they all want answers.&nbsp;Countless others are trying to stop this from happening. At any moment they can walk through that door or lock this broadcast. I'm scared but I don't know what else to do. I prepared my whole life for a moment like This. But nothing would prepare me for what happened next. . .</blockquote>&nbsp;<div class="raw-html-embed"><blockquote class="twitter-tweet">WATCH THE MOVIE THAT YouTube DOES NOT Want YOU TO SEE (and SHARE IT Far And Wide ) <a href="https://twitter.com/hashtag/LondonReal?src=hash&amp;ref_src=twsrc%5Etfw">#LondonReal</a> <a href="https://twitter.com/hashtag/WeWillNotBeSilenced?src=hash&amp;ref_src=twsrc%5Etfw">#WeWillNotBeSilenced</a> <a href="https://twitter.com/hashtag/StopCensorship?src=hash&amp;ref_src=twsrc%5Etfw">#StopCensorship</a> <a href="https://t.co/txcVpjPDWz">https://t.co/txcVpjPDWz</a>— Brian Rose, Founder &amp; Host of London Real (@LondonRealTV) <a href="https://twitter.com/LondonRealTV/status/1796285778517221575?ref_src=twsrc%5Etfw">May 30, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>&nbsp;Dr. Simone GoldDr. Simone Gold, founder of <a href="https://www.aflds.org" target="_blank" rel="noopener noreferrer">America's Frontline Doctors</a>, was one of the first doctors to understand that how she was being told to treat COVID patients wasn't normal. Very alarmed at what was taking place she, along with other doctors, held the “<a href="https://www.whitecoatsummit.com/" target="_blank" rel="noopener noreferrer">White Coat Summit</a>” on July 27, 2020, as well as a press conference on the Supreme Court steps. As she tweeted below, the press conference went viral, garnering millions of views before Big Tech and Big Media took the video down.She concluded by explaining their purpose and the result:<blockquote>Our fight was to show America the propaganda vs the truth, and then we were censored.</blockquote>&nbsp;<div class="raw-html-embed"><blockquote class="twitter-tweet">Our press conference in front of the Supreme Court on July 27th, 2020 was a turning point in the fight against COVID Tyranny. After 20 million views in 8 hours, Big Tech colluded to wipe the video from online platforms. We knew in this moment that we would win the fight. <a href="https://t.co/9CP0Ogpnfp">pic.twitter.com/9CP0Ogpnfp</a>— Dr. Simone Gold (@drsimonegold) <a href="https://twitter.com/drsimonegold/status/1610416861723729921?ref_src=twsrc%5Etfw">January 3, 2023</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>Dr. Gold continues to <a href="https://aflds.org/about-us" target="_blank" rel="noopener noreferrer">advance</a> the mission of America's Frontline Doctors, to protect medical freedom and civil liberties.'James RoguskiIndependent researcher James Roguski who, <a href="http://jamesroguski.com" target="_blank" rel="noopener noreferrer">according</a> to his website, has been calling out lies and propaganda for decades, found years of work gone when the company that hosted most of his websites terminated his account for what they said were “terms of service” violations. It did not deter him from continuing his work, either.<blockquote>They deleted many of my websites, but they ignited my passion to burn even brighter. I now have most of my work on Substack.&nbsp;</blockquote>Roguski is interested in building a holistic alternative to the WHO and <a href="https://jamesroguski.substack.com/about" target="_blank" rel="noopener noreferrer">recruits</a> others to join him.<blockquote>The old system is crumbling, and I intend to help speed its demise, but we must build its replacement quickly.If you are fed up with the government, hospital, medical, pharmaceutical, media, industrial complex and would like to help , then feel free to contact me directly anytime.</blockquote>&nbsp;The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives, or legal issues.&nbsp;Related articles:<ul><li><a href="https://frontline.news/post/covid-sceptics-won-out-globalists-fear-an-increasingly-disbelieving-public" target="_blank" rel="noopener noreferrer">'COVID skeptics won out' — Globalists fear an increasingly disbelieving public</a></li><li><a href="https://frontline.news/post/colorado-governor-signs-off-on-bill-establishing-state-ministry-of-truth-students-atarget-of-new-law">Colorado governor signs off on bill establishing state 'ministry of truth'? Students a target of new law</a></li></ul>

account suspended.jpg

Censorship

Globalism

How three individuals got up again after being de-platformed

Who's afraid of Big Bad Tech? 

A British vigilante group known as the “Blade Runners” is receiving widespread support from British taxpayers as it continues to destroy climate surveillance cameras across London.<h2>The ULEZ mandate</h2>By order of London Mayor Sadiq Khan, the city is peppered with ultra-low emission zones (ULEZs), areas accessible only to low-emission vehicles. Cars that do not meet the city’s environmental standards are charged £12.50 ($16) for entering the ULEZ. Automatic Number Plate Recognition (ANPR) cameras positioned around the zones read license plates and check them against the vehicles’ make and model in real time. If a vehicle does not meet the environmental threshold, a fine is levied against the car owner.&nbsp;The ULEZ climate mandate has drawn heavy&nbsp;<a href="https://frontline.news/post/london-hundreds-protest-against-climate-mandates">protests</a> from residents, including&nbsp;<a href="https://frontline.news/post/british-veteran-launches-hunger-strike-as-unrest-grows-over-climate-mandates">hunger strikes</a> and refusals to pay fines. Taxpayers have also taken to disabling the ANPR surveillance cameras which Transport for London (TfL), the city’s transportation department, said will be used both for climate and law enforcement.<h2>Taxpayers cheer the ‘Blade Runners’</h2>Since the climate restrictions were expanded last year, the Blade Runners have taken to disabling and destroying hundreds of cameras. Between April and September 2023, Metropolitan Police recorded 200 reports of cameras being stolen and 595 reports of cameras being vandalized.TfL began placing black boxes around ULEZ camera wirings to protect them from being cut, but taxpayers found other ways to disable the cameras — like removing them completely.<div class="raw-html-embed"><blockquote class="twitter-tweet" data-media-max-width="560"> MUST SEE: Blade Runners topple THREE ULEZ cameras in a coordinated strike… The people are fighting back! <a href="https://t.co/Yvr2Xr7Lun">pic.twitter.com/Yvr2Xr7Lun</a>— David Morgan #StayFree (@david_r_morgan) <a href="https://twitter.com/david_r_morgan/status/1802726912050995623?ref_src=twsrc%5Etfw">June 17, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>In response, the city&nbsp;<a href="https://frontline.news/post/london-taxpayers-attack-surveillance-vans-in-continued-revolt">deployed</a> mobile surveillance vans mounted with ANPR cameras across London in the hopes of evading attacks, but Blade Runners soon began targeting those as well. Some surveillance vans have been spotted covered in graffiti with their tires slashed, while others have been completely covered in tarp.Last month, 21 cameras were destroyed in the hours after Sadiq Khan was re-elected mayor of London, the&nbsp;Daily Mail&nbsp;<a href="https://www.dailymail.co.uk/news/article-13538797/Moment-Blade-Runner-uses-power-tool-cut-ULEZ-camera-traffic-light-latest-attack-Sadiq-Khans-hated-scheme.html">reported</a>. Last weekend, Blade Runners used power tools to topple a ULEZ camera and traffic lights to the delight of some fellow taxpayers. In a video that was posted to social media, passing cars can be heard honking in support.The video received over 37,000 likes. Comments on the post were largely supportive, with users writing that, “When tyranny becomes law, rebellion becomes duty,” and “Fair play to them, it's a complete scam that does nothing.”Blade Runner Matt Hardy told the&nbsp;Daily Mail&nbsp;that the Blade Runners are “people pissed off about the tyranny reigning over us and getting out and doing things about it – real votes, real boys here.”<h2>‘These cameras are not about the climate. They are about control’</h2>British actor and influencer Laurence Fox said this week he was just given back his electronic devices by police after being arrested earlier this year for cheering on the Blade Runners:<blockquote>These cameras are not about the climate. They are about control. They are the primary infrastructure for all sorts of things that ideologues like the midget dictator [Sadiq Khan] would like to impose upon us.I can now finally say the word ‘Bladerunners’ again. One of the ridiculous restrictions on free speech imposed by the police.It’s a dreadful shame to see so many of these cameras dying suddenly. I’m not at all thrilled about it. Just because I am smiling like a Cheshire Cat, it doesn’t mean that I am over the moon that these scameras continue to topple in high winds.&nbsp;Vive la résistance!</blockquote><div class="raw-html-embed"><blockquote class="twitter-tweet">POLICE UPDATE Following 6 coppers bursting into my house earlier this year to arrest me for saying how pleased I was that the <a href="https://twitter.com/hashtag/ULEZ?src=hash&amp;ref_src=twsrc%5Etfw">#ULEZ</a> scam was meeting such robust resistance, this morning the <a href="https://twitter.com/metpoliceuk?ref_src=twsrc%5Etfw">@metpoliceuk</a> were ordered by the magistrate to hand back all my devices, including my…— Laurence Fox (@LozzaFox) <a href="https://twitter.com/LozzaFox/status/1803030521095622912?ref_src=twsrc%5Etfw">June 18, 2024</a></blockquote> <script async="" src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div> &nbsp;

ulez sign camera.jpg

Pushback_Resistance

Climate Change

‘Pissed off about the tyranny reigning over us’

British taxpayers cheer vigilante group destroying climate cams

Fisker is filing for Chapter 11 bankruptcy, the electric vehicle (EV) company announced Tuesday.<h2>‘Like other companies in the electric vehicle industry’</h2>“Fisker has made incredible progress since our founding, bringing the Ocean SUV to market twice as fast as expected in the auto industry and making good on our promises to deliver the most sustainable vehicle in the world,” a spokesperson <a href="https://assets.ctfassets.net/cghen8gr8e1n/6W19OiEBJDVIFVEmo4feHA/df902c5cb2b067251a300efb0b35f611/Fisker-Filing-FINAL.pdf" target="_blank" rel="noopener noreferrer">said</a>.The California-based company added it is not the only EV maker that has been struggling to stay in business.“We are proud of our achievements, and we have put thousands of Fisker Ocean SUVs in customers’ hands in both North American [sic] and Europe. But like other companies in the electric vehicle industry, we have faced various market and macroeconomic headwinds that have impacted our ability to operate efficiently. After evaluating all options for our business, we determined that proceeding with a sale of our assets under Chapter 11 is the most viable path forward for the company.”Fisker’s collapse is the latest indication that the EV industry is folding due to sinking demand. Other EV industry players are also cutting their losses as they jump ship.<h2>Hertz</h2>In March, Hertz CEO Stephen Scherr&nbsp;<a href="https://www.motorfinanceonline.com/news/hertz-ceo-resigns-amid-ev-investment-setback/#:~:text=Scherr's%20departure%20coincides%20with%20Hertz's,electric%20vehicle%20(EV)%20rentals">resigned</a> after his bet on EVs cost the car rental giant its biggest quarterly loss since 2020. Hertz had been praised by the Biden administration for its ambition to convert 25% of its fleet to EVs by the end of this year. In January, however, the company announced it would instead be selling its 20,000 EVs — including Teslas — at heavily discounted prices and replacing them with gas-powered cars.<h2>Mercedes-Benz</h2>Mercedes-Benz also recently had to give up its ambition to only sell electric cars by 2030. Instead, EVs are expected to make up only 50% of the German carmaker’s sales over the next decade.<h2>Apple</h2>In February, Apple abandoned its multi-billion dollar effort to create an electric car. Despite being a decade in the works and employing 2,000 people, Project Titan was axed due to falling consumer demand.<h2>Aston Martin</h2>A lack of consumer demand is also partly to blame for Aston Martin&nbsp;<a href="https://www.dailymail.co.uk/news/article-13138123/Aston-Martin-puts-brakes-new-electric-supercar-2026-bosses-say-drivers-want-engines-throaty-roar.html">placing</a> its battery-operated “supercar” on hold until 2026.“Demand, certainly at an Aston Martin price point, is not what we thought it was going to be two years ago,” said Aston Martin Executive Chairman Lawrence Stroll.&nbsp;<h2>Ford</h2>In December, Ford slashed production of its flagship EV at its assembly plant in Dearborn, Michigan by half. The automaker cut the monthly production quote for the all-electric F-150 Lightning pickup truck from 3,200 units to 1,600 units per month.<h2>Biden administration continues to force EV production</h2>Nevertheless, the Biden administration in March issued new climate mandates aimed at forcing more EV production. The new rules from the Environmental Protection Agency (EPA) contain tight emissions standards that will&nbsp;<a href="https://apnews.com/article/epa-electric-vehicles-emissions-limits-climate-biden-e6d581324af51294048df24269b5d20a">require</a> 56% of new vehicle sales to be fully electric by 2032, with an additional 13% required to be hybrids.

car market decline.jpg

US News

Biden administration continues to force EV production

Electric car company files bankruptcy as EV market folds

For the last two years, British authorities have been testing AI-powered emotion recognition cameras on travelers in train stations, according to recently disclosed documents.<h2>What can the cameras see?</h2>In each of eight train stations around the UK, five to seven cameras or sensors scan the passing crowds. Using AI software from Amazon, the cameras use object recognition algorithms to spot criminal activity, trespassing, weapons, wet floors, overcrowding, and overstuffed trash cans.&nbsp;They can also alert authorities when passengers engage in “unusual behavior,” such as shouting, running, smoking, or skateboarding.&nbsp;A combination of existing cameras and newly installed smart cameras are being used for the surveillance project. All are equipped with Amazon’s Rekognition surveillance system.<h2>Emotional recognition</h2>Through a combination of facial and behavioral analyses, the Rekognition software allows officials to also <a href="https://www.wired.com/story/amazon-ai-cameras-emotions-uk-train-passengers/" target="_blank" rel="noopener noreferrer">analyze visitors’ emotions</a>. Internal documents note that the cameras can detect whether a passenger is “happy, sad [or] angry.” They can also recognize passenger satisfaction, which “could be utilized to maximum advertising and retail revenue.”<h2>Anti-social behavior</h2>Authorities can also detect passengers who exhibit “anti-social behaviour,” which&nbsp;<a href="https://www.met.police.uk/advice/advice-and-information/asb/asb/antisocial-behaviour/what-is-antisocial-behaviour/">according</a> to London’s Metropolitan Police Service means “behaviour by a person which causes, or is likely to cause, harassment, alarm or distress to persons not of the same household as the person.”<h2>Social distancing, face masks, and demographics</h2>Other&nbsp;<a href="https://www.documentcloud.org/documents/24757655-usecases_dpas_review_managed_stations?responsive=1&amp;title=1">use cases</a> for the surveillance cameras include detecting whether passengers are keeping to social distancing rules and wearing face masks. The cameras can also scan for demographics by identifying people’s age profiles and “socio-economic classification,” which the documents note can create “revenue opportunities for better targeted advertising and product placement.”<h2>‘Quite a concerning step’</h2>The documents were obtained by Big Brother Watch, a civil rights and government watchdog group, in response to a Freedom of Information (FOI) request. Network Rail, a body within the Department of Transportation which manages most of the country’s train network, has been overseeing the surveillance project.&nbsp;“The rollout and normalization of AI surveillance in these public spaces, without much consultation and conversation, is quite a concerning step,” Jake Hurfurt, head of research and investigations at Big Brother Watch,&nbsp;<a href="https://www.wired.com/story/amazon-ai-cameras-emotions-uk-train-passengers/">told</a> Wired.As of now, the surveillance systems do not use facial recognition technology, which analyzes faces and matches them against facial images stored in certain databases.

Urgent petition by clinicians, researchers, consumer advocates warns FDA against 'premature' COVID vaccine approval

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Who's afraid of Big Bad Tech?

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UK tests emotion recognition cameras in train stations