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October 29, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular, Video | 3 Comments

FDA Slow-Walked Studies on COVID Vaccine Safety Signals in Elderly

By Suzanne Burdick, Ph.D. | The Defender | October 26, 2022

The U.S. Food and Drug Administration (FDA) took more than a year to follow up on a potential increase in serious adverse events in elderly people who received Pfizer’s COVID-19 vaccine, according to an investigative report published Tuesday by The BMJ.

According to The BMJ, in July 2021, the FDA “quietly disclosed” the findings of a potential increase in four types of serious adverse events in elderly people who had received a Pfizer COVID-19 vaccine: acute myocardial infarction, disseminated intravascular coagulationimmune thrombocytopenia, and pulmonary embolism.

The FDA disclosure lacked specific details, such as the magnitude of the increased potential risk, and the agency said it would “share further updates and information with the public as they become available.”

The FDA did not alert physicians or the public, via a press release or any other means, The BMJ investigator said.

Eighteen days later, the FDA published a study planning document that outlined a protocol for a follow-up epidemiological study for investigating the matter more thoroughly.

The BMJ said:

“This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. (Neither absolute risk increases nor confidence intervals were provided.)”

That was over a year ago. “More than a year later, however, the status and results of the follow-up study are unknown,” The BMJ reported, adding:

“The agency has not published a press release, or notified doctors, or published the findings by preprint or the scientific literature or updated the vaccine’s product label.”

The BMJ report also alleged the FDA has not “ publicly acknowledged other published observational studies or clinical trial reanalyses reporting compatible results.”

FDA ‘irresponsible’ for keeping information from scientific community, critics say

Critics of the FDA’s failure to warn the public voiced their concerns about the data to The BMJ and called on the FDA to notify the public immediately.

“To keep this information from the scientific community and prevent us from analysing it ourselves, is irresponsible,” said Dr. Joseph Fraiman, an emergency medicine physician in New Orleans who recently carried out a reanalysis of serious adverse events in Pfizer and Moderna’s randomized trials. “It presumes that these organisations are perfect and cannot benefit from independent scrutiny.”

Dr. Tracy Høeg, an epidemiologist and physician currently conducting COVID-19 vaccine research with the Florida Department of Health and California’s Marin County Department of Health and Human Services, told The BMJ :

“The fact that the FDA found these four safety signals means they should have followed up on the results and I don’t understand why we haven’t had more information since then.

“It has been over a year.”

Fraiman concurred. “The protocols say that they’re looking into these data further, but I’d like to know the results now, it’s been long enough. They need to view this from a public health perspective, they need to consider a person’s right to informed consent.”

“As physicians, we recommend medical therapies and we need to explain the full risks and benefits to the patient. This is not happening,” Fraiman added.

Dr. Dick Bijl, an epidemiologist in the Netherlands, pointed out, “The FDA managed to determine the efficacy of the vaccines in a short period of time, but they have not analysed the pharmacovigilance data with the same speed. If they found signals in July 2021, they should have been analysed and published within months.”

Bijl is the president of the International Society of Drug Bulletins and has campaigned for years to get safety data communicated to doctors in a timely fashion. He told The BMJ he credits his organization for prompting the World Health Organization to begin publishing regular updates about drug safety signals in its WHO Pharmaceuticals Newsletter so that all doctors can take note of them.

Bijl said:

“The FDA should have informed doctors about any early safety signals from the vaccines.

“Most doctors are not trained to, nor are they focused on, recognising side effects, especially because vaccines are generally regarded as quite safe. It’s important that doctors are told what to look out for.”

Why the delay in acknowledging safety signal study results?

The FDA’s July 2021 findings came from the Centers for Disease Control’s (CDC) “near real-time” surveillance system called Rapid Cycle Analysis (RCA) that the FDA used to monitor a list of 14 adverse events of special interest.

Data obtained from the RCA system is not intended to establish a causal relationship between a vaccine and adverse events but rather is intended to detect potential safety signals rapidly.

The RCA data referenced by the agency in its July 2021 disclosure study appeared to only detect safety signals associated with the Pfizer COVID-19 vaccine.

“The agency said the associations were not identified for the other two COVID-19 vaccines authorised in the U.S. made by Moderna and Janssen (Johnson & Johnson),” The BMJ said.

The July 2021 follow-up study protocol stated there is a “manuscript in preparation” for the original RCA study but to date, nothing has been published for either that original study or the follow-up study.

According to The BMJ, the FDA’s medical record review and statistical analyses have recently been completed, and the overall study results are “currently under internal review.”

The FDA downplayed the findings:

“The findings to date from the fully adjusted epidemiologic study on the primary series vaccinations do not provide strong support for an association between the vaccine and any of the four outcomes described in the posting to the FDA website. Additional analyses, including evaluation of booster doses, are still being conducted. Release of the study findings is expected later this fall.”

Furthermore, according to The BMJ, the FDA made no public announcement when the results from an unspecified study it conducted raised safety concerns — but instead “buried” the findings in the introduction section of an Aug. 31, 2022, research protocol document:

“In a cohort study of the third dose safety in the Medicare population where historical controls were used, we detected a statistically significant risk for immune thrombocytopenia (incidence rate ratio 1.66, confidence interval 1.17 to 2.29) and acute myocardial infarction (IRR 1.15, CI 1.02 to 1.29) among people with prior covid-19 diagnosis as well as an increased risk of Bell’s palsy (IRR 1.11, CI 1.03 to 1.19) and pulmonary embolism (IRR 1.05, CI 1.0001 to 1.100) in general.”

Additionally, a June 2022 observational study from three Nordic countries — Denmark, Finland and Norway — found statistically significant increases in thromboembolic and thrombocytopenic outcomes following both Pfizer and Moderna mRNA COVID-19 vaccines.

Dr. Christine Stabell Benn, M.D., Ph.D., a vaccinologist and professor in global health at the University of Southern Denmark, told The BMJ of yet another study — this one done by her research group that is currently published in preprint.

“The safety signal seems to be gathering around cardiovascular and cerebral vascular events, things to do with circulation and our larger organs, and these are the same signals that appear to be popping up in the FDA surveillance data as well,” Benn said.

She added, “We don’t want to create a lot of unnecessary anxiety and we can’t say there is now proof that the vaccines cause these events because the data are of poor quality, but we can say there is a danger signal, and the medical profession needs to be alerted to this.”

Earlier this year, the CDC admitted to deliberately withholding critical data on the COVID-19 booster shots and hospital admissions, The BMJ reported.

Kristen Nordlund, CDC spokesperson, in February told the New York Times the agency had been slow to release data to the public on breakthrough infections “because they might be misinterpreted as the vaccines being ineffective.”

Suzanne Burdick, Ph.D., is a reporter and researcher for The Defender based in Fairfield, Iowa. She holds a Ph.D. in Communication Studies from the University of Texas at Austin (2021), and a master’s degree in communication and leadership from Gonzaga University (2015). Her scholarship has been published in Health Communication. She has taught at various academic institutions in the United States and is fluent in Spanish.

his article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

October 29, 2022 Posted by | Deception, Timeless or most popular, War Crimes | , , | Leave a comment

Leaked FBI document lists “misinformation” as an “election crime”

By Dan Frieth | Reclaim The Net | October 28, 2022

A whistleblower leaked a document to Project Veritas showing that the FBI is focusing on election misinformation ahead of the 2022 midterm elections. The document lists what the agency should categorize as “election crimes.”

Among the election crimes highlighted in the documents is “misinformation.” The document defines misinformation as “false or misleading information spread mistakenly or unintentionally.”

Disinformation is also an election “crime,” and is defined as “false or inaccurate information intended to mislead others.” It adds: “Disinformation campaigns on social media are used to deliberately confuse, trick, or upset the public.”

The document appears to be another effort by the federal government to determine what is true and what is false. A few months ago, the Biden administration created the “Disinformation Governance Board” under the DHS. It dismantled it a few weeks later due to public backlash.

The FBI document lists things to consider, including the 1st and 4th Amendments, the Privacy Act, and protected vs. unprotected speech.

October 29, 2022 Posted by | Civil Liberties | , | 3 Comments

Russia suspends participation in grain deal after Ukrainian attacks on ships

Samizdat | October 29, 2022

Moscow has halted its compliance with a grain deal with Kiev, brokered by the UN and Türkiye, after Ukraine launched a major drone attack on ships involved in securing safe passage for agricultural cargo, the Russian Defense Ministry announced on Saturday.

In a post on its Telegram channel, the ministry said Russia “is suspending its participation in the implementation of agreements on the export of agricultural products from Ukrainian ports”.

It explained that the move was prompted by “a terror attack” against the ships of the Black Sea Fleet and civilian vessels involved in ensuring the security of the grain corridor. The ministry also alleged that the bombing was organized with the involvement of British military.

The UK Defence Ministry has denied any involvement in the Ukrainian drone attack on the Black Sea Fleet in Sevastopol, claiming that Moscow “is resorting to peddling false claims of an epic scale” in an effort to distract the global community from “their disastrous handling of the illegal invasion of Ukraine.”

“This invented story, says more about arguments going on inside the Russian Government than it does about the West,” it added.

Commenting on Russia’s decision to suspend the grain deal, Andrey Ermak, Ukrainian President Vladimir Zelensky’s chief of staff, accused Moscow of “blackmail.”

“Russian blackmail is primitive across the board: blackmail in nuclear, energy and food field,” he stated, adding that all supposed Russian ploys are “too simple and predictable.”

Earlier on Saturday, Russia’s Agriculture Minister Dmitry Patrushev signaled that Moscow is ready, with Türkiye’s help, to send the world’s poorest countries up to 500,000 tons of grain within the next four next months.

He noted that considering this year’s harvest, Russia “is fully ready to replace Ukrainian grain” and arrange deliveries to “all interested countries” at a reasonable price.

“The grain deal not only did not solve the problems of countries in need, but even aggravated them in a sense. We can see where the ships from Ukraine were heading – Italy, Spain, and the Netherlands. For some cargoes, the share of EU countries ranges from 60 to 100%. These are not the states that are experiencing a real food problem,” the minister said.

Russia earlier warned that it could quit the grain deal if an agreement to ease restrictions on its food and fertilizer exports were not implemented. Moreover, following the blast on the strategic Crimean Bridge, Russian President Vladimir Putin said that if turns out that Ukraine – the country that Moscow accused of carrying out the attack – used grain corridors to transport explosives, “it would put the very existence of these corridors in question”.

The breakthrough deal between Moscow and Kiev was reached in Istanbul in July with mediation by the UN and Türkiye. It aimed to unlock agricultural exports via the Black Sea from Russia and Ukraine – two of the world’s leading grain exporters – which had ground to halt due to the conflict between the two nations.

October 29, 2022 Posted by | Aletho News | , , | 2 Comments

Massive Protest By Czechs Targets Russia Sanctions, High Prices

By Tyler Durden | Zero Hedge | October 29, 2022

Fed up with soaring food, energy and housing costs, tens of thousands of Czech protestors railed against their government on Friday, demanding the resignation of conservative Prime Minister Petr Fiala’s government, withdrawal from NATO and the negotiation of gas purchases from Russia.

“This is a new national revival and its goal is for the Czech Republic to be independent,” said organizer Ladislav Vrabel. “When I see a full square, no one can stop this.”

The protests occurred both in the capital city of Prague as well as the second-largest Czech city of Brno. Organized under the slogan of “Czech Republic First,” the demonstrations drew their strength from both the left and right wings of Czech politics.

“Russia’s not our enemy, the government of warmongers is the enemy,” one speaker said, according to the Associated Press. Czechia has donated tanks and other heavy weapons to Ukraine, and provided nearly a half million visas to Ukrainian refugees, along with benefits. Protest organizers are also demanding that the refugees not be granted permanent residency.

The protest was the third in a series organized by a group demanding Czechia’s withdrawal from NATO and better relations with Russia. As observed in the United States, the Czech government has attempted to marginalize them by calling them “pro-Kremlin propagandist narratives.”

The Czech government has tried to battle the rising prices with aid to businesses and household electricity price caps.

Friday’s protests were part of a rising wave of discontent throughout Europe. On Thursday, thousands protested in France, demanding higher wages to offset the rising cost of living — among them, striking teachers, healthcare providers and railway workers. Recent weeks have seen similar protests in Germany, Austria and Belgium too.

“This is merely the silence before the storm—the discontent is great, and people do not have any sense that the government has a plausible strategy to master the crisis,” German pollster Manfred Güllner tells The Wall Street Journal.

At a time when three quarters of German households are cutting back on energy consumption, just 9% say Chancellor Olaf Scholz has a sound strategy for surmounting the energy crisis. While the French protests didn’t target the Western sanctions regime against Russia, German protestors have called for an end to them.

The discontent is certain to rise all over the world, as more people connect the dots between Western sanctions and their personal misery… all for the latest proxy war over strategically irrelevant territory.

October 29, 2022 Posted by | Economics, Solidarity and Activism | , , , | Leave a comment

British experts helped Kiev’s forces to prepare “terrorist act” in Crimea: Russia

Samizdat | October 29, 2022

An unsuccessful Ukrainian attack on the port city of Sevastopol in Crimea early on Saturday involved nine aerial and seven naval drones, Russia’s defense ministry has said.

The “terrorist attack,” which targeted the vessels of Russia’s Black Sea Fleet and civilian ships docked in the city began around 4.20am local time, the ministry said in a statement on Saturday.

It added that the Russian Navy ships had been involved in providing security for the “grain corridor,” which was set up to allow exports of Ukrainian food products from the Black Sea ports in line with a deal reached between Moscow and Kiev with UN and Turkish mediation in the summer.

All of the incoming drones were shot down by Russian warships and naval aviation in the bay of Sevastopol, the ministry said.

According to the statement, the attack resulted in minor damage to the trawler vessel ‘Ivan Golubets’ and to the net boom barrier in the bay.

“The preparation of this terrorist act and training of the military personnel of the Ukrainian 73rd Special Center for Maritime Operations had been carried out under the supervision of the British experts, based in the city of Ochakov in Ukraine’s Nikolaev Region,” the ministry said.

Information obtained by the Russian military suggests that the same unit of the Royal Navy took part in planning, supplying and carrying out the sabotage of the Nord Stream 1 and Nord Stream 2 pipelines in the Baltic Sea on September 26, the statement read.

Earlier on Saturday, Governor of Sevastopol Mikhail Razvozhayev said it was the largest Ukrainian drone attack on the city since the start of Russia’s military operation in Ukraine in late February.

Located in Crimea, which became part of Russia after a referendum in 2014, Sevastopol has been designated as a federal city by Moscow due to its strategic importance and status as the base of Russia’s Black Fleet. The key port has frequently been the target of drone attacks by Ukraine during the conflict.

In July, six people were injured after a UAV crashed into the Black Sea Fleet’s headquarters in Sevastopol. The attack took place on Russia’s Navy Day and led to the cancellation of celebrations in the city. Another UAV hit the roof of the HQ in August, but failed to cause any significant damage.

October 29, 2022 Posted by | Militarism | , , | 1 Comment

British navy involved in Nord Stream 2 ‘terrorist attack’ – Russia

Samizdat – October 29, 2022

Units of the British Navy were involved in a “terrorist attack”, which destroyed the key Nord Stream gas pipelines, the Russian Defence Ministry alleged on Saturday.

Writing on its official Telegram channel, the ministry alleged that Royal Navy operatives “took part in planning, supporting and implementing” the plot to blow up the infrastructure in September. It did not provide any direct evidence to support its assertion.

The accusation follows a Russian Foreign Ministry claim that NATO conducted a military exercise during the summer, close to the location where the undersea explosions occurred.

The September incident put the pipelines, connecting Germany to Russia, out of commission. Western countries have blocked a transparent international investigation.

The Defence Ministry further alleged that the same UK operatives trained Ukrainians involved in a drone offensive in Crimea earlier on Saturday.

In late September, Russian Foreign Ministry spokeswoman Maria Zakharova noted that this summer, NATO conducted military drills not far from Bornholm, which featured intensive use of “deep-sea equipment.’’

While the officials stopped short of naming the culprit, they were said to be “working under the assumption that Russia was behind the blasts.” Moscow has repeatedly denied that it had anything to do with the incident.

Meanwhile, Sky News has cited a UK defense official as saying Nord Stream 1 and 2 could have been damaged by a remotely detonated underwater explosive device. At the time, the broadcaster said the pipelines might have been breached by mines lowered to the seabed, or explosives dropped from a boat or planted by an undersea drone.

October 29, 2022 Posted by | False Flag Terrorism, Timeless or most popular, War Crimes | , , | 4 Comments


August 16, 2022

October 29, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular, Video | 5 Comments