FDA Advisers Recommend Authorizing Novavax Covid Vaccine Despite Risks of Myocarditis

The U.S. Food and Drug Administration (FDA) panel experts recommended authorizing Novavax Covid-19 vaccine during a federal advisory committee on Tuesday.

FDA advisers ignored the previous assessment released by the agency. The FDA released a report on Friday regarding the causal relationship between the Novavax vaccine and heart inflammation or myocarditis.

In the FDA documents, the agency said that multiple events of myocarditis/pericarditis were reported after the administration of the Novavax vaccine. Thus, raising concern about a possible risk of heart inflammation from the vaccine.

“Multiple events of myocarditis/ pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA COVID-19 vaccines and raising concern for a causal relationship to NVX-CoV2373. Events of lymphadenopathy were infrequent but reported by a higher proportion of participants in the NVX arm, with the highest rate observed after Dose 2 (0.2%). Review of the data also identified small imbalances in certain thromboembolic events, including cardiac and neurovascular events, hypersensitivity events, cholecystitis, uveitis, cardiac failure, and cardiomyopathy,” according to the documents.

https://www.fda.gov/media/158912/download

“Data from passive surveillance during post-authorization use in other countries also indicate a higher-than-expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine,” the documents stated.

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The documents were released ahead of a June 7 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee. The agency indicated five of the six myocarditis/pericarditis cases were observed within two weeks of administration and four were in young men. There were almost 30,000 participants in the study, run between December 2020 and September 2021. Otherwise, overall efficacy was 90.4%, although lower, 78.6%, in people 65 years and older.

Data from the studies were prior to the Delta and Omicron variant surges, although the documents say, “based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease.”

Novavax has stated that the number of myocarditis events in the study was “within the range of expected background cases…. Despite the wide availability of authorized or approved vaccines, the SARS-COV-2 pandemic is not well controlled in the U.S…. there remains a desire for vaccines that have been developed using well-understood technology platforms.”

Meanwhile, the company initiated a Phase III trial of its vaccine against the Omicron strain on May 31. This particular vaccine trial is of a bivalent vaccine that contains both NVX-CoV2373 and NVX-CoV2515. NVX-CoV2373 is the vaccine currently on the market in other countries and up for review in the U.S. The trial will last 10 months with initial results expected in the second half of 2022.

The Novavax vaccine uses an older, traditional type of vaccine manufacturing process where copies of the spike protein are grown in insect cells, purified and placed into nanoparticles with an immune-stimulating adjuvant. That is compared to the newer mRNA vaccines that package a segment of mRNA coding for the spike protein in a nanoparticle. Protein vaccines have been used in numerous other vaccines, such as for hepatitis B and shingles.

In a statement, Novavax Inc. said “there is insufficient evidence to establish a causal relationship” between the vaccine and heart inflammation.

“The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%). Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate,” Novavax Inc stated.

https://www.thegatewaypundit.com/2022/06/just-fda-advisers-recommend-authorizing-novavax-covid-vaccine-despite-risks-myocarditis/

New Jesse Ventura Interview!

live

https://youtu.be/WiA-R-xjIKI

Karine Jean-Pierre: “The Economy is in a Better Place Than it Has Been Historically”

White House Press Secretary Karine Jean-Pierre answered questions for about 10 minutes after actor Matthew McConaughey gave an address on gun violence.

Jean-Pierre absurdly claimed the economy is in a better place now that it has been historically.

Fox News reporter Peter Doocy wasn’t having it and challenged Jean-Pierre.

“High gas prices, people can’t get baby formula, the supply chain is messed up, everything is more expensive — where’s the good part?” Fox News reporter Peter Doocy asked KJP.

“What I’m trying to say, Peter, is that we understand that people are feeling this,” Jean-Pierre said.

“We are in a historic place in history — historic place right now — as we look at where we are with the economy,” she said. “What I’m trying to say to you, is that the economy is in a better place than it has been historically.”

Does she actually believe the bs she is shoveling?

https://www.thegatewaypundit.com/2022/06/karine-jean-pierre-economy-better-place-historically-video/

World Bank says recession will be 'hard to avoid' for many countries

You can add the World Bank to the growing chorus sounding recession alarm bells. In its latest outlook, World Bank president David Malpass said "for many countries, recession will be hard to avoid".

Malpass joins many others on Wall Street and at central banks around the globe who are starting to warn about a sharp economic downturn.

JPMorgan Chase CEO Jamie Dimon referred to an economic "hurricane" on the horizon last week while Tesla's Elon Musk has said he has a "super bad feeling" about the economy.

The reasons for the gloom? Malpass said in the World Bank's latest outlook Tuesday that "the war in Ukraine, lockdowns in China, supply-chain disruptions and the risk of stagflation are hammering growth."

Stagflation, the combination of stagnant economic growth and high inflation, has become a major worry of late.

The trend is reminding experts and older consumers of the late 1970s, when an oil shock and sluggish economy led to two downturns, a so-called double-dip recession, in the early 1980s.

Investors are nervous about the fact that the Federal Reserve is raising interest rates aggressively to try and tamp down rising prices. The problem, though, is that some fear the Fed was too late starting its campaign to combat inflation. As a result, the central bank could spark a recession as it rushes to catch up with more rate hikes.

The prospect of higher short-term rates from the Fed have already led to a spike in longer-term Treasury bond yields this year. Mortgage rates have jumped as well, leading to worries that the housing market could slow dramatically.

Businesses are also grappling with higher costs for commodities and wages and now have to contend with higher interest rates potentially hurting their bottom lines as well.

Add all that up and it's easy to see why the World Bank is increasingly nervous. The international lending organization now expects the global economy to grow at an annualized pace of just 2.9 per cent this year. That is down sharply from the 5.7 per cent growth rate last year as well as the World Bank's January 2022 forecast of 4.1 per cent.

"The recovery from the stagflation of the 1970s required steep increases in interest rates in major advanced economies, which played a prominent role in triggering a string of financial crises in emerging market and developing economies," the World Bank said in its new forecast.

The World Bank isn't expecting a big rebound anytime soon. It said that global growth should "hover around" the 2.9 per cent level for both next year and 2024, describing the next few years as "a protracted period of feeble growth and elevated inflation."

https://www.9news.com.au/world/world-bank-says-recession-will-be-hard-to-avoid-for-many-countries/dbf897fe-3465-4f72-a912-b1b47b42014b

Ukrainian Soldiers Rapped By Their Commanders – Ukrainian POW

https://southfront.org/ukrainian-soldiers-rapped-by-their-commanders-ukrainian-pow/

SSNDOB Marketplace, A Series Of Websites That Listed More Than 20 Million Social Security Numbers For Sale, Seized And Dismantled In International Operation

https://www.justice.gov/usao-mdfl/pr/ssndob-marketplace-series-websites-listed-more-20-million-social-security-numbers-sale

Former LADWP Executive Sentenced to Four Years in Federal Prison for Lying to FBI About Secret Business Relationship with Lawyer

https://www.justice.gov/usao-cdca/pr/former-ladwp-executive-sentenced-four-years-federal-prison-lying-fbi-about-secret

UN comments on grain stealing allegations

The organization doesn’t have proof that Russia has been illegally exporting Ukrainian grain

The UN is unable to verify accusations raised by Kiev against Moscow of “stealing” and exporting Ukrainian grain, Stephane Dujarric, the spokesman for the UN Secretary-General, has said.

Asked about the claims by a reporter during a news briefing on Tuesday, Dujarric said that neither the UN Secretary-General’s office nor the UN World Food Programme (WFP) had any credible information on the matter.

“We’ve seen recent media reports, we’re talking to our colleagues at WFP. They have no way of verifying these allegations. I think WFP, as we all have, has been advocating for a free movement of food from the Black Sea to ensure that the needs of people around the world are met,” the official stated.

Ukraine has repeatedly accused Moscow of “stealing” its stockpiles of wheat amid the ongoing conflict that broke out in late February. Most recently, such accusations were flung at Russia by the Ambassador of Ukraine to Turkey, Vasyl Bodnar.

“Russia shamelessly steals Ukrainian grain and sends it overseas from Crimea, including to Turkey,” Bodnar said on Friday, adding that Kiev has asked Ankara to “help resolve the issue.”

Ukraine and Western states alike have repeatedly accused Moscow of impeding grain exports by blocking Ukraine’s Black Sea ports, namely the major trade hub of Odessa. Russia, however, has rejected such claims, maintaining it was ready to ensure safe passage for grain-carrying vessels from the ports. The disruption of grain flow stems from Kiev’s own actions and extensive mining of the shoreline by the Ukrainian military, Moscow insists.

Russia attacked the neighboring state following Ukraine’s failure to implement the terms of the Minsk agreements, first signed in 2014, and Moscow’s eventual recognition of the Donbass republics of Donetsk and Lugansk. The German- and French-brokered protocols were designed to give the breakaway regions special status within the Ukrainian state.

The Kremlin has since demanded that Ukraine officially declare itself a neutral country that will never join the US-led NATO military bloc. Kiev insists the Russian offensive was completely unprovoked and has denied claims it was planning to retake the two republics by force.

https://www.rt.com/news/556773-un-ukraine-grain-allegations/

ICE officially considers military service when deciding to deport non-citizen vets and families

The policy has been unofficial until now

Immigration and Customs Enforcement (ICE) announced Tuesday that it will officially consider migrants' US military service before deciding whether to enforce civil immigration actions, such as deportation, against them or their family members.

While ICE has previously recognized US military service as a mitigating factor, the Biden administration's directive makes consideration of US military service an official agency policy. The department will take into account the non-citizen US veteran's type of discharge, length of service, and other related factors before deciding to take action against an illegal immigrant and their immediate family members.

Immigration enforcement actions include "arrest, detention, return, and removal from the United States of foreign nationals who are inadmissible to or removable from the United States under U.S. immigration law," according to the Department of Homeland Security.

The Biden administration stressed in a press release announcing the policy that the focus of ICE is "the apprehension and removal of noncitizens who are a threat to national security, public safety, and border security."

The newly official policy will also create training, tracking, and reporting requirements for current and former US service members who are illegal immigrants.

"ICE values the incredible contributions of noncitizens who have served in the U.S. military," ICE Acting Director Tae D. Johnson said in a press release. "Through this directive, ICE will consider U.S. military service by a noncitizen or their immediate family members when determining whether to take civil immigration enforcement decisions against a noncitizen."

https://justthenews.com/government/federal-agencies/ice-officially-considers-military-service-when-deciding-deport-non

DeSantis Signs School Safety Bill

Florida Gov. Ron DeSantis signed a bipartisan-supported school safety bill on June 7 that addresses gun violence in schools.

The bill, HB 1421, adds to Florida’s list of school safety reforms that have been legislated since the shooting at Marjory Stoneman Douglas High School on Valentine’s Day in 2018.

Florida Democrats had begun pushing for a special session on gun violence before the governor signed the bill.

In a news release, DeSantis announced that he had signed the bipartisan-supported bill which embraces a number of recommendations by the task force that was created as a result of the shooting in the Parkland high school, where 17 students and faculty lost their lives.

“Every child needs a safe and secure learning environment,” DeSantis said in a June 7 press release.

The signing also comes after the recent tragedy in an elementary school in Uvalde, Texas, where 19 children and two teachers were killed by an 18-year-old gunman.

In Florida, HB 1421 requires law enforcement officers to train in active shooter drills, school boards to enact family reunification plans for the aftermath of an evacuation, and for schools to have an 80 percent certification rate of personnel receiving mandatory youth mental health awareness training. It will go into effect on July 1.

The bill will extend the Marjory Stoneman Douglas High School Public Safety Commission until 2026 and revise their responsibilities from investigating system failures at the school and other previous mass shootings in Florida. They are also charged with recommending improvements to those systems and monitoring the implementation of school safety laws.

The bill will authorize the state’s education commissioner to enforce school safety and security compliance, permit school officers to arrest people in charter schools, and requires those officers to complete an intervention training course to improve skills to de-escalate situations on school grounds.

The bill that was passed in March during the regular session did not address gun violence or any controls on weapons and background checks as has been called for in the wake of the Uvalde Elementary school shooting as well as other recent mass shootings.

https://www.ntd.com/desantis-signs-school-safety-bill_790700.html

https://www.ntd.com/desantis-signs-school-safety-bill_790700.html

Puppet Masters Pt 1.pdf

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Puppet Masters Pt 5.pdf

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