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Tuesday, September 3, 2024

Pfizer, Valneva unveil phase 2 proof that Lyme disease shot is still effective for 2nd booster

 Pfizer and Valneva may have about two more years to wait before they make the first approval filing to the FDA for a Lyme disease vaccine, but that hasn’t stopped the companies collecting more positive data in the meantime.

The multivalent protein subunit vaccine, dubbed VLA15, is currently in a pair of phase 3 trials the companies hope will provide the backbone for a filing to the FDA and European regulators sometime in 2026. There are currently no approved vaccines for Lyme disease, a bacterial infection that is spread via the bite of an infected tick.

Today, the companies announced data from a phase 2 trial where participants had received a second booster shot a year after their first booster. The immune response and the safety profile of VLA15 when assessed a month after this second booster “were similar to those reported after receiving the first booster dose,” said the companies, which claimed the results demonstrated “compatibility with the anticipated benefit of a booster vaccination prior to each Lyme season.”

This morning’s readout showed a “significant anamnestic antibody response” across all six serotypes of the disease that are covered by the vaccine across children, adolescent and adult participants in the trial

Specifically, the seroconversion rate (SCR)—the process by which the body produces antibodies in response to an infection or immunization—reached over 90% for all outer surface protein A serotypes in all age groups. This is in line with the SCRs recorded after the first booster was administered.

Geometric mean titers—a measurement of antibody level—at one month after both the first and second boosters were also “comparably high,” according to the Sept. 3 release. There was no change in safety profile between the two boosters across any of the age groups.

“We are encouraged by these data, which support the potential benefit of booster doses across all examined age groups,” Valneva Chief Medical Officer Juan Carlos Jaramillo, M.D., said in the release. “Each new set of positive data brings us one step closer to potentially bringing this vaccine to both adults and children living in areas where Lyme disease is endemic.”

Pfizer and Valneva used this morning’s release to reiterate their intention to file VLA15 with the FDA and the European Medicines Agency in the 2026 off the back of data from two phase 3 trials. One of these studies completed its primary vaccinations in July, while the second phase 3 study is still ongoing.

The companies had previously set their sights on a 2025 filing date, before CRO issues at some of the phase 3 trial sites forced them to instigate a delay. Still, the placement of the pair of phase 3 studies means Pfizer and Valneva have the most advanced Lyme disease vaccine in development.

https://www.fiercebiotech.com/biotech/pfizer-valneva-unveil-phase-2-proof-lyme-disease-shot-effective-2nd-booster

Six rating agencies to pay over $49 million over recordkeeping failures, SEC says

 Six credit rating agencies agreed to pay a total of more than $49 million in civil penalties to settle U.S. Securities and Exchange Commission charges they broke recordkeeping rules, the regulator said on Tuesday.

Moody's Investors Service, S&P Global Ratings, Fitch Ratings, HR Ratings de Mexico, A.M. Best Rating Services and Demotech each admitted to significant failures by the firms and personnel to maintain and preserve electronic communications, the SEC said.

Moody's and S&P agreed to pay $20 million each, while Fitch agreed to pay $8 million, the SEC said. A.M. Best will pay $1 million, HR Ratings de México agreed to pay $250,000 and Demotech will pay $100,000.

The SEC has hit dozens of firms with fines for failing to maintain records, largely in connection with employees' use of text messages and messaging apps such as WhatsApp.

Lawyers for the firms did not respond immediately to requests for comment.

https://finance.yahoo.com/news/us-sec-charges-six-credit-205129822.html

Armed Venezuelan Prison Gang In Denver Highlights Sanctuary Zones To Avoid

 Law-abiding Americans should be made well aware of the cities, counties, and states that have laws, ordinances, and policies that obstruct immigration enforcement and shield illegal alien criminals from US Immigration and Customs Enforcement. This is because the Biden-Harris administration has imported the third world into the first world, and with that comes elevated risks of violent crime and chaos.

Footage of the Venezuelan prison gang Tren de Aragua members raiding an apartment building with at least one AR-style rifle and pistols in the northern Denver suburb of Aurora shocked the nation last week about how quickly sanctuary cities run by far-left Democrats can spiral out of control after rolling out the red carpet to illegals. 

And now spillover risks?


Let's not forget sanctuary city NYC...

The big picture understanding is that sanctuary cities have imported millions of illegal aliens, some of which are prison gang members and have zero respect for first-world laws. Defunding the police has also been pushed nationwide by Democrat lawmakers, and with that comes the risk that local municipalities could become quickly overwhelmed. 

Independent think tank Center for Immigration Studies has done the easy work for readers, outlining the cities, counties, and states with laws, ordinances, regulations, resolutions, policies, or other practices that obstruct immigration enforcement and shield criminals from ICE.

In other words, these areas have a possibility of high risk for violent crime. And in our view, these areas should be avoided for safety reasons. 

Sigh... 

Here's the full list:

States

California

Colorado

Connecticut

Illinois

Massachusetts

New Jersey

New York

North Dakota

Oregon

Rhode Island

Utah

Vermont

Washington

Cities and Counties

District of Columbia

Washington

Georgia

Athens-Clarke County

Atlanta

Columbia County

DeKalb County

Douglas County

Idaho

Bonneville County

Power County

Indiana

Lake County

Monroe County

St. Joseph County

Wayne County

Kansas

Douglas County

Kentucky

Campbell County

Franklin County

Jefferson County

Louisville

Scott County

Louisiana

New Orleans

Maine

Cumberland County

Hancock County

Maryland

Baltimore

Baltimore County

Charles County

Howard County

Hyattsville

Montgomery County

Prince George's County

Queen Anne's County

Rockville

St. Mary's County

Michigan

Kalamazoo County

Kent County

Lansing

Leelanau County

Luce County

Muskegon County

Oakland County

Washtenaw County

Wayne County

Wexford County

Minnesota

Anoka County

Cottonwood County

Dakota County

Hennepin County

Jackson County

Kandiyohi County

Lincoln County

Lyon County

Nobles County

Pipestone County

Ramsey County

Todd County

Watonwan County

Nebraska

Arthur County

Banner County

Blaine County

Douglas County

Gosper County

Grant County

Greeley County

Hayes County

Hooker County

Howard County

Johnson County

Lincoln County

Logan County

Loup County

McPherson County

Nance County

Perkins County

Platte County

Sioux County

Thomas County

Wheeler County

New Hampshire

Hillsborough County

New Mexico

Bernalillo County

Chaves County

Colfax County

De Baca County

Dona Ana County

Eddy County

Farmington

Grant County

Hidalgo County

Las Cruces

Lincoln County

Los Alamos County

Luna County

McKinley County

Otero County

Quay County

Rio Arriba County

Roosevelt County

San Juan County

San Miguel County

Sandoval County

Santa Fe

Santa Fe County

Sierra County

Socorro County

Taos County

New York

Albany

Albany County

Dutchess County

Monroe County

Nassau County

New York City

Orange County

Putnam County

Rockland County

Saratoga County

Suffolk County

Sullivan County

Tompkins County

Ulster County

Warren County

Wayne County

Westchester County

Yates County

North Carolina

Buncombe County

Chatham County

Durham County

Forsyth County

Guilford County

Mecklenburg County

Orange County

Wake County

Watauga County

Ohio

Franklin County

Hamilton County

Lorain County

Mahoning County

Pennsylvania

Allegheny County

Berks County

Bucks County

Chester County

Delaware County

Lancaster

Lehigh County

Mifflin County

Montgomery County

Montour County

Northampton County

Philadelphia

Washington County

South Carolina

Charleston County

Tennessee

Shelby County

Virginia

* Denotes the jurisdiction is part of a regional jail system. Please click on map point for further information.

 

Albemarle County *

Alexandria

Alleghany County *

Amherst County *

Appomattox County *

Ashland *

Arlington County

Augusta County *

Bath County *

Bedford *

Bedford County *

Botetourt County

Brunswick County *

Buchanan County *

Campbell County *

Caroline County

Charles City County *

Charlotte County

Charlottesville *

Chesapeake *

Chesterfield County *

Colonial Heights *

Covington *

Dickenson County *

Dinwiddie County *

Dumfries *

Emporia *

Essex County *

Fairfax County

Franklin *

Gloucester County

Greensville County *

Halifax County *

Hampton *

Hanover County *

Harrisonburg *

Haymarket *

Hopewell *

Isle of Wight County *

James City County *

King and Queen County *

King William County *

Lee County *

Loudoun County

Lynchburg *

Manassas *

Manassas Park *

Martinsville

Mathews County *

Mecklenburg County *

Middlesex County *

Nelson County *

Newport News

Norfolk *

Northumberland County *

Norton *

Occoquan *

Petersburg *

Poquoson *

Portsmouth City *

Prince George County *

Prince William County *

Quantico *

Rappahannock County *

Richmond

Richmond County *

Rockingham County *

Russell County *

Scott County *

Shenandoah County *

Smyth County *

Southampton County

Staunton *

Suffolk *

Surry County *

Tazewell County *

Virginia Beach *

Warren County *

Warsaw *

Washington County *

Waynesborough *

Westmoreland County *

Williamsburg *

Wise County *

York County *

Wisconsin

Dane County

Milwaukee County

Winnebago Correctional Center (state facility)

Wyoming

Teton County

The chaos erupting in a Denver suburb, driven by a Venezuelan prison gang, is a wake-up call for Americans. It highlights how the Biden-Harris administration's disastrous open southern border policies could cause other sanctuary cities and areas to descend into turmoil. 

If the police are overwhelmed...

Who will come to help you? 

This is insanity! 

Iowa Clinic Signs Multi-Year Agreement with Clover Unit to Deploy AI Tech

  Counterpart Health, Inc. (“Counterpart”), a leading AI-powered physician enablement platform, announced a multi-year agreement with The Iowa Clinic, P.C., one of the most highly regarded multispecialty healthcare groups in the United States. This deal positions The Iowa Clinic as one of Counterpart's anchor customers in the Midwest, as Counterpart drives a broader strategic expansion across the country. Counterpart is a subsidiary of Clover Health Investments, Corp. (NASDAQ: CLOV) (“Clover Health”).

Under the terms of the agreement, clinicians serving The Iowa Clinic’s Medicare Advantage and Medicare Shared Savings Program patients will use Counterpart Assistant, Counterpart Health’s cutting-edge cloud-based software platform. Additionally, the platform will be made available to The Iowa Clinic’s clinically integrated network partners throughout the Midwest. Counterpart will receive a per-member, per-month fee, as well as potential incentive payments contingent on achieving certain care management goals.

https://www.globenewswire.com/news-release/2024/09/03/2940072/0/en/The-Iowa-Clinic-Signs-Multi-Year-Agreement-with-Counterpart-Health-to-Deploy-Proven-AI-Technology-to-Hundreds-of-Providers-Across-the-Midwest.html

Dem-Controlled States Refuse To Clean Voter Rolls, Fix Election Problems

 President Joe Biden has vowed to veto the Safeguard American Voter Eligibility Act, which simply requires proof of citizenship to register to vote in federal elections. His promise was made in reaction to congressional Republicans who want to include it with any continuing resolution required to fund the next fiscal year, which begins on Oct. 1. The president’s adamant opposition to what most Americans support demonstrates just how much Democrats are dedicated to making it easier to cheat in elections.

On Dec. 16, 2020, as chairman of the Senate Committee on Homeland Security and Governmental Affairs, I held a hearing titled, “Examining the Irregularities in the 2020 election.” In spite of the wailing and gnashing of teeth from the election irregularity deniers, there were many indisputable irregularities.

In Wisconsin, 170,000 faulty absentee ballots in Milwaukee and Dane County were improperly counted by election clerks. Representatives of the far-left “Zuckerbucks” program — which is designed to pour left-wing dollars into local election offices, benefiting their Democrat candidates — imposed such heavy-handed direction in Green Bay that the local election clerk resigned from the stress and allowed Zuckerberg’s minions to run the election. “Democracy in the Park” was allowed in Madison, where activists unlawfully collected 17,300 ballots. Seniors in nursing homes voted without the required voting deputies present, bordering on elder abuse for political gain. As was the case in other states, election observers were not allowed to effectively observe the election process.

More recently, as one of many examples of states cleaning voter rolls, Virginia cancelled 6,303 noncitizens’ voter registrations.

Unfortunately, the election irregularity deniers have been so effective — aided and abetted by the corporate media — that these abuses have not only been ignored, but those who wish to cheat in the 2024 election have been able to devise new election fraud schemes. Absent media scrutiny, Republicans are undertaking efforts to stop them.

In one of the most closely contested states, Wisconsin’s governor vetoed nine election reforms passed by the Republican legislature and designed to restore confidence in our state election system. The Wisconsin Election Commission refuses to remove more than 4 million ineligible voters from our out-of-date voter roll (Wisconsin has approximately 3.5 million eligible voters). Election integrity starts with clean voter rolls, and by refusing to clean up Wisconsin’s, Democrats are clearly stating that they’d rather leave room for fraud than increase confidence in our election system.

Following a pressure campaign from Senate Republicans and the Republican National Committee (RNC), Nevada just removed 90,000 voters from its lists. If Nevada can do it, why can’t the Badger State?

Biden Exec Order to Register Voters

Nationally, the potential for election interference and voter fraud seems to be growing, with minimal attention being paid to it. Let’s start with President Joe Biden’s executive order directing federal agencies to register voters. Does anyone seriously believe these registration drives will be done in a nonpartisan manner? How many taxpayer dollars will be spent registering individuals most likely to vote for the party of big government and more deficit spending?

The RNC and Trump campaign recently sued the Biden administration to stop this partisan activity. Will courts intervene in time?

States Cleaning Voter Rolls

The Democrats’ open border policy is guaranteed to result in widespread voter fraud. Democrat presidential nominee Harris’ vice presidential pick, Minnesota Gov. Tim Walz, signed a law giving driver’s licenses to illegal immigrants. That license, together with a utility bill, is all someone needs to register to vote in Minnesota. Democrats claim that because it is illegal for noncitizens to vote, illegal immigrants won’t register. We should be highly skeptical of that being an effective deterrent. Last week, the RNC sent a demand letter to Minnesota’s secretary of state following the revelation that a noncitizen in Minnesota received a ballot that he hadn’t even asked for. That is unlikely to be an isolated incident.

After all, Ohio just purged 499 illegal immigrants from its voter rolls following a multi-phase audit. But that’s in a state with Republican leadership that actually believes in election integrity and wants to make it difficult to cheat. Elsewhere, Boston officials disclosed that 70 illegal aliens contacted county election officials asking to be removed from voter registration lists. How did those Massachusetts noncitizens get registered, and how many remain on the registration lists? While it’s good to see officials in some states taking the lead to purge their voter rolls, there is much more work to be done.

Laundering Donations

In March 2023, journalist James O’Keefe first reported on a campaign financing violation dubbed “smurfing.” Unbeknownst to the “donors,” Federal Election Commission (FEC) reports show in some cases tens of thousands of small dollar donations being made in their names, totaling hundreds of thousands of dollars. One example in Wisconsin detailed five “smurfs” making a combined total of 28,471 donations, worth $401,326. Sen. Tammy Baldwin, D-Wisc., was a recipient of 531 of those donations, worth $5,147. No wonder Democrats report a resounding lead in small dollar donations!

My Senate staff has been pressuring the FEC to investigate these violations, but the FEC won’t even acknowledge whether they are investigating. Republican attorneys general such as Jason Miyares in Virginia have thankfully launched concurrent investigations to demand answers and stop this unfair practice.

Presidential Election

For well over a year, I have publicly expressed my doubts that Biden would be the Democrat nominee. I would generally add that whoever replaced him would immediately be placed on a pedestal and declared the new messiah. But even I am astonished by the extent to which my prediction has come true. Former President Donald Trump is not running against Kamala Harris, he is running against the entire corporate media, who are coordinating their efforts to defeat him.

This is not a new phenomenon. Remember the Russia hoax, which the corporate media cheered on? How about Google manipulating search results to favor Democrats and suppress Republicans? Most “journalists” in corporate media today are merely advocates for the left. Honest, unbiased reporting has largely gone the way of the dinosaur.

As alarming as the reality described above is, I have not written this column to discourage, but as a call to action. The RNC and Trump campaign have recruited 157,000 poll workers and poll watchers across the country ahead of November. Join the effort at ProtectTheVote.com, and make sure to get out and vote as soon as your state allows. We can beat the forces arrayed against us if we turn out in numbers that are too big to rig.

So Much For Sanctions: Russia Surpasses US For Gas Exports To EU

 By Liz Heflin of Rmxnews.com

From April to June, the European Union bought more than 12.7 billion cubic meters from Russia and 12.3 billion cubic meters from the United States.

Director of the Russian Department of Economic Cooperation of the Foreign Ministry, Dmitri Birichevski, says Russia now supplies 15 percent of the total volume of natural gas imported by the European Union. This despite the EU’s REPowerEU instituted back in May 2022 to shift away from Russia and cut it off from its flow of energy profits.

Birichevski noted, in particular, the fact that France imported 4.4 billion cubic meters of liquid natural gas (LNG) in the first quarter of 2024, more than double the circa 2 billion it imported in 2023.

Norway is still in first place, having supplied the EU with 23.9 billion cubic meters in Q2. Prior to its invasion of Ukraine, Russia held the top spot.

The German government maintains it no longer imports any gas from Moscow. However, many member states clearly do.

In the face of renewed demands to end Russian imports and defund Putin’s war chest, the energy policy spokesman for the Free Democratic Party (FDP) suggested that the EU “pay a fixed amount of aid and arms supplies to Ukraine for every cubic meter of imported Russian gas.“

The matter of Russian gas imports has been an ongoing saga, with reports of shipments from Russia being essentially laundered through other countries and pipelines to avoid being stamped as “Russian.”

This new data comes in the face of no less than 14 sanctions packages, including the latest one adopted in June, which specifically prohibits the transit of Russian LNG.

https://www.zerohedge.com/energy/so-much-sanctions-russia-surpasses-us-gas-exports-eu

Is Kamala Very, Very Afraid?

 by James Howard Kunstler via Kunstler.com,

“On many subjects important to public life today, vast numbers of people know the truth, and yet the official channels of information sharing are reluctant to admit it.”

- Jeffrey Tucker

You might wonder, as I do, whether Kamala Harris can even stay in the race until November 5. Based on her grim appearance in last week’s “interview” with Dana Bash, slumped at the table of a crummy Georgia café under poor lighting, her trademark cackle suppressed, she looked psychologically wilted. Don’t be surprised if late this week she “catches Covid” and asks to “postpone” the September 10 debate with Mr. Trump.

Consider the depressing reality of her situation, lately cloaked by the farcical “joy” motif put out by her party’s campaign spin doctors: First, the cabal running the White House bum-rushed “Joe Biden” out of the campaign, just hooked him offstage like a broke-down vaudevillian annoying the audience with his tired antics. Then, the same gang buffaloed Kamala onto center stage by some mystical process that disregarded her lack of preparation, her proven unpopularity in the 2020 primaries, and her near-invisibility in 3.5 years as veep.

For a couple of weeks her head must have been spinning with sheer intoxication at the amazing turn of events. Who wouldn’t be amazed to find him or herself unexpectedly selected to run for president? But now, post the artificial hoopla of the convention, the dread steals in. If she was previously used to self-medicating with chardonnay during the irksome veep years, imagine the pressure now on those campaign bus trips.

She has a lot to be afraid of. She’s not nimble of mind in the spotlight, and she knows it. When she tries to riff on anything off-the-cuff, all that comes out are laughable tautologies. She really doesn’t know much about the world, even about simple geography, certainly not the complex interplay of national interests. Her economic notions are a kind of Frappuccino® of processed Marxian sludge from the Berkeley cafés. If exposed regularly to even friendly reporters, she’d ignite howling embarrassment for herself (and the party). And, after all, there’s her record, including hundreds of videos on the Internet showing plainly the crazy policies she supports and now has to pretend to dissociate from.

Lurking behind her is not only the American intel blob of dark forces and sinister figures, but an international blob made up of malevolent groups within and throughout Western Civ, clearly working to bring it down — the Eurocrats wrecking their own countries’ agriculture and their industrial economies while jailing their opponents for thought crimes; the WEFers pushing the demented climate change agenda and ruinous migrant invasions; the bankers looking to seize the “collateral” (property, chattels, investment portfolios) of a billion everyday citizens when the bond Ponzi scheme blows up, as it must; the WHO steered by Bill Gates seeking to inject unsafe vaccines into everybody in order to greatly and quickly reduce the population; the Soros NGO legions working to subvert the public interest here, there, and everywhere; the NATO warmongers trying like hell to start World War Three. . . . Kamala Harris surely understands — if she understands anything — that she has become their chosen pawn, and is at their mercy (they have none).

She should be afraid especially of the American blob. That combine of higher-ups in the CIA, the DOD, the FBI, the DHS, the State Department, and Gawd knows how many lesser-known agencies and “black op” back offices, knows that it is in great danger if Mr. Trump happens to get elected (despite their best efforts to rig things). After all the trips laid on him, all the way up to attempted assassination, you can be sure that Mr. Trump will be coming after the cabal for committing real and serious crimes. They are running scared now. Despite all the power seemingly at their command, nothing has availed so far — not lawfare, not bullets — to stop Mr. Trump’s implacable march back into the Oval Office, where he could possibly succeed in turning the USA back into a functioning republic

Poor Kamala Harris is the blob’s wholly inadequate instrument to fend off this fate. If she continues to perform badly, the blob might not hesitate to try getting rid of her. That may be the blob’s last chance of stopping the election from happening altogether. The nation has never been in the predicament of having the head of a ticket resign or die in the homestretch of an election campaign. There is no provision in the Constitution for it because there are no provisions in the Constitution for political parties per se. It would all be a kind of improv.

And then, of course, America would be stuck with the unfit and incapable “Joe Biden,” heading the government, at least until something else can be worked out. Maybe that working out would just be the final stage of the coup that has been in motion, really, since 2016 when John Brennan, Barack Obama, and James Comey attempted to oust Mr. Trump with RussiaGate. Some kind of “interim commission” might be formed to “solve” the problem of the cancelled election. They’ll look for someone with “proven ability” to serve as provisional president — maybe, someone who has already been president. . . say, Mr. Obama. Voila and fait accompli! If he finds himself appointed rather than elected, he would not be in defiance of the 22ndAmendment. Okay, now try re-thinking how scared Kamala Harris must be.

https://www.zerohedge.com/political/kamala-very-very-afraid