German Study Finds Lockdown 'Had No Effect' In Stopping Spread Of COVID

 by Paul Joseph Watson via Summit News,

A major new study by German scientists at Munich University has found that lockdowns had no effect on reducing the country’s coronavirus infection rate.

Oh.

“Statisticians at Munich University found “no direct connection” between the German lockdown and falling infection rates in the country,” reports the Telegraph.

The study found that, on all three occasions before Germany imposed its lockdowns in November, December and April, infection rates had already begun to fall.

The R rate – the number that indicates how many other people an infected person passes the virus to – was already under 1 before the lockdown restrictions came into force.

As we highlighted last year, a leaked study from inside the German Ministry of the Interior revealed that the impact of the country’s lockdown could end up killing more people than the coronavirus due to victims of other serious illnesses not receiving treatment.

This is by no means the only study to have concluded that lockdowns are completely useless and don’t work.

A peer reviewed study published in January by Stanford researchers found that mandatory lockdowns do not provide more benefits to stopping the spread of COVID-19 than voluntary measures such as social distancing.

Back in March, Stanford medical professor Dr. Jay Bhattacharya told Newsweek that COVID-19 lockdowns are “the single worst public health mistake in the last 100 years.”

Earlier this year, academics from Duke, Harvard, and Johns Hopkins concluded that there could be around a million excess deaths over the next two decades as a result of lockdowns.

Other research has concluded lockdowns will conservatively “destroy at least seven times more years of human life” than they save.

https://www.zerohedge.com/covid-19/german-study-finds-lockdown-had-no-effect-stopping-spread-covid

Lawsuits grow as workers test employers’ right to mandate COVID-19 vaccination

 A growing number of workers hesitant about taking the COVID-19 vaccine are taking their bosses to court.

The swift adoption of synthetic biological cocktails to combat the pandemic, developed and scaled for human injection at record pace, is at the heart of an increasing number of lawsuits from workers. They argue that submitting to a novel drug to combat a still-mysterious virus shouldn’t be a condition of keeping their jobs.

In one of the latest lawsuits, 117 unvaccinated Texas hospital workers contend that their employer, The Methodist Hospital, is violating federal law and state public policy by firing workers over their refusal to take the vaccine, which still lacks full regulatory approval.

“The abbreviated timelines for the emergency use applications and authorizations means there is much the Food and Drug Administration (FDA) does not know about these products even as it authorizes them for emergency use, including their effectiveness against infection, death, and transmission of SARS-CoV-2…” the lawsuit states.

Houston Methodist did not respond to Yahoo Finance’s request for comment. According to the Washington Post, the hospital group’s president, Marc Boo, likened its COVID-19 vaccine mandate to flu vaccine mandates, saying health-care institutions can legally require them.

The Texas plaintiffs argue that COVID-19 vaccinations are specifically unlike flu vaccines, because they have undergone clinical trials resulting in full FDA approval.

Similar concerns have been introduced in suits pending in California, North Carolina, New Mexico. Legal threats from workers in Wisconsin, and students whose universities are excluding unvaccinated individuals from their campuses, are upping the ante as businesses prepare to call remote workers back to the offices.

Yet critics of the lawsuits highlight that the filings are the works of lawyers known to have advocated against vaccinations — and point out that immunology experts have pushed back on the plaintiff’s characterization of Pfizer-BioNTech’s (PFE) and Moderna’s (MRNA) mRNA vaccines as “gene modification injections.”

However, no controversy exists over the lawsuits’ central underlying facts. Plaintiffs hope they can use that to challenge prevailing legal thought: current vaccines are limited to use on an emergency basis (EUA), and their full FDA approval remains contingent upon results of yet-to-be concluded clinical trials.

‘A kind of leap’

According to the workers in Texas, a federal law that governs EUAs should preempt state and local laws that impose different or additional requirements on medical products under the authorization.

Under federal law, individuals must be given the option to accept or refuse any medical products limited to EUA, including COVID-19 vaccines, and must be advised of the vaccines’ known and unknown benefits and risks. Houston Methodist provided neither, they claim.

According to Matthew Bodie, a professor of law for St. Louis University and an expert on employee privacy law, the statute is silent on whether private employers must extend the same protections as the federal government. As a result, the plaintiffs’ augment may be tenuous but perhaps not impossible, Bodie told Yahoo Finance.

The argument is difficult “because the connection is not direct — there’s nothing in the law that specifically says private employers cannot require EUA vaccines,” Bodie said. “So there has to be kind of a leap from the federal EUA provision...to private employers.”

He added: “Telling the government it can’t do something is not the same as telling private employers,” — emphasizing why legal experts have largely concluded that private employers are at liberty to create their own vaccination rules.

And the theory faces additional challenges.

According to recently updated federal EEOC guidelines, requiring vaccines for employees who are physically entering the workplace does not violate federal employment laws, so long as employers comply with the accommodation provisions of the Americans with Disabilities Act (ADA) and Title VII, Aaron Holt, a board certified labor & employment attorney with Cozen O’Connor, said.

Still, a Texas court could hold differently, Bodie said.

“There’s a possibility the Texas court will say, ‘Under Texas law, we believe that there is a public policy here...that there should be an exception to the employment at will doctrine,’” the expert said. Alternatively, the court could adopt a separate theory that extends protections to unvaccinated workers, Bodie added.

University of California Hastings College of the Law professor, Dorit Rubinstein Reiss, described the EUA statute a “wrinkle.” Referencing Rutgers University students who object to the school’s mandatory vaccine policy, she told Inside Higher Ed that while the outcome of a challenge to the statute is not certain, the school’s policy stood on firm legal ground.

Another uncertainty is whether courts will consider the Centers for Disease Control’s (CDC) data in weighing whether workers and students who decline vaccination can be stripped of their jobs or education. According to the CDC, a small percentage but increasing number of fully vaccinated Americans have died from COVID-19-related illness.

Centers for Disease Control (CDC) data on Americans fully vaccinated for COVID-19 as of May 24, 2021.

As of April 26, among approximately 95 million fully vaccinated Americans — excluding deaths reported as asymptomatic or not related to the coronavirus — 112 reportedly died. Deaths among fully vaccinated Americans, excluding asymptomatic and non-COVID-19-related, increased to 183 as of May 10, when approximately 115 million Americans had received full vaccinations. As of May 24, the CDC said, the number climbed to 368, when approximately 130 million Americans were fully vaccinated. The agency's most recent data on more than 135 million fully vaccinated shows 447 deaths.

The CDC stopped monitoring all reported vaccine breakthrough cases as of May 1, to include only those cases resulting in hospitalization or death.

As part of their arguments, the workers’ lawsuits also stress that following World War II, allied nations agreed to adhere to the Nuremberg Code to prevent recurrence of tests performed by Nazi physicians on non-consenting individuals for malaria, epidemic jaundice, smallpox, and cholera.

The complaints go on to note the FDA’s characterization of the injections as “investigational products.”

https://finance.yahoo.com/news/workers-are-testing-employers-right-to-mandate-vaccination-130402535.html

Sen. Josh Hawley calls on Fauci to resign, full probe of COVID-19 origins

 Sen. Josh Hawley, R-Mo., called on top government epidemiologist Anthony Fauci to resign from his post amid revelations about emails Fauci sent early in the coronavirus pandemic. He also called for a congressional inquiry into the virus' origins. 

"Anthony Fauci’s recently released emails and investigative reporting about #COVID19 origins are shocking," Hawley tweeted Friday, adding: "The time has come for Fauci to resign and for a full congressional investigation into the origins of #COVID19 - and into any and all efforts to prevent a full accounting." 

"The public deserves to know if persons within the US govt tried to stop a full investigation into #COVID origins, as recently reported," the Missouri Republican continued. "And Congress must also find out to what extent Fauci’s NIAID was involved in financing research at the Wuhan Institute of Virology." 

Buzzfeed obtained and published thousands of Fauci's emails from the early stages of the coronavirus pandemic this week, some of which sparked outrage for a variety of reasons. A group of emails appear to show Fauci's opposition to mask-wearing early in the pandemic, which was consistent with his public statements, before he and other public health officials reversed that stance. 

Other emails, however, indicated that the possibility the COVID-19 virus leaked from a Chinese lab was raised to Fauci, who is the director of the National Institute for Allergy and Infectious Diseases, as early as January 2020, and that he and some other reputable scientists took the possibility seriously. 

Nevertheless, Fauci, other public health experts and many in the media were strongly dismissing the possibility that the virus leaked from a lab, even as Fox News reported in April 2020 that at least some in the U.S. intelligence community believed a lab leak to be more likely than other theories. 

The expert who raised lab leak concerns to Fauci on Jan. 31, Kristian G. Andersen, later said that he is quite sure the virus was not artificially altered after looking at the "data." 

Also sparking outrage against Fauci are two other sets of emails, including one in which Fauci tells his deputy, Hugh Auchincloss, to read a paper about "SARS Gain of function."

"The paper you sent me says the experiments were performed before the gain of function pause but have since been reviewed and approved by NIH," Auchincloss said in an email to Fauci. "Not sure what that means since Emily is sure that no Coronavirus work has gone through the P3 framework. She will try to determine if we have any distant ties to this work abroad."

That's being interpreted by some to indicate that Fauci and those close to him were concerned that his agency – which has indeed funded research at the Wuhan Institute of Virology – may have indirectly funded experiments on coronaviruses that may have led to the creation and accidental release of the COVID-19 virus. 

"It seems like he was very troubled early on that there was gain of function. He's like ‘What, is gain of function still going on? I thought we paused it.' He seemed unclear about whether or not the gain-of-function research, how it got started again in Wuhan," Paul said on the "Tom Roten Morning Show" Wednesday. "And I think he was very concerned – although he doesn't say it in the email – concerned that he continued to fund it through NIH even though there weren't doing gain of function."

Some are also upset about correspondence between Fauci and a man named Peter Daszak. Daszak's organization EcoHealth received millions in grants from the National Institutes of Health (NIH), including a $600,000 grant from Fauci's agency, the National Institute of Allergy and Infectious Diseases (NIAID) that it later paid to the Wuhan Institute of Virology to study the risk that bat coronaviruses could infect humans.

"I just wanted to say a personal thank you on behalf of our staff and collaborators, for publicly standing up and stating that the scientific evidence supports a natural origin for COVID-19 from a bat-to-human spillover, not a lab release from the Wuhan Institute of Virology," Daszak said in an email. Fauci replied: "Many thanks for your kind note." 

Daszak was also notably on the World Health Organization team that investigated the Wuhan Institute of Virology earlier this year, an inquiry that's been panned even by the Biden White House as lacking transparency. 

"These emails show that Dr. Fauci coordinated with one of the Wuhan Lab's funders to cover-up the plausible notion that the virus could have come from inside the lab. Dr. Fauci needs to stop playing games and answer questions about his role in funding the very lab that may have unleashed this pandemic on the world," Sen. Tom Cotton, R-Ark., said in a statement to Fox News Wednesday. 

"It's all so incestuous," Paul added on the Tom Roten Morning Show. 

The NIAID did not immediately respond to a request for comment from Fox News on Hawley's call for Fauci to resign. NIAID did not respond to a request for comment from Fox News earlier this week about the content of Fauci's emails and the backlash against him. 

The White House, which has elevated Fauci's role to a top adviser to President Biden, meanwhile, is standing by Fauci amid the fallout from his emails. 

"The President and the administration feel that Dr. Fauci has played an incredible role in getting the pandemic under control, being a voice to the public throughout the course of this pandemic," Press Secretary Jen Psaki said Thursday when asked if the emails changed the White House's confidence in Fauci. "And, again, I would reiterate a lot of these emails are from 17 months ago or more, certainly predating this administration, but some time ago in — as we look to history."

https://www.foxnews.com/politics/josh-hawley-fauci-resign-investigation-covid-origins

Coherus BioSciences Sees Positive Results From Toripalimab Study

 Coherus BioSciences Inc. and Shanghai Junshi Biosciences Co. said they saw positive results from a study evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

The companies said the interim analysis met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression free survival compared with chemotherapy alone.

The study also met secondary endpoints of progression free survival assessed by the investigator and objective response rate assessed by a blinded independent review committee. There also was a longer duration of response, a higher disease control rate and higher one- and two-year survival rates for the toripalimab arm.

The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.

https://www.marketscreener.com/quote/stock/COHERUS-BIOSCIENCES-INC-18460920/news/Coherus-BioSciences-Sees-Positive-Results-From-Toripalimab-Study-35518177/

Surface Oncology in Clinical Trial Collaboration With Roche

 Surface Oncology Inc. on Friday said it is in a clinical trial collaboration with Roche Holding AG to evaluate SRF388 in combination with Roche's atezolizumab and bevacizumab in patients with treatment-naive hepatocellular carcinoma.

The clinical-stage immuno-oncology company said atezolizumab plus bevacizumab has been shown to significantly improve overall survival and is the new standard of care for unresectable or metastatic HCC. Surface said the addition of SRF388 to the proven efficacy of the atezolizumab/bevacizumab regimen has the "potential to further improve outcomes in this challenging disease."

Surface Oncology shares were up 4% to $9.42 in premarket trading.

Surface Oncology also said Friday that SRF388 demonstrated monotherapy activity in data being presented at the American Society of Clinical Oncology Annual Meeting. Surface said SRF388 produced a partial response in a heavily pretreated patient with lung cancer.

Preliminary SRF388 results indicate promising single-agent activity in a heavily pretreated population, including a confirmed partial response demonstrating 66% tumor shrinkage and symptomatic improvement in a patient with squamous cell non-small-cell lung carcinoma.

https://www.marketscreener.com/quote/stock/SURFACE-ONCOLOGY-INC-42796669/news/Surface-Oncology-in-Clinical-Trial-Collaboration-With-Roche-35520640/

Investors, patients await FDA decision on Biogen Alzheimer's drug due Monday

 

U.S. regulators are slated to decided by Monday whether to approve Biogen Inc's controversial Alzheimer's disease drug, and Wall Street analysts and industry observers are deeply divided on its chances of making it over the finish line.

Given the desperate need for anything that can help patients with the mind-wasting disease, some analysts are betting on approval, while others put the chances well below 50%.

If approved, Biogen's aducanumab would be the first treatment to address an underlying cause of the memory-robbing, condition, which is the sixth leading cause of death in the United States.

The Food and Drug Administration decision will impact not only Biogen and its partner Eisai Co Ltd, but other drugmakers developing Alzheimer's drugs such as Eli Lilly and Co. And, as a signal of the agency's permissiveness, the decision could have ramifications for other neurological treatments and the broader pharmaceutical industry.

Aducanumab is an antibody designed to remove amyloid plaque from the brain, but only one of two large-scale trials showed that it significantly slowed progression of the disease. All previous experimental medicines employing the same approach to Alzheimer's so far have failed. Patient advocates are lobbying for the drug to be approved, citing the high unmet medical need, but many doctors remain skeptical.

A panel of outside advisers to the FDA voted in November that aducanumab had not been proven to slow Alzheimer's progression, despite a report from agency staff that said results from the successful trial were persuasive.

"We support a decision for approval of aducanumab ... It ushers in a new era of potential treatments," Dr. Joanne Pike, chief strategy officer at the Alzheimer's Association, told Reuters.

Oppenheimer last month raised to 50% from 33% its odds for an aducanumab approval, citing comments from Biogen that it is preparing for a commercial launch. "If the FDA approves aducanumab, (Biogen) could go to circa $400, and if not, to circa $200," Mizuho Securities analyst Salim Syed said in a recent research note.

Biogen shares were trading near $271 on Thursday, down from their 52-week high of $355.63 reached in November before the advisory committee vote. Bank of America Securities analyst Geoff Meacham said in an interview that he puts the odds at 75% that the FDA will not approve Biogen's drug.

Others said approval remains possible. "I am going out on a limb, saying a two in three chance or so," ISI Group analyst Umer Raffat said in a recent webcast.

Analysts have also speculated that the FDA could proffer a narrow approval - limiting aducanumab's use to certain patients, for instance, or requiring more data to prove that the drug is effective.

Biogen declined to comment on whether the FDA may make such a move.

The FDA's decision may be viewed as a barometer for how strict the agency will be under the Biden administration, which has yet to name an FDA commissioner. Currently, the agency is being run by Acting Commissioner Janet Woodcock.

"If the FDA does approve, I think it could signal probably more regulatory flexibility," BofA's Meacham said.

Aducanumab was studied in patients with early disease who test positive for a component of amyloid brain plaques. Some trial patients needed to be monitored for brain swelling. Biogen estimates that around 1.5 million Americans would be eligible for the drug, which is given by monthly infusion, raising concerns about costs for both diagnostics and treatment. Analysts project annual aducanumab sales of $1.26 billion by 2023, according to Refinitiv data.

https://www.marketscreener.com/quote/stock/EISAI-CO-LTD-6492461/news/Eisai-nbsp-Investors-patients-await-FDA-decision-on-Biogen-Alzheimer-s-drug-due-Monday-35518334/

Putin Plans to Offer Vaccinations to Visiting Foreigners for a Fee

 Russia may provide coronavirus vaccinations for a fee to foreigners who travel to the country, President Vladimir Putin told an economic forum on Friday, as Moscow seeks to enhance its global reputation with its Sputnik V vaccine.

Addressing the St Petersburg International Economic Forum (SPIEF), Putin said many people are coming to Russia to get a shot. "I am asking the government to study this issue in full by the end of the month, to establish conditions for foreign citizens to get vaccinated in our country for a fee," he said without providing more detail.

The Russian vaccine has been approved by 66 nations and is under review both by the World Health Organization and the European Medicines Agency(EMA). Approval by the latter agency is required for use in the European Union.

The pace of vaccination in Russia has been slower than in many developed countries. The health minister said last week around 17 million of Russia's 144 million people had received at least one dose.

Those attending the conference were required to have coronavirus tests and wear masks and gloves. Moscow pitches the gathering as the Russian version of the annual World Economic Forum in Davos, Switzerland. Many other big global events were either cancelled or moved online amid the pandemic.

Attended by a couple thousand people, the SPIEF is intended to attract foreign investment to Russia, but activity was more subdued this year.

Rosneft, Russia's top oil company, skipped its usual booth, and its CEO, Igor Sechin, decided against running a public panel about the global oil market as he has traditionally done.

Sechin, in a mask and gloves, told a Reuters correspondent to "mind a distance" when approached. The former and current CEOs of BP Plc, Bob Dudley and Bernard Looney, were there in masks. BP holds a 19.75% stake in Rosneft.

https://www.usnews.com/news/world/articles/2021-06-04/putin-plans-to-offer-vaccinations-to-visiting-foreigners-for-a-fee