French Health Authority Warns Men Under 30 To Avoid Moderna Jab

 In the wake of a weak earnings report that sent Moderna shares cratering last week, French health authorities have just released a new advisory recommending that people under 30 don't get the Moderna vaccine, recommending that they choose the Pfizer-BioNTech jab instead.

The decision draws on recently released data showing that the risk of heart inflammation from Pfizer's jab "appears to be around five times lesser...compared to Modera's spikevax jab", per an opinion published by the HAS.

Cases of myocarditis mostly manifest within 7 days of vaccination, typically after the second dose has been given. Most patients who experience side effects are typically men under the age of 30, according to the HAS, which cited research studies.

HAS acts as an advisor to the French health sector but it doesn't have the power to ban medicines or vaccines. The recommendation will apply to first and second doses, as well as a any "booster shot" doses available while the agency awaits additional data.

For French men and women aged 30 and over, however, HAS says it sees no problem with administering Moderna's Spikevax in this group, stating that its efficacy was slightly higher than Pfizer-BioNTech's jab.

Last month saw a handful of Nordic nations place varying restrictions on Moderna’s vaccine.

Tiny Iceland, meanwhile, has banned the Moderna jab from being used across the entire population. 

Initially. Stockholm announced it would pause the use of Moderna for all of its population born in 1991 or after.

Helsinki followed suit, but halted the jabs for young, male Finns only based on a study involving Finland, Denmark, Norway, and Sweden which found that men under 30 had a slightly higher risk of developing heart inflammation. Oslo also suggested that young Norwegian men should consider choosing Comirnaty, the Pfizer jab, over Moderna's or any of the other options.

The EMA, the EU's medical watchdog, has acknowledged that inflammatory conditions like myocarditis and pericarditis, two different types of heart inflammation, should be added to a list of rare side effects from the vaccines that could be potentially harmful.

https://www.zerohedge.com/covid-19/french-health-authority-warns-men-under-30-avoid-moderna-jab

Valneva wins deal with European Commission over COVID-19 vaccines

  French vaccines company Valneva said it had won approval from the European Commission for a deal under which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years.

The European Commission will also have the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023.

“We are grateful to the European Commission for its support and are eager to help address the ongoing pandemic,” said Valneva chief executive Thomas Lingelbach.

https://www.reuters.com/article/health-coronavirus-valneva/french-company-valneva-wins-deal-with-european-commission-over-covid-19-vaccines-idUSASN001VB4

Feds Seek To Block Promotion Of Nasal Spray Against COVID-19

 by Alice Giordano via The Epoch Times (emphasis ours),

The leading U.S. manufacturer of xylitol-based products says the federal government is deliberately trying to conceal a nasal spray it developed that it says has been scientifically proven to be effective in treating and preventing COVID-19.

The U.S. Department of Justice filed a lawsuit in federal court against Utah-based company Xlear on Oct. 28, saying it has deceptively advertised its nasal spray as a treatment and preventative of COVID-19.

The lawsuit asks a federal court to permanently ban the company from promoting the nasal spray as a treatment for COVID-19 and also asks that monetary penalties be levied against it.

COVID-19 is the disease caused by SARS-CoV-2, commonly known as the novel coronavirus.

The DOJ filed the complaint on behalf of the Federal Trade Commission, which alleges the company has violated the Federal Trade Commission Act and the Consumer Protection Act by making false claims about the benefits.

The spray’s main ingredients are saline, grapefruit seed extract, and xylitol, a plant-derived sweetener commonly used in oral care products.

“Companies can’t make unsupported health claims, no matter what form a product takes, or what it supposedly prevents or treats,” said Samuel Levine, director of the trade commission’s Bureau of Consumer Protection, said in a press release on the lawsuit.

“That’s the lesson of this case and many others like it, and it’s why people should continue to rely on medical professionals over ads.”

The commission and the Justice Department declined to make any further comment.

Xlear’s attorney Robert Housman, of the Washington firm Book Hill Partners, told The Epoch Times that the commission is “flat out lying” about the company’s claims being unsupported.

Housman pointed out that the National Institute of Allergy and Infectious Diseases (NIAID)—along with the National Institutes of Health (NIH), an arm of the Department of Health and Human Services—funded clinical studies of the use of nasal sprays like Xlear’s and published findings last year that found they were an effective treatment and method of prevention for COVID-19.

“When Xlear tells people about scientific studies, even ones republished by the NIH, we are somehow misleading people and making false claims. It’s nonsensical,” Housman told The Epoch Times.

“Rather than embrace nasal interventions, the government is trying to eliminate their use because they don’t fit the government’s highly flawed, vaccine-only agenda.”

On Sept. 20, 2020, the NIH and NIAID published the findings of a random clinical trial they funded at the Vanderbilt University Medical Center in Tennessee on the merits of using hypertonic nasal saline irrigations to combat the CCP virus.

The researchers in that study wrote that the “effect of nasal irrigation on symptom resolution was substantial,” reporting that “nasal congestion and headaches in COVID patients resolved an average seven to nine days earlier” in the study group.

“Our analysis suggests that nasal irrigations may shorten symptom duration and may have potential as a widely available and inexpensive intervention to reduce disease burden among those affected,” the researchers wrote in their findings.

“We would advocate the use of hypertonic nasal saline irrigations in non-hospitalized COVID-19 patients as a safe and inexpensive intervention to reduce symptom burden.”

Housman pointed out that the NIH also published the results of a clinical trial, held a few months later in November at the Larkin Community Hospital in Florida, that found the Xlear nasal spray specifically cleared symptoms of the disease in half the time.

In addition to the Tennessee and Florida trials, another random clinical trial—more recently conducted at Augusta University’s Emergency Department in Georgia—also concluded that the use of nasal spray was beneficial in treating COVID-19.

Researchers in the university trial, which is still ongoing, have so far found that patients with the CCP virus that participated in daily nasal irrigation were eight times less likely to be hospitalized than the national rate.

The Justice Department didn’t specifically cite the Larkin, Vanderbilt, or Augusta trials in its lawsuit.

It instead cited the results of lab studies conducted earlier at the University of North Carolina–Chapel Hill and the University of Tennessee involving in vitro and animal testing, neither of which the DOJ and FTC argue is a viable way to test nasal spray for live, human COVID-19 patients.

The lawsuit additionally pointed out that the University of Tennessee study is based on a nasal spray containing iota-carrageenan, which the Xlear spray does not contain and, therefore, cannot be used as scientific evidence to support Xlear’s claims.

The lawsuit also stated that researchers at Chapel Hill admitted that without further research it couldn’t conclusively determine that  “administering treatment through the nose is the best way to treat COVID-19.”

Housman said the trade commission cherry-picked findings within the lab studies to make them fit its agenda.

The federal government has warned companies against promoting nasal sprays for the treatment and prevention of COVID-19.

BlueWillow Biologics, a Michigan biopharmaceutical company that manufactures a nasal antiseptic, and the Miami-based company Halodine, which created a proprietary iodine-based nasal antiseptic swab, both received warning letters earlier this year from the FDA to discontinue their promotion of their nasal products as a safe and effective treatment for COVID-19.

https://www.zerohedge.com/covid-19/feds-seek-block-promotion-nasal-spray-against-covid-19

Kansas state lawmakers move to protect employees who refuse COVID-19 vaccine

 Kansas state lawmakers are pushing to enact legislation that will protect workers who refuse to get the COVID-19 vaccine.

The state's Senate president, Ty Masterson (R), urged lawmakers Tuesday to reconvene for a special session before Thanksgiving to consider proposals that will make it easier for workers to use religious exemptions from vaccine mandates, The Associated Press reported.

The proposals also push for workers to get unemployment benefits if they're fired for not getting the shot.

Masterson blasted what he called "all this garbage" from the Biden administration, the AP reported.

The GOP-controlled legislature is able to call a special session without Democratic Gov. Laura Kelly if two-thirds of lawmakers sign a petition.

The state legislature's Special Committee on Government Overreach and the Impact of COVID-19 Mandates on Tuesday endorsed calling a special session soon, the AP reported. State Rep. Stephen Owens (R), a member of the panel, told the outlet that "we now have a plan."

The news comes after Kelly last week came out against President Biden’s COVID-19 vaccine mandate for businesses with 100 or more employees, arguing that it's not the "correct" or "most effective" strategy for combating the virus. 

https://thehill.com/homenews/state-watch/580847-kansas-gop-moves-to-protect-employees-who-refuse-covid-19-vaccine

Moderna and NIH can't agree on who invented the lifesaving Covid-19 vaccine

 Moderna’s ongoing feud with the NIH over Covid-19 vaccine patents has spilled into the open.

In a new report from the New York Times published Tuesday afternoon, Moderna is asserting that three NIH scientists were not involved in inventing the key component in the biotech’s vaccine, to the surprise of the institute. The claim comes from a July filing with the US Patent and Trademark Office, which the NYT posted in full along with its report.

Within the filing, Moderna said it had “reached the good-faith determination” that three NIH scientists — John Mascola, Barney Graham and Kizzmekia Corbett — “did not co-invent” the sequence that prompts the body’s immune response to the coronavirus spike protein. The NIH, meanwhile, says the trio worked with Moderna at the outset of the pandemic to design the component in question.

In response to an Endpoints News request for comment, a Moderna spokesperson said the company has “all along” recognized the role the NIH played in developing the Covid-19 shot. But the spokesperson insisted only Moderna scientists invented mRNA-1273 — the codename for the company’s vaccine.

The spokesperson also claimed that Moderna wasn’t not allowed to “choose” who to list on the patent application, per US law. It’s not clear to which law or laws Moderna is referring to.

“Following those rules, as we must, Moderna is required to only list Moderna scientists as the inventors for the patent claims to mRNA-1273,” the spokesperson wrote in an email. “Moderna’s conclusion is driven by nothing other than our obligation to comply with U.S. patent law.”

Endpoints has also reached out to the NIH and will update this story accordingly.

The patent has not yet been issued, and the NIH is reportedly insisting the three scientists be included on the application.

At the center of the debate is whether Moderna’s Covid-19 vaccine originally sprung from a collaboration between the biotech and the institute, as the pair had been researching other coronaviruses for four years when SARS-CoV-2 first emerged. The NIH called the shot the “NIH-Moderna vaccine” in press releases last year at the Phase III readout, though Moderna CEO Stéphane Bancel pushed back on that description in an interview with MIT Technology Review.

Should the PTO issue Moderna a patent based on the current application, the government would have to go to court to obtain a license. It’s not clear when the PTO is expected to make its decision.

Moderna’s back-and-forth with the NIH has been ongoing for over a year now. The NYT reports that the agency would not need Moderna’s permission to license the vaccine technology to other companies, countries or organizations if the scientists are named on the patent. Such a move could, theoretically, help boost vaccine supply.

The biotech has said previously it won’t enforce its patents during the pandemic, but the NIH backing would provide the authority of the US government rather than just a public company statement. The NIH could also benefit financially from its researchers being listed, though it’s not clear how much, the NYT’s report says.

Tuesday’s report comes as President Joe Biden’s administration has been ramping up pressure and criticism on Moderna for primarily selling vaccines to wealthier countries, despite pulling in billions of dollars in profits, and resisting calls to share its vaccine IP. Last week, Public Citizen also called on Moderna to “clarify” the NIH’s role in inventing the vaccine tech in a letter to agency director Francis Collins.

In the new book A Shot to Save the World out last month detailing the inventions of the mRNA Covid-19 vaccines, Wall Street Journal reporter Gregory Zuckerman wrote the three NIH scientists in question designed a sequence for a vaccine and sent it to Moderna. The biotech then used it to confirm their own designs and produce that vaccine.

Zuckerman wrote:

On Thursday, January 23, Wang packed his material in a container, trying hard to ensure it didn’t leak, and shipped it all to Kizzmekia Corbett, the government scientist who was doing similar work with other’s in Graham’s lab. Corbett, Graham and John Mascola chose an ideal spike-protein design and sent it to Moderna. The company’s scientists, relying on McLellan and Wang’s earlier work, had built their own spike-protein design. It matched the one from the government scientists, confirming they made the right choice. Moderna took their chosen sequence, employed some sophisticated computer software, and built an mRNA molecule capable of producing the stabilized spike protein. This would become Moderna’s vaccine antigen.

https://endpts.com/moderna-and-nih-cant-agree-on-who-invented-the-lifesaving-covid-19-vaccine-and-their-feud-is-now-public-report/

Lack of important molecule in red blood cells causes vascular damage in type 2 diabetes

 Altered function of the red blood cells leads to vascular damage in type 2 diabetes. Results from a new study in cells from patients with type 2 diabetes and mice show that this effect is caused by low levels of an important molecule in the red blood cells. The study by researchers at Karolinska Institutet in Sweden has been published in the journal Diabetes.

It is well known that patients with type 2 diabetes have an increased risk of cardiovascular disease. Overtime type 2 diabetes may damage blood vessels, which could lead to life-threatening complications such as heart attack and stroke. However, the disease mechanisms underlying cardiovascular injury in type 2 diabetes are largely unknown and there is currently a lack of treatments to prevent such injuries.

In recent years, research has shown that the red blood cells, whose most important job is to transport oxygen to bodily organs, become dysfunctional in type 2 diabetes and can act as mediators of vascular complications. In the current study, researchers at Karolinska Institutet have in cells from patients with type 2 diabetes and mice examined which molecular changes in the red blood cells could explain these harmful effects in type 2 diabetes.

The researchers found that levels of the small molecule microRNA-210 were markedly reduced in red blood cells from 36 patients with type 2 diabetes compared with red blood cells of 32 healthy subjects. Micro-RNAs belong to a group of molecules that serve as regulators of vascular function in diabetes and other conditions. The reduction in microRNA-210 caused alterations in specific vascular protein levels, and impaired blood vessel endothelial cell function. In laboratory experiments, restoration of microRNA-210 levels in red blood cells prevented the development of vascular injury via specific molecular changes.

“The findings demonstrate a previously unrecognized cause of vascular injury in type 2 diabetes,” says Zhichao Zhou, researcher at the Department of Medicine, Solna, Karolinska Institutet, who conducted the study in collaboration with among others Professor John Pernow at the same department. “We hope that the results will pave the way for new therapies that increase red blood cell microRNA-210 levels and thereby prevent vascular injury in patients with type 2 diabetes.”

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Story Source:

Materials provided by Karolinska Institutet. Note: Content may be edited for style and length.

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Journal Reference:

1. Zhichao Zhou, Aida Collado, Changyan Sun, Yahor Tratsiakovich, Ali Mahdi, Hanna Winter, Ekaterina Chernogubova, Till Seime, Sampath Narayanan, Tong Jiao, Hong Jin, Michael Alvarsson, Xiaowei Zheng, Jiangning Yang, Ulf Hedin, Sergiu-Bogdan Catrina, Lars Maegdefessel, John Pernow. Downregulation of Erythrocyte miR-210 Induces Endothelial Dysfunction in Type 2 Diabetes. Diabetes, 2021; db210093 DOI: 10.2337/db21-0093

https://www.sciencedaily.com/releases/2021/11/211109080857.htm

Swiss socialists say government should buy Sandoz

 Switzerland’s Social Democratic Party has argued that the government should step in and acquire Novartis’ generics unit Sandoz if the company decides to sell it, according to local press reports.

The largest left-leaning party in Switzerland said that national ownership of Sandoz would democratise the production and development of new medicines, maintain a stable supply of affordable drugs, and allow less profitable R&D to be carried out with state support.

Novartis said last month it was considering options for Sandoz – which could involve a spin-off or outright sale or retaining the business –  to “maximise shareholder value,” but has said it may not take a decision until the end of 2022.

The generics drug unit has seen its sales and operating income come under pressure of late, thanks largely to downward pricing pressure that has been particularly strong in the US, as well as rising competition in the generics market.

In its third-quarter results, Novartis reported that Sandoz’ sales fell 4% to $7.11 billion in the first nine months of the year, and were down 17% in the US.

Novartis is working with Bank of America and UBS Group to explore the future of the business, which Bloomberg has suggested could be valued at more than $20 billion as a standalone business.

A motion tabled by the party’s executive suggests that the federal government should buy Sandoz directly or indirectly, and potentially together with partners.

The Socials Democrats’ position takes into account the impact of the pandemic, which exposed how much European nations are reliant on finished pharmaceuticals and raw materials from elsewhere in the world.

The motion notes that Sandoz produces 15 drugs that reduce the symptoms of COVID-19, and also references the company’s role in the supply of antibiotics.

Bloomberg says nationalisation of Sandoz is unlikely, “not least because voters in cost-conscious Switzerland probably would reject the expenditure.”

https://pharmaphorum.com/news/swiss-socialists-say-government-should-buy-sandoz/