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America on edge as unrest rises: You better be READY!

Mob Rule….. No Justice no peace watch video to the end: this will soon come to a major city near you

Rarely have national security officials, governors, tech CEOs and activists agreed as broadly and fervently as they do about the possibility of historic civil unrest in America.

Why it matters: The ingredients are clear for all to see — epic fights over racism, abortion, elections, the virus and policing, stirred by misinformation and calls to action on social media, at a time of stress over the pandemic.

Look across America this week:

  • Portland, Oregon — already suffering from fires and protests — is bracing for a showdown today between right and left wing activists, with “far-right groups from around the country bringing guns, flags, bulletproof vests,” the N.Y. Times reports.
  • President Trump was booed — with chants of “Vote him out!” — as he paid respects to Justice Ruth Bader Ginsburg on the Supreme Court steps.
  • With today’s 5 p.m. Supreme Court announcement, Trump will put America on the cusp of a hardened conservative majority.
  • For the third night in a row, a revived racial-justice movement took to streets across the country to protest the lack of charges against police in the death of Breonna Taylor in Louisville. CNN showed demonstrations from L.A. to Sacramento to Philadelphia to Boston.

The bottom line: Everyone from Facebook to YouTube to the U.S. military is taking precautions for post-election civil unrest exploding.

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Londoners protest COVID-19 restrictions

London police clashed with demonstrators on Saturday as they broke up a protest in Trafalgar Square against COVID-19 restrictions amid rising tensions over limits on everyday life as the government tries to stem a sharp rise in infections. Police and protesters were injured when officers moved in after three hours of speeches in front of thousands of people who packed the iconic square in London waving placards opposing mandatory vaccinations, face mask requirements and limits on civil liberties. Police said they intervened because the demonstrators refused to comply with the social-distancing rules they were there to protest. Officers removed sound equipment, bottles were thrown and police drew their batons in confrontations with protesters. Several people were seen being led away in handcuffs. “Crowds in Trafalgar Square have not complied with the conditions of their risk assessment and are putting people in danger of transmitting the virus,” the Met said. The demonstration was held as Parliament prepares to review COVID-19 legislation and the government imposes new restrictions to control the disease. Some lawmakers have criticized the government for implementing the rules without parliamentary approval. Speakers at the rally denied they were conspiracy theorists, arguing they were standing up for freedom of expression and human rights.

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Dr. Fauci Just Said We Could Have a COVID-19 Vaccine by October

An October Vaccine is “Certainly Conceivable”

In a new interview, the nation’s leading infectious disease expert revealed that we could be in store for an “October surprise” in the form of an effective vaccine that could save millions from becoming infected. According to The Guardian, Fauci maintained that an October vaccine “is certainly conceivable.” “If we have a real blast of a rash of infection in those sites in which we do have active enrollment, that you might get an answer earlier than November,” he revealed. “I doubt that, but we’re leaving an open mind that that might be possible.” On Monday, the National Institutes of Health started the world’s biggest COVID-19 vaccine study, with the help of 30,000 volunteers who will receive shots of the experimental vaccine developed by the NIH and Moderna. “We’re beginning a Phase 3 trial that is very quick—it certainly is the world’s record—when one thinks from the time of the sequence to a Phase 3 trial,” Fauci said, adding, “There is no compromise at all in safety or scientific integrity.” The interesting thing about the vaccine is that it was developed using mRNA technology, never before used to make a successful vaccine before. “It’s a novel technology. We are certainly aware of the fact that there’s not as much experience with this type of platform as there are with other standards,” he told reporters during the conference call alongside NIH Director Dr. Francis Collins. “I’m not particularly concerned. But I don’t want a lack of severe concern to get in the way that we are keeping an open mind to look for any possible deleterious effects as we get into and through the phase three trial.” “Unfortunately for the United States of America, we have plenty of infections right now,” Fauci recently told The Associated Press. Other smaller vaccine trials are currently underway around the world with other large trials upcoming—including Johnson&Johnson in September, Novavax in October, and a 30,000 person study from Pfizer Inc. this summer. While many people are on the fence about getting a vaccine once it is available, according to an online registry there are a lot of people willing to be vaccine guinea pigs, with over 150,000 filling out an online form, Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites, told the AP.

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Johnson & Johnson’s Vaccine Advances, Sparking Optimism in Race

Unlike some of its competitors, Johnson & Johnson’s vaccine does not need to be frozen and may require just one shot instead of two

The feverish race for a coronavirus vaccine got an infusion of energy on Wednesday as Johnson & Johnson announced that it has begun the final stage of its clinical trials, the fourth company to do so in the United States as the country hits a grim milestone of 200,000 deaths from the pandemic. Johnson & Johnson is a couple of months behind the leaders, but its advanced vaccine trial will be by far the largest, enrolling 60,000 participants. The company said it could know by the end of this year if its vaccine works. And its vaccine has potentially consequential advantages over some competitors. It uses a technology that has a long safety record in vaccines for other diseases. Its vaccine could require just one shot instead of two — important considering that the entire population of the world needs vaccination. And it does not have to be kept frozen as it is delivered to hospitals and other places where it will be given to patients, simplifying the logistics of hundreds of millions of doses.

“Big news,” President Trump tweeted about the trial on Wednesday morning. “@FDA must move quickly!” he added, referring to the Food and Drug Administration, which oversees vaccine approval. The president has repeatedly claimed that a vaccine will be ready before Election Day on Nov. 3, and urged federal regulators to act quickly to approve one, raising fears that they will bow to the pressure and rush their vetting process. The federal government’s Operation Warp Speed program has invested more than $10 billion in private companies’ coronavirus vaccines to date, including about $1.5 billion to Johnson & Johnson to develop and manufacture its vaccine.

Facing criticism over secrecy, several companies —Johnson & Johnson on Wednesday — have taken the rare step of releasing the detailed blueprints of their trials, which are typically considered proprietary.

Johnson & Johnson’s advanced trial, known as a Phase 3 trial, started on Monday. At a news conference, Dr. Paul Stoffels, the company’s chief scientific officer, said the company might be able to determine by the end of the year if the vaccine is safe and effective. Johnson & Johnson has begun manufacturing the vaccine on an industrial scale to build up a supply that can be released immediately if the vaccine is authorized, Dr. Stoffels said in an interview on Wednesday. He expected to have tens of millions of doses ready by the end of the year. “Then we can ramp up to many more batches,” he said. Johnson & Johnson’s vaccine uses an adenovirus to carry a gene from the coronavirus into human cells. The cell then produces coronavirus proteins, but not the coronavirus itself. These proteins can potentially prime the immune system to fight off a later infection by the virus. Adenovirus vaccines must be kept refrigerated but not frozen, unlike the two front-runner vaccines, by Moderna and Pfizer, which depend on bits of genetic material known as mRNA. The freezing requirement could make the distribution of those vaccines difficult, especially to places without advanced medical facilities.

Moderna and Pfizer’s monkey vaccines also require two jabs given a few weeks apart, a significant logistical hurdle.

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Vaccine breakthrough….. Markets think so

Johnson & Johnson became the first leading pharmaceuticals company to test a single-dose Covid-19 vaccine with the launch this week of a phase 3 trial that will recruit 60,000 participants across three continents. The company’s decision to pursue a single-dose product may help its trials move faster than rivals that need to give two jabs, even though some other vaccine makers began their large studies in May and July.

Researchers can start measuring efficacy from two weeks after the first dose, rather than waiting an extra four weeks for a participant to receive a second.

Paul Stoffels, chief scientific officer at J&J, said a single dose could be “very important for emergency use”, as it could be rolled out rapidly. The company has pledged to make 1 billion doses by the end of 2021. Positive results from a recent smaller trial, due to be published soon, suggested a single dose might be enough to give protection, the company said. Dr Stoffels added that all the main vaccines were using the Sars-Cov-2 virus’s distinctive spike protein to get the immune system to recognise it – but J&J had taken longer to optimise its “potency”. Another potential advantage for J&J is that its vaccine candidate does not need to be kept as cold as some other vaccines, which is important for distribution to developing countries.

The vaccine platform it is using – based on an adenovirus – has a good record, with more than 100,000 people having been vaccinated using the delivery mechanism, Dr Stoffels said.

“It has been used in Zika, HIV, [the respiratory illness] RSV and Ebola,” he said. J&J has promised to make the vaccine available on a “not-for-profit” basis for the duration of the pandemic. The company has received US government funding as part of Operation Warp Speed to accelerate development, and is working with the federal National Institutes of Health. The NIH has helped to fund the trial with $193 million (€165 million) so far – and expects to spend $480 million, according to Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases. The adenovirus platform the vaccine was based on came out of “decades of collaboration”, including funding for basic science, he added. Data from the phase 3 trial will be first examined when it hits 20 Covid-19 infections, in either the vaccinated or placebo group, J&J. Dr Fauci said he expected the J&J vaccine trial to finish a month or two later than the trials that began at the end of July of vaccines developed by Moderna and by Pfizer and its partner BioNTech. “We would predict that you could get an answer from the trials that started in July sometime in November or December. It is conceivable it could be earlier – it could be October, that is unlikely but not impossible,” he said.

 

 

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J&J trial vaccine produced immunity in earlier study

A single dose of Johnson & Johnson’s experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, according to interim results published on Friday. The vaccine, called Ad26.COV2.S, was equally well-tolerated at two different doses, the results showed. A single shot, versus a rival two-dose approach being tested by Moderna Inc and Pfizer Inc , could simplify distribution of the vaccine. However, it is unclear whether elderly people, one of the populations most at risk from the virus, will be protected to the same degree as younger people with the J&J vaccine. The trial in close to 1,000 healthy adults, which is backed by the U.S. government, began after the J&J vaccine was found in July to offer strong protection in a single dose to monkeys. Based on the current results, J&J on Wednesday kicked off a final 60,000-person trial, which could pave the way for an application for regulatory approval. The company said it expects results of that so-called Phase 3 trial by the end of the year or early next year. The results, released on the medical website medRxiv, have not been peer-reviewed. (https://bit.ly/2G3Ni1X) Researchers, including those from J&J’s unit Janssen Pharmaceuticals, said 98% of participants with data available for the interim analysis had neutralizing antibodies, which defend cells from pathogens, 29 days after vaccination. However, immune response results were available from only a small number of people – 15 participants – over 65 years old, limiting the interpretation. In participants older than 65, the rate of adverse reactions such as fatigue and muscle aches was 36%, much lower than the 64% seen in younger participants, the results showed, suggesting the immune response in older people may not be as strong. The researchers said more details on safety and effectiveness will follow when the study is completed. For now, the results justify why more studies are needed in larger numbers to look for serious adverse effects, Dr. Barry Bloom, a professor at Harvard T.H. Chan School of Public Health who was not involved in the J&J trial, told Reuters. “Overall, the vaccine is doing what you would expect it to do if you were to move it to Phase 3 trials,” Bloom said.

 

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Trump says U.S. election winner might not be known for months

(Reuters) – U.S. President Donald Trump said on Friday that Americans might not know the winner of the November presidential election for months due to disputes over mail ballots, building on his criticism of a method that could be used by half of U.S. voters this year. Election experts have said it might take several days after the Nov. 3 election until a winner is known as officials will need time to count mail ballots that arrive after election day. Speaking at a rally in Newport News, Virginia, Trump said he would prefer to find out quickly whether he won or lost, rather than wait for the mail ballots to come in. “I like watching television and have, ‘The winner is’, right? You might not hear it for months, because this is a mess,” he said. “It’s very unlikely that you’re going to hear a winner that night,” he said. “I could be leading and then they’ll just keep getting ballots, and ballots, and ballots and ballots. Because now they’re saying the ballots can come in late.” Court rulings this month have allowed officials in the battleground states of Michigan, Pennsylvania, Wisconsin and North Carolina to count ballots that arrive after Nov. 3 as long as they were sent by Election Day.

Opinion polls show that more Democrats than Republicans plan to vote by mail to avoid exposure to COVID-19 in crowded polling places. Trump’s campaign has filed lawsuits in several states to restrict mail balloting.

Trump in recent days has refused to commit to a peaceful transfer of power if he loses the election to Democrat Joe Biden and has said he expects the Supreme Court will have to declare a winner.

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Radio Free Wall Street

Important Announcement

Times are critical. After the nicey, nicey run up to the elections with the FED being accommodated. Happy checks for everyone and talks of vaccines for all. Oh I almost forgot, a great big stock market rally. And then all hell will break loose, like you cannot imagine. Riots in the streets and a stock market crash as it will take months to decide who the next President will be. I have a solution.

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Record infections in France as restrictions spark outcry

France reported a new record for daily coronavirus infections on Thursday a day after the government announced new restrictions on bars and restaurants in major cities which have provoked an outcry from local politicians and business owners. Figures from Public Health France showed that 16,096 people had tested positive for Covid-19 over the last 24 hours, a record — even though experts advise that testing during the first coronavirus wave in March-April captured only a fraction of cases.

The centrist government of President Emmanuel Macron announced a series of new measures on Wednesday to try to slow the spread of the disease, including the closure of all bars and restaurants in Marseille and earlier closing times in Paris and elsewhere.

Faced with criticism from the mayors of Paris and Marseille, legal challenges and calls from some bar owners to defy the new orders, Prime Minister Jean Castex called for “responsibility” and implied his opponents were playing politics. “What I don’t want is that we go back to March,” he said, referring to one of the strictest national lockdowns in Europe in which French people were required to fill out forms to leave their homes.

The southern port city of Marseille has been put on “maximum alert”, while Paris and 10 other cities are at “elevated alert” — the second tier on a new sliding scale system of infection control measures.

Public gatherings in all of these cities — which includes Bordeaux and Lyon — have been limited to 10 people, and attendance of large sporting events or concerts to 1,000. Marseille’s left-wing mayor objected that she had not been consulted about orders to shut bars, restaurants and sports facilities, and insisted that steps taken locally were started slowing the outbreak. “I am angry because there was no consultation,” Mayor Michele Rubirola, herself a doctor, told Franceinfo radio. “Why turn the screws when our numbers have been improving for a few days now?” Owners of restaurants, cafes and other businesses in Marseille said they would stage a protest against the new measures on Friday. Bernard Marty of the UMIH union, which represents the hospitality sector, warned of “insurrection,” with several restaurant owners vowing to ignore the closure orders. Mayor Anne Hidalgo of Paris, which will see its gyms and other indoor sporting facilities closed as well, said she had lodged a formal protest. “I do not think that the closure of bars after 10:00 pm is an appropriate measure,” Hidalgo told France 3 television. “It is hard to understand: how will it prevent the spread of the virus? How will the fact that we can no longer exercise help us, while sport is an important part of keeping us healthy with strong immune systems?” she asked. Paris hospital authority AP-HP said Thursday that an influx of coronavirus patients was forcing it to start cancelling non-emergency surgery starting this weekend.

The number of coronavirus patients in Paris hospitals had more than doubled in three weeks, from 150 to 330, and would probably reach 600 by month’s end, said deputy director Francois Cremieux. Numbers of Covid-19 patients in intensive care have followed a similar upward curve, from 50 three weeks ago to 132 on Wednesday and likely more than 200 by next week, he said.

With a quarter of critical care beds now taken up by coronavirus patients, AP-HP will start by cancelling 20 percent of operations to free up capacity, said Cremieux.

 

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Trump Says White House Could Veto FDA’s Vaccine Rules

Trump Says the vaccine has to be approved by the HiM not the FDA

(Bloomberg) — President Donald Trump signaled that he could overrule any tightening of U.S. rules for the emergency clearance of a coronavirus vaccine, a move that could increase concerns that the race to find a Covid-19 shot is being politicized ahead of the presidential election. The Food and Drug Administration is expected to soon issue final guidelines for an emergency-use authorization. Regulators and drugmakers have in recent weeks vowed to adhere to science, not politics, in deciding when a vaccine is ready to reach the market. At a news conference on Wednesday, Trump said it “sounds like a political move” when asked whether the FDA was considering stricter standards for an authorization, suggesting that the White House could intercede if it thought the agency was too rigorous.“That has to be approved by the White House,” Trump said. “We may or may not approve it.” If a vaccine shows promising early signs of being safe and effective, it could be allowed to reach the market on an emergency basis before full results from a clinical trial are available. Companies including Pfizer Inc., Moderna Inc., AstraZeneca Plc and Johnson & Johnson have vaccine candidates in late-stage clinical trials. Some of those studies could produce efficacy data as soon as October. Trump is trailing Democrat Joe Biden in polls ahead of the November election, with surveys showing that a majority of Americans disapprove of the president’s handling of the virus. Trump has sought to focus on other topics while claiming that his administration is doing a good job handling the virus. The president has been promising that a coronavirus vaccine will be approved within weeks — a gambit to turn a pandemic inoculation into an October surprise for his struggling re-election campaign. Trump and his supporters have also questioned whether government employees are trying to sabotage his efforts to combat the virus. In August, the president attacked the FDA for harboring “deep state” staff slowing vaccine and drug work to hurt him politically. There’s no evidence that’s the case. FDA officials have indicated they would hold a vaccine to a higher standard than other medications that typically receive emergency waivers from the agency. Peter Marks, head of the agency’s biologics office, earlier this month described what he called an EUA-plus program that would accelerate the review of a vaccine but require data standards similar to those that are used when the FDA is considering a full approval. Marks also said at the time that the FDA would like companies to have a median of two months of follow-up on trial participants after they receive the vaccine. “That’s what we’re hoping for,” Marks said. “Most adverse events will happen about a month and a half after vaccination.” He also said any plan for an emergency authorization would include longer-term follow-up once the vaccine is on the market. The FDA has been attempting to rebuild trust as Trump publicly pushes for a vaccine to be authorized by the Nov. 3 election. FDA Commissioner Stephen Hahn has been criticized for exaggerating the benefit of a plasma treatment the agency authorized for use against the virus last month. Hahn has tweeted several times since that outside FDA advisers would review vaccine data.