Infectious disease expert Dr. Anthony Fauci says he isn’t eating at indoor or outdoor restaurants.
As summer winds down in New York City, restaurant diners who’ve been eating on tables set up in the street will finally be allowed back inside, but health experts say it’s best to proceed with caution. After a six-month ban, restaurants in the city will be allowed to serve guests indoors at 25% of their usual capacity starting Sept. 30, Gov. Andrew Cuomo announced Wednesday. Unlike restaurants in other regions of the state, New York City restaurants had only been allowed to serve patrons outside.
Health experts say indoor dining still poses major risks even though restaurants will be required to follow health guidelines including temperature checks, spacing tables at least six feet apart, and closing at midnight.
In an interview with MarketWatch, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases for three decades, said he would not dine out at any restaurant, be it inside or outside. ‘If you’re going to go to a restaurant, try as best as you can to have outdoor seating that is properly spaced between the tables’
— Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases
He acknowledged, however, that indoor dining is “much worse” than outdoors. “If you’re going to go to a restaurant, try as best as you can to have outdoor seating that is properly spaced between the tables,” Fauci said. Other health experts have echoed Fauci’s advice. Although diners will be required to be seated six feet apart — the distance people have been told to maintain to avoid potentially coming in contact with respiratory droplets that can transmit coronavirus — there’s evidence that these droplets have the ability to travel well beyond six feet. “There’s nothing magical about six feet,” Ryan Malosh, an infectious disease epidemiologist at the University of Michigan School of Public Health, told MarketWatch in late July. “That’s about that average distance respiratory droplets can travel, so being further apart from people is always better.” On top of that, air circulation is generally better outdoors than indoors because particles have more room to be dispersed, Malosh said. “Outdoors, a light breeze can disperse particles with no constraint on the distance they can then travel.” That’s important because diners don’t tend to wear masks outdoors. ‘Outdoors, a light breeze can disperse particles with no constraint on the distance they can then travel’ Nick Bit: We have proof the coronavius as a aerosol can travel hundreds of yards and stayi n the air as a vapour cloud for OVER 12 hours
— Ryan Malosh, an infectious disease epidemiologist at the University of Michigan School of Public Health
If people wear masks indoors, however, it can significantly lower the chances of dispersing virus-containing particles, said Thomas Russo, chief of the division of infectious disease at the University at Buffalo. “Whenever there’s a scenario where everyone can wear masks at all times the risk is lower,” Russo said. “When eating you physically can’t wear a mask but you can minimize that risk by popping it back on between bites.” Nick Bit: this is getting down fight silly. the mask does not work, impossible to fit properly and they are advising “popping” it on and off between bites…. As of Thursday, COVID-19, the disease caused by the virus SARS-CoV-2, had infected 27.9 million people globally and 6.4 million in the U.S. It had killed more than 900,000 people worldwide and at least 191,168 in the U.S., according to Johns Hopkins University. Nick Note: 70% of people hospitalized with the coronavirus have eaten in a restaurant within the prior 2 weeks. This is information they have are not disseminating…… Its the power of the restaurant lobby my friend. May they burn in hell for this evil.
Boris Johnson vowed to roll out new tests which can deliver results in just 15 minutes. He said a negative result would give Brits a “freedom pass” — allowing people to mingle like they did before Covid. But this morning Transport Secretary Grant Shapps admitted that the new tech wasn’t ready yet. He told Sky News this morning: “This is technology that, to be perfectly blunt, requires further development – there isn’t a certified test in the world that does this but there are people that are working on prototypes.” He added: “We know this isn’t simple to achieve, but we hope it will be possible through technology and new tests to have a test which works by not having to return the sample to a lab.” Britain will bring its testing capacity up from 300,000 a day to 500,000 by the end of October. And after that ministers want to roll out mass testing to everyone as soon as it’s possible.
It was also revealed yesterday:
Groups of more than six will be banned from Monday – and anyone who disobeys faced a £100 minimum fine
Pub-goers and diners will be FORCED to hand over their details when they go out as part of a ramping up of track and trace
A new army of health and safety inspectors will be rolled out by local authorities to crack down on places not enforcing safety rules
Britain’s borders will be beefed up with fresh plans to force airlines into making sure everyone fills out new passenger forms – leaving officials more time to check people are in quarantine
Stadium pilots will be reviewed and any that go ahead will be limited to 1000 only – putting the return of live sport in doubt
Night-time curfews for businesses could be slapped on other areas of the country in future
The PM said last night: “Through that Moonshot of daily testing – everybody gets a rapid turn-around test in the morning, 15 minutes later you know whether you are infectious or not.”He added: “Our plan will require a giant, collaborative effort from government, business, public health professionals, scientists, logistics experts and many, many more. “Work is underway — and we will get on at pace until we get there, round the clock. We are hopeful this approach will be widespread by the spring.” Ministers have drawn up plans to pump £100billion into the programme, according to a document leaked to the British Medical Journal, but this was played down by Government sources.
Under the plan, Brits would swab themselves in the morning and be given a 24-hour pass to mingle without having to stick to social distancing rules. A person could prove they had tested negative by either electronically presenting their result, or showing a printed card. The tests will be trialled in the Covid hotspot of Salford from next month. However, critics have pointed out that the hugely expensive plan costs almost as much as the NHS’s yearly budget for England – £130bn. The health service represents some 20 per cent of all public spending. The ‘moonshot’ spending also equates to the cost of the nation’s education budget and represents a near-30-fold increase in the UK’s testing capacity. In a memo sent to the first minister and cabinet secretaries in Scotland revealed by the BMJ, it was warned: “This is described by the prime minister as our only hope for avoiding a second national lockdown before a vaccine, something the country cannot afford.” Currently, around 350,000 daily tests being carried out at the moment. However, many have recently reported problems getting a test as labs reach a “critical pinch-point”. Nick Note: Won’t they be surprised when the immensities wear off in 3 months, Ad the whole Kabuki Dance will start again.
The American Petroleum Institute reported late Wednesday that U.S. crude supplies rose by 3 million barrels for the week ended Sept. The API data, which was released a day later than usual because of Monday’s Labor Day holiday, also showed gasoline stockpiles dropped 6.9 million barrels, while distillate inventories rose by 2.3 million barrels. Crude stocks at the Cushing, Okla., storage hub, meanwhile, climbed by 2.6 million barrels for the week.
The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning. The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said. The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan. Soriot also confirmed that the clinical trial was halted once previously in July after a participant experienced neurological symptoms. Upon further examination, that participant was diagnosed with multiple sclerosis, deemed to be unrelated to the Covid-19 vaccine treatment, he said. The new disclosures made by Soriot were heard by three investors participating on the call and were shared with STAT.
To date, AstraZeneca’s public statements on the pause have been sparse with few details. For instance, the company has not publicly confirmed that this is the second time its trials have been stopped to investigate health events among participants.
AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold. AstraZeneca only began its Phase 3 trial in the U.S. in late August. The vaccine — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. Transverse myelitis is a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems. In some instances, vaccines have triggered cases of transverse myelitis
The problem is this is a never been a proven RNA vaccine. The reason they went this rout is it is easy and cheap to manufacture. As with all vaccines, the idea is to trick our body into thinking it’s been infected. Those self-made spike proteins would train our bodies to detect and terminate any real SARS-CoV-2 infections before the virus wreaks havoc. The technique that has NEVER been successful and has been in development for more than 3 decades. This is known as an adenoviral vector vaccine using several unporven and untested technologies like messenger RNA (mRNA) vaccines. The first problem is as human bodies develop immune responses to most real viral infections, our bodies also develop immunity to adenoviral vectors. That makes booster shots of adenoviral vector vaccines problematic. Upon a second injection, our bodies will unleash an antibody attack on the vaccine itself. And since adenoviral vectors are based on natural viruses that some of us might already have been exposed to, the vaccines might not work for everyone. So far, no adenoviral vector vaccines have demonstrated they can prevent disease in humans. The way it works is that researchers take the genome of the adenovirus and cut out the section that allows it to reproduce. Then they splice in a section of (monkey) DNA that codes for the spike protein, turning the adenovirus into a recombinant vector. Because the adenovirus is a DNA virus, it has to get its genetic material not just into a cell but into the cell’s nucleus. Once in the nucleus, the DNA coding for the spike protein is transcribed into mRNA and then transported out of the nucleus into the cell’s cytoplasm, where it’s translated into protein. But it gets uglier. Because there are some drawbacks. Versions of the adenovirus spread in humans, there are many people who have immunity. To get around this, groups like the team at Oxford are using a chimpanzee adenovirus as a vector, which is different enough from human adenoviruses that most people’s immune systems won’t react to it right away. But once a vaccine is delivered using a chimpanzee adenovirus, it’s likely that many people would develop immunity to the new vector. That would make it difficult to use the same platform again for another dose of the vaccine. And here is the next problem they forget to tell you about. Since coronaviruses mutate so quickly immunity wears off… So the solution is a 2 shot regiment within thirty days and a booster show a month or two later. By that time the body is now building immunities to the coronal virus and the chimpanzee adenovirus. And an event sets up that could be deadly known as super sensitivity. And one of the diseases that is associated with super sensitivity to the monkey DNA is Transverse myelitis a deadly crippling neurological disease. And now it has been confirmed their has been at least 2 (finally disclosed) life threatening neurological events as mentioned to you earlier. As you well know i warned you about this very reaction months ago. Their will be no vaccine that works. But i guess with a man like Trump working or not does not matter as long as he gets the vote….
President Donald Trump admitted he knew weeks before the first confirmed US coronavirus death that the virus was dangerous, airborne, highly contagious and “more deadly than even your strenuous flus,” and that he repeatedly played it down publicly, according to legendary journalist Bob Woodward in his new book “Rage.”
“This is deadly stuff,” Trump told Woodward on February 7.
In a series of interviews with Woodward, Trump revealed that he had a surprising level of detail about the threat of the virus earlier than previously known. “Pretty amazing,” Trump told Woodward, adding that the coronavirus was maybe five times “more deadly” than the flu.Trump’s admissions are in stark contrast to his frequent public comments at the time insisting that the virus was “going to disappear” and “all work out fine.”
The book, using Trump’s own words, depicts a President who has betrayed the public trust and the most fundamental responsibilities of his office. In “Rage,” Trump says the job of a president is “to keep our country safe.” But in early February, Trump told Woodward he knew how deadly the virus was, and in March, admitted he kept that knowledge hidden from the public.
“I wanted to always play it down,” Trump told Woodward on March 19, even as he had declared a national emergency over the virus days earlier. “I still like playing it down, because I don’t want to create a panic.”
If instead of playing down what he knew, Trump had acted decisively in early February with a strict shutdown and a consistent message to wear masks, social distance and wash hands, experts believe that thousands of American lives could have been saved. The startling revelations in “Rage,” which CNN obtained ahead of its September 15 release, were made during 18 wide-ranging interviews Trump gave Woodward from December 5, 2019 to July 21, 2020. The interviews were recorded by Woodward with Trump’s permission, and CNN has obtained copies of some of the audio tapes. “Rage” also includes brutal assessments of Trump’s presidency from many of his former top national security officials, including former Defense Secretary James Mattis, former Director of National Intelligence Dan Coats and former Secretary of State Rex Tillerson. Mattis is quoted as calling Trump “dangerous” and “unfit” to be commander in chief. Woodward writes that Coats “continued to harbor the secret belief, one that had grown rather than lessened, although unsupported by intelligence proof, that Putin had something on Trump.” Woodward continues, writing that Coats felt, “How else to explain the president’s behavior? Coats could see no other explanation.” The book also contains harsh evaluations of the President’s leadership on the virus from current officials.
Dr. Anthony Fauci, the administration’s top infectious disease expert, is quoted telling others Trump’s leadership was “rudderless” and that his “attention span is like a minus number.”
“His sole purpose is to get reelected,” Fauci told an associate, according to Woodward. Woodward reveals new details on the early warnings Trump received — and often ignored. In a January 28 top secret intelligence briefing, national security adviser Robert O’Brien gave Trump a “jarring” warning about the virus, telling the President it would be the “biggest national security threat” of his presidency. Trump’s head “popped up,” Woodward writes. O’Brien’s deputy, Matt Pottinger, concurred, telling Trump it could be as bad as the influenza pandemic of 1918, which killed an estimated 50 million people worldwide, including 675,000 Americans. Pottinger warned Trump that asymptomatic spread was occurring in China: He had been told 50% of those infected showed no symptoms. At that time, there were fewer than a dozen reported coronavirus cases in the US. Three days later, Trump announced restrictions on travel from China, a move suggested by his national security team — despite Trump’s later claims that he alone backed the travel limitations. Nevertheless, Trump continued to publicly downplay the danger of the virus. February was a lost month. Woodward views this as a damning missed opportunity for Trump to reset “the leadership clock” after he was told this was a “once-in-a-lifetime health emergency.” “Presidents are the executive branch. There was a duty to warn. To listen, to plan, and to take care,” Woodward writes. But in the days following the January 28 briefing, Trump used high-profile appearances to minimize the threat and, Woodward writes, “to reassure the public they faced little risk.”
During a pre-Super Bowl interview on Fox News February 2, Trump said, “We pretty much shut it down coming in from China.” Two days later during his State of the Union address, Trump made only a passing reference to the virus, promising, “my administration will take all necessary steps to safeguard our citizens from this threat.” Asked by Woodward in May if he remembered O’Brien’s January 28 warning that the virus would be the biggest national security threat of his presidency, Trump equivocated. “No, I don’t.” Trump said. “I’m sure if he said it — you know, I’m sure he said it. Nice guy.”
The book highlights how the President took all of the credit and none of the responsibility for his actions related to the pandemic, which has infected 6 million Americans and killed more than 185,000 in the US. “The virus has nothing to do with me,” Trump told Woodward in their final interview in July. “It’s not my fault. It’s — China let the damn virus out.”
‘It goes through the air’
When Woodward spoke to Trump on February 7, two days after he was acquitted on impeachment charges by the Senate, Woodward expected a lengthy conversation about the trial. He was surprised, however, by the President’s focus on the virus. At the same time that Trump and his public health officials were saying the virus was “low risk,” Trump divulged to Woodward that the night before he’d spoken to Chinese President Xi Jinping about the virus. Woodward quotes Trump as saying, “We’ve got a little bit of an interesting setback with the virus going in China.” “It goes through the air,” Trump said. “That’s always tougher than the touch. You don’t have to touch things. Right? But the air, you just breathe the air and that’s how it’s passed. And so that’s a very tricky one. That’s a very delicate one. It’s also more deadly than even your strenuous flus.”But Trump spent most of the next month saying that the virus was “very much under control” and that cases in the US would “disappear.” Trump said on his trip to India on February 25 that it was “a problem that’s going to go away,” and the next day he predicted the number of US cases “within a couple of days is going to be down to close to zero.” By March 19, when Trump told Woodward he was purposely downplaying the dangers to avoid creating a panic, he also acknowledged the threat to young people. “Just today and yesterday, some startling facts came out. It’s not just old, older. Young people too, plenty of young people,” Trump said. Publicly, however, Trump has continued to insist just the opposite, saying as recently as August 5 that children were “almost immune.” Even into April, when the US became the country with the most confirmed cases in the world, Trump’s public statements contradicted his acknowledgements to Woodward. At an April 3 coronavirus task force briefing, Trump was still downplaying the virus and stating that it would go away. “I said it’s going away and it is going away,” he said. Yet two days later on April 5,
Trump again told Woodward, “It’s a horrible thing. It’s unbelievable,” and on April 13, he said, “It’s so easily transmissible, you wouldn’t even believe it.”
Shares on major stock markets in the United States extended gains on Wednesday with the Dow Jones Industrial Average jumping more than 400 index points as investors’ hopes over the country’s next coronavirus stimulus increased. Senate Minority Leader Chuck Schumer claimed there is a “good chance” of reaching the agreement on the bill in the Senate, asserting the Republicans may “come around” to overcome differences between the two sides on the country’s fourth aid package. The Dow surged 1.62% at 10:16 am ET, while the Nasdaq 100 and the S&P 500 soared 1.93% and 1.75% at the same time, respectively. The euro went up by 0.31% against the greenback, changing hands for 1.18141 at 10:17 am ET. Nick Note: I do not want to tell you i told you so. BUT i told you so….. So let them have their little ditty and when it gets high enough we can start pissing on their parade,,,,,,, again.
President Trump has been nominated for the Nobel Peace Prize by Christian Tybring-Gjedde, a member of the Norwegian Parliament, who cited the recent peace deal brokered between Israel and the United Arab Emirates. “For his merit, I think he has done more trying to create peace between nations than most other Peace Prize nominees,” Tybring-Gjedde told Fox News. In his nomination letter to the Nobel Committee, the politician said the Israel-UAE agreement “could be a game changer” because other Middle Eastern countries may follow suit, turning “the Middle East into a region of cooperation and prosperity.”
Also cited in the letter was the president’s “key role in facilitating contact between conflicting parties and … creating new dynamics in other protracted conflicts, such as the Kashmir border dispute between India and Pakistan, and the conflict between North and South Korea, as well as dealing with the nuclear capabilities of North Korea.”
Tybring-Gjedde, further, praised Trump for withdrawing a large number of troops from the Middle East. “Indeed, Trump has broken a 39-year-old streak of American Presidents either starting a war or bringing the United States into an international armed conflict. The last president to avoid doing so was Peace Prize laureate Jimmy Carter,” he wrote. (Fox News)
This marks the second time Tybring-Gjedde has nominated Trump. In 2018, the lawmaker submitted a nomination for the Singapore summit with North Korea’s Kim Jong Un. Nevertheless, he insists he is “not a big Trump supporter.” “The committee should look at the facts and judge him on the facts – not on the way he behaves sometimes,” he told Fox News. “The people who have received the Peace Prize in recent years have done much less than Donald Trump. For example, Barack Obama did nothing.” Though he had been in office less than a year, Obama won the Peace Prize in 2009 for his “extraordinary efforts to strengthen international diplomacy and cooperation between people … [the Committee attached] special importance to Obama’s vision of and work for a world without nuclear weapons.” There are 318 candidates this year for the prize, the “fourth-highest number of candidate’s ever,” according to the Committee. Of those, “211 are individuals and 107 are organizations.” Nick Note: Ah yes the plastic explosive company peace prize. And they think we are crazy. Trump joins Nelson Mandela, Assar Arafat and his good buddy Mohammad Obama…… Get out the jack hammers and lets redue Mount Rushmore!
President Trump said there could be a coronavirus vaccine “before a very special date.” While Trump did not specially mention which date, he has previously suggested that a vaccine for coronavirus could be ready before Election Day. “President Trump is getting this vaccine in record time. By the way, if this were the Obama administration, you wouldn’t have that vaccine for three years, and you probably wouldn’t have it at all,” Trump said today at a news conference. “So, we’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he added.
Facts First:It’s possible that a vaccine could be approved by the Food and Drug Administration at some point in November, but there is obviously no firm timeline or guarantee that one will be. And even when one is approved, it will likely still be many months before it’s widely available across the US.
White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won’t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1. At a health conference, Fauci said it’s more likely a vaccine will be ready by “the end of the year” as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September. “It’s unlikely we’ll have a definitive answer” by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum. The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day. “We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about,” Trump told reporters. Infectious disease experts and scientists have said they worry the vaccine approval process in the U.S. could be polluted by politics, not science. The CDC has asked governors and health departments to prepare to distribute a vaccine as soon as Nov. 1, just two days before the election. Dr. Stephen Hahn, commissioner of the Food and Drug Administration, has also said the agency is prepared to bypass the full federal approval process in order to make a vaccine available as soon as possible. Earlier Tuesday, nine drugmakers released a public letter pledging to “uphold the integrity of the scientific process” as they work toward potential global regulatory filings and approvals of the first Covid-19 vaccines. “We saw it critical to come out and reiterate our commitment,” Pfizer CEO Albert Bourla told NBC’s “TODAY” on Tuesday. “We will develop our product, develop our vaccine using the highest ethical standards.” On Thursday, Health and Human Services Secretary Alex Azar also tried to alleviate concerns about the review process, insisting the government’s Nov. 1 deadline for states is not linked to the presidential election. Nick Bit: HA HA HA HA HA HA!! “It has nothing to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on “CBS This Morning.” “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.” Dr. Moncef Slaoui, who is leading the Trump administration’s Operation War Speed initiative, told NPR a vaccine ready for public distribution in November is “extremely unlikely.” The FDA has said it would authorize a coronavirus vaccine so long as it is safe and at least 50% effective. The flu vaccine, by comparison, generally reduces the risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the CDC. Hahn said the FDA wouldn’t authorize a vaccine that’s not safe, even if it is fairly effective. Fauci said Tuesday the trial results will also be reviewed by the Data and Safety Monitoring Board, an independent group of medical experts who observe patient safety and treatment data. He added he “wouldn’t be surprised” if the U.S. had more than one vaccine. In the meantime, he said, the U.S. coronavirus response still needs to improve. He called the coronavirus outbreak in the U.S. a “mixed bag” as new cases fall in the southern region of the country and cases surge in states such as Montana, the Dakotas, Michigan, Minnesota and Iowa. “When you look at the country as a whole, we need to be doing much better than we’re doing,” he told told PBS’ Judy Woodruff at the conference. Nick Note: If Trump wants to win the election i believe he must have a vaccine berore the elections. More important Trump believes he must have a vaccine before the election……. We shall see what we will see! I see a lote of CDC and FDA staff changes coming!
A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.
The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.” An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.”
A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.
Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold. Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said. AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa. There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K. While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available. Those data are considered integral to any bid to seek an emergency use authorization for the vaccine from the U.S. Food and Drug Administration — and potentially jeopardize President Trump’s efforts to fast-track a vaccine ahead of the November election. A Phase 1/2 study published in July reported that about 60% of 1,000 participants given the vaccine experienced side effects. All of the side effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate. All of the side effects reported also subsided during the course of the study. The vaccine — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. The Phase 3 trial in the U.S. aims to enroll about 30,000 participants at 80 sites across the country, according to a release last week from the National Institutes of Health. It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing. Nick Note: I do not want to tell you i told you so… But i did. Please observe that the “open” Phase III study authorities refused to reveal the nature of the “adverse event” As in the Monkey DNA did not protect humans. Trump’s great white hope is turning into another Trumo fuck up. But remember their is the Reality show altered reality…..
