Author: BigGuy

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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.

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Dow Rides Tech, Stimulus Hopes Higher

https://youtu.be/mWHqZ-oC_9Y

The Dow rose Thursday as an Apple-infused rebound in tech and signs U.S. lawmakers are ready to resume talks on stimulus lifted investor sentiment. The Dow Jones Industrial Average rose 0.88%, or 234 points. The S&P 500 was up 0.96%, while the Nasdaq Composite gained 1.34%. Tech awoke from its slumber this week, with Apple (NASDAQ:AAPL), Microsoft (NASDAQ:MSFT) and Amazon.com (NASDAQ:AMZN) gaining more than 2% and leading the rebound in the Fab 5. Alphabet (NASDAQ:GOOGL) and Facebook (NASDAQ:FB) added more than 1%

Investor sentiment on stocks was also boosted by signs U.S. lawmakers are still seeking to get a deal done on further stimulus before the U.S. election.

Treasury Secretary Steven Mnuchin reportedly plans to resume talks with House Speaker Nancy Pelosi to iron out differences on a fresh round of stimulus to boost the economy. Sectors tied to the progress of the economy such as industrials and financials also found their footing. Financials were pushed higher by a 6% jump in Goldman Sachs Group Inc (NYSE:GS) after UBS upgraded its rating on the stock to buy from neutral, citing opportunity ahead for higher trading revenue. UBS suggested a closely fought U.S. presidential election could trigger volatility, boosting Goldman’s trading revenue. JPMorgan Chase (NYSE:JPM), Morgan Stanley (NYSE:MS) and Wells Fargo (NYSE:WFC) all traded higher, with the latter up more than 3%. On the economic front, the latest jobs data showed an expected rise in weekly jobless claims, but analysts played down the importance of the headline number. The Labor Department reported that 870,000 people filed for unemployment insurance in the week ended Sept. 19, up from the prior week’s 866,000 and above economists’ forecasts of 840,000.

“[Pandemic unemployment assistance] initial claims and continuing claims remain the more important area to watch in our opinion. This week’s data was especially encouraging,” Jefferies (NYSE:JEF) said.

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Bullard: US economy may be within reach of full recovery by year-end

Federal Reserve Bank of St. Louis President James Bullard, in the most upbeat comments by a central banker since the start of the Covid-19 outbreak, said the U.S. economy may surge at a 35% annualized rate in the third quarter and the nation may be close to a complete recovery by year-end. Rapid expansion in gross domestic product in the third quarter “may put the U.S. economy within reach of a sort of ‘full recovery’ by the end of 2020,” Bullard, who doesn’t vote on monetary policy this year, said in comments prepared for a virtual presentation to the Global Interdependence Center Thursday.

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US initial jobless claims up by 4,000 to 870,000

Slightly more Americans applied for state unemployment benefits in the week ended Sept. 19 than in the prior week. Jobless claims rose 4,000 to 870,000, the Labor Department said Thursday. Claims in the prior week were raised by 6,000 to 866,000. The number of people already collecting economic benefits, known as continuing claims fell 167,000 to 12.58 million. These claims are reported with a one-week lag. This is the lowest level of continued claims since mid-April. Jobless claims have been drifting lower lately. Roughly half of the 22 million payroll jobs that were lost in March and April have been regained as people return to work. The prospects for this trend to continue are mixed and economists say high unemployment will remain a problem for at least a couple of years. The Labor Department’s weekly unemployment claims report did showed a significant drop in the total number of people claiming benefits across all unemployment programs, including several emergency programs that extend benefits. That number fell by 3.7 million to 26 million in the week ending September 5th.

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House Democrats push to renew efforts for second round of $1,200 stimulus checks

The stimulus stalemate has left lawmakers at odds over how to get more relief to millions of Americans who need it. Earlier this month, Senate Republicans attempted to get a smaller bill through Congress as the standoff between both parties continued. But that relief bill did not include a second round of $1,200 stimulus checks, a measure that both parties had all but signed off on. The bill failed to get the 60 votes it needed to advance. Still, House Democrats pushed back on the stimulus check exclusion on Tuesday during a congressional hearing with Federal Reserve Still, House Democrats pushed back on the stimulus check exclusion on Tuesday during a congressional hearing with Federal Reserve Chairman Jerome Powell and Treasury Secretary Steven Mnuchin.

“The economic impact payments must be made because the rent must be paid,” said Rep. Al Green, D-Texas.

“If we do not do this, we will put persons at risk of being evicted at a time when we are having a pandemic that is still taking lives in this country,” he said.

Green also said a new Government Accountability Office report that found the Treasury Department does not have adequate data on the number of people who qualify for the first stimulus checks, but who have not yet received them, is cause for concern. The number excluded, including gig workers, could be in the millions, he said. The IRS is in the process of mailing letters to about 9 million Americans to notify them that they may be eligible for the money. Rep. Rashida Tlaib, D-Mich., also spoke out about the prospect of a second round of payments, asking Mnuchin, “Yes or no, do you believe another stimulus check could help stabilize the economy?” Mnuchin: Administration does support another stimulus payment “I do,” Mnuchin said. “The administration does support another stimulus payment.” The likelihood and timing of that money still remains unclear. House Democrats and Senate Republicans had both put forward proposals that included a second round of direct payments. Other issues, however, have made it impossible for both sides to come to an agreement, at least for now. “We obviously can’t pass a bill in the Senate without bipartisan support,” Mnuchin said. “Our job is to continue to work with Congress to try to get additional help to the American public.” In response, Tlaib urged Mnuchin to push for more stimulus checks. “I think you need to be very clear with the senators … that direct payments to individuals is critical to preventing economic collapse in our country,” Tlaib said. Some experts have speculated that the death of Supreme Court Justice Ruth Bader Ginsburg, and the ensuing fight over the nomination to fill the now vacant seat, could make it impossible for Congress to come up with another coronavirus stimulus deal now. In a separate interview with CNBC on Tuesday, Larry Kudlow, director of the National Economic Council, dismissed that idea as “not necessarily a given.” The two parties were already at odds before the judicial issues came up, he said. The White House is advocating for another package targeting “kids and jobs,” Kudlow said. That would include more than $100 billion to help schools and another $100 billion to extend Paycheck Protection Program funds to small businesses. “I wish we could break the stalemate, because even though I think the economy is improving nicely, I think it could use some help in some key targeted places,” Kudlow said.

 

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House passes bill to avoid govt shutdown

House passes spending bill to avoid government shutdown, sends it to Senate
Key Points
  • The House passed a funding bill to avoid a government shutdown, sending the legislation to the Senate ahead of a Sept. 30 deadline.
  • Democrats and the Trump administration earlier reached a spending deal, House Speaker Nancy Pelosi said.

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    The House passed a bill Tuesday that would fund the government into December and avoid a shutdown before a Sept. 30 deadline. After clearing the House in an overwhelming vote, the legislation heads to the Republican-held Senate. Earlier Tuesday, House Speaker Nancy Pelosi said she reached a spending agreement with Treasury Secretary Steven Mnuchin and Republicans. Pelosi said the proposal would include $8 billion for nutrition assistance for schoolchildren and families. It renews Pandemic EBT, a program that provides food benefits while schools are closed set to expire at the end of September, for a full year. It also adds increased accountability for farm aid money to prevent it from gong to large oil companies, according to Pelosi. Senate Majority Leader Mitch McConnell had criticized a lack of farm assistance funds in a bill House Democrats released Monday. The bill would fund the government through Dec. 11, avoiding a potentially chaotic shutdown during the coronavirus pandemic and before the Nov. 3 election. Lawmakers then aim to hash out an agreement to fund the government through Sept. 30, 2021, the end of the next fiscal year. Lawmakers have said they want to get past the shutdown threat to focus on passing more coronavirus relief, which they have failed to do for months amid disagreements over the size of a fifth aid package. Pelosi said the agreement included nutritional assistance for schoolchildren and additional accountability for farm aid.

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200,000 coronavirus fatalities, U.S. hits Trump’s upper limit for doing ‘a very good job’

The United States witnessed another painful milestone on Tuesday as the tally of coronavirus-related fatalities surpassed 200,000. In March, President Trump said that keeping the nation’s death toll between 100,000 and 200,000 — numbers that seemed inconceivable at the time — would signal that his administration had done “a very good job.”

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FDA to announce tougher standards for a coronavirus vaccine

The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day. The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted. The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that made missteps in its handling of those clearances. With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.

The agency also is looking for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people, as a sign the vaccine works.

These standards, plus the time it will take companies to prepare their applications and the agency to review the data, make it highly improbable for any vaccine to be authorized before the election. The agency has previously said any vaccine would have to be 50 percent more effective than a placebo.

“It’s hard to imagine how an EUA could possibly occur before December,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines. The guidance is just one way of trying to shore up confidence in the agency. FDA allies, intent on building trust, are also spotlighting agency career scientists, noting that the one overseeing the vaccine-approval process has threatened to quit if he is pressured to greenlight a vaccine before he is convinced it is safe and effective. But, administration critics note, such efforts are undercut on an almost daily basis by overly rosy and contradictory comments by Trump and continued revelations about administration actions to strong-arm government scientists and regulators, and curb their independence.In addition, the FDA guidance is unlikely to satisfy some critics, who say the agency should not use an emergency authorization for a vaccine at all. “Things are so revved up right now that there is quite a possibility that the American public won’t accept a vaccine because of all the things that are going on,” said Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions.” The FDA career staff itself is trying to reassure the public. In a highly unusual move, Peter Marks, the head of the center that oversees vaccine regulation, and seven other senior career officials vowed in a column to maintain “independence to ensure the best possible outcomes for public health.” The agency also has pledged to take any vaccine data to its panel of outside advisers, called the Vaccine and Related Biological Products Advisory Committee, before making decisions. The agency has scheduled a public meeting of the panel for Oct. 22 and said others sessions can be held as needed, depending on when data is available. But some FDA watchers say those steps are not enough and that the agency should forswear use of an emergency authorization for a vaccine and instead require a full approval. “If we don’t get this right, we’ll see a deep corrosion of trust over the long term — and that will be the darkest legacy for a post-covid world,” said Lawrence Gostin, a public health expert at Georgetown University’s law school.

Eric Topol, founder and director of Scripps Research Translational Institute, opposes using an emergency authorization in the next several weeks or months. “We are not in a high-trust mode, and the last thing you want to do is take a short cut and put everything at risk,” he said.

He said the agency should not consider such an authorization until at least early next year to ensure it has adequate safety data.

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CDC “mistakenly” modifies its COVID-19 guidance

sell out….again

The Centers for Disease Control and Prevention “erroneously” said on Monday the coronavirus could spread through the air beyond 2 meters, and not just through close person to person contact as initially supposed.

“There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet,” the CDC’s updated COVID-19 guidance noted, but was corrected shortly after.

“A draft version of proposed changes to these recommendations was posted in error to the agency’s official website,” the CDC stated, adding that it “is currently updating its recommendations regarding the airborne transmission of SARS-CoV-2. Once this process has been completed, the updated language will be posted.”

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CDC study highlights threat of coronavirus spread on lengthy flights

“The risk for on-board transmission of SARS-CoV-2 during long flights is real and has the potential to cause COVID-19 clusters of substantial size, even in business class-like settings with spacious seating arrangements well beyond the established distance used to define close contact on airplanes,” the study concluded.

A single airline passenger unknowingly sickened with coronavirus managed to infect 15 other people aboard the 10-hour trip to Vietnam, highlighting the dangers of travel amid the pandemic. The global health crisis had only just begun its spread across Europe when the plane took off from a London airport back in March. By the time it touched down in the Vietnamese city of Hanoi, 12 passengers in business class, two in economy and a single crew member had contracted the fast-spreading disease. Researchers behind a new Centers for Disease Control study, slated to be published in November, identified a 27-year-old business woman from Vietnam to be the likely source of the outbreak. She’d been based in London since early January and was experiencing a sore throat ahead of her return home. “On February 22, case 1 and her sister returned to Milan, Italy, and subsequently traveled to Paris, France, for the yearly Fashion Week before returning back to London on February 25,” they wrote in the journal Emerging Infectious Diseases. Around that time, few cases had been reported in Britain and masks had not yet been required for the flight, which departed on March 1. “She was seated in business class and continued to experience the sore throat and cough throughout the flight,” the researchers added. Five days later, she went to the hospital and tested positive for coronavirus. CDC researchers then tracked down all 217 passengers and crew, tested them for the virus and ordered them quarantine. Investigators said there was no other likely way any of the 15 people could have been infected aside from exposure to the sick patient. “The most likely route of transmission during the flight is aerosol or droplet transmission from case 1, particularly for persons seated in business class,” they wrote. “Contact with case 1 might also have occurred outside the airplane at the airport, in particular among business class passengers in the predeparture lounge area or during boarding.” And while researchers believe masks are an effective tool to prevent the spread of the virus, they called for additional on-board precautions and screening procedures.

“The risk for on-board transmission of SARS-CoV-2 during long flights is real and has the potential to cause COVID-19 clusters of substantial size, even in business class-like settings with spacious seating arrangements well beyond the established distance used to define close contact on airplanes,” the study concluded.