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    Trump officials scramble to justify decision not to buy extra Pfizer vaccine doses

    The Trump administration on Tuesday scrambled to justify a decision not to buy millions of backup doses of a Covid-19 vaccine developed by Pfizer as the vaccine appeared likely to become the first approved for use in the United States.Government regulators with the Food and Drug Administration (FDA) announced favorable preliminary findings on Tuesday from a review of Pfizer data, following approval for use in the UK and the first post-approval vaccination there.The Trump administration last spring made a deal for 100m doses of the Pfizer vaccine candidate, but the administration turned down an offer to reserve additional doses, Scott Gottlieb, a current Pfizer board member and former FDA commissioner, confirmed on Tuesday.“Pfizer did offer an additional allotment coming out of that plan, basically the second-quarter allotment, to the US government multiple times – and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb told CNBC.“I think they were betting that more than one vaccine is going to get authorized and there will be more vaccines on the market, and that perhaps could be why they didn’t take up that additional 100m option agreement.”With global demand for its vaccine soaring following successful trial results and approval in the United Kingdom, New York-based Pfizer cannot guarantee the United States additional doses before next June, the New York Times reported.The extent to which the decision not to acquire more of the Pfizer vaccine could impede the vaccination effort in the United States was unclear.The news came as the US was on the verge of surpassing 15 million coronavirus cases, the highest number in the world.A second vaccine candidate is currently up for emergency approval from the FDA, and multiple additional vaccine candidates – some of them easier to manage than the Pfizer vaccine, which must be stored at extremely cold temperatures – are in the final stages of clinical review.But Donald Trump and officials involved in the vaccine development program scrambled on Tuesday to head off the perception that the government had failed to get first in line for sufficient supplies of a vaccine produced by an American-based company. US-based Pfizer partnered and its German pharmaceutical partner, BioNTech, are on track to have the first vaccine approved in the US.To celebrate the good vaccine news and tout his role in it, Trump planned to host an event at the White House on Tuesday billed as a “vaccine summit”. He planned to unveil an executive order to prioritize vaccine shipments to “Americans before other nations,” but as with many headline-grabbing orders issued by Trump the decree did not appear to be impactful or enforceable, analysts said.Asked on ABC’s Good Morning America on Tuesday how the order would work, the official in charge of the government’s vaccine development program, Operation Warp Speed, Moncef Slaoui, said: “Frankly, I don’t know.”Health officials named by president-elect Joe Biden, who will lead the vaccine rollout effort after taking office next month, were not invited to the White House event, underscoring the risks of a lack of continuity in the effort.And executives from two drug companies, Pfizer and Moderna – whose own vaccine candidate is also up for approval from the FDA – were invited to the White House by Trump but declined, Stat News reported.Slaoui defended the administration’s decision not to buy more doses of the Pfizer vaccine, in his appearance Tuesday on ABC, saying they were looking at several different vaccines during the summer when it had the option to lock in additional Pfizer vaccine doses.“No one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one would be better than the other,” said Slaoui. Before taking his current post, Slaoui resigned from the Moderna board.The US government has also contracted for 100m doses of the Moderna vaccine. Both vaccines require two doses per patient, although a preliminary report on the Pfizer vaccine issued on Tuesday by the FDA found some protection after just one dose.The report, which found “no specific safety concerns identified that would preclude issuance” of an emergency use authorization, accelerated the path to approval. “FDA has determined that [Pfizer] has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the report said.A spokeswoman for the Department of Health and Human Services told the Times that in addition to Pfizer and Moderna, the government had signed contracts for doses for other vaccine candidates that have not yet reached the stage of seeking regulatory approval.“We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna,” she said. More

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    Can America Come Together to Fulfil Its Failed Promise?

    With America in the grips of a ravaging pandemic, a corrupt loser narcissist still at the helm and unmasked “freedom” fighters meandering among us, there is so much to do and so much opposition to doing it. It remains utterly inexplicable how uncoordinated and erratic the national response continues to be to the spectacle of …
    Continue Reading “Can America Come Together to Fulfil Its Failed Promise?”
    The post Can America Come Together to Fulfil Its Failed Promise? appeared first on Fair Observer. More

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    Trump administration refused offer to buy millions more Pfizer vaccine doses

    The Trump administration passed up a chance last summer to buy millions of additional doses of Pfizer’s coronavirus vaccine, a decision that could delay the delivery of a second batch of doses until the manufacturer fulfills other international contracts.
    The revelation, first reported by the New York Times and confirmed to the Associated Press on Monday, came a day before Donald Trump aimed to take credit for the speedy development of forthcoming vaccines at a White House summit.
    Pfizer’s vaccine, one of the leading Covid-19 vaccine contenders, is expected to be approved by a panel of Food and Drug Administration scientists as soon as this week, with delivery of 100m doses – enough for 50 million Americans – expected in coming months.
    Under its contract with Pfizer, the Trump administration committed to buy an initial 100m doses, with an option to purchase as many as five times more. This summer, the White House opted not to lock in an additional 100m doses for delivery in the second quarter of 2021, according to people who spoke to the Associated Press on condition of anonymity.

    Days ahead of the vaccine’s expected approval, the administration is reversing course, but it is not clear that Pfizer, which has since made commitments to other countries, will be able to meet the latest request on the same timeline.
    The Pfizer vaccine is one of two on track for emergency FDA authorization this month, the other coming from drugmaker Moderna.
    The Trump administration insisted late Monday that between those two vaccines and others in the pipeline, the US will be able to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.
    Health and Human Services secretary Alex Azar told NBC the administration is “continuing to work across manufacturers to expand the availability of releasable, of FDA-approved vaccine as quickly as possible. We do still have that option for an additional 500m doses.”
    The “Operation Warp Speed” summit on Tuesday will address the Trump administration’s plans to distribute and administer the vaccine. But officials from president-elect Joe Biden’s transition team, which will oversee the bulk of the largest vaccination program in the nation’s history, were not invited.
    Both the Pfizer and the Moderna vaccines have been determined to be 95% effective against the virus that causes Covid-19. Plans call for distributing and then administering about 40m doses of the two companies’ vaccines by the end of the year – with the first doses shipping within hours of FDA clearance. Each of the forthcoming vaccines has unique logistical challenges, including storage, distribution and administration.
    The news comes as states across the US continue to experience some of the worst surges since the pandemic began. On Monday, millions in California went back under the nation’s harshest lockdowns, as Covid-19 cases hit record levels. New York is also weighing further restrictions as hospitalisations climb.
    Health officials are warning Americans not to let their guard down, even with a vaccine on the horizon. Dr Anthony Fauci, the nation’s leading infectious disease expert, said that “without substantial mitigation, the middle of January can be a really dark time for us”. More

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    Congress to pass shutdown-averting bill to continue coronavirus stimulus talks

    Congress is poised to pass a stopgap funding measure that will avert a government shutdown and provide lawmakers more time to negotiate an emergency coronavirus stimulus legislation amid deepening economic pain.Negotiations over a $1.4tn catch-all spending package are playing out alongside bipartisan efforts to pass long-delayed Covid-19 economic relief.Congressional leaders hope to attach the stimulus bill to the must-pass spending bill, though several key sticking points remain.On Monday, the Democratic House majority leader, Steny Hoyer, said that the House would vote on Wednesday on a one-week spending bill, known as a continuing resolution (CR), to avoid a government shutdown while lawmakers race to reach an agreement. Government funding for federal agencies is due to expire on Friday.Hoyer had initially told lawmakers that the House would finalize its end-of-year business this week, allowing lawmakers to leave Washington for the year, but negotiations over the omnibus spending bill were proceeding more slowly than he had hoped.“I am disappointed that we have not yet reached agreement on government funding,” Hoyer wrote on Twitter. “The House will vote on Wednesday on a one-week CR to keep government open while negotiations continue.”A bipartisan group of senators expressed optimism about a $908bn aid proposal to help alleviate the financial disaster facing millions of American families and businesses as a rise in coronavirus cases threatens the labor market, which has struggled to fully recover from the economic downturn that followed the pandemic’s arrival in March.But their plan, the details of which could be released as early as Monday, remains hung up over provisions to aid states and localities, a Democratic priority, and liability protections for businesses from Covid-related lawsuits, which Republicans want.The proposal is less than half of the $2.2tn relief package passed by the Democratic-controlled House in October and does not include the direct payments to Americans that Trump sought before the election.Yet the senators’ plan is nearly double the $500bn package proposed by the Senate majority leader, Mitch McConnell, who advocated a list of “targeted” relief provisions he said the president would sign.Lawmakers quickly enacted a $3tn aid package to salvage the economy earlier this year, but they have been deadlocked for months over whether to approve another stimulus plan.President-elect Joe Biden has urged Congress to act immediately and endorsed the senators’ bipartisan framework, calling it a “down payment” that would provide immediate relief to those suffering the economic consequences of the virus. The House speaker, Nancy Pelosi, and Senate minority leader, Chuck Schumer, also tentatively expressed support, saying they would use the plan as a “framework” for their negotiations with Republican leaders, which are proceeding on a different track from the talks with the senators. On Monday, the White House economic adviser Larry Kudlow said the Trump administration and Congress were nearing an agreement on aid.“We are moving in the right direction, I think,” Kudlow said in an online interview with the Washington Post. “We are getting closer.”The US Chamber of Commerce said in a new memo to Congress that failure to enact relief would risk a “double-dip recession” – which occurs when a recession is followed by a brief recovery and then another recession – that would permanently shutter small businesses and leave millions of Americans with no means of support.The same issues have blocked coronavirus relief legislation for months, leading to mounting frustrations among business owners, unions, state and local government officials, and ordinary Americans.Considering the weakening of the economy coupled with a surge in Covid-19 cases at a time when previously approved relief mechanisms are due to expire, it would be “stupidity on steroids if Congress doesn’t act”, said the Democratic senator Mark Warner, a member of the bipartisan group that wrote the proposal, to CNN’s State of the Union on Sunday.A group of emergency aid programs implemented in response to the pandemic, including additional unemployment benefits and a moratorium on renter evictions, is due to expire at the end of December.With US coronavirus deaths topping 283,000 and pressure mounting for aid to a fragile economy, the new package is expected to include fresh emergency assistance for small businesses, unemployment benefits, and funding for Covid-19 vaccine distribution.“We have to get something done for the American people,” Schumer said in a floor speech on Monday, “before the end of the year.” More

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    Trump says 'Rudy's doing well' after Giuliani taken to hospital with Covid

    Donald Trump has said that the former New York City mayor Rudy Giuliani, who was admitted to hospital on Sunday after being diagnosed with Covid-19, was “doing well” with the virus.“Rudy’s doing well,” Trump said in response to a question from reporters at the White House. “He’s doing very well. No temperature and he actually called me earlier this morning. Was the first call I got.”Neither the White House nor doctors for Giuliani released information about Giuliani’s condition, and the basics of Giuliani’s health status remained unknown. He was admitted to Georgetown University hospital on Sunday.Giuliani, 76, who has kept up a schedule of constant public appearances in recent weeks as the spearhead of Trump’s campaign to spread conspiracy theories about the US election, announced his Covid diagnosis on Twitter on Sunday.“I’m getting great care and feeling good,” Giuliani tweeted. “Recovering quickly and keeping up with everything.”Giuliani has appeared frequently in public recently closely surrounded by people not wearing masks or observing the social distancing measures health officials recommend to prevent the spread of coronavirus.The Giuliani appearances, which have included press conferences as well as video-streamed meetings with Republican legislators in Michigan and Pennsylvania, are part of an improvised traveling show that Trump has put together to challenge the election result.Following one such appearance, at the offices of the Republican National Committee in November, multiple attendees announced Covid diagnoses, including Giuliani’s son, Andrew, who appears to have had a mild case.For years, Giuliani has worked to build and feed conspiracy theories designed to help Trump politically. Before the impeachment inquiry that concluded earlier this year, Giuliani tried to get Ukrainian officials to make public statements the Trump campaign hoped would be damaging to Joe Biden.But Giuliani’s remit has changed since Trump lost the presidency, shifting from weaving complicated stories about a shady conspiracy in a former Soviet republic to weaving similar – entirely false – stories about a shady conspiracy among US elections officials.While he has made a great show of his fraud allegations for the cameras, with likely corrosive effects on US democracy, Giuliani did not dare advance fraud allegations in a court appearance last month, where lying could come with a price in the form of disbarment or other sanction.“It’s not fraud,” Giuliani told a district judge in Pennsylvania of the Trump campaign’s case. “This is not a fraud case.”As one of the highest-profile members of Trump’s inner circle, Giuliani had previously served as a significant source of misinformation about coronavirus. In one Fox News appearance, he mocked contact tracing, asking why it was not used to fight obesity and heart disease.Trump, 74, was hospitalized in early October at Walter Reed medical center in Maryland. He spent three days in the hospital. More

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    Anti-vaccine doctor to testify at Senate committee hearing on Covid mandates

    The doctor heading a controversial physician’s advocacy group opposing government involvement in medicine has been announced as a leading witness at a US Senate homeland security and governmental affairs committee hearing on Tuesday.Jane Orient has rejected any “anti-vaxxer” label but her criticism of coronavirus vaccines has drawn scathing rebukes from some senior politicians infuriated by her invitation to testify to Congress.“At such a crucial time, giving a platform to conspiracy theorists to spread myths and falsehoods about Covid vaccines is downright dangerous and one of the last things Senate Republicans should be doing right now,” the Senate minority leader and New York Democrat, Chuck Schumer, said in a statement released on Sunday.Critics have cited Orient’s promotion of the anti-malaria drug hydroxychloroquine as a Covid-19 treatment as well as her organization’s view that federal vaccine mandates are a violation of human rights.In a statement provided to the Senate last year, Orient called vaccine mandates “a serious intrusion into individual liberty, autonomy and parental decisions”.“The regulation of medical practice is a state function, not a federal one,” she wrote. “Governmental pre-emption of patients’ or parents’ decisions about accepting drugs or other medical interventions is a serious intrusion into individual liberty, autonomy, and parental decisions about child-rearing.”Orient is one of four medical professionals set to testify in the hearing in which federal health officials will weigh vaccine mandates and other initiatives to combat a worsening coronavirus pandemic that, so far, has killed more than 282,000 Americans.The Association of American Physicians and Surgeons is a fringe group of fewer than 5,000 doctors that offers advice experts say isn’t “consistent with evidence-based medicine”. It had even been cited by Donald Trump’s former campaign manager Brad Parscale when explaining why the president had taken hydroxychloroquine as a preventive measure.At that time, Orient told the Guardian she believed the drug “should be prescribed more often”, and in a statement claimed the drug offered “about 90% chance of helping Covid-19 patients”.That claim was based on a flawed database.As infections surge towards 15m confirmed cases, Orient has opposed government plans for all Americans to be vaccinated, noting that those emerging vaccines currently awaiting approval by US regulators, one made by the Pfizer and BioNTech partnership and the other by Moderna – use a new scientific method.There is currently no plan for a federal mandate that Americans be inoculated against Covid-19.In a phone interview on Sunday with the New York Times, she called it “reckless to be pushing people to take risks”.“People’s rights should be respected. Where is ‘my body, my choice’ when it comes to this?” Orient said, adding she would not get a coronavirus vaccine, telling the Times that she has an autoimmune condition.Republicans have presented mixed messages on support for government vaccine mandates, with many expressing concerns about the legality of businesses requiring them and infringements on individual liberties.Meanwhile, even as some Republicans questioned the CDC on the safety of the vaccine, Ivanka Trump – White House adviser and daughter of the president – as well as former Republican president George Bush have both confirmed they would publicly take the vaccine. More

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    'Right now, I'm in panic mode': US freelancers plead with Congress to pass Covid relief

    Suzy Young, an artist in Winterport, Maine, cheered when Congress enacted an innovative program that provided unemployment benefits to artists, freelancers and the self-employed after Covid-19 hit the US. But like many others, Young – whose art sales have plunged in recent months – is angry that this pandemic aid program is due to expire the day after Christmas.Young was already upset that the most generous part of the program – $600 a week in supplemental jobless benefits – expired in July, but now she fears she will lose all her jobless benefits. Four months behind on her $1,800 rent, she is fighting her landlord’s effort to evict her and her disabled husband on 1 January.“Congress needs to do something, or a lot of people are going to face homelessness,” said Young, 58. A fiber artist who weaves works out of wool, Young saw her income disappear when the farmers market where she sold her work was closed due to the lockdown. “That killed my business,” she said. She was getting by while receiving the $600 weekly supplement, but once that disappeared, her unemployment benefits fell to $172 a week.A study by the Century Foundation estimates that 7.3 million freelancers, artists, self-employed and others will lose their weekly benefits if the Pandemic Unemployment Assistance program (known as PUA) expires, as scheduled, after Christmas. That program is unusual because jobless benefits traditionally go only to laid-off workers who are considered employees – and not to freelancers or the self-employed. A second program – Pandemic Emergency Unemployment Compensation – is also scheduled to expire 26 December, ending special federal benefits for 4.6 million laid-off workers who were considered employees.“A lot of these people [freelancers and the self-employed] were out of work, and not eligible for regular unemployment benefits,” said Andrew Stettner, a senior fellow at the Century Foundation. “This program has been really successful. These people really need this bridge until the economy gets back to a better place.” After the $600 benefit supplement expired in July, freelancers and the self-employed continued receiving regular unemployment benefits, but the average nationwide for them has been just $207 a week, although it’s two or three times that in some states.Last Tuesday, a bipartisan group of nine senators proposed a $908bn stimulus and relief package that included a $300 weekly jobless supplement, half the former $600. The senators said their plan “would increase unemployment benefits to help families make ends meet”. That same day, five Democratic senators, including the minority leader, Chuck Schumer, proposed a relief plan that would restore the $600 boost in benefits as well as extend normal jobless benefits by 26 weeks. The Senate majority leader, Mitch McConnell, threw cold water on the bipartisan plan, saying: “We just don’t have time to waste time.”Rafael Espinal, president of the 500,000-member Freelancers Union, said the senators’ $300-a-week proposal was inadequate. “Considering the cost of living in cities, $300 isn’t going to allow people to pay their rent or meet other demands.”Grant McDonald, a New York-based video director who films concerts and special events, has had little work since March and worries about PUA expiring. “It’s pretty drastic sitting here, waiting for my savings to run out,” he said. McDonald fears he will soon fall behind on his rent; he may then move in with his father.“I have worked very hard to build a career in this city,” McDonald said, worried that leaving New York will set back his career.McDonald and Stephanie Freed, who lights fashion shows and other special events, founded ExtendPUA, a group that has lobbied dozens of senators and representatives to extend pandemic assistance and restore the $600 supplement. Many Republicans oppose the $600 level, saying it costs too much and discourages people from seeking work.We need to help people out here from starving. We need Congress to hear us, we’re in the worst placeBut ExtendPUA argues that it’s not wise to press people to look for work when the pandemic is raging or when skilled people with long careers, on Broadway, for instance, have little idea when they’ll return to regular work.“Any economist will say you don’t want skilled people to give up their work and not be able to get back to what they’ve given up,” Stettner said. “We can see that the vaccine will make everything better, and if we can just extend these benefits a little longer, it will make a big difference for a lot of people. If you lose your car or get evicted, those are not easy things to recover from.”Steve Gregg stopped working as an Uber driver in San Francisco after Covid-19 hit – he has diabetes and lung problems. Greg said the $600 supplement, on top of his $450 in regular weekly jobless benefits, “saved me, I would have lost my home”. But with the $600 expired, Gregg, divorced and paying child support, has moved into a single room in Modesto he shares with a cousin. “If they want us not to be homeless, they better pass something,” Gregg said. “I have no flexibility. I’ve cut back on many things.”Friends tell Gregg he has an extraordinary voice and should do TV voiceovers, but he doesn’t have the several hundred dollars to go to a studio to prepare a proper sample recording.Shan Grimm, a guitarist for jazz and R&B bands in New Orleans, fears she and her daughter will be evicted once the moratorium on evictions ends. She receives $247 a week in jobless benefits, but her rent is $850 a month, her car insurance $193 and her phone $60. “I’m trying to figure out what I’m going to do, where I’m going to go,” said Grimm, who also worked as a bartender. “Even $300 a week would make a big difference. Right now, I’m in panic mode. I have $107 in my bank account. I’ve been eating once a day.”“We are the people and Congress needs to hear us,” Grimm added. “We need to help people out here from starving. We need Congress to hear us, we’re in the worst place.” More