Vaccines and immunisation

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      Biden should get Covid vaccine soon as possible for ‘security reasons’, Fauci says

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      Pfizer-made vaccine being administered while second vaccine, made by Moderna, receives encouraging assessmentUS politics – live coveragePresident-elect Joe Biden should be vaccinated against the coronavirus as soon as possible for “security reasons”, top US public health expert Anthony Fauci said on Tuesday, as a second vaccine candidate, made by Moderna, received an encouraging assessment ahead of likely approval by the Food and Drug Administration. Related: Can US employers order workers to get the coronavirus vaccine? Continue reading… More

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      Donald Trump reverses plan to give White House officials Covid vaccine

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      The US recorded another 1,389 deaths from Covid-19 on Sunday, pushing the toll closer to 300,000 as hospitalisations continued to hit new heights. There was a ray of hope on Monday morning, however, as the first vaccinations were carried out using the Food and Drug Administration-approved Pfizer vaccine.
      “I feel hopeful today. Relieved,” said critical case nurse Sandra Lindsay after getting a shot at Long Island Jewish Medical Center in New York.
      Watching via video, New York governor Andrew Cuomo said: “This is the light at the end of the tunnel. But it’s a long tunnel.”
      From Washington, Donald Trump tweeted: “First Vaccine Administered. Congratulations USA! Congratulations WORLD!”
      Earlier, responding to a New York Times report that senior administration staffers would be among those vaccinated first, Trump rowed back, tweeting: “People working in the White House should receive the vaccine somewhat later in the programme, unless specifically necessary. I have asked that this adjustment be made.”
      According to Johns Hopkins University, the US death toll stood at 298,949 out of a caseload of 16,242,953, itself up by 190,920 on Sunday. Deaths were down from a daily peak of more than 3,000 last week but according to the Covid Tracking Project 109,331 people were hospitalised, a record. A record 21,231 people were in intensive care.
      States across the US are under increasing strain, healthcare systems creaking and economies, already battered, close to damaging collapse.
      In California, where large parts of the state are under lockdown until after Christmas, Alan Auerbach, director of the Burch Center for Tax Policy and Public Finance at the University of California, Berkeley, told the Guardian an eventual recovery could look more like a “K” than a “V”, as high earners thrive and the most vulnerable plunge.
      “We have lacked a coherent national strategy for dealing with the pandemic and 2021 is probably going to be a pretty tough year for California,” he said.
      In Washington, a bipartisan group of senators was due to unveil a $908bn stimulus package, though it was reported to have little chance of success. Agreement between House speaker Nancy Pelosi and Senate majority leader Mitch McConnell remains elusive.
      Though the vaccination effort just beginning will be the biggest public health push in US history, it will take some time for the vaccine to reach most of the population. On Monday, health secretary Alex Azar told NBC the vaccine will be available to the broader public “by late February going into March”. By that time, he said, vaccine distribution will be “like a flu vaccination campaign” at local pharmacies.
      That timeline is ambitious, especially in light of news that the administration did not expand its order for the Pfizer vaccination, sparking concerns there will be a shortage after initial doses. Vaccines made by Pfizer and Moderna, which is expected to be approved by the FDA for emergency use this week, require two doses.
      According to the Times, the Trump administration is “rushing to roll out a $250m public education campaign to encourage Americans to take the coronavirus vaccine”. Former presidents Barack Obama, Bill Clinton and George W Bush are among famous names who have said they are willing to be vaccinated in public and an ABC News poll released on Monday said 80% of respondents said they would take the vaccine.
      Speaking to Fox News Sunday, however, Dr Moncef Slaoui, chief science adviser to the federal effort to speed vaccine development, said he was “very concerned” about skepticism about the vaccine in some circles.
      “Unfortunately … there’s been a confusion between how thorough and scientific and factual the work that has been done is, and the perception that people are thinking that we cut corners,” Slaoui said. “I can guarantee you that no such things have happened, that we follow the science.”
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      Trump, who recovered from Covid-19 in October, said he would not initially be taking the shot and was reversing an administration directive to vaccinate top officials while public distribution is limited to frontline health workers and people in nursing homes and long-term care.
      Trump made the announcement hours after his administration confirmed that senior officials, including some aides who work in close proximity to Trump and Mike Pence, would be offered vaccines as soon as this week.
      “I am not scheduled to take the vaccine,” Trump tweeted, “but look forward to doing so at the appropriate time.”
      It was not immediately clear what effect Trump’s tweet would have on efforts to protect top leadership, two people briefed on the matter told the Associated Press.
      News that White House staff would receive the vaccine early drew criticism on social media. Trump and his aides have flouted Covid-19 guidelines issued by his own administration, including hosting large holiday parties with maskless attendees this month.
      Officials said earlier on Sunday doses of the Pfizer vaccine would be made available to those who work in close quarters with the nation’s leaders, to prevent Covid-19 spreading in the White House and other critical facilities. The move would be consistent with the rollout of rapid testing machines, which were reserved to protect the White House and other facilities.
      According to guidance from the Centers for Disease Control and Prevention, there is not yet enough information to determine whether those who have had Covid-19 should also get the vaccine.
      Pence has not come down with the virus, and his aides have been discussing when and how he should receive the shot. Aides to the president-elect, Joe Biden, have been discussing how he should receive the vaccine and working to establish plans to boost virus safeguards in the West Wing. More

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      FDA chief reportedly urged by White House to approve Pfizer vaccine or quit

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      The White House chief of staff, Mark Meadows, has reportedly told the head of the US Food and Drug Administration to authorize Pfizer’s coronavirus vaccine on Friday or prepare to resign.Meadows leaned on Hahn during a phone conversation on Friday, according to the Washington Post. It came after Donald Trump tweeted that the FDA was “a big, old, slow turtle”, and told FDA commissioner Stephen Hahn to “get the dam vaccines out NOW”.The warning from Meadows led the FDA to speed up its timetable for potential emergency approval of the Pfizer/BioNTech vaccine from Saturday morning to later on Friday, according to the Post. The vaccine would be the first to roll out across the US, after also being approved in the UK and Canada.An unnamed official told Reuters that Meadows’ comment about resigning “wasn’t a red line” but was more of a quip with the intention of urging “the FDA to act quickly and get the job done and stop the delays”.The White House declined to comment, although an administration official said Meadows does request regular updates on the progress toward a vaccine.“This is an untrue representation of the phone call with the chief of staff,” Hahn said in a statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”Earlier in the day, the health secretary, Alex Azar, said the FDA was “very close” to granting emergency use authorization for the vaccine and that vaccination of the first Americans outside clinical trials could begin on Monday.“I’ve got some good news for you here,” Azar told ABC’s Good Morning America on Friday. “Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine.“We will work with Pfizer and get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.”The step followed a vote on Thursday by an outside panel of experts convened by the FDA to recommend authorization of the vaccine. The recommendation signaled that the first approval of a Covid-19 vaccine for use in the US was imminent.That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally. The US would become the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.A similar advisory panel will review a second vaccine, developed by Moderna with the National Institute of Allergy and Infectious Diseases, on 17 December.The United States recorded more than 224,000 confirmed cases on Thursday and 2,768 deaths, slightly down from a record high 3,124 deaths a day earlier, according to the coronavirus resource center at Johns Hopkins University.“If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. “Into the summer, and certainly into the fall.”But that was a distant promise for many communities with overtaxed healthcare systems struggling to handle the surge of patients. At least 200 US hospitals were at full capacity last week and in one-third of all hospitals, more than 90% of all ICU beds were occupied, according to a CNN review of weekly data released by the health department.A top coronavirus adviser to President-elect Joe Biden warned that Americans should plan “no Christmas parties”, with weeks of continued pressure on healthcare systems anticipated ahead.“The next three to six weeks at minimum … are our Covid weeks,” Dr Michael Osterholm, the director of the center for infectious disease research and policy in Minnesota and a member of Biden’s coronavirus advisory board, told CNN. “It won’t end after that, but that is the period right now where we could have a surge upon a surge upon a surge.”The US Congress failed again on Thursday to strike a deal on a new package for coronavirus relief, after the Senate majority leader, Mitch McConnell, torpedoed $160bn in state and local funds from what had been an emerging $900bn deal.The Senate adjourned until next week when legislators were expected to resume their efforts.The United Kingdom began administering the Pfizer/BioNTech vaccine earlier this week. Azar said that the FDA had reviewed a recommendation by UK health officials that people with a medical history of serious allergic reactions should avoid the vaccine, after two healthcare workers who suffer from severe allergies and carry epipens had allergic reactions to the vaccine, and had to be treated. They have since recovered.“There was really good discussion at the advisory committee yesterday, especially around these issues of the allergic reactions that we saw in the United Kingdom,” Azar said.As a last step before issuing the authorization, the regulator needs to finalize guidance for doctors about prescribing the vaccine and advising patients.“It’s very close, it’s really just the last dotting of Is and crossing of Ts,” Azar said.Azar said earlier this week that he had been in contact with members of the Joe Biden transition team to ensure a smooth rollout of the vaccines. Both the Pfizer and Moderna vaccines require two does for maximum efficacy. Hundreds of millions of Americans could be vaccinated over the next year.Jessica Glenza contributed to this report More

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

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

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      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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      It's only fake-believe: how to deal with a conspiracy theorist

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      Unless you’ve been on a silent retreat for the past year, you will have almost certainly heard the rumours – that the pandemic is an elaborate hoax, or that the virus was created as a Chinese weapon, or that dangerous elites are trying to kill off the elderly and to establish a new world order, or that the symptoms are caused by 5G.It is troubling enough to see these ideas on social media. But when you are hearing them from your family, your friends, or a casual acquaintance, it is even harder to know how to respond. You are going to struggle to convince the most committed believers, of course, but what about people who are only flirting with the ideas?These difficult conversations are only set to increase now that a new vaccine is on the horizon. Certain niches of internet are already rife with the “plandemic” theory, which alleges that the spread of the virus has been designed to create big bucks for pharmaceutical companies and the philanthropist Bill Gates (whose charity is funding many of the efforts). The idea has been debunked numerous times, whereas there is good evidence that conspiracy theorists such as David Icke are themselves reaping huge profits from spreading misinformation. The danger, of course, is that their ideas will discourage people from taking the vaccine, leaving them vulnerable to the actual disease. More

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      G20 leaders pledge to distribute Covid vaccines fairly around world

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      G20 leaders meeting remotely pledged on Sunday to “spare no effort” to ensure the fair distribution of coronavirus vaccines worldwide, but offered no specific new funding to meet that goal. The virtual summit hosted by Saudi Arabia was an awkward swan song for Donald Trump, who skipped some sessions on Saturday to play golf, paid little attention to other leaders’ speeches and claimed the Paris climate agreement was designed not to save the planet but to the kill the US economy.Joe Biden has promised to rejoin the accord on day one of his presidency, giving other world leaders hope that the UN climate change conference at the end of next year will see more ambitious pledges, including from China, to cut carbon emissions by 2050.Trump’s isolationist diplomacy has allowed China to escape some scrutiny both on its climate and debt forgiveness measures. “To protect American workers, I withdrew the country from the unjust Paris agreement,” Trump told the G20. “I refuse to surrender millions of American jobs and send trillions of American dollars to the world’s worst polluters and environmental offenders, and that’s what would have happened.”The bulk of the summit focused on ensuring that the coronavirus vaccines expected to hit the market imminently are available for distribution at affordable prices in poorer countries.The EU and the UN say there is a £4.5bn funding shortfall this year that the G20 nations should fill. Countries have so far invested $10bn in the Access to Covid-19 Tools (ACT) Accelerator and its vaccine pillar, the Covax Facility. The two schemes are designed to ensure the vaccines do not remain the preserve of the wealthiest economies.The UN secretary general, António Guterres, said: “The recent breakthroughs on Covid-19 vaccines offer a ray of hope. But that ray of hope needs to reach everyone. That means ensuring that vaccines are treated as a global public good, a people’s vaccine accessible and affordable to everyone, everywhere,” he said.“This is not a ‘do-good’ exercise. It is the only way to stop the pandemic dead in its tracks. Solidarity is indeed survival.”The final G20 communique simply said: “We have mobilised resources to address the immediate financing needs in global health to support the research, development, manufacturing and distribution of safe and effective Covid-19 diagnostics, therapeutics and vaccines.“We will spare no effort to ensure their affordable and equitable access for all people, consistent with members’ commitments to incentivise innovation.” It gave no supporting evidence or statistics.In a sign of the competition for access to vaccines and national prestige, Russia said its Sputnik V would be much cheaper than those offered by Pfizer and Moderna. More