Vaccines and immunisation

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      Blow to US vaccination campaign as J&J ‘one-shot’ vaccine deliveries plummet

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      US deliveries of the “one-shot” Johnson and Johnson vaccine are set to drop by 85% next week, in a setback to the government’s vaccination campaign.The Biden administration has allocated just 700,000 J&J doses to states for the week beginning 12 April, according to the Centers for Disease Control and Prevention, a huge drop from the nearly 5m shots allocated the week before.The decline comes after J&J reported a batch of its Covid-19 vaccines developed in Baltimore had failed quality standards and cannot be used – as Anthony Fauci warned the US is at risk from a new coronavirus surge.Distribution of the J&J vaccine – which requires just one dose, as opposed to the two-shot Moderna and Pfizer vaccines also authorized for use in the US – has been uneven since it was introduced.The government allocated 2.8m doses to states at the beginning of March, only for that to drop to 493,000 the next week, but the drop to 12 April is the steepest yet.The slowdown comes after workers at the plant manufacturing coronavirus shots for J&J and AstraZeneca accidentally conflated the vaccines’ ingredients several weeks ago, the New York Times reported.It is unclear if the mix-up is the reason for the drop in J&J doses, and a J&J spokesman told the Wall Street Journal that the company still aimed to deliver 100m doses to the US by the middle of year, most of those by the end of May. The federal government has a deal with J&J for 200m doses.On Thursday Fauci, the top infectious diseases expert in the US, told CNN coronavirus cases had plateaued at a “disturbingly high level”. More than 61,000 new cases were reported on Wednesday, according to Johns Hopkins University.“It’s almost a race between getting people vaccinated and this surge that seems to want to increase,” Fauci said.Health experts have warned the rising number of coronavirus cases in dozens of US states is probably attributable to the spread of virus variants. Michigan has recorded the worst increase in infections over the past two weeks, at a rate not seen since early December.On Tuesday, the Associated Press reported that nearly half of new US virus infections are in just five states, with New York, Michigan, Florida, Pennsylvania and New Jersey responsible for nearly 197,500 new cases in the latest available seven-day period.Despite Michigan’s rate of new infections in the past two weeks, Gretchen Whitmer, the states Democratic governor, has stopped short of ordering restrictions, instead asking for voluntary compliance. She has blamed the virus surge on pandemic fatigue, which has people moving about more, as well as more contagious variants.This week, Joe Biden said half of all American adults are on track to have received at least one Covid-19 vaccination by this weekend. The president has set a goal of delivering 200m vaccinations by 30 April – which marks his first 100 days in office.One in four American adults have now been fully vaccinated against the virus, according to the CDC. More

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      Johnson & Johnson one-shot Covid vaccine gets nod from FDA advisory panel

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      The battle against Covid-19 took a major step forward on Friday as the US moved closer to distributing its first one-shot Covid-19 vaccine, after an independent expert advisory panel recommended drug regulators authorize the Johnson & Johnson vaccine for emergency use.The authorization would be a significant boost to the Biden administration’s vaccination plans, making Johnson & Johnson’s vaccine the third available to the public. Janssen, Johnson & Johnson’s vaccine subsidiary, told a congressional hearing this week that it expects to deliver 20m doses by March and a total of 100m doses before the end of June.The Johnson & Johnson vaccine, along with those from Pfizer and Moderna, should provide the US with more than enough supply to vaccinate every vaccine-eligible person.“We’re still in the midst of this deadly pandemic,” said Dr Archana Chatterjee, a voting member of the panel and an infectious disease pediatrician at Chicago Medical School, as she explained her vote in favor of recommending the vaccine. “There is a shortage of vaccines that are currently authorized, and I think authorization of this vaccine will help meet the needs at the moment.”While regulators at the US Food and Drug Administration (FDA) do not always take the advice of their advisory panels, the agency is expected to authorize the vaccine for emergency use.“We urgently need more vaccines [authorized] to protect the millions of Americans who remain at risk” of Covid-19 infection, said Dr Greg Poland, the editor-in-chief of the medical journal Vaccine and leader of the Vaccine Research Group at the Mayo Clinic.“Today, we have seen clear and compelling evidence that the Janssen vaccine candidate is well tolerated, has an acceptable safety profile and most importantly is highly efficacious against Covid-19,” he said. “To me, it is clear that the known benefits vastly outweigh the known risks.”The recommendation comes soon after the US marks 500,000 deaths from Covid-19, a toll that comes as cases decline in the US and across many countries worldwide. More than 28 million Americans have been infected by Covid-19.“We are seeing positive trends in terms of declining cases,” said Dr Adam MacNeil, a member of the Covid-19 epidemiology taskforce with the US Centers for Disease Control and Prevention. He later added: “We are certainly not out of the woods yet.”Importantly, Johnson & Johnson’s vaccine would also be the easiest to distribute. Unlike vaccines from Pfizer and Moderna, which require sub-zero storage, Johnson & Johnson’s vaccine can be stored at common refrigerator temperatures for up to three months. When frozen it has a shelf life of three years.The convenience of the Johnson & Johnson vaccine comes with caveats. The company’s clinical trials were the first to show the potential impacts of Covid-19 variants, or evolutionary changes in the virus.The vaccine was found to 85% effective at preventing severe disease and to provide complete protection against Covid-19-related hospitalization and death after 28 days. Johnson & Johnson’s vaccine was found to be 72% effective in clinical trials in the US, but only 57% effective in South Africa, where a variant called B1351 originated.However, vaccination remains a powerful weapon, even with threats posed by variants. “Even with decreased effectiveness, vaccination may still provide partial protection against variants,” said MacNeil. Like the Moderna vaccine, Johnson & Johnson’s product will only be available to people 18 and older. Pfizer’s vaccine is available to teenagers older than 16. Also, as with other vaccines, researchers are uncertain how long the vaccine protects against Covid-19, and whether it reduces asymptomatic transmission of the virus, although studies are promising.Johnson & Johnson’s vaccine uses different technology from the two vaccines currently available in the US. The new vaccine uses “viral vector” technology, which introduces the body to the genetic code for the spike protein covering the outside of the coronavirus. This code is transmitted by a second, weakened virus called an adenovirus.Immunity is provoked when the body’s immune system then recognizes the coronavirus by this key structure. Vaccines developed by Pfizer and Moderna also prompt the body to recognize spike proteins on the outside of the coronavirus, but deliver the genetic code through lipid nanoparticles, or tiny molecules of fatty acids.Because scientists are still researching the degree to which any of the authorized vaccines prevent people from spreading Covid-19 to other people, public health authorities recommend people continue to social distance and wear masks after being vaccinated. In theory, a vaccinated person could still spread the SARS-CoV-2 virus, even if they do not experience any symptoms of the disease Covid-19.Johnson & Johnson’s vaccines and the doses already scheduled to be delivered by Moderna and Pfizer, the makers of the two vaccines currently authorized in the US, mean there could be enough supply to vaccinate 400 million people by July. Roughly 267 million people in the US are eligible for a vaccine.This ease of storage and one-dose regime is likely to increase pressure on the US government to pledge doses to low- and middle-income countries, which often lack the cold chain infrastructure needed to distribute the Pfizer or Moderna vaccines. Currently, dozens of low- and middle-income countries do not expect to begin broadly distributing vaccine doses until 2022.Activists, many of whom also worked to expand access to Aids medications, have described this as “vaccine apartheid”, and a threat to the “project of global population immunity”. More

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      Kamala Harris promises federal relief for Texas victims of winter storms

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      Kamala Harris has sent a message to residents of Texas and other states hit by power outages and prolonged winter conditions that help is on the way.“I just want to mention all of those folks in Texas and the mid-Atlantic,” the vice-president said in a live interview on Wednesday morning on NBC’s Today show, her first national network interview since taking office.“I know they can’t see us right now, because they’re without electricity, but the president and I are thinking of them, and really hope we can do everything that is possible through the signing of the emergency orders to get federal relief to support them.”Biden signed a declaration of emergency for Texas on Sunday, opening the way for state officials to move more quickly to tap a larger share of federal aid.Harris also echoed a promise made by Joe Biden on Tuesday night that the United States would have enough doses on hand to vaccinate “all Americans” by July. “We have a vaccine now, and that is great, but we need to get it in the arms of all Americans,” Harris told the Today show host Savannah Guthrie.“And as the president said last night, we expect that that will be done in terms of having the available supply by the end of July, and so we are very excited about that.”Harris touted the speed with which the federal government is sending vaccine doses to states, a rate the White House pegs at 13.5m doses a week or a 57% increase since the inauguration.“As quickly as we’re producing it, we’re getting it out,” she said.Challenged on a guideline issued by the Centers for Disease Control and Prevention saying teachers could return to work without being vaccinated, Harris said the White House felt strongly that teachers should be bumped up in line for vaccine doses.“Teachers should be a priority,” she said. “We think they should be a priority, and the states are making decisions individually.”Teachers’ unions have expressed concern that Biden’s plan to reopen most elementary schools in the next three months could expose teachers to health risks.While the federal government issues recommendations about who should receive vaccine doses in what order, each state maintains its own priority list.Harris said that a $1.9tn Covid relief and economic stimulus package the Biden administration is trying to guide through Congress would help make schools safer by providing funds to improve ventilation, erect social distancing barriers and other measures.“Our goal is that as many K-8 schools as possible will reopen within the first 100 days,” Harris said. “Our goal is that it will be five days a week. And so we have to work to achieve that goal.”To respond to complaints from states that there remained a lack of coordination on federally supplied aid, Harris said the Biden administration had begun to put national protocols in place to support states “that need that kind of coordination and support”.As part of its vaccine initiative, federal agencies have doubled direct shipments of vaccine doses to pharmacies, Harris said, and expanded a program to ship doses to community health centers serving vulnerable populations.“We just want to say to everybody, just please get vaccinated,” Harris said. “And in the interim, wear a mask, social distance and make sure you wash your hands and do that frequently.”Harris deflected a question about whether Donald Trump should face criminal charges after being acquitted in his Senate impeachment trial earlier this month.“You know, right now Savannah I’m focused on what we need to do to get relief to American families,” Harris said. “And that is my highest priority, it is our administration’s highest priority, it’s our job, it’s a job we were elected to do, and that’s our focus.“I haven’t reviewed the case through the lens of being a prosecutor, I’m reviewing the case of Covid in America through the lens of being vice-president of America.” More

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      Biden's pandemic problem: Politics Weekly Extra podcast

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      Jonathan Freedland speaks to the Pulitzer prize-winning author and journalist Laurie Garrett about what Joe Biden needs to do to get a grip on the Covid crisis in the US

      How to listen to podcasts: everything you need to know

      When Joe Biden entered the Oval Office as president, he got to work trying to figure out how to mitigate the coronavirus situation in the US, and what exactly he was up against. Jonathan speaks to the expert on how governments plan for pandemics, Pulitzer prize-winning author and journalist Laurie Garrett about how she knew a crisis like this was coming but why no one in government chose to act. They also discuss what the Biden administration needs to do next. Send us your questions and feedback to podcasts@theguardian.com Help support the Guardian by going to gu.com/supportpodcasts More

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      The 8 January Guardian Weekly – when will the vaccines make life better?

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      Welcome to another edition of the Guardian Weekly. Monday should have been a celebratory day in the United Kingdom as the potentially game-changing Oxford/AstraZeneca vaccine was administered for the first time since being approved. Alas … it was also the day when it became clear that the country’s Covid crisis had moved drastically out of control.The spread of a new, more transmissible variant of the virus has seen infections in the UK soar and hospitals at breaking point. In a primetime television address, Boris Johnson informed the nation that all schools in England – openings had already been delayed elsewhere in the UK – would be closed until at least mid-February and that already-tight lockdown restrictions would be extended further.Will vaccines offer a way out of this disaster? And when? In this week’s cover story, Observer science editor Robin McKie looks at how we might judge the success of mass inoculation programmes. Then Peter Beaumont considers the global vaccine picture and Oliver Holmes reports from Israel which has stormed ahead, having already given more than 10% of its population the jab.Elsewhere, it’s a vital week in American politics. As the Weekly was being printed, Georgians were voting in a double special Senate election that could tip the balance of the upper house. That vote was preceded by the wild phone call made by Donald Trump to Georgia state election officials demanding that they find him enough votes to reverse the decision of the state to elect Joe Biden in November. There were also extraordinary, dangerous moves by other Republicans to challenge the electoral college results in Congress on Wednesday. David Smith tries to make sense of Trump’s final, desperate attempt to subvert democracy.This week’s edition also features reporting from Sally Williams on how people in Mozambique recovered from Cyclone Idai, which caused havoc in early 2019. Ed Pilkington looks at the case of Lisa Montgomery, the only woman on federal death row in the United States. And, in a fascinating report, Laura Spinney looks at the future and history of hospital design in the post-Covid era. If we ever get to it …Get the Guardian Weekly delivered to your home More

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      Biden criticises Trump over slow Covid-19 vaccine rollout – video

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      US President-elect Joe Biden has criticised the Trump administration’s promise of a swift coronavirus vaccine rollout, saying it has ‘fallen far behind’ expectations. Biden, speaking in Wilmington, Delaware, said some 2 million people have been vaccinated, well short of the 20 million Trump had promised by the end of the year. Biden said the vaccine rollout is the ‘greatest operational challenges we’ve ever faced as a nation’ and outlined his plan for ramping up vaccinations, including the use of the Defense Production Act More

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      US government agrees to buy 100m extra doses of Pfizer vaccine

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      Pfizer and BioNTech will provide the US with an additional 100m doses of coronavirus vaccine by mid-summer under a new $2bn deal with the American government.This addition means that Pfizer and BioNTech will deliver a total of 200m doses to the US and enable some 100 million people to be inoculated against the deadly virus.The pharmaceutical companies announced their plan on Wednesday morning in a press release. They plan to deliver all these doses by mid-summer, with a minimum of 70m delivered by 30 June and the remainder “no later than” 31 July. Under this agreement, the US will also have the option to obtain another 400m doses.There have been 18,238,233 Covid-19 cases in the US, with 322,849 recorded deaths, according to Johns Hopkins University data. The US will see its deadliest year in history largely due to Covid-19. Experts believe that overall US life expectancy could drop by as much as three years.“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio,” said Alex Azar, the secretary of health and human services. “This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021.”Pfizer and BioNTech’s vaccine was the first to receive emergency use authorization by the Food and Drug Administration. The first shipments were sent to states last week.The FDA has also granted emergency use authorization to Moderna’s Covid-19 vaccine. While both vaccines require two doses, Moderna does not have to be stored in ultra-cold freezers.News of these additional doses came several weeks after reports revealed that the Trump Administration had passed on the opportunity to purchase millions of additional doses of Pfizer’s vaccine. The administration’s contract with Pfizer was for 100m doses, and provided an opportunity to buy up to 500m additional doses.Trump’s administration decided not to secure an additional 100m doses of Pfizer-BioNTech’s vaccine for the second quarter of 2021, however.While more vaccines are expected to come on line, US officials are also contending with apparent vaccine hesitancy. New data indicated that approximately 50% of Americans would take the vaccine, but 25%of adults said they weren’t certain and another 25% said they would not.Experts have maintained that “herd immunity” – when the overall population has mostly become immune because a significant proportion is – will be achieved when 60% to 70% acquire some level of immunity.The news comes as the devastating current surge has wreaked havoc across the US and especially in California, where officials are warning that the state’s healthcare system may fracture in weeks if people ignore holiday social distancing.Top executives from the state’s largest hospital systems Kaiser Permanente, Dignity Health and Sutter Health, which together cover 15 million Californians, said on Tuesday that increasingly exhausted staff, many pressed into service outside their normal duties, are now attending to Covid-19 patients in hallways and conference rooms.The chief executive of the Martin Luther King community hospital in Los Angeles, Dr Elaine Batchlor, separately said patients there have spilled over into the gift shop and five tents outside the emergency department.“We don’t have space for anybody. We’ve been holding patients for days because we can’t get them transferred, can’t get beds for them,” said Dr Alexis Lenz, an emergency room physician at El Centro regional medical center in Imperial county, in the south-east corner of the state.California is closing in on 2m confirmed cases of Covid-19. The state on Tuesday reported nearly 32,700 newly confirmed cases. Another 653 patients were admitted to hospitals, one of the biggest one-day hospitalization jumps for a total approaching 18,000.State data models have predicted the hospitalizations could top 100,000 in a month if current rates continue.More worrying than lack of beds is a lack of personnel. The pool of available travel nurses is drying up as demand for them jumped 44% over the last month, with California, Texas, Florida, New York and Minnesota requesting the most extra staff, according to San Diego-based health care staffing firm Aya Healthcare.“We’re now in a situation where we have surges all across the country, so nobody has many nurses to spare,” said Dr Janet Coffman, a professor of public policy at the University of California in San Francisco.California is contacting places like Australia and Taiwan to fill the need for 3,000 temporary medical workers, particularly nurses trained in critical care. More