Vaccines and immunisation

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      ‘We take safety seriously’: Fauci says J&J vaccine pause should raise confidence

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      Joe Biden’s chief medical adviser said on Sunday the recent pause on the Johnson & Johnson Covid-19 vaccine should raise confidence in health agencies’ focus on vaccine safety, as the administration tries to curb deadly outbreaks across the US.The most dangerous outbreak is in Michigan, where more younger people are being hospitalized than at any point in the pandemic.“Something we need to pay attention to is that we’re having still about 50,000 new infections per day,” Dr Anthony Fauci told ABC’s This Week. “That’s a precarious level and we don’t want that to go up.”An independent government advisory panel on Friday voted in favor of resuming use of the Johnson & Johnson single-shot vaccine after it was put on pause to review cases of a blood clotting disorder in six women who received it. The vaccine will now include a warning on its label about the potential risk for rare blood clots and a fact sheet on potential side effects will be given to medical providers and vaccine recipients.Fauci said the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) were “the gold standard for both safety and the evaluation of [vaccine] efficacy”.“I think in the long run what we’re going to see – we’ll probably see it soon – is that people will realize that we take safety very seriously.”The risk of developing the clotting disorder after receiving the Johnson & Johnson vaccine is extremely low. The highest-risk group appears to be women aged 30 to 39, in which there have been 11.8 cases per million doses given. Among men and women 50 and older, there has been less than one case per million doses.“We’ve looked at it,” Fauci said. “Now let’s get back and get people vaccinated. And that’s what we’re going to be doing, get as many people vaccinated as we possibly can.”Fauci said he expected updated guidance on mask use for vaccinated people to be released soon. In the US, 28% adults are fully vaccinated, according to the CDC.He said he was encouraged by the effectiveness of the vaccines available, but warned that the US has still not reined in Covid-19. More than 568,000 people have died from the virus in the US.Across the country, people in their 20s, 30s and 40s account for a growing share of hospitalizations. Michigan has confirmed 91,000 new cases in the past two weeks, more than in the two most populous states, California and Texas, combined.The seven-day average for Covid-19 hospitalizations last week was 38,550, according to the CDC. At the peak of the pandemic, in December and January, the highest such average was 123,907.The majority of the Michigan residents 65 and older have been vaccinated but that does not fully explain why cases have risen among those 60 and younger. Part of the change is being attributed to the B117 virus variant, which is more contagious and more deadly, and to an easing of restrictions on dining, crowds and mask wearing.Dr Mark Hamed, medical director in the emergency department at McKenzie Hospital in Sandusky, Michigan, said people may have been lulled into a false sense of security because the region was spared from rampant cases last year.Many people are still unvaccinated and the area “is being hit pretty hard”, Hamed told the Associated Press. “Our ER is absolutely swamped beyond belief.”On ABC, Fauci was asked to address those who are hesitant to be vaccinated, including the Wisconsin Republican senator Ron Johnson, who has no medical expertise or background but said this week there was no reason to “push” vaccines on the American people.“We have a highly efficacious and effective vaccine that’s really very, very safe,” Fauci said. “That is the reason why you want everyone to get vaccinated, so I don’t understand the argument.”Surveys have shown Republicans to be one of the most vaccine hesitant groups. Democrats (67%) are more likely than independents (47%) and Republicans (36%) to report getting a first dose, according to a Monmouth University poll in early April.Former president Donald Trump, who downplayed the severity of the pandemic throughout 2020, has encouraged people to get a vaccine.On Sunday the Republican senator Shelley Moore Capito, of West Virginia, encouraged people to get vaccinated and said of Johnson: “I definitely think that comments like that hurt. I believe that we should all have confidence that we should to not just protect ourselves, but our communities and our neighbors. We should get vaccinated.”West Virginia was an early national leader in the vaccine rollout and 28.8% of residents are now fully vaccinated.“We’re starting to find that we have more vaccine than we do have people who are willing to step forward,” Capito, who has been vaccinated, told CNN’s State of the Union. “So I’m trying to do whatever I can to say it’s safe, it’s reliable and it’s really about you and your neighbor.” More

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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

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      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