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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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      in World Politics

      Will Biden Overturn Sanctions on the ICC?

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      From the get-go, US President Joe Biden’s administration has focused on reversing the worst of Donald Trump’s policy decisions. One of the very worst was the imposition of sanctions on individual officials of the International Criminal Court (ICC). The Trump administration was so enamored of sanctions as a weapon of mass intimidation that it extended the policy beyond the traditional response to hostile governments to target individuals who failed to show the US sufficient respect.

      This was a logical consequence of Trump’s vaunted “America First” policy. This translates as national interest first, international law last. In September 2020, Trump’s secretary of state, Mike Pompeo, singled out ICC prosecutor Fatou Bensouda for sanctions. He “announced a freeze on assets held in the US or subject to US law by Bensouda and the court’s head of jurisdiction, Phakiso Mochochoko.” Even Rodrigo Duterte, the thuggish Filipino president who unilaterally withdrew the Philippines from membership in the Rome Treaty after the ICC received a complaint of crimes against humanity resulting from his brutal and chaotic war on drugs, never imagined imposing sanctions on the chief prosecutor.

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      In other words, Trump’s initiative can only be considered extreme. Bensouda, whose job consists of carrying out investigations related to procedures of justice, complained of “unprecedented and wholly unacceptable threats, attacks and sanctions.” Appearing to sympathize, the Biden administration issued this statement: “Much as we disagree with the ICC’s actions relating to the Afghanistan and Israeli/Palestinian situations, the sanctions will be thoroughly reviewed as we determine our next steps.”

      Today’s Daily Devil’s Dictionary definition:

      Thoroughly review:

      Examine an abusive practice with the hope of finding a devious way to justify its continuation

      Contextual Note

      The word “review” literally means “to look at again.” When politicians use the term, they imply that they will take a more critical look at the issue under consideration with a view to engaging remedial action. This is especially significant at moments in history where one party or political personality has been replaced by another with a highly contrasted worldview. Biden has already taken steps to return to the essential international treaties Trump so casually abandoned, as well as undo the former president’s complicity with the murderous Saudi crown prince, Mohammed bin Salman. The Biden administration needs to show that it is free not just to review but to thoroughly overturn dangerous and sometimes criminal policies.

      Embed from Getty Images

      In reality, the promise to “thoroughly review” often serves a more devious purpose. It creates an expectation that whatever policy emerges — even if it is identical with that of the past — will be legitimized. Rather than remedy a mistake, it may stand as a ploy to seek a better argument in favor of perpetuating the effects of the mistake. Former President Barack Obama campaigned on the theme of ending the war in Iraq. After thoroughly reviewing it with the help of the Pentagon, he continued it.

      The question of the ICC is no ordinary political issue. It contains within it the very idea of justice and fairness that Americans like to see as the core of their “exceptional” ideology, a system of values that never tires of proclaiming its allegiance to the idea of “liberty and justice for all.” On that basis, it should be easy for the Biden administration to cancel Trump’s sanctions and apologize for his arrogance. In terms of PR, it provides a perfect pretext for a new president to demonstrate a willingness to correct the injustices of the past.

      But as with so many issues Biden has inherited from Trump, there is a hidden risk and potentially a serious embarrassment. By provoking the ICC, Trump shouted from the rooftops what previous presidents accomplished by whispering in private amongst themselves. The US has never demonstrated the intention of respecting the principles it so assiduously promoted when the victorious Allies launched the Nuremberg trials. The message those trials sent was that every nation on earth must answer the accusation of crimes against humanity and war crimes. The refusal to be judged by the legal criteria it uses to judge others may provide the best definition of the meaning of “American exceptionalism.”

      Because the nation that invented democracy “believes” with all its soul in everything that is good and just, it can never be held to account for being bad and unjust. At best, American individuals are sometimes guilty of a lapse of judgment, but the American nation as a whole is, as the song says, “a soul whose intentions are good.” Since “no one alive can always be an angel,” the nation feels justified pleading to the heavens, “Lord, please don’t let me be misunderstood.” 

      If Biden follows through and repeals Trump’s sanctions, the consequences could be serious. It would implicitly allow the ICC to pursue the complaints against both the US in Afghanistan and Israel with regard to Palestinians within its borders. Those were the two causes that prompted Pompeo to impose sanctions, citing the principle of national sovereignty. 

      That the US should defend Israel’s putative sovereignty — especially if it means shielding that nation from being prosecuted for war crimes — makes no serious legal sense. But it does reveal a basic truth about US foreign policy. If anything, the immunity the US claims for Israel can be compared with the principle in US law of someone who pleads the fifth amendment in a courtroom to avoid incriminating their spouse (“the spousal testimonial privilege”). Do both Trump and Biden consider the US and Israel a married couple?

      How far is Biden willing to go to undo Trump’s devilry? How much can he backtrack without exposing the US to the principle of universal justice? This is a serious quandary for a president who repeats in nearly every one of his speeches that the US must “not lead by the example of its power, but by the power of its example.”

      Historical Note

      Another issue has just emerged in the news cycle that also requires a thorough review. It concerns the production of semiconductors. The Verge offers this headline: “Biden signs executive order calling for semiconductor supply chain review.” American industry is facing a penury of chips, the essential component of nearly everything Americans buy these days (apart from fast food). From PCs and smartphones to cars, watches and refrigerators, chips rule the consumer economy. Will this be as “thoroughly reviewed” as the reconsideration of the ICC sanctions? It should be because it concerns a problem that affects the entire economy.

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      Not so long ago in recent history, the US was the world’s major manufacturer of semi-conductors. But because it became cheaper to outsource production to Asian nations, US manufacturers preferred to move their supply chain across the Pacific Ocean. Asia has since achieved a quasi-monopoly on semiconductor production.

      The Associated Press recently reported on the “widening global shortage of semiconductors for auto parts” that has forced “major auto companies to halt or slow vehicle production just as they were recovering from pandemic-related factory shutdowns.” The penury of semi-conductors could send an economy already battered by the pandemic into a tailspin. 

      This would be especially true if the Asian countries that produce more than 80% of the world’s and America’s supply were unable or unwilling to deliver. The entire question has evolved into something even more dire. Business Insider summarizes the dilemma in a headline: “The global chip shortage is hurting businesses and could be a national security issue.”

      It is not hard to imagine a war, even a limited war, breaking out between the US and China over navigation in the contested South China Sea or Chinese threats against Taiwan. In such an event, the US could potentially be starved of the supply of essential components required both for its military capacity and its consumer economy. The Biden administration must be aware of this and ready to review it. But once the review is completed, what can they do to remedy it? Not much, at least in the time frame that would be required to lead a military campaign.

      Rather than challenge China and risk alienating nearly all of Asia, the Biden administration can only hope to solve the problem of penury through cooperation and the recognition of interdependence, in contrast with the attitude of confrontation nurtured by Donald Trump. The Biden administration may be forced to engage a particularly “thorough review” on this issue.

      *[In the age of Oscar Wilde and Mark Twain, another American wit, the journalist Ambrose Bierce, produced a series of satirical definitions of commonly used terms, throwing light on their hidden meanings in real discourse. Bierce eventually collected and published them as a book, The Devil’s Dictionary, in 1911. We have shamelessly appropriated his title in the interest of continuing his wholesome pedagogical effort to enlighten generations of readers of the news. Read more of The Daily Devil’s Dictionary on Fair Observer.]

      The views expressed in this article are the author’s own and do not necessarily reflect Fair Observer’s editorial policy. More

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      in US Politics

      'We shouldn't still be fighting for equal rights': LGBTQ+ bill faces tough battle ahead

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      Sign up for the Guardian’s First Thing newsletterThe US House of Representatives voted to pass a landmark bill that would establish federal anti-discrimination protections for LGBTQ+ people, setting up a tough battle in the Senate to turn the proposal into law. “We shouldn’t still be having to fight for equal rights,” said Nic Talbott, a 27-year-old Ohio resident, who was forced to abandon his plans of joining the military due to Donald Trump’s ban on trans service members. “We should be able to go to work, find housing and just live our lives without having to worry about whether or not we’re going to be excluded just for being transgender or gay.”The Equality Act passed the Democratic-led House in a 224-206 vote, with three Republicans joining the Democrats. The bill amends existing civil rights laws to explicitly prohibit discrimination based on gender identity and sexual orientation and provides clear legal protections for transgender and queer people in employment, housing, education, public accommodations, federally funded programs and other sectors.But the proposal’s future is uncertain. Joe Biden has said signing the bill into law is one of his top priorities, but it first has to clear the Senate, where GOP lawmakers could block the legislation with a filibuster. The Equality Act builds on the landmark US supreme court ruling last year prohibiting employment discrimination against LGBTQ+ workers. Biden has already issued executive orders to defend trans rights, undoing some of Trump’s anti-LGBTQ+ policies and directing federal departments to follow the guidance of the supreme court decision. But advocates say the Equality Act is vital because it would enshrine protections into law beyond employment, and prevent future administrations from rolling back anti-discrimination rules.The act would be particularly significant for LGBTQ+ residents in the 27 states that do not have anti-discrimination laws on the books for trans and queer people, where it is legal to deny them housing based on their identities.“Legislation like this is crucial for shifting the tides for trans folks, especially in red states,” said Aria Sa’id, the executive director of the Compton’s Transgender Cultural District, a community group in San Francisco. Trans people flee to California from other states where they have fewer rights or access to services, she said: “We’re coming from other places in the US where we are not safe. We come to San Francisco for refuge … We should be protected in the law no matter where we live.”The Equality Act fight comes amid unprecedented attacks on trans rights in the US and overseas. Republican lawmakers in at least 20 states are currently pushing local bills targeting trans people, backed by rightwing groups. Many of the bills seek to block trans-affirming healthcare or ban trans youth and adults from certain spaces, including by prohibiting them from using the correct bathroom or participating in sports teams that match their gender.Some extremist GOP members of Congress have supported those efforts and have been promoting misinformation and transphobic hate speech this week as the House debated the Equality Act.David B Cruz, a constitutional law professor at University of California, Los Angeles, said federal protections would, in effect, make it illegal for states to enforce discriminatory rules meant to exclude trans people. The Equality Act would also make it harder for the supreme court, which has become more conservative since last year’s ruling, to carve out trans rights in the next LGBTQ+ discrimination case it reviews, he said.Legislation like this is crucial for shifting the tides for trans folks, especially in red states“It would be a monumental achievement,” said Cruz. “It’s not always simple or easy for people to enforce their statutory rights, but even having a federal law that expressly protects those rights on the books, by itself will deter discrimination against LGBTQ+ people.” It would help disrupt “cycles of poverty, due to anti LGBTQ+ prejudice”, he added.Some Republican legislators are vocally opposing the act by citing concerns about religious freedoms. But Cruz noted that a super-majority of Americans in every state support anti-discrimination laws for LGBTQ+ people, including a majority of Republican voters.Khloe Rios-Wyatt, the president at Alianza Translatinx, a Latinx trans rights group in Orange county, California, said she faced discrimination for being trans when she was terminated from her first job out of college: “It can be traumatizing. You lose your income and then you’re facing potential homelessness.”She said she regularly talks to trans people who were denied housing even though they qualified: “You show up in person and they tell you it’s no longer available. It breaks my heart and it has to change.”Bamby Salcedo, the president of the TransLatin@ Coalition in Los Angeles, noted that 2020 was the deadliest year on record for violence against trans and gender non-conforming people, the majority people of color. While the Equality Act could make a difference for the broader LGBTQ+ community, it would not end discrimination for trans people, she said.“The reality is that even in California and places that are super progressive, trans people continue to experience discrimination while trying to obtain employment, housing, healthcare and the basic things we need to exist … There is still a lot of work that needs to be done.”There are at least nine LGBTQ+ members in the House and two in the Senate, and supporters in Congress spoke of their trans and queer family members while championing the bill. Polling released earlier this week confirmed that more Americans than ever before now identify as LGBTQ+. More

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      in US Politics

      Trans doctor Rachel Levine faces historic Senate confirmation hearing

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      Dr Rachel Levine, a pediatrician and health official from Pennsylvania, faced a Senate confirmation hearing on Thursday as Joe Biden’s nominee for assistant health secretary. The process could see her become the first openly transgender federal official to be confirmed by the US Senate.If confirmed, Levine, 63, would make history and break several glass ceilings. In a country which still only has a handful of openly trans public officials, she would be the most high-profile, occupying a senior position in the Biden administration with major responsibilities in the pandemic response.Announcing her nomination last month, Biden said Levine would bring “steady leadership and essential expertise we need to get through this pandemic … She is a historic and deeply qualified choice to help lead our administration’s health efforts.”As the confirmation hearing got under way on Thursday Levine faced hostile questioning from some of the Republican members of the Senate. Rand Paul, senator from Kentucky, compared transgender surgery misleadingly to genital mutilation and accused Levine of supporting “surgical destruction of a minor’s genitalia”.Levine replied by saying that transgender medicine was very complex. “If I am fortunate enough to be confirmed, I will look forward to working with you and your office on the standards of care” in this field, she said.Paul was rebuked by the chair of the committee, Patty Murray, for his “harmful misrepresentations”.Levine is practiced in the art of negotiating confirmation hearings. She had to be confirmed by the Pennsylvania senate in 2015 for her first public role as physician general of the state.The following year she told the Washington Post that she succeeded in securing a unanimous confirmation vote after she sat down one-on-one with the state senators. “With very few exceptions my being transgender is not an issue,” she told the newspaper.Since the start of the pandemic she has led Pennsylvania’s effort to combat the health crisis as the state’s health secretary. In such a highly visible role she has been confronted by a rash of hostile and anti-trans mockery and abuse on social media and even at a public fair.Last July the governor of Pennsylvania, Tom Wolf, who brought Levine into public office, felt it necessary to put out a statement defending her against what he called “vile acts” and “relentless comments and slurs”. He said she was a “highly skilled, valued and capable member of my administration and transgender”.Biden’s nomination of Levine is one of several moves taken by the new administration to promote LGBTQ+ rights. Last month the president lifted Donald Trump’s ban on transgender people serving in the US military.Earlier this month Pete Buttigieg became the first openly gay person to be confirmed to a cabinet post as transportation secretary. More

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      in US Politics

      Biden reverses Trump actions on green cards, architecture and 'anarchist jurisdictions'

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      Sign up for the Guardian’s First Thing newsletterJoe Biden has formally reversed a series of executive actions taken by Donald Trump, including a proclamation that blocked many green card applicants from entering the United States.Trump issued the ban last year, saying it was needed to protect US workers amid high unemployment due to the coronavirus pandemic. Biden rejected that reasoning in a proclamation rescinding the visa ban on Wednesday. The president said it had prevented families from reuniting in the United States and harmed US businesses.Other actions undone by the president included one that sought to cut funding from several cities Trump had deemed “lawless” and “anarchist jurisdictions”, and another mandating that federal buildings should be designed in a classical aesthetic.The reversals come as the new president seeks to press forward with his own agenda and undo key aspects of his predecessor’s legacy. Since taking office last month, Biden has revoked dozens of Trump orders and issued dozens more of his own.Immigrant advocates had pressed in recent weeks for him to lift the visa ban, which was set to expire on 31 March. Biden left in place another ban on most foreign temporary workers.Curtis Morrison, a California-based immigration attorney who represents people subject to the ban, said Biden will now have to tackle a growing backlog of applications that have been held up for months as the pandemic shut down most visa processing by the state department. The process could potentially take years, he said.“It’s a backlog that Trump created,” Morrison said. “He broke the immigration system.”The latest slate of revocations targeted a grab-bag of issues, including a few that Trump signed in his last months in office.Trump issued a memorandum in September that sought to identify municipal governments that permit “anarchy, violence and destruction in American cities.” The memorandum followed protests over George Floyd’s killing by Minneapolis police. The justice department identified New York City, Portland, Oregon, and Seattle as three cities that could have federal funding slashed.Those cities in turn filed a lawsuit to invalidate the designation, and fight off the Trump administration’s efforts to withhold federal dollars.Pete Holmes, the city attorney of Seattle, welcomed the Biden revocation, saying he was “glad to have this nonsense cleared from the decks”.Another reversed order included one issued by Trump in his waning days, which mandated federal buildings return to a more classical style of architecture. The memorandum added that architects should look to “America’s beloved landmark buildings” such as the White House, the US Capitol, the supreme court, the Department of the Treasury and the Lincoln Memorial for inspiration.Biden also revoked a 2018 order that called for agency heads across the government to review welfare programs – such as food stamps, Medicaid and housing aid – and strengthening work requirements for certain recipients. More