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The Conversation

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What are emergency use authorizations, and do they guarantee that a vaccine or drug is safe?

 Tony Potts, a 69-year-old retiree, removes his face mask for a temperature check just before receiving his first injection in a phase 3 COVID-19 vaccine clinical trial sponsored by Moderna. Potts is one of 30,000 participants in the Moderna trial.

Paul Hennessy/NurPhoto via Getty ImageS

Christopher Robertson, Boston University and Jeremy Greene, Johns Hopkins University

In coming days, the Food and Drug Administration is likely to authorize new COVID-19 vaccines based on applications submitted by two companies. These authorizations have happened very fast in a process called “emergency use authorizations,” or EUAs.

Does this swift action mean that products are proven safe and effective? Not exactly. But it suggests that they may present a reasonable balance of risks and benefits.

We are a physician and a lawyer, and we also study drug development from the perspectives of history and philosophy. The longer view is helpful to understand the differences between full FDA approval and EUAs.

Peru's democracy faces greatest trial since Fujimori dictatorship after two presidents are ousted in one week

  Gisselle Vila Benites, University of Melbourne and Anthony Bebbington, Clark University


Peru’s new interim president took office on Nov. 17 under unenviable circumstances.



Francisco Sagasti became the South American country’s third president in a week after President Martin Vizcarra was impeached for “moral incapacity” in what many Peruvians saw as a coup by Congress. Then Vizcarra’s successor, congressional president Manuel Merino, was quickly forced to resign after furious public protest.



New president Sagasti must now steer a shaken nation not just toward elections, scheduled for April 2021, but also toward renewed faith in democracy.



It’s not an unprecedented mandate for a Peruvian leader. Exactly 20 years ago, Peru’s political leaders faced – and ultimately failed – a similar test, after the fall of dictator Alberto Fujimori.



And their failures explain why Peru, in the words of political scientist Alberto Vergara, peered into the “abyss” of repressive authoritarianism for six days this November – with protesters facing indiscriminate and deadly violence, even kidnapping, torture, illegal detention and sexual abuse by Peruvian police.



Great expectations fall short



During Fujimori’s corrupt military-backed rule between 1990 and 2000, Peru’s democratic institutions were dismantled and its democratic values subverted. Dissenters faced death, disappearance and torture.



Fujimori’s regime came crumbling down in November 2000 because of electoral fraud and a mass popular uprising. Fujimori was removed from office by Congress and replaced by congressional leader Valentín Paniagua.



As interim president, Paniagua had a mandate – as Sagasti does today – to lead a deeply scarred nation into a formal democratic transition and help society heal. In 2001, Paniagua established a truth and reconciliation commission to document Fujimori’s atrocities and created a constitutional commission tasked with identifying the structural changes required to safeguard Peruvian democracy in the future.



Paniagua’s successors did not see his initiatives through.



The truth commission meticulously documented state crimes, and in 2009 Fujimori was convicted of mass human rights abuses. But prosecutions of others and redress for victims – particularly poor, rural and Indigenous populations – have been excruciatingly slow and inadequate.



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Confrontations with security forces, like this 1992 encounter outside a Peruvian prison, were a feature of life under Fujimori.
Roberto Schmidt/AFP via Getty Images



Peru’s leaders after Paniagua also discarded arguments that Peru needed a new constitution with greater protections for democracy and the rule of law. Drafting a new constitution might have ensured, as the late Peruvian politician Henry Pease put it, that “scoundrels won’t feel free to dissolve the Congress” as Fujimori had.



Instead, Alejandro Toledo, the first democratically elected president after Fujimori, channeled reform demands into 2002’s “National Agreement.” This document, developed jointly by government, civil society and political parties, laid out the basis for Peru’s democratic transition and established a shared national vision.



But it did little to tackle Peru’s chronic governance problems. Social, environmental and accountability controls over public and private investment remained weak. So did Peruvian courts, which are vulnerable to special interests because of a politicized and often corrupt judicial appointment process.



Uneven growth



The consequences of Peru’s lack of reform were dramatically revealed in recent years in the Lava Jato corruption scandal, in which construction companies bribed politicians across Latin America to snag big government contracts.



Since 2016, four Peruvian presidents and Fujimori’s own daughter have been criminally implicated in Lava Jato. Vizcarra, whose impeachment set off Peru’s current political crisis, became vice president because of this long-running scandal. He came to power in 2018 when then-president Pedro Pablo Kuczynski resigned after accusations of bribery.



But when lawmakers ousted President Vizcarra with the same charges in November 2020, it caused immediate public condemnation. Protesters felt lawmakers’ interpretation of “moral incapacity” – a clause in the Peruvian constitution – was dubious at best. At worst, they feared, it was a cynical manipulation by congressional conservatives to seize Peru’s government.



When Vizcarra’s successor, Merino, appointed as his prime minister politician Antero Flores-Araoz – an ally of congressional extreme right-wingers – those fears seemed to be confirmed. Some 2.7 million Peruvians – almost one-tenth of the population – took to the streets. Merino resigned after six days, having failed to secure the military’s support.



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Performance artists commemorate the victims of police killings during November’s protests.
Carlos Garcia Granthon/Fotoholica Press/LightRocket via Getty Images



Today, 85% of Peruvians surveyed by the Vanderbilt University pollsters Latinobarometro agree that Peru “is ruled by a handful of powerful groups for their own benefit”. The country loses about US$6.5 billion to corruption every year, according to the national comptroller.



Still, Peru’s economy has boomed since 2000, fueled primarily by mineral extraction, gas and crops like asparagus, grapes and avocados. Mining accounts for about 60% of exports.



While these activities occur in rural areas, Peru’s countryside remains extremely poor. People in gold-rich Cajamarca are about five times more likely to live in poverty than those in metropolitan Lima.



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Peruvian National Police at an illegal gold mine near Puerto Maldonado, June 11, 2013.
Lig Ynnek/flickr, CC BY-NC



Peruvians who protest against the environmental damage and disruption of livelihoods caused by mining – both legal and illegal – are often met with police and security force violence.



Protests and legal battles over mining in Peru have earned little political response. Oversight of mining operations is so weak that police and military forces sometimes sign agreements with companies to protect mines from protests.



Sagasti’s task



Improving political and economic inclusion and reforming the police are now high on Peruvian protesters’ list of demands.



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President Francisco Sagasti after taking his oath of office Nov. 17.
Hugo Curotto/Getty Images



As in 2000, some protesters and politicians are again calling for a new constitution that will strengthen the separation of powers in Peru and hold elected officials more accountable for their actions.



[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]



Back in the 2000s, Congress neglected such structural changes, allowing the problems that gave rise to Fujimori’s regime to continue after his overthrow.



Today Peru’s vigilant young protesters expect Sagasti to do more. To succeed as a post-crisis leader, he’ll need to restore Peruvians’ trust in government and lay the foundation for a more democratic future.The Conversation



Gisselle Vila Benites, Adjunct Researcher at the Center for Mining and Sustainability Studies at the Universidad del Pacífico (Peru) and PhD Candidate in Geography, University of Melbourne and Anthony Bebbington, Milton P. and Alice C. Higgins Professor of Environment and Society, Professor of Geography, Clark University



This article is republished from The Conversation under a Creative Commons license. Read the original article.


How Joe Biden did so well in Georgia


In Atlanta, people gather to dance and celebrate the election of Joe Biden as the next president.
AP Photo/Brynn Anderson


Bev-Freda Jackson, American University School of Public Affairs


For nearly 30 years, the state of Georgia has voted reliably Republican in presidential elections. Not since 1992 has the state backed a Democrat for president. Now, the hand recount of 2020 election ballots has confirmed Joe Biden won the state.



The initial returns from Georgia on election night leaned Republican, but in the days that followed, the balance of the count shifted steadily, as ballots from in and around Atlanta were counted. These votes were largely from communities of color, mostly African American – and they represent much of the state’s rich history of civil rights advocacy.



Atlanta, often called the “cradle of the civil rights movement,” was the birthplace of Martin Luther King Jr. and made up much of the congressional district represented by the late John Lewis.



I am a political scientist and race scholar, with specific emphasis on examining social justice movement strategy and the impact of collective action. To me, the story behind how those Biden-Harris voters were mobilized – with others across the state – is the latest chapter in the state’s history of community organizing for peaceful democratic political change.



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Martin Luther King Jr. speaks to a church gathering in Albany, Ga., about desegregation efforts and civil rights, in July 1962.
AP Photo



A long history



Social justice movements and civil rights activism have always been important in Georgia. Even during Reconstruction, in the wake of the Civil War, the organizers worked to teach Georgians about voting rights and the rules for qualifying to vote in a state that had long denied them that right.



Efforts continued through the years, including rule changes that added more than 100,000 Black voters to the state’s rolls between 1940 and 1947. In the 1950s and 1960s, voting rights campaigns across the South sought to remove the vestiges of a Jim Crow system that suppressed Black voters with literacy tests, grandfather clauses and physical intimidation.



One major effort was the 1961-1962 Albany Movement, based in the Georgia town of that name. The effort was led initially by the Student Nonviolent Coordinating Committee, with later help from the Southern Christian Leadership Conference, two of the nation’s leading civil rights organizations at the time. At the outset, Albany’s population was 40% Black, but many of them were not registered to vote.



The Albany Movement was the first attempt to completely desegregate a community, including through teaching nonviolence for people to engage in civil disobedience. The tactics and strategies pioneered there were successful in Albany and, as King and his movement shifted to Birmingham, Alabama, formed the basis for their work as well.



Between 1960 and 1964, half a million Black voters were registered in Georgia, as part of a larger Student Nonviolent Coordinating Committee voter registration drive across the South.



Those decades of activism built strong networks for grassroots organizing and taught many people how to effectively fight segregation and racism with boycotts, sit-ins and other nonviolent methods of direct action resistance. After King’s assassination in 1968, the movement slowed significantly, showing how important it was to decentralize future civil rights efforts, rather than focusing them on one specific person or place.



Decades later, the Movement for Black Lives arose in response to police brutality against Black Americans, and built on the lessons learned through the 1960s.



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Georgia politician and activist Stacey Abrams speaks to a crowd in advance of the 2020 election.
AP Photo/Brynn Anderson



A new movement



The latest push for Black voters in Georgia came in 2018, after former State Representative Stacey Abrams, a Black Democratic woman, narrowly lost the race for governor to Brian Kemp, a white Republican man.



Her loss was largely attributed to the efforts of Kemp, who had been the state’s top elections official, to suppress Black votes. Those efforts included throwing more than half a million voters off the rolls – most of them Black – and tightening other voting rules.



In the wake of that election, Abrams committed herself to fight voter suppression in Georgia. She created an organization called Fair Fight to get the purged voters back on the rolls and to register others who were eligible to vote as well.



She began these efforts when Black Georgians’ attention had turned strongly to politics after the killing of Ahmaud Arbery. The 2020 death of civil rights icon and longtime Congressman John Lewis brought more attention to racial inequality. Many people realized they had been disenfranchised and were suffering from “intolerance fatigue,” the feeling of being “sick and tired of being sick and tired.”



Abrams and Fair Fight benefited from the state’s 2016 implementation of the 1993 National Voter Registration Act, sometimes called the “motor voter” law, which gives people the opportunity to register to vote at the same time that they apply for or renew a driver’s license.



Altogether, that collective effort registered 800,000 new voters in Georgia since Abrams’ 2018 loss. Some of those were likely among the many that Secretary of State Kemp had forced off the rolls, but many were also people who had never before been registered to vote in Georgia.



In addition to getting people’s names on the voting rolls, these groups pushed the importance of actually voting and taught people how to vote safely, including by mail or in-person before Election Day. Their efforts resulted in a 63% increase over the 2016 statistics for mail-in and early in-person voting ballots cast.



Overall, Georgia’s 2020 turnout was roughly 800,000 more than in the 2016 presidential election.



An additional factor in the Georgia election result may have been President Donald Trump’s own statements discouraging his supporters from voting, but the real key was the grassroots organization, the modern echo of the Albany Movement, the Student Nonviolent Coordinating Committee and other efforts, that brought new voters into the fold.The Conversation



Bev-Freda Jackson, Adjunct Professorial Lecturer, American University School of Public Affairs



This article is republished from The Conversation under a Creative Commons license. Read the original article.


How mRNA vaccines from Pfizer and Moderna work, why they're a breakthrough and why they need to be kept so cold

 Moderna’s new mRNA vaccine is almost 94.5% effective in large-scale trials.

JUSTIN TALLIS/AFP via Getty Images


Sanjay Mishra, Vanderbilt University


As the weather cools, the number of infections of the COVID-19 pandemic are rising sharply. Hamstrung by pandemic fatigue, economic constraints and political discord, public health officials have struggled to control the surging pandemic. But now, a rush of interim analyses from pharmaceutical companies Moderna and Pfizer/BioNTech have spurred optimism that a novel type of vaccine made from messenger RNA, known as mRNA, can offer high levels of protection by preventing COVID-19 among people who are vaccinated.



Although unpublished, these preliminary reports have exceeded the expectations of many vaccine experts, including mine. Until early this year, I worked on developing vaccine candidates against Zika and dengue. Now I am coordinating an international effort to collect reports on adult patients with current or previous cancers who have also been diagnosed with COVID-19.



Promising preliminary results



Moderna reported that during the phase 3 study of its vaccine candidate mRNA-1273, which enrolled 30,000 adult U.S. participants, just five of the 95 COVID-19 cases occurred among the vaccinated, while 90 infections were identified in the placebo group. This corresponds to an efficacy of 94.5%. None of the infected patients who received the vaccine developed severe COVID-19, while 11 (12%) of those who received the placebo did.



Similarly, the Pfizer-BioNTech vaccine candidate, BNT162b2, was 90% effective in preventing infection during the phase 3 clinical trial, which enrolled 43,538 participants, with 30% in U.S. and 42% abroad



How does mRNA vaccine work?



Vaccines train the immune system to recognize the disease-causing part of a virus. Vaccines traditionally contain either weakened viruses or purified signature proteins of the virus.



But an mRNA vaccine is different, because rather than having the viral protein injected, a person receives genetic material – mRNA – that encodes the viral protein. When these genetic instructions are injected into the upper arm, the muscle cells translate them to make the viral protein directly in the body.



This approach mimics what the SARS-CoV-2 does in nature – but the vaccine mRNA codes only for the critical fragment of the viral protein. This gives the immune system a preview of what the real virus looks like without causing disease. This preview gives the immune system time to design powerful antibodies that can neutralize the real virus if the individual is ever infected.



While this synthetic mRNA is genetic material, it cannot be transmitted to the next generation. After an mRNA injection, this molecule guides the protein production inside the muscle cells, which reaches peak levels for 24 to 48 hours and can last for a few more days. 1200w, 1800w, 754w, 1508w, 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">

The immunization timeline for the Moderna vaccine trial.
undefined undefined/iStock/Getty Images Plus



Why is making an mRNA vaccine so fast?



Traditional vaccine development, although well studied, is very time-consuming and cannot respond instantaneously against novel pandemics such as COVID-19.



For example, for seasonal flu, it takes roughly six months from identification of the circulating influenza virus strain to produce a vaccine. The candidate flu vaccine virus is grown for about three weeks to produce a hybrid virus, which is less dangerous and better able to grow in hens’ eggs. The hybrid virus is then injected into a lot of fertilized eggs and incubated for several days to make more copies. Then the fluid containing virus is harvested from eggs, the vaccine viruses are killed, and the viral proteins are purified over several days.



The mRNA vaccines can leapfrog the hurdles of developing traditional vaccines such as producing noninfectious viruses, or producing viral proteins at medically demanding levels of purity.



MRNA vaccines eliminate much of the manufacturing process because rather than having viral proteins injected, the human body uses the instructions to manufacture viral proteins itself.



Also, mRNA molecules are far simpler than proteins. For vaccines, mRNA is manufactured by chemical rather than biological synthesis, so it is much quicker than conventional vaccines to be redesigned, scaled up and mass-produced.



In fact, within days of the genetic code of the SARS-CoV-2 virus becoming available, the mRNA code for a candidate vaccine testing was ready. What’s most attractive is that once the mRNA vaccine tools become viable, mRNA can be quickly tailored for other future pandemics. 1200w, 1800w, 754w, 1508w, 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">

A comparison of traditional with the new mRNA vaccines.



What are problems with mRNA?



MRNA technology isn’t new. It was shown a while back that when synthetic mRNA is injected into an animal, the cells can produce a desired protein. But the progress remained slow. That’s because mRNA is not only notoriously unstable and easy to degrade into smaller components, it is also easily destroyed by the human body’s immune defenses, which make delivering it to the target very inefficient.



But beginning in 2005, researchers figured out how to stabilize mRNA and package it into small particles to deliver it as a vaccine. The mRNA COVID-19 vaccines are expected to be the first using this technology to be approved by the FDA.



After a decade of work, the mRNA vaccines are now ready for evaluation. Physicians will be watching for unintended immune reactions, which can be both helpful and detrimental.



Why keep mRNA supercold?



The most important challenge for development of a mRNA vaccine remains its inherent instability, because it is more likely to break apart above freezing temperatures.



Modification of the mRNA building blocks and development of the particles that can cocoon it relatively safely have helped the mRNA vaccine candidates. But this new class of vaccine still requires unprecedented freezer conditions for distribution and administration.



What are the refrigeration requirements?



The Pfizer-BioNTech mRNA vaccine will need to be optimally stored at minus 94 degrees Fahrenheit and will degrade in around five days at normal refrigeration temperatures of slightly above freezing.



[Get facts about coronavirus and the latest research. Sign up for The Conversation’s newsletter.]



In contrast, Moderna claims its vaccine can be maintained at most home or medical freezer temperatures for up to six months for shipping and longer-term storage. Moderna also claims its vaccine can remain stable at standard refrigerated conditions, of 36 to 46 degrees Fahrenheit, for up to 30 days after thawing, within the six-month shelf life.



Not surprisingly, Pfizer is also developing shipping containers using dry ice to address shipping constraints.The Conversation



Sanjay Mishra, Project Coordinator & Staff Scientist, Vanderbilt University Medical Center, Vanderbilt University



This article is republished from The Conversation under a Creative Commons license. Read the original article.


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