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Coronavirus Debate Safety: A New Issue Grips the 2020 Race

Mr. Biden and his campaign have for months sought to make the race a referendum on Mr. Trump and, in particular, his stewardship of the virus response. Mr. Biden’s team believes that the president’s conduct around his diagnosis has further highlighted the contrasts between the two campaigns and their approaches to a virus that has killed 211,000 people in the United States and caused staggering economic fallout.

Mr. Trump has mocked masks, held large-scale rallies and minimized the risks of the virus even after contracting it. “Don’t be afraid of Covid,” he tweeted on Monday. After taking a drive with Secret Service agents to greet supporters on Sunday — alarming some medical experts — he returned to the White House from the hospital on Monday and ripped off his mask, even as positive cases among his staff continued to grow.

Mr. Biden had moved to take down negative ads after news of Mr. Trump’s positive test last week, but with the president out of the hospital, the Biden campaign confirmed Wednesday that it was resuming “contrast and negative spots” along with pressing an affirmative case for the former vice president. The president had already resumed his attacks in recent days on Democrats, including Mr. Biden.

Representatives for Mr. Trump’s campaign did not respond to questions about the president’s plans for the debates and around testing.

Former Representative Sean Duffy of Wisconsin, a Republican who has attended Trump rallies during the pandemic, dismissed any idea that Mr. Trump’s approach to the virus set a bad example or was imprudent.

“Everyone’s making choices,” he said. “They assess risk and make choices that are right for them, their families. Some say they are going to wear masks, some choose not to. In a free society, that’s what we allow for.”

Mr. Biden, by contrast, has called for mask mandates and has cast wearing a mask as a patriotic duty. He faced criticism for months — from Republicans and some Democrats — for running an exceptionally cautious campaign with very little in-person campaigning. Even now he is holding only tightly controlled, socially distanced events. But in a stark reversal of campaign activities, it is now Mr. Biden who remains on the trail, while Mr. Trump is at home.

Thomas Kaplan contributed reporting.

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Q&A: Where Are We in the COVID-19 Vaccine Race? | Top News

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

U.S. drugmaker Pfizer Inc with German partner BioNTech SE <22UAy.F>, U.S. biotech Moderna Inc

and Britain-based AstraZeneca Plc

in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials over the next two months. Johnson & Johnson

is not far behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo than in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. It the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial also can be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. On Tuesday, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines

Where are we in the COVID-19 vaccine race?

By Carl O’Donnell

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

Who is furthest along?

U.S. drugmaker Pfizer Inc <PFE.N> with German partner BioNTech SE <22UAy.F>, U.S. biotech Moderna Inc <MRNA.O> and Britain-based AstraZeneca Plc <AZN.L> in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials over the next two months. Johnson & Johnson <JNJ.N> is not far behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo than in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. It the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial also can be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. On Tuesday, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s

ACGME Issues Statement on the Executive Order on Race and Sex Stereotyping

ACGME Issues Statement on the Executive Order on Race and Sex Stereotyping

PR Newswire

CHICAGO, Sept. 30, 2020

CHICAGO, Sept. 30, 2020 /PRNewswire/ — The ACGME today issued a statement on the Presidential Executive Order on Combating Race and Sex Stereotyping. The Order, issued September 22, 2020 seemingly promotes training of employees to create an inclusive environment by avoiding race and sex stereotyping; however, that intent is subverted by defining divisive concepts in a way that turns mechanisms intended to protect into weapons of divisiveness and exclusion. The Executive Order is inconsistent with work done over the past 50 years to advance civil rights of minoritized and thereby marginalized communities in the United States and, through its mandates, risks further division and fostering a culture of enmity. This approach works against the ACGME’s mission to improve both health and health care for patients and communities and ultimately results in worsening health outcomes for those we are dedicated to serve.

(PRNewsfoto/ACGME)
(PRNewsfoto/ACGME)

The ACGME has sought to advance the work of diversity, equity, and inclusion and the elimination of health disparities through its programs, policies, and requirements. The goal of the ACGME is to foster a professional, equitable, respectful, and civil environment that is free from discrimination, sexual and other forms of harassment, mistreatment, abuse, or coercion of students, residents, and faculty and staff members, for the betterment of patient care through its accreditation processes.

Prohibiting institutions from providing certain types of education and training that the Executive Order deems to be promoting racial and sexual stereotypes would have devastating consequences on educating residents and fellows toward the goal of eliminating disparities in health outcomes and achieving equity within the health care profession. The Executive Order would similarly preclude residency and fellowship programs from developing curricula that reflect the needs of their communities, particularly in those of color and women, and promote inclusivity.

Read the full ACGME statement.

The ACGME is a private, non-profit, professional organization responsible for the accreditation of over 12,000 residency and fellowship programs and the approximately 865 institutions that sponsor these programs in the United States. Residency and fellowship programs educate approximately 145,000 resident and fellow physicians in 157 specialties and subspecialties. The ACGME’s mission is to improve health care and population health by assessing and advancing the quality of resident physicians’ education through accreditation.

Cision
Cision

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SOURCE Accreditation Council for Graduate Medical Education

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