Originally published by Sexual Violence Research Initiative (SVRI). Also available in French and Spanish.

Researchers often grapple with a major challenge when researching sexual violence or evaluating programs focused on sexual violence—how to collect information without retraumatizing survivors.

Gathering accurate data from survivors of sexual violence is essential to document or develop programs for their benefit. Obtaining that information, however, can come with serious risks to survivors, especially in conflict-affected contexts, where security risks for survivors can be grave.

Standard research methods, such as interviewing survivors, may retraumatize them or expose them to additional stigma and discrimination. Similarly, efforts to monitor and evaluate programs involving survivors run the risk of causing more distress.

Physicians for Human Rights (PHR) is trying to address that challenge. Our Program on Sexual Violence in Conflict Zones provides capacity development for medical, legal, and law enforcement professionals who support survivors of sexual violence as they seek justice. Our team designs research and monitoring and evaluation mechanisms that generate data, while ensuring the safety and security of the survivors.

We use mixed methodologies, examples of which we will highlight below, to avoid placing the burden of documentation solely on survivors. We rely on credible sources of data and information instead of the testimonies of sexual violence survivors. These sources can serve as both additional sources of information and appropriate proxies in the place of sexual violence survivors.

Human Rights Documentation: Research on Sexual Violence and the Rohingya

Our organization’s recently published report “Sexual Violence, Trauma, and Neglect: Observations of Health Care Providers Treating Rohingya Survivors in Refugee Camps in Bangladesh” focuses on sexual violence and attacks against Rohingya communities, causing the exodus of more than 720,000 Rohingya to Bangladesh.

In this research, PHR sought, in a methodologically rigorous way, to document and explore patterns of injuries and conditions suffered by the Rohingya—with a focus on sexual violence–-by speaking with healthcare workers who provided care to Rohingya refugees in Bangladesh. Doctors, nurses, and other clinicians treating affected communities are often the first people to whom survivors may disclose their trauma and the intimate details. These frontline health workers have unique perspectives and experiences that should be documented as part of research on sexual violence. Health care provider interviews not only allowed PHR to collect survivor accounts—without the retraumatization risks of speaking directly to survivors—but also to corroborate survivor histories that had previously been documented.

Monitoring and Evaluation: MediCapt App as an Evaluation Tool in Kenya

Our organization is also incorporating methodologies that avoid risks of retraumatizing survivors in our monitoring and evaluation efforts. With the support of the Sexual Violence Research Initiative and the World Bank Group, through the Development Marketplace Award for Innovation in the Prevention and Response of Gender Based Violence, we are conducting an evaluation of MediCapt.

MediCapt is a mobile application that was collaboratively designed to collect forensic medical evidence of sexual violence and securely transmit the data to authorities engaged in seeking accountability for these crimes.

We are conducting a review of medical records to understand how this digital intervention impacts the ability of clinicians who are using the app in Kenya to collect, document, and preserve medical evidence of sexual violence. We are doing this by comparing the quality of evidence collected digitally in MediCapt with information collected on paper. Medical record reviews, when conducted ethically and confidentially, provide insights into the experiences of survivors and what programmatic interventions are working—and not working—to improve access to justice for survivors without risking retraumatizing them.

These innovative methods are critical for reducing the potential harm to survivors that can result from traditional research and monitoring and evaluation approaches for sexual violence. They also allow for the collection of additional experiences and perspectives that are critical to understanding sexual violence. While it is important to explore creative methodologies that avoid risks of retraumatization, it is also necessary to prioritize the voices of survivors in research and monitoring and evaluation on sexual violence.

Using a variety of approaches—some that involve survivors and others that tap into alternative sources of information—can reduce the burden on survivors and empower them to share their experiences.

Originally published on Devex, November 25, 2020.

While infectious diseases – measles, flu, polio, tuberculosis, severe acute respiratory syndrome, malaria, Ebola, HIV/AIDS, COVID-19 – have swept the globe, with the lowest-income communities bearing the brunt of suffering and death, there is one other pandemic that has surpassed and outlasted them all: sexual and gender-based violence, especially domestic violence.

The magnitude of violence against women and girls is staggering. Globally, 35% of women have experienced physical or sexual intimate partner violence, and more than 1 billion women lack legal protection from sexual violence by an intimate partner or family member. Worldwide, 243 million women and girls ages 15-49 have been subjected to sexual or physical violence by an intimate partner in the previous 12 months. Over 100 women are killed by a family member every day.

Researchers say that a conservative estimate of the welfare costs of intimate partner violence, or IPV, is $4.4 trillion, or 5.2% of global gross domestic product. IPV costs us significantly more than the societal toll of deaths from homicides or civil war. These costs do not begin to convey the short- and long-term damage to the mental and physical health of survivors.

Women subjected to domestic violence and sexual assault experience more miscarriages, abortions, mental illness, attempted suicide, and exposure to HIV/AIDS. Witnessing or experiencing violence as a child causes long-term mental health problems in both boys and girls and is a significant predictor of future violence: Boys are more likely to become violent abusers and girls to be victimized in adulthood.

Even where domestic violence is criminalized, few cases are reported and fewer still reach a court of law. Survivors often fear that reporting will put them at greater risk or deprive the family of a breadwinner. Where domestic violence is culturally embedded and ubiquitous, local police officers are likely to consider violent crimes against women and children a “family matter.” Additionally, the lack of safe spaces, shelters, and other support services makes it often impossible for women to be protected from further abuse.

The effect of COVID-19 on gender-based violence

COVID-19’s lockdowns, school closings, and joblessness have poured gas on an already blazing fire. Reports of domestic violence have increased by 40% or more in some countries. “Building back better” from the COVID-19 pandemic must include the prioritization of “building back safer” to confront the pandemic of gender-based violence that causes suffering, disability, injury, or death for a third of the women on the planet.

Building back safer means that national governments, donor nations, and international development institutions must do now what they have not done in the past: commit to measurable reductions in sexual assault, murder, and battery of women and children. Criminal justice institutions should prosecute perpetrators and deploy a full complement of protection strategies, including restraining orders, home checks, and access to family shelters for women and children in immediate danger.

Addressing IPV requires a holistic, multi-sectoral approach. Health professionals must work with police officers, lawyers, and the judiciary, while civil society organizations must work in partnership with government agencies to support the survivors at the center of the process. Civil society groups can mobilize the community against IPV, which will encourage local authorities to act on it.

Emergency response and building back from COVID-19 globally will be a monumental public health endeavor, with more than 1 million people dead from COVID-19 and many millions more out of work. But for half the world’s population — women and girls — access to effective justice services, including accountability for perpetrators, is an essential element of public health.

Health workers are not only responding to COVID-19 patients, but also tending to the wounds of millions of women and children from IPV. But only criminal justice officials have the sovereign duty of holding perpetrators to account. In many places, they are not exercising it now and will not be able to do so in the future if police, prosecutors, courts, and social welfare agencies are not properly resourced and held to account for just outcomes.

Best practices

There are promising models in communities around the world. In Kenya, for example, Physicians for Human Rights’ program on sexual violence in conflict zones has applied a multi-sectoral approach to train doctors, clinical officers, nurses, psychotrauma counselors, police officers, lawyers, and judges to strengthen the way they capture and preserve forensic evidence to bolster investigations and enhance prosecutions to increase the likelihood that a survivor will obtain meaningful access to justice.

By working with medical, law enforcement, and legal partners, PHR seeks to emphasize trauma-informed, survivor-centered techniques for gathering comprehensive and compelling evidence and helping survivors obtain justice and accountability.

International Justice Mission’s government partners have achieved hundreds of convictions for sexual assault in Bolivia and Guatemala, while also establishing child-friendly investigation and courtroom protocols. IJM’s pilot effort in northern Uganda to help local justice officials prosecute cases of IPV resulted in convictions for offenders and restitution for survivors. When given options and support, survivors brought cases to the police, and police officers were more than willing to act on them.

In criminal justice, like public health, struggling and underfunded institutions in impoverished countries are not likely to reform themselves. It takes investment, political will, accountability, and partnership by national governments, foreign donors, and civil society – all of which are crucial to beating back viral pandemics.

The same investment and collaboration – but this time for faltering criminal justice systems – is required to take on the world’s most durable pandemic: violence against women and children.

---

Authors

Naitore Nyamu

Naitore Nyamu is a human rights advocate and as the head of Physicians for Human Rights’ Kenya office and responsible for the advancement of the program on sexual violence in conflict zones in Kenya. Nyamu has more than 10 years’ experience working with various national and international NGOs, and previously managed multi-country campaigns aimed at addressing sexual and gender-based violence in Kenya, Liberia, Sierra Leone, Tanzania, and Zambia.

Sharon Cohn Wu

Sharon Cohn Wu is the principal advisor on violence against women and children for International Justice Mission, leading IJM’s center of excellence in addressing sexual violence against children and intimate partner violence and developing globally applicable best practices from IJM’s extensive programmatic experience worldwide.

The toll of the COVID-19 pandemic has spread to nearly every country on earth. But in countries where populations are already subject to, or at risk of, mass atrocities – such as extrajudicial killings, forced displacement, mass rape, and the destruction of health facilities and entire communities – the pandemic poses even more acute risks.

Civil society activists have expressed significant concern that the pandemic could be “weaponized” by world leaders and guardians of law and order who hold unmonitored excessive powers. These leaders could deny, and in some cases have already denied, marginalized populations their right to health and access to information, movement, and services; they could also expand military operations while the world’s attention is elsewhere.

But despite these grave and widespread threats, the global spread of COVID-19 also creates an opportunity for positive change. The pandemic reminds us of the need to rebuild healthier and more equitable societies and for the international community to re-commit to the essential pillars of universal human rights and global cooperation.

“Weaponizing” a pandemic

Over the past six months, as COVID-19 has spread, governments, military officials, and other authorities around the world have restricted access to information, communication services, and basic medical services. In Myanmar, for example, the organization Progressive Voice claims that the military is using the pandemic as a cover to expand military operations against ethnic armed organizations, to continue to commit war crimes and crimes against humanity in minority areas, and to actively target medical facilities, all the while casting themselves as benevolent protectors.  

In Myanmar and beyond, many ethnic and religious groups who had been restricted to particular areas and small spaces prior to the spread of COVID-19 have been kept confined, even as the virus moves across domestic and international borders. Many internally displaced people, such as those in Myanmar, have not had access to basic and regular information about the virus, preventing self-protection measures.

“Every attack on health care is a tragedy, every attack is an attack on humanity.”

Ali Naraghi, head of Health Care in Danger, International Red Cross and Red Crescent Movement

Restricting Access to Health and Humanitarian Aid

For health care workers in conflict settings, the conditions and threats were already alarming before the COVID-19 pandemic. While health care workers should be protected at all times, they are instead increasingly targeted, with more than 1,203 reported incidents of violence against health care workers in conflict regions in 2019. The recent killing of a World Health Organization driver who was transporting COVID-19 surveillance samples supplies in Rakhine state, Myanmar exemplifies this increased threat. Such attacks on health care workers present a clear danger to populations’ access to essential health care.  

Further, humanitarian workers, civil society, and communities are all too often prevented from helping the record 168 million people in need of aid worldwide due to various barriers imposed by governments and non-state groups. Additional restrictions, whether genuinely designed to contain the spread of the coronavirus or not, pose grave threats to many communities worldwide. In Bangladesh, for example, the lockdown measures have restricted all but humanitarian workers deemed to be providing “essential services” from entering the vast and high-density Rohingya refugee camps – the largest in the world – creating severe risks of food and water shortages. In Syria, the government has been accused of denying life-saving assistance and deliberately destroying health facilities in opposition areas throughout the country’s nine-year armed conflict. This situation is further worsened by the UN Security Council’s decision, in July 2020, to limit the provision of cross-border humanitarian assistance into Syria; Russia, the Syrian government’s ally, forced the Security Council to scale down humanitarian operations from four crossing points to just two in January 2020, and then to just one. With life-saving aid needed in conflict zones now more than ever, the limiting of access to health care and humanitarian aid can constitute grave breaches of international humanitarian law.

Worsening Rights Crises

The pandemic has laid bare the deep-rooted and systemic inequalities and discrimination facing many marginalized communities and communities at risk of atrocities. The rapid rise in sexual and gender-based violence (SGBV) during the pandemic indicates the way in which the COVID-19 pandemic presents a “double crisis.” In the Democratic Republic of the Congo, COVID-19 is threatening the progress made in combatting SGBV as authorities order school closures, restrict movement, and require people to self-isolate in their homes. In Iraq, where atrocities include the use of sexual violence as a weapon of war, PHR has reported a “current of stigmatization” that is “driving those infected, particularly women, to deny that they have the virus and avoid potentially life-saving medical interventions.”

The socio-economic and political consequences of the pandemic are becoming all too evident: a marked rise in xenophobia and other forms of discrimination, an increased number of people falling into unemployment, hunger and, poverty, and the excessive or arbitrary use of power by leaders. These well-known risk factors for mass atrocities should be of serious concern to state leaders and the international community.

“COVID-19 is a human tragedy. But it has also created a generational opportunity. An opportunity to build back a more equal and sustainable world.”

António Guterres, Secretary-general of the United Nations

An Opportunity to Rebuild with Human Rights at the Core

COVID-19 has been identified as the greatest crisis since World War II by the UN Secretary-general, António Guterres. There are lessons learned from past crises – whether epidemics, pandemics, or experiences of mass atrocities – that can guide leaders in this moment to ensure that the risks of mass atrocities are limited. The UN is calling on its member states to reflect on the situation and to come together to “build back better.”

The pandemic’s universal threats and unique risks to marginalized and war-affected populations underscore the need to “build back better” with human rights placed at the core of the national- and international-level recovery. We cannot afford to delay this process. States must show greater commitment to global cooperation and human rights to bridge the gaps opened by the pandemic. The risk of inequalities growing and the foundations for future atrocities being built is all too real.

This article draws from comments made during PHR’s webinar on the Risk of Mass Atrocities During a Pandemic, which focused on the situation in Myanmar. The conversation featured expert panelists Yee Htun, of the International Human Rights Clinic at Harvard Law School; Akila Radhakrishnan, of the Global Justice Center; and Lawrence Woocher, of the U.S. Holocaust Memorial Museum’s Simon-Skjodt Center and was moderated by PHR Board Member Ambassador Stephen J. Rapp. The article represents the views of the authors and does not serve to summarize the webinar discussion.

As you read this, we still do not know who will occupy the White House for the next four years. This uncertainty can be unnerving, but I’m reaching out to you to make sure you know that, regardless of the outcome, we at Physicians for Human Rights (PHR) have a formidable roadmap to chart our way forward.

Together with our supporters, PHR has built an incredibly powerful movement of physicians, nurses, social workers, public health experts, and scientists – exceptional, dedicated professionals who have been on the front lines, protecting fundamental human rights in unprecedented ways.

Over the past four years, PHR’s membership has skyrocketed, and so has our impact. Throughout the COVID-19 emergency, our extraordinary network has prioritized a science-based approach to ensure that the public knows the facts about the pandemic. Medicine, at its best, is about truth, about listening deeply and understanding. It is about respect for people when they are at their most vulnerable.

From exposing the tremendous psychological and physical suffering of migrant children and families separated at the U.S. border, to highlighting the catastrophic health impacts of systemic racism, to sounding the alarm about the dangers of a U.S. withdrawal from the World Health Organization – never have the voices and skills of health workers been so critical in informing our understanding of issues and so powerful in mounting a call for justice, in the United States and around the world.

These health professionals and scientists have become some of our most trusted leaders today.

After so much abuse and loss, PHR is clear-eyed about the fact that it will take much more than one election to heal the nation and safeguard human rights for the years to come.

So here we are – and we’ve got work to do.

That is why, today, PHR is committing to making a major investment in growing our network. We know that health professionals will play a critical role in the future we want to build and we need a powerful new wave of human rights advocates to bring their unique skills and voices to the great challenges that lie ahead.

The United States should NEVER be a country that puts children in cages and takes them from parents, or that bans the free movement of Muslims, or puts our health workers’ lives at risk because of politics. And we should not and cannot be a country that turns our back on science and a global community facing an historic pandemic.

We have seen the profound role that truth, evidence, and science play in fundamentally changing the conversation when it comes to human rights and in advocating for vulnerable communities. And there is no question that, moving forward in the weeks and months to come, health professionals and the medical and scientific community will be one of the most trusted and influential groups leading the call for change, providing leadership during the pandemic, and protecting the human rights of all people.

In the days ahead we must focus on ensuring that all votes are counted, but regardless of the final outcome, I look forward to working side by side with you as we chart a path forward together.

Thank you for everything you do and for being a part of this dynamic and influential community.

With COVID-19 cases rising across the world, there is a tremendous sense of urgency to develop, test, and approve a variety of therapeutic and preventive interventions for the disease, including safe and effective vaccines. The health and economic costs of the pandemic have been astronomical. There is wide agreement on the pressing need to open up economies, jobs, and schools as soon as doing so is safely possible – and the swift production of a vaccine offers the most promising way to do that.

There is legitimate disagreement, however, on what level of evidence should be sufficient to justify an “emergency authorization”[1] for use of a vaccine by federal regulators. Such an authorization would allow the use of a novel vaccine that has shown early promise but that has not been through complete, rigorous testing for safety and efficacy. The 2004 law[2] that allows the U.S. Food and Drug Administration (FDA) to issue such Emergency Use Authorizations (EUA) during national emergencies requires only that “it is reasonable to believe that the product may be effective.” This low bar offers useful regulatory flexibility in an emergency, but risks being misused. In particular, using the EUA mechanism to encourage widespread adoption of an inadequately tested vaccine outside of clinical trials would be a mistake. How this process is – and should be – handled is especially fraught at a time of considerable pressures to politicize science and public health in dangerous ways.

The Pressure to Approve

Federal regulators have already come under intense political pressure to grant emergency use authorization for novel therapeutics for COVID-19. Examples have included hydroxychloroquine, which received an EUA from the FDA on March 28, 2020,[3] and remdesivir, which received an EUA on May 1, 2020.[4] But the revocation of the EUA for hydroxychloroquine in June, 2020,[5] just weeks after it was issued, illustrates the potential risks of using the EUA authority based on inadequate data and in response to political pressure. Very soon after the EUA was issued, further data emerged showing that hydroxychloroquine provided no benefit to patients with COVID-19 and could be harmful,[6] with the harm for some patients leading to death.  

As the response to the COVID-19 pandemic has become increasingly politically polarized, there is growing concern that scientific findings might be hidden, manipulated, or manufactured for political purposes. In this regard, recent attacks[7] on federal regulatory and public health agencies and the career scientists in them have been alarming. The muzzling, intimidation, and forcing out or firing of scientists responsible for assessing evidence of the safety and efficacy of investigational drugs and vaccines directly threatens the integrity of the review process and undermines public health during the spread of a deadly, global pandemic. As concerning, these actions also harm public and professional trust in the process itself.  This harm is already manifesting in rising rates of mistrust in any potential COVID-19 vaccines: a September 2020 Pew Research Center nationally representative U.S. survey,[8] for example, found an alarming 77 percent of those surveyed believed that it is very or somewhat likely a COVID-19 vaccine will be approved in the United States before its safety and effectiveness are fully understood.

As the response to the COVID-19 pandemic has become increasingly politically polarized, there is growing concern that scientific findings might be hidden, manipulated, or manufactured for political purposes.

Such mistrust may in turn erode confidence in other vaccines and treatment. As we have seen in prior epidemics, such as the Ebola virus disease outbreaks beginning in 2014, such distrust can result not only in poor uptake of effective treatments or vaccines, but even in community violence and resistance to other essential measures to contain an infectious illness.

In short, pressuring scientists to meet a political timeline poses an existential threat to the fundamental human right to benefit from the outcomes of medical science and to protection from infectious disease. Moreover, because shrouding political agendas in medical pseudo-science has a tragic history in the United States and around the world, health professionals today hold a profound obligation to guard against any politically motivated misuse of science.

Considerations for the Authorization of a COVID-19 Vaccine

Three major elements are essential to consider in decisions on authorizing use of a novel vaccine intended to protect against COVID-19. 

• Ensuring safety is as important as ensuring efficacy. Any medication or vaccine that will be given to large numbers of healthy people must be carefully tested for safety as well as efficacy. The world learned this lesson through witnessing the deaths and deformities of thousands of babies only 70 years ago from the hasty approval of thalidomide. Safety concerns have already arisen with COVID-19 vaccine candidates, with two efficacy trials experiencing FDA-mandated pauses[9] while safety indicators are being assessed. While a great deal is known about vaccine science – and it bears reinforcing that existing, FDA-approved vaccines are safe and effective – it is equally important to recognize that some proposed COVID-19 vaccines are being built using novel methods, some are being tested by companies with no prior track record of bringing a vaccine safely to market, and all COVID-19 vaccines will be novel in that there are no prior vaccines against a coronavirus for humans.
• Corners cannot be cut in vaccine development and testing cannot be rushed. While steps can be taken to safely speed production and distribution of novel vaccines, development and testing of vaccines is one of the most scientifically and technically challenging processes in medical and biological science. To find safe and effective vaccines against COVID-19 requires multiple essential steps. First, it requires the engagement of many scientific teams working at the boundaries of molecular understanding and technology. Second, it requires testing and monitoring tens of thousands of volunteers from diverse populations – with different rates, intensities, and sources of exposure, among other epidemiological factors – over many months. This is necessary to ascertain whether one or several of the candidate vaccines are both safe and effective in achieving clinical outcomes, such as reduction of COVID-19 infections, disease severity, or mortality.
• Research on individuals without full informed consent and rigorous research oversight is unethical. Physicians and scientists who knowingly use inadequately tested interventions on human beings without appropriate oversight and/or without the full, informed consent of participants violate core principles of medical ethics, which were developed in the wake of appalling Nazi medical crimes against institutionalized and disabled people, stigmatized and powerless populations, and concentration camp inmates in the 1930s and 1940s. Authorization to use a vaccine before it is proven safe and effective would comprise de facto experimentation on those receiving the vaccine prior to completion of full testing. The reliability and completeness of the testing and approval processes are therefore of absolute importance.

The International Rush to Market

There is currently an international effort underway to develop, test, and manufacture safe and effective COVID-19 vaccines. The United States, through its Operation Warp Speed, has chosen to implement a series of large-scale Phase III safety and efficacy trials of five vaccine candidates. It is also pre-purchasing large volumes (100 million doses) of a sixth, the Pfizer vaccine. All these candidates were selected, as is appropriate, based on early phase safety and immunogenicity studies (Phase I and II vaccine trials in human volunteers). Phase III efficacy trials are underway.  The major time-saving approach for the United States has been to simultaneously incentivize manufacture of the multiple candidate products, such that if a candidate is safe and effective, it may be immediately available at some scale. 

Health professionals today hold a profound obligation to guard against any politically motivated misuse of science.

Other countries have bypassed this proven and essential pathway. Russia has approved a candidate vaccine without conducting a Phase III randomized controlled trial[10] for safety or efficacy. Russia’s Sputnik 5 vaccine is thus an untested product, and its use outside of clinical trials is an abuse of medical ethics, public health, and human rights. China has also begun immunizations in its armed forces personnel without Phase III efficacy and safety testing.[11]  This, too, should be seen as inherently unethical and is a special case, since military personnel are often subject to immunization without consent for military preparedness reasons. The fact that many military personnel cannot realistically refuse vaccination means any vaccines given to soldiers must be fully vetted — not experimental.

An EUA for a U.S. vaccine prior to full safety and efficacy testing would risk putting the United States in the same category of a country violating fundamental safety and scientific principles around medical research ethics. Moreover, doing so with one vaccine candidate could also undermine other vaccine trials still underway or planned. This could have disastrous consequences by delaying the testing and use of a proven safe and effective vaccine, an essential tool that all agree will be required to control the COVID-19 pandemic.

A U.S. Failure of Governance

Many prominent practitioners and medical scientists have criticized the handling of the COVID-19 pandemic in the United States, saying, for example, that its national political leaders have “taken a crisis and turned it into a tragedy.”[12] This failure arose out of these leaders’ “refusal to look at the evidence and act accordingly”[13] and a “shameful record of interference in health and science agencies — thus undermining public trust in the very institutions that are essential to keeping people safe.”[14] A recent editorial in the Journal of the American Medical Association noted the “immense”[15] pressure on the FDA to authorize a vaccine prior to full testing for safety and efficacy, noting that “some clinicians, public health officials, and members of the public [are] bewildered about what is actually happening and concerned that vaccines will be made available before safety and effectiveness are fully established.”

To date, the U.S. response to COVID-19 represents a serious failure of governance. Much of this failure stems from the politicization of science and public health.

To ensure public and clinician trust in any vaccine that is approved, it will be essential both to support the regular scientific review process for a novel vaccine and to buttress transparency and communication about the evidence underlying any approved vaccine. This will mean ensuring full public access to data on safety and efficacy, as well as disclosure of all communications about safety and efficacy from the relevant vaccine trial Data Safety Monitoring Boards and with the FDA and Centers for Disease Control and Prevention (CDC) review committees. Finally, no vaccine should be approved by the U.S. Department of Health and Human Services or FDA leadership that has not been approved by both the FDA review committee and the CDC review committee. 

To date, the U.S. response to COVID-19 represents a serious failure of governance.[16] Much of this failure stems from the politicization of science and public health. Political considerations must not be allowed to taint the process of ensuring the safety and efficacy – and subsequent equitable access to and distribution of – vaccines and therapeutics to prevent and mitigate harms from COVID-19. Allowing short-term political aims to drive the hasty approval of a potential vaccine could pose a significant danger to the American people and to the whole of humanity. Both in the United States and in countries throughout the world, it will only be possible to successfully contain, prevent, and treat communicable diseases – or any public health challenge – if there is public confidence in the integrity and transparency of the scientific process. 

---

Endnotes

[1] Office of the Commissioner, “Emergency Use Authorization,” U.S. Food and Drug Administration, accessed October 29, 2020, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

[2] Project BioShield Act of 2004, 42 U.S.C. 243 et seq. (2004), accessed October 29, 2020, https://www.govinfo.gov/content/pkg/PLAW-108publ276/pdf/PLAW-108publ276.pdf.

[3] “Frequently Asked Questions on the Emergency Use Authorization (EUA) for Chloroquine Phosphate

and Hydroxychloroquine Sulfate for Certain Hospitalized COVID-19 Patients,” U.S. Food and Drug Administration, accessed on October 29, 2020, https://www.fda.gov/media/136784/download.

[4] Gilead Sciences, Inc., “Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Veklury® (remdesivir),” U.S. Food and Drug Administration, October 2020, accessed October 29, 2020,  https://www.fda.gov/media/137566/download.

[5] Denise Hinton, Letter Revoking Emergency Use Authorization for

Emergency Use of Chloroquine Phosphate and Hydroxychloroquine, U.S. Food and Drug Administration, June 15, 2020, accessed October 29, 2020,  https://www.fda.gov/media/138945/download.

[6] Center for Drug Evaluation and Research, “FDA Cautions Use of Hydroxychloroquine/Chloroquine for COVID-19,” U.S. Food and Drug Administration, updated July 1, 2020, accessed October 29, 2020, https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or.

[7] Michelle M. Mello, “Attacks on Public Health Officials During COVID-19,” Journal of the American Medical Association, JAMA Network, August 25, 2020, accessed October 29, 2020, https://jamanetwork.com/journals/jama/fullarticle/2769291.

[8] Alec Tyson, Courtney Johnson, and Cary Funk, “U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine,” Science & Society, Pew Research Center, September 18, 2020, accessed October 29, 2020, https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/.

[9] Amanda Heidt, “COVID-19 Vaccine Trial Pauses After Adverse Reaction,” Scientist, September 9, 2020, accessed October 29, 2020, https://www.the-scientist.com/news-opinion/covid-19-vaccine-trial-pauses-after-adverse-reaction-67917.

[10] Sarah Caddy, “Russian SARS-CoV-2 Vaccine,” British Medical Journal, August 24, 2020, accessed October 29, 2020, https://www.bmj.com/content/370/bmj.m3270.

[11] Lili Pike, “China Has Quietly Vaccinated More than 100,000 People for Covid-19 before Completing Safety Trials,” Vox, September 11, 2020, accessed October 29, 2020, https://www.vox.com/2020/9/11/21431416/coronavirus-vaccine-china-sinopharm-sinovac-emergency-authorization.

[12] Editorial, “Dying in a Leadership Vacuum,” New England Journal of Medicine, October 8, 2020, accessed October 29, 2020, https://www.nejm.org/doi/full/10.1056/NEJMe2029812.

[13] The Editors, “Scientific American Endorses Joe Biden,” Scientific American, October 1, 2020, accessed October 29, 2020, https://www.scientificamerican.com/article/scientific-american-endorses-joe-biden1/.

[14] Editorial, “Why Nature Supports Joe Biden for US President,” Nature News, October 14, 2020, accessed October 29, 2020, https://www.nature.com/articles/d41586-020-02852-x.

[15] Howard Bauchner, “Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine,” Journal of the American Medical Association, JAMA Network, October 6, 2020, accessed October 29, 2020, https://jamanetwork.com/journals/jama/fullarticle/2770681.

[16] Eric C. Schneider, “Failing the Test – The Tragic Data Gap Undermining the U.S. Pandemic Response,” New England Journal of Medicine, October 8, 2020, accessed October 29, 2020,  https://www.nejm.org/doi/full/10.1056/nejmp2014836.

On May 29, President Trump announced the United States would terminate its relationship with the World Health Organization (WHO), cutting off one of the largest sources of funding for the agency in the middle of a global health emergency. Withdrawal from the only intergovernmental platform coordinating international health would threaten the health and safety of both Americans and the greater global community, a particularly dangerous and irresponsible decision as we face the COVID-19 pandemic.

On Thursday, October 29 at 2 p.m. EDT, PHR hosted a discussion on the global implications of the U.S. withdrawal from the WHO, including the added strain on global health systems and capacities, impacts on future vaccine development, limited access to vaccine supplies in the U.S., threats to diplomacy, and the decimation of vital U.S. public health institutions.

The event was also featured in The New York Times: “The U.S. should strengthen the W.H.O., not quit it, experts argue.”

The conversation was moderated by Roopa Dhatt, MD, MPA, executive director and co-founder of Women in Global Health and primary care physician.

Panelists were:

• Georges C. Benjamin, MD is executive director of the American Public Health Association and member of the National Academy of Medicine of the National Academies of Science, Engineering, and Medicine.
• Lawrence Gostin, JD is a university professor, director, and founding chair of the O’Neill Institute for National and Global Health Law at Georgetown Law School. He is a Georgetown University professor of medicine and Johns Hopkins University Bloomberg School of Public Health professor of public health. He serves as director of the WHO Collaborating Center on National and Global Health Law.
• Ebere Okereke, MBBS, DTM&H, MSc, MFPHM, is a public health physician who serves as a consultant in communicable disease control, and global public health lead, for Public Health England’s international health regulations strengthening project.

See all events in PHR’s COVID-19 Webinar Series.