Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: 

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
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– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

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David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Vaccines and Global Health: The Week in Review :: 26 September 2020

Posted on 27 September 2020

Vaccines and Global Health: The Week in Review is a weekly digest  summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated with the current issue date

.– Request an Email Summary: Vaccines and Global Health : The Week in Review is published as a single email summary, scheduled for release each Saturday evening before midnight (EDT in the U.S.). If you would like to receive the email version, please send your request to david.r.curry@centerforvaccineethicsandpolicy.org.

– pdf version:  A pdf of the current issue is available here: vaccines-and-global-health_the-week-in-review_26-sep-2020Download

– blog edition: comprised of the approx. 35+ entries posted below.

– Twitter:  Readers can also follow developments on twitter: @vaxethicspolicy.
.
– Links:  We endeavor to test each link as we incorporate it into any post, but recognize that some links may become “stale” as publications and websites reorganize content over time. We apologize in advance for any links that may not be operative. We believe the contextual information in a given post should allow retrieval, but please contact us as above for assistance if necessary.

Support this knowledge-sharing service: Your financial support helps us cover our costs and to address a current shortfall in our annual operating budget. Click here to donate and thank you in advance for your contribution.

.
David R. Curry, MS
Executive Director
Center for Vaccine Ethics and Policy

Featured Journal Content

Lancet COVID-19 Commission Statement on the occasion of the 75th session of the UN General Assembly
The Lancet COVID-19 Commissioners, Task Force Chairs, and Commission Secretariat
[Editor’s text bolding in red]
Executive summary
The Lancet COVID-19 Commission was launched on July 9, 2020, to assist governments, civil society, and UN institutions in responding effectively to the COVID-19 pandemic. The Commission aims to offer practical solutions to the four main global challenges posed by the pandemic: suppressing the pandemic by means of pharmaceutical and non-pharmaceutical interventions; overcoming humanitarian emergencies, including poverty, hunger, and mental distress, caused by the pandemic; restructuring public and private finances in the wake of the pandemic; and rebuilding the world economy in an inclusive, resilient, and sustainable way that is aligned with the Sustainable Development Goals (SDGs) and the Paris Climate Agreement. Many creative solutions are already being implemented, and a key aim of the Commission is to accelerate their adoption worldwide.

The origins of COVID-19 and averting zoonotic pandemics
The COVID-19 pandemic is the latest—but certainly not the last—emerging infectious disease, preceded by HIV/AIDS, Nipah, severe acute respiratory syndrome coronavirus, H1N1 influenza, Middle East respiratory syndrome coronavirus, Zika, Ebola, and others. These diseases are zoonoses, resulting from pathogens being transmitted from animals to humans. To protect against zoonoses, we require new precautions, such as ending deforestation and protecting conservation areas and endangered species. The origins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are yet to be definitively determined, but evidence to date supports the view that SARS-CoV-2 is a naturally occurring virus rather than the result of laboratory creation and release. Research into the origins of SARS-CoV-2 should proceed expeditiously, scientifically, and objectively, unhindered by geopolitical agendas and misinformation.

The urgency of suppressing the pandemic
The COVID-19 epidemic can and should be suppressed through non-pharmaceutical interventions, including effective community health services, that cut transmission of the virus, to be followed by the introduction of effective and safe vaccines as rapidly as science permits. Countries should not rely on herd immunity by natural infection to suppress the epidemic. The disease and death that would accompany natural infection rates to reach herd immunity, typically estimated as 40–60% of the population infected, would be unacceptably high. Uncertainty also remains about the duration of acquired immunity from past infections.

The great divide in the outcomes of the epidemic has been the relative success of the Asia–Pacific region compared with western Europe and the Americas. The Asia–Pacific region has largely suppressed transmission and mortality (less than 10 deaths per million). Western Europe and the Americas have had very high transmission and mortality (several hundred deaths per million in several countries). Many low-income countries have suppressed the epidemic, such as Cambodia, Lao People’s Democratic Republic, and Viet Nam.

To implement non-pharmaceutical interventions, we urge countries to scale up with all urgency their public health workforces, including epidemiologists, public health technicians, nurses, testers, contact tracers, and community health workers. Community health workers can contribute to controlling community spread and protecting vulnerable people in the community, particularly through testing, education on prevention and treatment, and education on the mental health effects of social isolation.

The vexing question of whether to close schools is perhaps the single most challenging non-pharmaceutical intervention. Schools can safely reopen when community transmission is low and school facilities and staff have been appropriately prepared. When it is not safe to open schools, countries and localities should aim to implement online education accessible to all students.

Health professionalism
One reason for failure to suppress the epidemic is a style of political leadership that has been called medical populism; Lasco has described political leaders as “simplifying the pandemic by downplaying its impacts or touting easy solutions or treatments, spectacularizing their responses to crisis, forging divisions between the ‘people’ and dangerous ‘others’, and making medical knowledge claims to support the above”. Lasco makes three cases in point: the US President, Donald Trump, the Philippine President, Rodrigo Duterte, and the Brazilian President, Jair Bolsonaro.

We call on governments to prioritise advice from the professional public health community, working in cooperation with international agencies and learning from the best practices of other nations. All countries should combat decisions based on rumour-mongering and misinformation. Leaders should desist from expressing personal viewpoints that are at odds with science.

Addressing the inequities of the epidemic
The COVID-19 pandemic is bringing to light and exacerbating pre-existing social, economic, and political inequalities, including inequalities of wealth, health, wellbeing, social protection, and access to basic needs including food, health care, and schooling. The pandemic is bringing about a sharp increase in income inequality and jobs crises for low-paid workers. Health inequalities also pose major issues in this pandemic; as of December, 2017, half of the world’s population did not have access to essential health services. Vulnerable populations (including the poor, older people, people with previous health conditions, people who are incarcerated, refugees, and Indigenous peoples) are bearing a disproportionate burden of the pandemic.

The abrupt shift to an online economy came in the context of a deep, pre-existing digital divide in high-quality digital access. We call on all relevant UN agencies to take concrete steps with the digital industry and governments to accelerate universal access to digital services, including public–private financing to extend connectivity to hard-to-reach populations.

Among the most urgent challenges of the COVID-19 pandemic are hunger and food insecurity for poor and vulnerable populations. The pandemic also poses great concerns for mental health, especially for lower-income populations, and there is high inequality in the provision of services for mental health, especially in lower-income and middle-income countries. The gender dimensions of COVID-19 must also be prioritised, in recognition of the documented increase in unplanned pregnancies for teenage and young women, and the increase in gender-based violence.

Data needs
The UN Statistical Commission, working with partner UN institutions and with national statistical agencies, should prepare near-real-time data on highly vulnerable populations and their conditions, with a special focus on infection and death rates, poverty, joblessness, mental health, violence, hunger, forced labour, and other forms of extreme deprivation and abuses of human rights. Urgent surveying should be undertaken to identify humanitarian needs and hunger hotspots, especially among the poor, older people, people living with disabilities, Indigenous peoples, women who are vulnerable, young children, refugees, people who are incarcerated, people working in high-risk jobs (eg, meatpacking plants or guest workers), and other minority populations (including ethnic, racial, and religious minorities).

Meeting the urgent fiscal needs of the developing countries
One of the characteristics of the global crisis is the sharp drop in public revenues at all government levels. The situation for developing countries will become increasingly dire as many countries find themselves facing rising social needs without the means to finance social services. Moreover, many developing countries currently do not have the kinds of social protection programmes that are most urgently needed at this juncture, such as unemployment insurance, income support, and nutrition support.

Some developing countries will require considerable international concessional financing (ie, grants and low-interest, long-term loans) from the international financing institutions, notably the International Monetary Fund, the World Bank, and the multilateral and regional development banks, as well as the orderly restructuring of their sovereign debts to both public and private creditors. Now, more than ever, is the time for countries to meet their commitments to providing 0·7% of gross domestic product as official development aid. Special efforts must be made to fight corruption, to ensure that new aid flows reach the intended beneficiaries.

Global justice in access to safe and effective vaccines, therapeutics, diagnostics, and equipment
The pharmaceutical industry and academic community, supported by governments, have undertaken a remarkable effort to develop new approaches for the suppression of the pandemic, including vaccines, therapeutics, rapid diagnostics, and treatment regimens. The introduction of new vaccines and therapeutics should follow rigorous testing and evaluation through all clinical phases and must not be subject to dangerous political interference.

In the early phases of the COVID-19 pandemic, there have already been breakdowns in the global health governance of vaccine development, even leading to the new term vaccine nationalism. Any new vaccine or therapeutic must be developed and implemented with a view to equitable access across and within countries. No population should be prohibited from accessing a vaccine because of cost or have its access predicated on its participation in clinical trials. We strongly support the multilateral initiative Access to COVID-19 Tools Accelerator to promote the universal, equitable access to COVID-19 vaccines, therapeutics, and other tools, and within that initiative, COVAX Facility, the vaccine pillar. Complementary approaches in support of this multilateral initiative would help to strengthen equitable access across and within countries.

Promoting a jobs-based green recovery
Economic recovery plans should support the transition towards sustainable and inclusive societies based on the SDGs and the Paris Climate Agreement. Public investment should be oriented towards sustainable industries and the digital economy, and should spur complementary private investments. Preventing a wave of bankruptcies among small and medium-sized businesses with viable prospects is an important priority. A major goal of the recovery should be an unprecedented commitment to reskilling and upskilling people, including the skills to prepare workers for the digital economy.

The EU Green Deal, long-term budget (2021–27), and new recovery fund marks an exemplary framework for long-term recovery, including mid-century goals on climate safety, energy transition, and circular economy, with a comprehensive €1·8 trillion budget. This approach can serve as an exemplar for other regions. In general, recoveries should be smart (based on digital technologies), inclusive (targeting lower-income households), and sustainable (featuring investments in clean energy and reduced pollution).

Multilateralism and the UN system
Global recovery will be greatly facilitated by cooperation at the regional and international level, both in controlling the epidemic and in adopting new green recovery programmes. We strongly urge the United States, EU, China, Russia, India, Mercosur, the African Union, the Association of Southeast Asian Nations, the Community of Latin American and Caribbean States, the Caribbean Community, and other nations and regional groupings to put aside rivalries and beggar-thy-neighbour policies (such as trade and financial sanctions) in favour of coordinated regional responses. Trade and financial sanctions, or other isolationist policies, and talk of a new cold war between the United States and China, are dangerous for global recovery and peace.

The COVID-19 pandemic hit during the 75th anniversary year of the UN. The indispensable role of the UN has been evident throughout the course of the pandemic to date, especially for the world’s most vulnerable populations, and yet the UN system is also under attack and international law has been undermined. We strongly support the UN and call on all nations to honour the UN Charter and the Universal Declaration of Human Rights, and to contribute to the efficacy of the UN multilateral system, including through crucial financing of UN institutions. We call on the United States to reverse its decisions to withdraw from the WHO, the Paris Climate Agreement, the UN Educational, Scientific and Cultural Organisation, and the UN Human Rights Council.

We strongly support the unique role of the International Monetary Fund, the World Bank, and multilateral development banks in providing urgent financing and technical assistance for emerging and developing economies. We call on their shareholders to consider scaling up the already unprecedented efforts at securing larger financing for these countries through an increased allocation or more efficient use of special drawing rights, or through debt restructuring when needed. We also urge the more affluent shareholder countries to provide additional concessional resources.

We strongly support the indispensable role of the WHO in controlling the COVID-19 pandemic, and call on all nations to increase, rather than decrease, their funding support and political backing for the work of the WHO at this fraught time. In this regard, we also support the call for an independent analysis of the WHO response, to strengthen the institution and its central, unique role in global public health.

Future work of The Lancet COVID-19 Commission
The Lancet COVID-19 Commission will monitor the global progress in suppressing the pandemic and making an inclusive and sustainable recovery with a new set of metrics that it will regularly publish. The Commission Task Forces will consider in detail many of the complex issues already raised, including the best ways to promote decent jobs and sustainable development. The ten priority actions of the Commission are summarised in panel 1. The next scheduled Statement of the Commission will be in early 2021.

[Panel 1] Ten priority actions
1 Origins: track down the origins of the virus in an open, scientific, and unbiased way not influenced by geopolitical agendas

2 Non-pharmaceutical interventions: suppress the epidemic through the proven package of non-pharmaceutical interventions, as accomplished by several countries including several in the Asia–Pacific region

3 Science-based policy making: base policy making on objective scientific evidence and stop politicians and others in positions of power from subverting clinical trials and other scientific protocols

4 Timely and consistent data: collect and publish timely and internationally consistent data on the state of the pandemic, including humanitarian and economic consequences

5 Justice in access to tools to fight COVID-19: ensure universal access to the tools to fight COVID-19, including test kits, therapeutics, and prospective vaccines

6 Emergency financing: secure access of developing countries to financing from international sources, especially from the International Monetary Fund and World Bank

7 Protect vulnerable groups: direct urgent protection towards vulnerable groups, including older people, people in poverty and hunger, women who are vulnerable, children, people with chronic diseases and disabilities, the homeless, migrants, refugees, Indigenous Peoples, and ethnic and racial minorities

8 Long-term financial reform: prepare for a deep restructuring of global finances, including debt relief, new forms of international financing, and reform of monetary arrangements

9 Green and resilient recovery: economic recovery will be based on public-investment-led growth in green, digital, and inclusive technologies, based on the Sustainable Development Goals

10 Global peace and cooperation: support UN institutions and the UN Charter, resisting any attempts at a new cold war

Featured Journal Content

New England Journal of Medicine
October 8, 2020
N Engl J Med 2020; 383:1479-1480
DOI: 10.1056/NEJMe2029812
Editorial
Dying in a Leadership Vacuum
The Editors
Covid-19 has created a crisis throughout the world. This crisis has produced a test of leadership. With no good options to combat a novel pathogen, countries were forced to make hard choices about how to respond. Here in the United States, our leaders have failed that test. They have taken a crisis and turned it into a tragedy.

The magnitude of this failure is astonishing. According to the Johns Hopkins Center for Systems Science and Engineering,¹ the United States leads the world in Covid-19 cases and in deaths due to the disease, far exceeding the numbers in much larger countries, such as China. The death rate in this country is more than double that of Canada, exceeds that of Japan, a country with a vulnerable and elderly population, by a factor of almost 50, and even dwarfs the rates in lower-middle-income countries, such as Vietnam, by a factor of almost 2000. Covid-19 is an overwhelming challenge, and many factors contribute to its severity. But the one we can control is how we behave. And in the United States we have consistently behaved poorly.

We know that we could have done better. China, faced with the first outbreak, chose strict quarantine and isolation after an initial delay. These measures were severe but effective, essentially eliminating transmission at the point where the outbreak began and reducing the death rate to a reported 3 per million, as compared with more than 500 per million in the United States. Countries that had far more exchange with China, such as Singapore and South Korea, began intensive testing early, along with aggressive contact tracing and appropriate isolation, and have had relatively small outbreaks. And New Zealand has used these same measures, together with its geographic advantages, to come close to eliminating the disease, something that has allowed that country to limit the time of closure and to largely reopen society to a prepandemic level. In general, not only have many democracies done better than the United States, but they have also outperformed us by orders of magnitude.

Why has the United States handled this pandemic so badly? We have failed at almost every step. We had ample warning, but when the disease first arrived, we were incapable of testing effectively and couldn’t provide even the most basic personal protective equipment to health care workers and the general public. And we continue to be way behind the curve in testing. While the absolute numbers of tests have increased substantially, the more useful metric is the number of tests performed per infected person, a rate that puts us far down the international list, below such places as Kazakhstan, Zimbabwe, and Ethiopia, countries that cannot boast the biomedical infrastructure or the manufacturing capacity that we have.² Moreover, a lack of emphasis on developing capacity has meant that U.S. test results are often long delayed, rendering the results useless for disease control.

Although we tend to focus on technology, most of the interventions that have large effects are not complicated. The United States instituted quarantine and isolation measures late and inconsistently, often without any effort to enforce them, after the disease had spread substantially in many communities. Our rules on social distancing have in many places been lackadaisical at best, with loosening of restrictions long before adequate disease control had been achieved. And in much of the country, people simply don’t wear masks, largely because our leaders have stated outright that masks are political tools rather than effective infection control measures. The government has appropriately invested heavily in vaccine development, but its rhetoric has politicized the development process and led to growing public distrust.

The United States came into this crisis with enormous advantages. Along with tremendous manufacturing capacity, we have a biomedical research system that is the envy of the world. We have enormous expertise in public health, health policy, and basic biology and have consistently been able to turn that expertise into new therapies and preventive measures. And much of that national expertise resides in government institutions. Yet our leaders have largely chosen to ignore and even denigrate experts.

The response of our nation’s leaders has been consistently inadequate. The federal government has largely abandoned disease control to the states. Governors have varied in their responses, not so much by party as by competence. But whatever their competence, governors do not have the tools that Washington controls. Instead of using those tools, the federal government has undermined them. The Centers for Disease Control and Prevention, which was the world’s leading disease response organization, has been eviscerated and has suffered dramatic testing and policy failures. The National Institutes of Health have played a key role in vaccine development but have been excluded from much crucial government decision making. And the Food and Drug Administration has been shamefully politicized,3 appearing to respond to pressure from the administration rather than scientific evidence. Our current leaders have undercut trust in science and in government,4 causing damage that will certainly outlast them. Instead of relying on expertise, the administration has turned to uninformed “opinion leaders” and charlatans who obscure the truth and facilitate the promulgation of outright lies.

Let’s be clear about the cost of not taking even simple measures. An outbreak that has disproportionately affected communities of color has exacerbated the tensions associated with inequality. Many of our children are missing school at critical times in their social and intellectual development. The hard work of health care professionals, who have put their lives on the line, has not been used wisely. Our current leadership takes pride in the economy, but while most of the world has opened up to some extent, the United States still suffers from disease rates that have prevented many businesses from reopening, with a resultant loss of hundreds of billions of dollars and millions of jobs. And more than 200,000 Americans have died. Some deaths from Covid-19 were unavoidable. But, although it is impossible to project the precise number of additional American lives lost because of weak and inappropriate government policies, it is at least in the tens of thousands in a pandemic that has already killed more Americans than any conflict since World War II.

Anyone else who recklessly squandered lives and money in this way would be suffering legal consequences. Our leaders have largely claimed immunity for their actions. But this election gives us the power to render judgment. Reasonable people will certainly disagree about the many political positions taken by candidates. But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.

Featured Journal Content

COVAX

China commits to sharing vaccines
Updated: 2020-10-10 | China Daily
Decision to join global effort expected to bolster access to COVID immunization
China has joined the COVID-19 Vaccines Global Access Facility, an important step to advance the building of a global community of health for all, the Foreign Ministry said on Oct 9.

Ministry spokeswoman Hua Chunying said the move shows that China honors its commitment to turn COVID-19 vaccines into a global public good.

Hua’s remarks, in a statement on the ministry’s website, came after China signed an agreement with the Global Alliance for Vaccines and Immunization on its participation in the COVAX facility on Thursday.

“Even when China is leading the world with several vaccines in advanced stages of R&D and with ample production capacity, it still decided to join COVAX,” Hua said.

“We are taking this concrete step to ensure equitable distribution of vaccines, especially to developing countries, and hope other capable countries will also join and support COVAX,” she said. China will strengthen vaccine cooperation with other countries through the COVAX network, she said.

With the COVID-19 pandemic still posing a severe threat to all countries, Hua stated that China will continue to work together with COVAX partners and contribute its share to the global fight against the pandemic to safeguard the safety and health of everyone…

Featured Journal Content

COVID-19 Vaccines and Therapeutics: Regulatory Integrity

News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020
The European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines.

In an open letter sent to European Ombudsman Emily O’Reilly in response to an enquiry on the role of EMA and its pandemic task force during the COVID-19 crisis, the Agency explains that it is applying the same independence measures to its experts dealing with COVID-19 treatments and vaccines as it does for those dealing with all medicines. This includes the experts involved in providing advice on these medicines’ development, as well as the experts evaluating them.

These tried and tested measures ensure that EMA’s recommendations are driven only by science and public-health needs, and not by any other interests.

The letter also sets out the Agency’s transparency plans for COVID-19 treatments and vaccines. EMA will publish the clinical data underpinning its recommendations for all COVID-19 medicines. This falls under the scope of EMA’s landmark policy on proactive publication of clinical data, which the Agency is reinstating – exclusively for COVID-19 medicines at this point – following its suspension in August 2018 to allow the Agency to focus resources on its relocation from the United Kingdom to the Netherlands.

Because EMA considers maximum transparency as a pre-condition for fostering trust and confidence in the EU regulatory system, it is also planning a range of additional measures to provide the public prompt insights into its development and safety-monitoring processes. This includes for example the publication of the product information with details of the conditions of use even before the formal marketing authorisation will be granted, the expedited publication of the full European Public Assessment Report (EPAR) and the publication of the risk management plans for authorised COVID-19 medicines in their entirety, rather than as a summary.

The scale of the COVID-19 public health crisis has led to unprecedented efforts by all those involved in the development of medicines to treat and prevent COVID-19, compressing a process that typically requires several years into one lasting only several months.

EMA and the national competent authorities have responded to these challenges by fully mobilising their resources to expedite their advice and evaluation processes, while maintaining their safety and efficacy standards and applying tested independence and transparency rules.

Featured Journal Content

COVID-19 Vaccines – New FDA Guidance and Webpage

Guidance for Industry: Emergency Use Authorization for Vaccines to Prevent COVID-19
October 2020
Docket Number: 2020-D-1137
Issued by: Center for Biologics Evaluation and Research
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency.
PDF: https://www.fda.gov/media/142749/download
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)): https://www.regulations.gov/docket?D=2020-D-1137

FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
10/06/2020
…Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research: “Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”
Additional Information
:: Today, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.

:: The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.

:: This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency’s June guidance regarding the development and licensure of COVID-19 vaccines.

:: An EUA is a different standard than an approval, as noted in the June guidance, however, in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.

:: This guidance reiterates that any assessment regarding an EUA will be made on a case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.

:: The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines. While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.

::::::

FDA launched a new webpage at www.fda.gov/covid19vaccines to highlight new information as it becomes available.

Featured Journal Content

COVID-19 and IP

MSF supports India and South Africa ask to waive COVID-19 patent rights
Press Release 7 Oct 2020
Geneva – In a landmark move, India and South Africa on 2 October asked the World Trade Organization (WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic, until global herd immunity is achieved. This bold step is akin to efforts by governments nearly 20 years ago, which spearheaded the use of affordable generic HIV/AIDS medicines, and, if approved, could signal a major turning point in countries’ response to the pandemic, according to Médecins Sans Frontières (MSF).

In the context of the COVID-19 pandemic, MSF called on all governments to support this waiver request at the WTO, whose TRIPS Council (Trade-related Aspects of Intellectual Property Rights Agreement) is meeting on 15 October to start building consensus on the issue.

“A global pandemic is no time for business-as-usual, and there is no place for patents or corporate profiteering as long as the world is faced with the threat of COVID-19,” said Leena Menghaney, South Asia Head of MSF’s Access Campaign. “During the pandemic, treatment providers and governments have had to grapple with intellectual property barriers to essential products such as masks, ventilator valves and reagents for test kits.”

“With this bold action, India and South Africa have shown that governments want to be back in the driver’s seat when it comes to ensuring all people can have access to needed COVID-19 medical products, medicines and vaccines, so that more lives can be saved,” said Menghaney.

WTO member countries can seek a waiver from certain obligations in WTO treaties under exceptional circumstances. If members agree on the waiver, countries can choose not to grant or enforce IP (patents, industrial designs, copyright and trade secrets) related to all COVID-19 medical products and technologies…

Featured Journal Content

COVID 19 Vaccine Programs Update

Johnson & Johnson Announces European Commission Approval of Agreement to Supply 200 Million Doses of Janssen’s COVID-19 Vaccine Candidate
Oct 08, 2020
Agreement provides option for European Union Member States to secure up to 200 million additional doses for a total of up to 400 million doses
NEW BRUNSWICK, N.J., Oct. 8, 2020 /PRNewswire/ Johnson & Johnson (NYSE: JNJ) (the Company) today announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Purchase Agreement in which the Janssen Pharmaceutical Companies will supply 200 million doses of its COVID-19 vaccine ..
candidate to EU Member States following approval or authorization from regulators. The EU Member States also have the option to secure up to 200 million additional doses…

DARPA Awards Moderna up to $56 Million to Enable Small-Scale, Rapid Mobile Manufacturing of Nucleic Acid Vaccines and Therapeutics
October 08, 2020
Award part of DARPA’s Nucleic Acids On-Demand World-Wide (NOW) initiative to develop a medical countermeasure manufacturing platform.
…Award involves development of a mobile manufacturing protype leveraging Moderna’s existing manufacturing technology that is capable of rapidly producing vaccines and therapeutics.

Moderna Announces Updates on Respiratory Syncytial Virus (RSV) Vaccine Program
October 08, 2020
Moderna regains rights to adult RSV vaccine program from Merck
Start of Phase 1 dosing for mRNA-1345, Moderna’s vaccine candidate against RSV 
Moderna has consolidated all rights to its prophylactic vaccines portfolio
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has regained all rights to the respiratory syncytial virus (RSV) vaccine (mRNA-1172) from Merck, known as MSD outside the United States and Canada, including rights to develop RSV vaccines for adult populations. mRNA-1172, which uses a Merck lipid nanoparticle for delivery, entered Phase 1 development in 2019. Under the terms of the agreement, Merck will complete the Phase 1 study and transition the program to Moderna. Moderna has now consolidated all global commercial rights to all development candidates in its core prophylactic vaccines modality…

Accenture Launches Vaccine Management Solution to Support COVID-19 Immunization Programs
October 07, 2020
Solution includes modular components to fit varying public health authorities’ needs and priorities
NEW YORK–(BUSINESS WIRE)–Accenture (NYSE: ACN) today announced a comprehensive vaccine management solution to help government and healthcare organizations rapidly and effectively plan and develop COVID-19 vaccination programs and related distribution and communication initiatives.
The solution expands on Accenture’s contact tracing capability to help public health jurisdictions meet newly released guidelines from the U.S. Centers for Disease Control and Prevention (CDC) in preparation for COVID-19 vaccine distribution. It brings together Accenture’s industry, analytics and consulting experience and includes components built on the Salesforce platform. Local, state and national governments as well as healthcare organizations worldwide are expected to similarly undertake planning, development, coordination, distribution and management of COVID-19 immunization programs…

EMERGENCIES

Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)

Weekly Epidemiological and Operational updates
last update: 8 October 2020, 20:00 GMT-4
Confirmed cases :: 36 754 395 [week ago: 34 495 176]
Confirmed deaths :: 1 064 838 [week ago 1 025 729]
Countries, areas or territories with cases :: 235

Weekly Epidemiological Update
Coronavirus disease 2019 (COVID-19)
5 October 2020
Global epidemiological situation
The number of new cases per week has remained stable at 2 million for the past three weeks (Figure 1), with the cumulative total of over 34.8 million cases. Over 1 million deaths have now been reported globally, of which the majority were reported in the Region of the Americas (55%), followed by Europe (23%). In the past week, the regions of the Americas, South-East Asia, and Europe account for 91% of new cases. Five countries (namely India, the United States of America, Brazil, Argentina and France) reported 60% of new global cases this past week, while Israel registered the highest incidence (3717 new cases per 1 million population). Globally, the highest percentage of cases have been reported in the 25-39 age group, with approximately 50% of cases in the 25-64 age group. However, the percentage of deaths increases with age, and approximately 75% of deaths are in those aged 65 years and above.

Although globally the number of new cases was similar to the number of cases in the previous week, there is considerable variation on a country- by-country basis. In several countries, the number of new cases is rising again, and in many (most notably within the European Region) the second wave is exceeding previous peaks; this can be partly attributed to enhancements in surveillance capacities over time. In other countries we have seen a gradual decline in new cases from earlier peaks in August, for example in Brazil, Colombia and Peru. In India and the Philippines, the number of new cases appear to have stabilized, but they are still reporting high numbers. There are also examples of countries that have consistently shown an increasing incidence as their first wave continues; these include Indonesia, Iraq, and Myanmar, although Indonesia is reporting a slight drop this week. South Africa and Australia are examples of countries that have successfully managed to reduce the number of new cases and have seen large reductions from earlier peaks.

Key weekly updates
:: Diagnostics: WHO issued the first and second Emergency Use Listing for a quality antigen based rapid diagnostic test. WHO published guidance highlights the value of these tests in areas where community transmission is widespread and where nucleic acid amplification-based diagnostic testing is either unavailable or where test results are significantly delayed. On 28 September, the Access to COVID-19 Tools (ACT) Accelerator announced 120 million high-quality, affordable COVID-19 antigen rapid tests to be made available to low- and middle-income countries.

:: Diagnostics: WHO published the final version of Target Product Profiles (TPP) for priority diagnostics. These TPPs describe the desirable and minimal acceptable profiles for four tests: (i) point of care tests for suspected cases and their close contacts where reference assay testing is unavailable, or turnaround times obviate clinical utility; (ii) tests for diagnosis or confirmation of acute or subacute infection, suitable for low or high-volume needs; (iii) point of care test for prior infection; and (iv) tests for prior infection for moderate to high volume needs.

:: COVAX: The Director-General Dr Tedros, in his regular media briefing on 2 October, highlighted 168 have joined COVAX. Through the ACT Accelerator and COVAX Facility, any vaccines that are proven to be safe and effective will be rolled out equitably across the world.

:: International Day of Older Persons: On 1 October, the International Day of Older Persons, WHO launched a package of tools, including a digital application to help health and social workers provide better care for older people . A data portal was also launched that will compile data on global indicators for monitoring the health and well-being of people aged 60 and over. Globally, older persons and those receiving long term care, accounts for a majority of COVID-19 severe cases and deaths.

:: Mental Health: Billions of people around the world have been affected by the COVID-19 pandemic, which is having an added impact on people’s mental health. On 10 October, World Mental Health Day, WHO is organizing a Big Event for Mental Health. The advocacy event will focus on the urgent need to address the world’s chronic under-investment in mental health – a problem that has been thrown into the spotlight during the COVID-19 pandemic.

:: Preparedness: During the United Nations General Assembly, a high-level event on ‘Sustainable preparedness for health security and resilience: Adopting a whole-of-society approach and breaking the “panic-then-forget” cycle’ was organized and co-hosted by Finland, France and Indonesia, along with the WHO. As the world crossed a grim milestone with over a million lives lost to COVID-19, with many more expected to have died from unprecedented disruptions to health systems. The event highlighted the need for sustainable health emergency preparedness as COVID-19 will not be the world’s last health emergency.

::::::
::::::

Emergencies

POLIO
Public Health Emergency of International Concern (PHEIC)

Polio this week as of 07 October 2020
:: From 30 August to 3 September, Somalia conducted an integrated measles and polio campaign in the Banadir region – the first immunization campaign held since the COVID-19 pandemic reached Somalia. Take a look at our latest photo story detailing the campaign.

:: In preparation for Sudan’s National Polio Campaign, 10 million doses of polio vaccines arrived on Thursday October 1st at Khartoum international Airport. Planned for October, the campaign will immunize 8.6 million children under the age of five.

:: On 19 September 2019, a polio outbreak was declared in the Philippines after a 3-year-old child and several environmental samples tested positive for polioviruses. Fifteen other children have been paralyzed by polio since the outbreak started. To protect children from lifelong paralysis due to polio, vaccination rounds have been conducted in parts of the country. Meet the #HeroesEndingPolio who have been working to combat polio in the Philippines.

Summary of new WPV and cVDPV viruses this week (AFP cases and environmental samples):
:: Afghanistan: Four WPV1 cases, eight cVDPV2 cases and two cVDPV2 positive environmental samples
:: Pakistan: 14 WPV1 positive environmental samples and 10 cVDPV2 positive environmental samples
:: Burkina Faso: six cVDPV2 cases
:: Chad: three cVDPV2 cases
:: Democratic Republic of the Congo (DR Congo): one cVDPV2 positive environmental sample
:: Egypt: one cVDPV2 positive environmental sample
:: Somalia: three cVDPV2 positive environmental samples

::::::
::::::

WHO Grade 3 Emergencies [to 10 Oct 2020]

Democratic Republic of the Congo – No new digest announcements identified
Mozambique floods – No new digest announcements identified
Nigeria – No new digest announcements identified
Somalia – No new digest announcements identified
South Sudan – No new digest announcements identified
Syrian Arab Republic – No new digest announcements identified
Yemen – No new digest announcements identified

::::::

WHO Grade 2 Emergencies [to 10 Oct 2020]
Afghanistan – No new digest announcements identified
Angola – No new digest announcements identified
Burkina Faso [in French] – No new digest announcements identified
Burundi – No new digest announcements identified
Cameroon – No new digest announcements identified
Central African Republic – No new digest announcements identified
Ethiopia – No new digest announcements identified
Iran floods 2019 – No new digest announcements identified
Iraq – No new digest announcements identified
Libya – No new digest announcements identified
Malawi Floods – No new digest announcements identified
Measles in Europe – No new digest announcements identified
MERS-CoV – No new digest announcements identified
Mozambique – No new digest announcements identified
Myanmar – No new digest announcements identified
Niger – No new digest announcements identified
occupied Palestinian territory – No new digest announcements identified
HIV in Pakistan – No new digest announcements identified
Sao Tome and Principe Necrotizing Cellulitis (2017) – No new digest announcements identified
Sudan – No new digest announcements identified
Ukraine – No new digest announcements identified
Zimbabwe – No new digest announcements identified

::::::

WHO Grade 1 Emergencies [to 10 Oct 2020]

Chad – No new digest announcements identified
Djibouti – Page not responding at inquiry
Kenya – No new digest announcements identified
Mali – No new digest announcements identified
Namibia – viral hepatitis – No new digest announcements identified
Tanzania – No new digest announcements identified

::::::
::::::

UN OCHA – L3 Emergencies
The UN and its humanitarian partners are currently responding to three ‘L3’ emergencies. This is the global humanitarian system’s classification for the response to the most severe, large-scale humanitarian crises. 
Syrian Arab Republic
:: Syrian Arab Republic: COVID-19 Response Update No. 11 – 7 October 2020

Yemen
:: 07 October 2020 Yemen Humanitarian Update Issue 9 (September 2020)

::::::

UN OCHA – Corporate Emergencies
When the USG/ERC declares a Corporate Emergency Response, all OCHA offices, branches and sections provide their full support to response activities both at HQ and in the field.
COVID-19
:: Coronavirus disease 2019 (COVID-19) Situation Report 47: occupied Palestinian territory, issued 8 October 2020, information for period: 5 March – 8 October 2020

East Africa Locust Infestation
– No new digest announcements identified

::::::
::::::

WHO & Regional Offices [to 10 Oct 2020]
11 October 2020
International Day of the Girl Child

8 October 2020 Joint News Release
One stillbirth occurs every 16 seconds, according to first ever joint UN estimates

7 October 2020 Joint News Release
Global challenge for movement on mental health kicks off as lack of investment in mental health leaves millions without access to services

5 October 2020 News release
COVID-19 disrupting mental health services in most countries, WHO survey

::::::

Weekly Epidemiological Record, 9 October 2020, vol. 95, 41 (pp. 489–496)
Progress towards poliomyelitis eradication – Afghanistan, January 2019–July 202

::::::

WHO Regional Offices
Selected Press Releases, Announcements
WHO African Region AFRO
:: Coping with mental health impact of COVID-19 08 October 2020

WHO Region of the Americas PAHO
No new digest content identified

WHO South-East Asia Region SEARO
:: 8 October 2020 News release
Collectively strengthen pandemic response; plan for COVID-19 vaccination: WHO

WHO European Region EURO
:: When silence is not a virtue: how traditional masculinities keep men from seeking mental health advice 09-10-2020
:: Estonia and WHO to work together on digital health and innovation 07-10-2020
:: Developing new partnerships for health at European Health Forum Gastein 07-10-2020
:: How to counter pandemic fatigue and refresh public commitment to COVID-19 prevention measures 07-10-2020
:: New centre of excellence on humanitarian and health emergencies inaugurated in Istanbul 05-10-2020

WHO Eastern Mediterranean Region EMRO
No new digest content identified

WHO Western Pacific Region
:: 9 October 2020 | News release
Region’s health ministers endorse action to promote access to vaccines, safe surgery and healthy ageing
Health ministers across the World Health Organization (WHO) Western Pacific Region endorsed action plans to improve access to life-saving vaccines and safe and affordable surgery and to promote healthy ageing.
:: 6 October 2020 | Statement
Virtual press conference on the 71st session of the WHO Regional Committee in the Western Pacific

CDC/ACIP [to 10 Oct 2020]
http://www.cdc.gov/media/index.html
https://www.cdc.gov/vaccines/acip/index.html
Latest News Releases, Announcements
CDC Updates “How COVID is Spread” Webpage
Monday, October 5, 2020
…CDC continues to believe, based on current science, that people are more likely to become infected the longer and closer they are to a person with COVID-19.  Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19-positive person left an area.  In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise.  Such environments and activities may contribute to the buildup of virus-carrying particles…

Africa CDC [to 10 Oct 2020]
http://www.africacdc.org/
Press Releases
Team Europe supports Africa’s COVID-19 response with 1.4 million test kits donated by Germany and delivered by the EU Humanitarian Air Bridge
8 October 2020

China CDC
http://www.chinacdc.cn/en/
No new digest content identified.

National Health Commission of the People’s Republic of China
http://en.nhc.gov.cn/
News
Oct 10: Daily briefing on novel coronavirus cases in China
On Oct 9, 31 provincial-level regions and the Xinjiang Production and Construction Corps on the Chinese mainland reported 15 new cases of confirmed infections.

China commits to sharing vaccines
Updated: 2020-10-10 | China Daily
Decision to join global effort expected to bolster access to COVID immunization
[See Milestones above for detail]

Announcements

Paul G. Allen Frontiers Group [to 10 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
The Paul G. Allen Frontiers Group Announces New Allen Distinguished Investigators
October 8, 2020
Collaborative projects funded by the awards will address important questions about neurodegenerative disease, nucleus biology, and protein turnover

News
Accelerating Frontier Science | The Paul G. Allen Frontiers Group
October 7, 2020
The Paul G. Allen Frontiers Group seeks pioneers and explorers willing to make big advancements, take risks, ask questions, be tenacious, and have curiosity to change the face of biology.

BARDA – U.S. Department of HHS [to 10 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
October 9, 2020: Trump Administration Expands Collaboration with AstraZeneca to Develop and Manufacture an Investigational Monoclonal Antibody to Prevent COVID-19
To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD ) today announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent infection with SARS-CoV-2, the coronavirus that causes COVID-19.
The goal of AstraZeneca’s partnership with the U.S. Government is to develop a monoclonal antibody cocktail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine. If the FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, as outlined in agency guidance, the federal government will distribute the doses at no cost. As is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product…

October 6, 2020: HHS funds development of needle-free vaccine administration technology
A patch that could administer vaccines without traditional needles will receive development support from the U.S. Department of Health and Human Services (HHS).
Under an approximately $22 million, 3-year agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and Vaxxas – headquartered in Brisbane, Australia with offices in Cambridge, Massachusetts – the company will undertake U.S. and Australian Phase 1 clinical trials to evaluate the safety and efficacy of an easy-to-use, high-density micro-array patch (HD-MAP) and other development activities for the patch.
“Protecting health and saving lives in public health emergencies such as pandemics often requires rapid, widespread vaccination among large groups of people, which poses multiple logistics challenges,” said BARDA Acting Director Gary Disbrow, Ph.D. “Imagine placing a patch on your arm or leg instead of having to go to a clinic or doctor’s office to get a shot. Not only would needle-free technology simplify vaccination logistics and potentially lower costs, but a self-administered patch also may improve vaccination rates.”…

BMGF – Gates Foundation [to 10 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

Bill & Melinda Gates Medical Research Institute [to 10 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

CARB-X [to 10 Oct 2020]
https://carb-x.org/
News
10.04.2020  |
CARB-X is funding GangaGen Biotechnologies to develop a new drug to treat pneumonia caused by multidrug-resistant Klebsiella pneumoniae bacteria
CARB-X is awarding up to US$2.5 million to GangaGen Biotechnologies to develop novel antibacterial proteins, called klebicins, to treat pneumonia caused by Klebsiella pneumoniae.

CEPI – Coalition for Epidemic Preparedness Innovations [to 10 Oct 2020]
http://cepi.net/
Latest News
No new digest content identified.

EDCTP [to 10 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
06 October 2020
EDCTP joins the GloPID-R funders network on (re-)emerging infectious diseases

Emory Vaccine Center [to 10 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

European Medicines Agency [to 10 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases 
News: EMA starts second rolling review of a COVID-19 vaccine
Last updated: 06/10/2020
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer.
The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.
The CHMP’s decision to start the rolling review of BNT162b2 is based on preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.
Large-scale clinical trials involving several thousands of people are ongoing…

News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020
[See COVID-19 above for detail]

European Vaccine Initiative [to 10 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

FDA [to 10 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
October 9, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 9, 2020

October 8, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 8, 2020
:: Today, the FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of September 30, 2020, 550+ drug development programs were in planning stages, 350+ trials were reviewed by FDA and 5 COVID-19 treatments were currently authorized for emergency use.

October 8, 2020 – FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
:: Today, the U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years. These trial research grants, awarded through the Congressionally-funded Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases.

October 8, 2020 – FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

October 7, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020
:: The FDA issued a letter to health care providers recommending that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.

October 6, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 6, 2020
:: Today, the FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support issuance of an emergency use authorization (EUA) for investigational vaccines intended to prevent COVID-19.
:: Today, FDA launched a new webpage at www.fda.gov/covid19vaccines to highlight new information as it becomes available.
[See COVID-10 above for detail]

October 5, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 5, 2020

Fondation Merieux [to 10 Oct 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

Gavi [to 10 Oct 2020]
https://www.gavi.org/
News releases
8 October 2020
Japan pledges US$ 130 million to support global access to COVID-19 vaccines
:: Japanese Government pledges US$ 130 million in funding to the Gavi COVAX Advance Market Commitment (AMC), bringing the total raised to roughly US$ 1.8 billion
:: This brings Gavi even closer to its initial fundraising goal of US$ 2 billion by the end of 2020 to help accelerate and reserve COVID-19 vaccines for low- and middle-income countries, following a series of significant pledges in the past week
:: Seth Berkley: “This vital funding not only helps us ensure lower-income countries aren’t left at the back of the queue when safe and effective COVID-19 vaccines become available, it will also play a vital role in ending the acute phase of this pandemic worldwide”
:: Motegi Toshimitsu, Foreign Minister of Japan. “Japan will contribute more than US $ 130 million for the COVAX Advance Market Commitment (AMC), in order to enable lower income countries to reinforce equitable access to COVID-19 vaccines.”

6 October 2020
Countries pledge nearly US$ 1 billion to support equitable access to COVID-19 vaccines
:: The United Kingdom, Canada, Germany, Italy and Sweden pledge approximately US$ 960 million to Gavi’s COVID-19 Vaccines Advance Market Commitment (COVAX AMC)
:: This week’s announcements mean nearly US$ 1.7 billion has been raised towards the effort to ensure equitable access to COVID-19 vaccines for low- and middle-income countries, with at least US$ 300 million more urgently needed by end 2020
:: H.E. Issoufou Mahamadou: “I would like to reiterate my support to Gavi and applaud the COVAX initiative as a way to assure universal and fair access to the COVID-19 vaccine.”

GHIT Fund [to 10 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

Global Fund [to 10 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Global Fund and Chevron: United Against HIV, TB and Malaria
05 October 2020
The Global Fund and Chevron Corporation have celebrated a 12-year partnership that served as an example of the private sector’s contribution to the fight against infectious diseases and to building resilient health systems.

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 10 Oct 2020]
https://www.glopid-r.org/news/
News
European & Developing Countries Clinical Trials Partnership (EDCTP) joins the GloPID-R network
06/10/2020
GloPID-R is delighted to announce that the European & Developing Countries Clinical Trials Partnership (EDCTP) is now a member of the GloPID-R network. The EDCTP will be represented by Pauline Beattie and joins WHO and CEPI as an observer organization.

Hilleman Laboratories [to 10 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

Human Vaccines Project [to 10 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
‘Comet’ Supercomputer Calculations Boost Our Understanding of Immune System
Oct 08, 2020
SDSC assists Vanderbilt University Human Vaccines Project
While researchers around the world race to develop an effective and safe COVID-19 vaccine, a team from the San Diego Supercomputer Center (SDSC) at UC San Diego contributed to a study led by Vanderbilt Vaccine Center of Vanderbilt University Medical Center (VUMC) on T cell receptors, which play a vital role in alerting the adaptive immune system to mount an attack on invading foreign pathogens including the Coronavirus SARS-CoV-2.

IAVI [to 10 Oct 2020]
https://www.iavi.org/newsroom
FEATURES
October 8, 2020
What are monoclonal antibodies, and can they treat COVID-19?
Monoclonal antibodies have changed the way we treat many diseases. They are a promising treatment for COVID-19, and IAVI is committed to developing SARS-CoV-2 antibodies that will be globally accessible. 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

IFFIm
http://www.iffim.org/
Announcements
No new digest content identified.

IFRC [to 10 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
World Mental Health Day: New Red Cross survey shows COVID-19 affecting mental health of one in two people
Geneva, 8 October (ICRC/IFRC) – Half of all respondents – 51 percent – in a seven-country survey said that the COVID-19 pandemic has negatively affected their mental health, an International Committee of the Red Cross (ICRC) survey found. In a new repo …
8 October 2020

IRC International Rescue Committee [to 10 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
New IRC data: Nearly 500 children sent to Libyan detention centres in past 6 months; IRC calls for immediate closure of inhumane centres
October 8, 2020

Press Release
Twelve fold increase in Ethiopia COVID-19 cases, severe weather and locusts creating massive need in Ethiopia, warns IRC
October 7, 2020

IVAC [to 10 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

IVI [to 10 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Event
Building Vaccine Diplomacy and Advocacy
IVI Virtual State Forum 2020
Tuesday, October 13, 2020
04:00 New York / 10:00 Geneva, Copenhagen, Oslo / 17:00 Seoul
Watch live: bit.ly/ivi-state-forum-2020
Registration Required

JEE Alliance [to 10 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

MSF/Médecins Sans Frontières [to 10 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Lebanon
“I needed to make myself useful to overcome the panic”
Voices from the Field 9 Oct 2020

Kenya
COVID-19 further fuels mental health crisis in Dadaab as durable soluti…
Project Update 9 Oct 2020

Greece
EU must stop trapping people in miserable conditions on the Greek isl…
Statement 8 Oct 2020

Coronavirus COVID-19 pandemic
MSF supports India and South Africa ask to waive COVID-19 patent rights
Press Release 7 Oct 2020
[See Week in Review above for detail]

Coronavirus COVID-19 pandemic
High COVID-19 rates found among people living in extreme hardship in and …
Press Release 6 Oct 2020

Refugees, IDPs and people on the move
Enough is enough: new pact, same misery for refugees
Op-Ed 5 Oct 2020

National Vaccine Program Office – U.S. HHS [to 10 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

NIH [to 10 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 Begins
October 8, 2020 — The study is taking place in hospitalized adults in the United States, Mexico and 16 other countries.

NIH to launch the Serological Sciences Network for COVID-19, announce grant and contract awardees
October 8, 2020 — The initiative is aimed at quickly increasing the nation’s antibody testing capacity.

NIH RADx initiative advances six new COVID-19 testing technologies
October 6, 2020 — Addition of new, rapid point-of-care platforms will expand national testing options.

NIH to support 85 new grants featuring high-risk, high-reward research
October 6, 2020 — The 2020 Director’s Awards will feature highly innovative biomedical research by investigators at all career stages.

PATH [to 10 Oct 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

Sabin Vaccine Institute [to 10 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

UNAIDS [to 10 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
7 October 2020
Lessons from the Ashodaya PrEP project in India

6 October 2020
Faith communities discuss the way forward in the HIV response

5 October 2020
Tanzanian community-based organizations support women who use drugs

5 October 2020
Women living with HIV are more likely to access HIV testing and treatment

UNICEF [to 10 Oct 2020]
https://www.unicef.org/media/press-releases
Statement
10/09/2020
Statement by UNICEF Executive Director Henrietta Fore on awarding of Nobel Peace Prize to WFP

Press release
10/07/2020
One stillbirth occurs every 16 seconds, according to first ever joint UN estimates
COVID-19-related health service disruptions could worsen the situation, potentially adding nearly 200,000 more stillbirths over a 12-month period

Statement
10/06/2020
UNICEF Statement on the Nagorno-Karabakh conflict

Press release
10/06/2020
Unrelenting violence continues to impact children in Ituri, eastern DRC

Statement
10/05/2020
Teachers: Leading in crisis, reimagining the future
Joint statement from David Edwards, General Secretary, Education International, Guy Ryder, Director-General, International Labour Organization, Audrey Azoulay, Director-General of UNESCO and Henrietta Fore, Executive Director, UNICEF

Press release
10/05/2020
Education Cannot Wait, the Global Partnership for Education, UNESCO & UNICEF call for the resumption of salary payments for teachers for the coming school year in Yemen

Statement
10/05/2020
Statement by Henrietta Fore, UNICEF Executive Director, to UNHCR Executive Committee
[As delivered]

Unitaid [to 10 Oct 2020]
https://unitaid.org/
Featured News
No new digest content identified.

Vaccination Acceptance Research Network (VARN) [to 10 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

Vaccine Confidence Project [to 10 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

Vaccine Education Center – Children’s Hospital of Philadelphia [to 10 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

Wellcome Trust [to 10 Oct 2020]
https://wellcome.ac.uk/news
Explainer | 5 October 2020
What are monoclonal antibodies – and can they treat Covid-19?
For more than 30 years, monoclonal antibodies have transformed the way we treat many diseases. Researchers think they are also one of the most promising treatments for Covid-19. Here’s why.

Explainer | 5 October 2020
How can we get effective treatments for Covid-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat Covid-19 patients.

The Wistar Institute [to 10 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

WFPHA: World Federation of Public Health Associations [to 10 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

World Organisation for Animal Health (OIE) [to 10 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

::::::

ARM [Alliance for Regenerative Medicine] [to 10 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine Applauds the Award of the Nobel Prize to CRISPR Pioneers
October 7, 2020
Washington, DC

BIO [to 10 Oct 2020]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. McMurry-Heath Applauds FDA Release of Guidance for Covid-19 Vaccines
October 6, 2020
Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), today applauded the Food and Drug Administration (FDA) for publicly releasing new guidance related to the emergency use authorization of future Covid-19 vaccines…
“In the midst of a pandemic, transparency and collaboration are critical if we are going to quickly and safely eradicate this global health threat. That is why we recently called for the public release of any new FDA guidance concerning emergency use authorization for Covid-19 vaccines. The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering.
“We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. Science should stand on its own. While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public.”

DCVMN – Developing Country Vaccine Manufacturers Network [to 10 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

ICBA – International Council of Biotechnology Associations [to 10 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

IFPMA [to 10 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement for the Special session of the Executive Board on implementation of Resolution WHA73.1
06 October 2020
OVID-19 is a human, social, and economic tragedy that, as of September 2020, has cost more than a million lives globally and is estimated to contract global GDP by $US 7 trillion in 2020.

Since the early days of this pandemic, the R&D-based biopharmaceutical industry has responded through many initiatives aimed at providing and prioritizing delivery of critical products to tackle COVID-19, motivated by a strong sense of responsibility to act together, in partnership with WHO and governments, to support health systems across the world in a concerted and collective response. In this spirit, IFPMA is  proud to be a founding member of the ACT-A Accelerator.

The R&D-based biopharmaceutical industry firmly believes that a coordinated, inclusive, and multi-stakeholder action is necessary to mitigate the impact of this unprecedented global health emergency, ensuring that no one is left behind. The private sector has an essential role to play in combating this public health crisis through its expertise, innovation, and resources. In the endeavour of finding effective and safe treatments and vaccines at record speed, the private R&D business model, enabled by strong and effective intellectual property incentives, has significantly contributed to the discovery and development of treatments that are currently being tested.

IFPMA member companies are deeply aware that science and innovation are a key part of the equation but not the entire solution. We remain committed to the principle of equitable and affordable access to COVID-19-related health products and call upon governments to do their part in ensuring adequate resources are appropriately allocated to build resilient, and sustainable healthcare systems. Investing in health is critical to ensuring growth and prosperity. With COVID-19 having exposed major weaknesses in pandemic preparedness, we welcome the WHO’s decision to conduct an independent evaluation of the global COVID-19 response to identify lessons learned.

PhRMA [to 10 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
The latest: What they are saying: Intellectual property protections vital to incentivize ongoing COVID-19 research and development
October 7, 2020
America’s biopharmaceutical companies are committed to COVID-19 treatment and vaccine research and development (R&D). Reliable IP protections have helped drive innovation and enhance patient access to breakthrough therapies. Innovators are also relying on these strong protections to discover new medical advances that will keep patients healthy during this pandemic and after…Strong and reliable IP protections support America’s robust innovation ecosystem by promoting innovation and affordability for patients who rely on new treatments and cures, like those in development to treat COVID-19. America’s biopharmaceutical companies remain committed to ensuring that treatments and vaccines developed for COVID-19 are available to all who need them.

PhRMA Statement on U.S. Food and Drug Administration COVID-19 Emergency Use Authorization Vaccine Guidelines
October 6, 2020
Pharmaceutical Research and Manufacturers of America president and CEO, Stephen J. Ubl made the following statement about reporting around the U.S. Food and Drug Administration (FDA) drafting new guidelines to bring about greater clarity and continued scientific rigor to the review and potential approvals of COVID-19 vaccines for emergency use authorization:
“PhRMA represents an industry built on the bedrock of scientific rigor. Back in September, leading biopharmaceutical companies researching and developing potential vaccines for COVID-19 issued a pledge ‘to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.’
“This commitment to supporting a sound, scientific and deliberative process for the development and review of COVID-19 vaccines has not wavered.
“PhRMA supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines. To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time. We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.
“Science is guiding every aspect of our work. We remain focused on ensuring the highest of standards of patient safety, research, clinical testing and manufacturing are upheld throughout the vaccine research and development process.”

Journal Watch
Vaccines and Global Health: The Week in Review continues its weekly scanning of key peer-reviewed journals to identify and cite articles, commentary and editorials, books reviews and other content supporting our focu-s on vaccine ethics and policy. Journal Watch is not intended to be exhaustive, but indicative of themes and issues the Center is actively tracking. We selectively provide full text of some editorial and comment articles that are specifically relevant to our work. Successful access to some of the links provided may require subscription or other access arrangement unique to the publisher.
If you would like to suggest other journal titles to include in this service, please contact David Curry at: david.r.curry@centerforvaccineethicsandpolicy.org

Annals of Internal Medicine
6 October 2020 Volume 173, Issue 7
http://annals.org/aim/issue

Medicine and Public Issues
Institutional Review Board Quality, Private Equity, and Promoting Ethical Human Subjects Research
Holly Fernandez Lynch, JD, MBE and Stephen Rosenfeld, MD, MBA
Several U.S. senators have raised concerns about the growing trends of private equity ownership and consolidation of for-profit institutional review boards (IRBs). This article summarizes the challenges in assessing IRB quality, explores the pros and cons of the for-profit and nonprofit IRB models, and presents a new model of IRB oversight.

BMC Medical Ethics
http://www.biomedcentral.com/bmcmedethics/content
(Accessed 10 Oct 2020)

Debate
Human genome editing: how to prevent rogue actors
Authors: Beverley A. Townsend
6 October 2020

BMC Public Health
http://bmcpublichealth.biomedcentral.com/articles
(Accessed 10 Oct 2020)

Exploring attitudes of adolescents and caregivers towards community-based delivery of the HPV vaccine: a qualitative study
Human Papillomavirus (HPV) vaccination among adolescents is an important strategy to prevent cervical and other cancers in adulthood. However, uptake remains far below the Healthy People 2020 targets for the U…
Authors: Shoba Ramanadhan, Constance Fontanet, Marina Teixeira, Sitara Mahtani and Ingrid Katz
Citation: BMC Public Health 2020 20:1531
Content type: Research article
Published on: 9 October 2020

Health Research Policy and Systems
http://www.health-policy-systems.com/content
[Accessed 10 Oct 2020]

Content type: Research
Strengthening National Immunization Technical Advisory Groups in resource-limited settings: current and potential linkages with polio national certification committees
Authors: Sharon A. Greene, Blanche-Philomene Melanga Anya, Humayun Asghar, Irtaza A. Chaudhri, S. Deblina Datta, Morgane E. Donadel, Koffi Isidore Kouadio, Abigail M. Shefer and Kathleen F. Cavallaro
6 October 2020
Countries are transitioning assets and functions from polio eradication to integrated immunization and surveillance activities. We assessed the extent of linkages between and perceptions of National Immunization Technical Advisory Groups (NITAGs) and National Certification Committees (NCCs) for polio eradication to understand how linkages can be leveraged to improve efficiencies of these expert bodies.

Humanitarian Exchange Magazine
Number 78, October 2020
https://odihpn.org/magazine/inclusion-of-persons-with-disabilities-in-humanitarian-action-what-now/

Disability inclusion in humanitarian action
by HPN October 2020
The theme of this edition of Humanitarian Exchange, co-edited with Sherin Alsheikh Ahmed from Islamic Relief Worldwide, is disability inclusion in humanitarian action. Persons with disabilities are not only disproportionately impacted by conflicts, disasters and other emergencies, but also face barriers to accessing humanitarian assistance. At the same time, global commitments and standards and the IASC Guidelines on the inclusion of persons with disabilities in humanitarian action all emphasise how persons with disabilities are also active agents of change. Disability and age-focused organisations have led on testing and demonstrating how inclusion can be done better. Yet despite this progress, challenges to effective inclusion remain.

As Kirstin Lange notes in the lead article, chief among these challenges is humanitarian agencies’ lack of engagement with organisations of persons with disabilities. Simione Bula, Elizabeth Morgan and Teresa Thomson look at disability inclusion in humanitarian response in the Pacific, and Kathy Al Jubeh and Alradi Abdalla argue for a ‘participation revolution’, building on learning from the gender movement. Tchaurea Fleury and Sulayman AbdulMumuni Ujah outline how the Bridge Article 11 training initiative is encouraging constructive exchange between humanitarian and disability actors. The lack of good, disaggregated data is highlighted by Sarah Collinson; Frances Hill, Jim Cranshaw and Carys Hughes emphasise the need for training resources in local languages and accessible formats; and Sophie Van Eetvelt and colleagues report on a review of the evidence on inclusion of people with disabilities and older people.

Rebecca Molyneux and co-authors analyse the findings of a review of a DFID programme in north-east Nigeria, while Carolin Funke highlights the importance of strategic partnerships between disability-focused organisations, drawing on her research in Cox’s Bazar. Sherin Alsheikh Ahmed describes Islamic Relief Worldwide’s approach to mainstreaming protection and inclusion, while Pauline Thivillier and Valentina Shafina outline IRC’s Client Responsive Programming. The edition ends with reflections by Mirela Turcanu and Yves Ngunzi Kahashi on CAFOD’s SADI approach.

Infectious Diseases of Poverty
http://www.idpjournal.com/content
[Accessed 10 Oct 2020]

Towards integrated surveillance-response systems for the prevention of future pandemics
Authors: Jakob Zinsstag, Jürg Utzinger, Nicole Probst-Hensch, Lv Shan and Xiao-Nong Zhou
Content type: Opinion
7 October 2020

JAMA
October 6, 2020, Vol 324, No. 13, Pages 1261-1362
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
COVID-19 and the Path to Immunity
David S. Stephens, MD; M. Juliana McElrath, MD, PhD
free access has active quiz
JAMA. 2020;324(13):1279-1281. doi:10.1001/jama.2020.16656
This Viewpoint reviews what is known about acute and long-term B-cell, antibody, and T-cell responses to SARS-CoV-2 infection and explains how each are implicated in vaccine candidates likely to be effective and durably protective again COVID-19.

JAMA
October 6, 2020, Vol 324, No. 13, Pages 1261-1362
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Emergency Use Authorizations During the COVID-19 PandemicLessons From Hydroxychloroquine for Vaccine Authorization and Approval
Kyle Thomson, JD, MPH; Herschel Nachlis, PhD
free access has active quiz has multimedia has audio
JAMA. 2020;324(13):1282-1283. doi:10.1001/jama.2020.16253
This Viewpoint uses the FDA’s Emergency Use Authorization (EUA) of hydroxychloroquine for COVID-19 treatment to emphasize the costs of premature regulatory authorizations to public health and trust, and proposes the use of advisory committees, requirements for postmarketing surveillance, and adherence to standards of transparency for any future EUAs.

JAMA
October 6, 2020, Vol 324, No. 13, Pages 1261-1362
https://jamanetwork.com/journals/jama/currentissue

Viewpoint
Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency
Jerry Avorn, MD; Aaron Kesselheim, MD, JD, MPH
free access has active quiz has multimedia has audio
JAMA. 2020;324(13):1284-1285. doi:10.1001/jama.2020.17101
This Viewpoint reviews the enormous political and public pressures the FDA is likely to be under in fall 2020 to provide emergency authorization or approval of candidate COVID-19 vaccines, and urges adherence to existing science-based protocols for approval to ensure vaccine safety and acceptance and thus protect the public’s health.

JAMA
October 6, 2020, Vol 324, No. 13, Pages 1261-1362
https://jamanetwork.com/journals/jama/currentissue

Editorial
Reassuring the Public and Clinical Community About the Scientific Review and Approval of a COVID-19 Vaccine
Howard Bauchner, MD; Preeti N. Malani, MD, MSJ; Joshua Sharfstein, MD
Public perception of the review of medications and vaccines for coronavirus disease 2019 (COVID-19) has become enmeshed in politics. The pressure on the US Food and Drug Administration (FDA) and Commissioner Stephen Hahn, MD, to approve the broad use of a COVID-19 vaccine in the coming months will be immense. However, a lack of clarity about the agency’s approach—coupled with a stream of announcements from various federal agencies and pharmaceutical companies—has led to confusion and concern. Greater clarity and transparency about the review process as well as the full engagement of the relevant federal advisory committees can inspire understanding and trust.

A flurry of recent statements has captured headlines. Commissioner Hahn indicated that the FDA is willing to use an Emergency Use Authorization (EUA) for vaccines before phase 3 trials are complete.¹ An EUA provides a rapid approach to facilitate availability and use of biologics, drugs, vaccines, devices, and diagnostic tests (referred to as “medical countermeasures”) during a public health emergency.² Some medical experts have suggested that this approach is inappropriate. On August 27, 2020, the US Centers for Disease Control and Prevention (CDC) instructed states to begin to prepare for distribution of a vaccine in the coming months.³ On September 3, the chief executive officer (CEO) of Pfizer announced that the company will have sufficient data to know if its vaccine is effective by the end of October and will consider filing for EUA.^4,5 But on September 4, the White House chief advisor for the coronavirus vaccine development program, Operation Warp Speed, announced that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.⁶

On September 8 the CEOs of 9 pharmaceutical companies released a joint pledge that they are committed to “developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”⁷ The pledge indicates that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.” The statement does not include any commitment or suggestion that the data underpinning their application be shared with any other group.⁸ These announcements have left some clinicians, public health officials, and members of the public bewildered about what is actually happening and concerned that vaccines will be made available before safety and effectiveness are fully established.

The goal of making available a safe and effective COVID-19 vaccine is widely seen as critical for ending the pandemic, and Operation Warp Speed has accelerated the development, testing, and eventual distribution of such a vaccine. However, recent polls of adults suggest that as few as 50% of US adults are committed to receiving a COVID-19 vaccine,⁹ and misinformation and conspiracy theories about a vaccine abound. Prematurely approving a vaccine could undermine COVID-19 vaccination efforts and erode confidence in vaccines more generally.

The path forward starts with support, not mistrust, of the career FDA scientists and officials with the expertise to determine whether emerging vaccine candidates are ready for use in specific populations. The director of the FDA center responsible for vaccine review, Peter Marks, MD, told the Washington Post that the COVID-19 vaccine will only be authorized or licensed when it meets the existing guidelines for safety and efficacy.¹⁰ This statement of agency policy is reassuring. Rather than prejudging any decision, and consistent with the scientific method, FDA staff should have the ability to evaluate the data from phase 3 trials and make the case for whether those trials establish safety and effectiveness. The staff scientists should then be able to recommend either an EUA or full licensure to provide access to a safe and effective vaccine as quickly as possible. If the recommendation is for an EUA, the staff scientists should explain why this path was taken and how this would not mean compromising on the answers to critical questions.

Beyond internal deliberations within the FDA, a thorough and transparent review process of data supporting vaccine approval is essential to building public confidence in a COVID-19 vaccine.

Important safeguards should be established to reassure the clinical community and the public about any vaccine approval. The FDA should explain the role of the data and safety monitoring boards (DSMBs) for the vaccine trials, the first “independent” group that reviews the data, and any correspondence between the DSMB and the project investigators should be shared with the public. Two additional groups have an important consultant responsibility to the government and the public: the FDA Vaccines and Related Biological Products Advisory Committee^11,12 and the Advisory Committee on Immunization Practices (ACIP).¹³ These advisory groups are composed of medical, scientific, health policy, and public health experts who review data and develop recommendations for the use of vaccines.

The FDA should share all allowable and available data about a vaccine candidate with the FDA vaccine advisory committee and ACIP prior to making any decision about an EUA or approval. Typically, the FDA’s vaccine committee makes recommendations prior to agency action, and ACIP soon afterward. In this challenging situation, the FDA should seek the input of both committees prior to making a decision. An FDA decision consistent with the advice of these independent experts will then reassure the public. However, if the FDA goes in a different direction, the agency will need to explain the reasons well to avoid confusion and vaccine hesitancy. If either panel is excluded from reviewing data, the FDA may struggle to convince the public and clinical community about the strength of the evidence, and vaccine uptake may be adversely affected.

Some have expressed concern that political appointees in the executive branch may insist on an EUA for a vaccine over the recommendation of FDA career scientists. Such interference would both present a direct risk to the US public and cause incalculable damage to public trust in the federal government’s ability to make critical scientific decisions. The FDA should be clear at the time of the announcement of an EUA or approval of a vaccine if such an EUA or approval had been mandated by members of the executive branch against the advice of the agency scientists. In such a scenario, Congress should take action to protect the public.

A more nuanced issue is the potential effect of an EUA or approval on ongoing research. The agency should work with the National Institutes of Health (NIH) to develop a joint approach to support ongoing vaccine trials, including further research on the vaccines in question. It would be unfortunate for the FDA and NIH to present conflicting views of a vaccine, as happened with convalescent plasma for treatment of severe COVID-19.

This is a time of great societal upheaval, and the response to the pandemic has required difficult decisions. An effective COVID-19 vaccine, if widely available and with substantial uptake, will allow society over time to return to some semblance of normalcy. The FDA remains the agency to answer the core question of when vaccines are safe and effective for the US population. It also remains essential for the FDA to be fully informed by independent scientific experts, to promote trust and confidence on the path to ending the pandemic.

JAMA
October 6, 2020, Vol 324, No. 13, Pages 1261-1362
https://jamanetwork.com/journals/jama/currentissue

Clinical Update
Vaccine Refusal and Measles Outbreaks in the US
Varun K. Phadke, MD; Robert A. Bednarczyk, MS, PhD; Saad B. Omer, MBBS, MPH, PhD
has audio
JAMA. 2020;324(13):1344-1345. doi:10.1001/jama.2020.14828
This JAMA Insights feature provides a narrative update of a 2016 systematic review documenting an association between vaccine refusal and measles epidemiology in the US, and reaffirms based on the new evidence that vaccine refusal remains a significant contributor to measles resurgence in the postelimination era.

JAMA Network
COVID-19 Update October 10, 2020

These articles on COVID-19 were published across the JAMA Network in the last week.

JAMA Pediatrics
October 2020, Vol 174, No. 10, Pages 919-1012
http://archpedi.jamanetwork.com/issue.aspx

Viewpoint
School Closure During the Coronavirus Disease 2019 (COVID-19) PandemicAn Effective Intervention at the Global Level?
Susanna Esposito, MD; Nicola Principi, MD
free access has active quiz
JAMA Pediatr. 2020;174(10):921-922. doi:10.1001/jamapediatrics.2020.1892
This Viewpoint discusses the effectiveness of school closure as a preventive measure during the coronavirus disease 2019 (COVID-19) pandemic.

JAMA Pediatrics
October 2020, Vol 174, No. 10, Pages 919-1012
http://archpedi.jamanetwork.com/issue.aspx

Impact of Policy on Children
Study Designs and Statistical Methods for Studies of Child and Adolescent Health Policies
Benjamin French, PhD; Elizabeth A. Stuart, PhD
JAMA Pediatr. 2020;174(10):925-927. doi:10.1001/jamapediatrics.2020.3408
This Viewpoint discusses selection of data and statistical methods that can be used to estimate policy effects using that data.
Rigorous empirical studies of the effect of a policy intervention seek to consider (or estimate) what outcomes are (or would be) with the policy compared with what outcomes are (or would be) without the policy. For example, consider whether decriminalization of adult marijuana use (medical or recreational) is associated with adolescent marijuana use.¹ As detailed below, one can use data over time from states that did and did not decriminalize adult marijuana use and compare observed trends in adolescent marijuana use among states with the policy change to expected (or predicted) trends in marijuana use, had the policy change not occurred, to estimate the policy effect. Of note, the policy effect could also be estimated in settings in which there is not a comparison group, such as if marijuana were decriminalized nationwide. We focus on settings often referred to as group panel data, for which there are aggregate data available on groups of interest with outcomes measured over time both before and after the policy change and ideally with comparison groups that did not experience a policy change; individual-level data could also be available within the groups. The data in some cases correspond with full population data at each time point; in others, there might be repeated cross-sections of data, such as annual surveys of marijuana use among 10th graders. As long as the data can be thought of as representative of the unit under study, either data structure can be appropriate. We broadly consider the selection of data to examine (eg, the units to study, the time period to examine) as well as the statistical methods that can be used to estimate policy effects using that data.

JAMA Pediatrics
October 2020, Vol 174, No. 10, Pages 919-1012
http://archpedi.jamanetwork.com/issue.aspx

Review
Gene and Stem Cell Therapies for Fetal Care – A Review
Amy E. O’Connell, MD, PhD; Stephanie Guseh, MD; Larissa Lapteva, MD, MHS, MBA; et al.
JAMA Pediatr. 2020;174(10):985-991. doi:10.1001/jamapediatrics.2020.1519
Abstract
Importance  Gene and stem cell therapies have become viable therapeutic options for many postnatal disorders. For select conditions, prenatal application would provide improved outcomes. The fetal state allows for several theoretical advantages over postnatal therapy, including immune immaturity and cellular niche accessibility.
Observations  Advances in prenatal diagnostic accuracy and surgical precision, as well as improvements in stem cell and gene therapy methods, have made prenatal gene and stem cell therapy realistic. Studies in mouse models and early human trials demonstrate the feasibility of these approaches. Additional efforts are under way to streamline fetal applications of stem cell and gene therapy while carefully considering best ethical practice and following established regulatory pathways.
Conclusions and Relevance  Fetal stem cell and gene therapy bring important therapeutic opportunities for select disorders that present in the fetal and neonatal periods. While this field is in its infancy, these therapies are starting to be available clinically, and clinicians should be aware of their benefits and challenges.

Journal of Development Economics
Volume 147 November 2020
https://www.sciencedirect.com/journal/journal-of-development-economics/vol/147/suppl/C

Research article Open access
Managing the spread of disease with mobile phone data
Sveta Milusheva
Article 102559
Abstract
While human mobility has important benefits for economic growth, it can generate negative externalities. This paper studies the effect of mobility on the spread of disease in a low-incidence setting when people do not internalize their risks to others. Using malaria as a case study and 15 billion mobile phone records across nine million SIM cards, this paper quantifies the relationship between travel and the spread of disease. The estimates indicate that an infected traveler contributes to 1.66 additional cases reported in the health facility at the traveler’s destination. This paper develops a simulation-based policy tool that uses mobile phone data to inform strategic targeting of travelers based on their origins and destinations. The simulations suggest that targeting informed by mobile phone data could reduce the caseload by 50 percent more than current strategies that rely only on previous incidence.

The Lancet
Oct 10, 2020 Volume 396 Number 10257 p1045-1128
https://www.thelancet.com/journals/lancet/issue/current

Commission Statement
Lancet COVID-19 Commission Statement on the occasion of the 75th session of the UN General Assembly
The Lancet COVID-19 Commissioners, Task Force Chairs, and Commission Secretariat
[See COVID-19 above for detail]

Nature
Volume 586 Issue 7828, 8 October 2020
http://www.nature.com/nature/current_issue.html

Editorial | 06 October 2020
Why Nature needs to cover politics now more than ever
Science and politics are inseparable — and Nature will be publishing more politics news, comment and primary research in the coming weeks and months.
[Editor’s text bolding in red]

Since Nature’s earliest issues, we have been publishing news, commentary and primary research on science and politics. But why does a journal of science need to cover politics? It’s an important question that readers often ask.

This week, Nature reporters outline what the impact on science might be if Joe Biden wins the US presidential election on 3 November, and chronicle President Donald Trump’s troubled legacy for science. We plan to increase politics coverage from around the world, and to publish more primary research in political science and related fields.

Science and politics have always depended on each other. The decisions and actions of politicians affect research funding and research-policy priorities. At the same time, science and research inform and shape a spectrum of public policies, from environmental protection to data ethics. The actions of politicians affect the higher-education environment, too. They can ensure that academic freedom is upheld, and commit institutions to work harder to protect equality, diversity and inclusion, and to give more space to voices from previously marginalized communities. However, politicians also have the power to pass laws that do the opposite.

The coronavirus pandemic, which has taken more than one million lives so far, has propelled the science–politics relationship into the public arena as never before, and highlighted some serious problems. COVID-related research is being produced at a rate unprecedented for an infectious disease, and there is, rightly, intense worldwide interest in how political leaders are using science to guide their decisions — and how some are misunderstanding, misusing or suppressing it. And there is much interest in the fluctuating relationship between politicians and the scientists who governments consult or employ.

Scholarly autonomy under threat

Perhaps even more troubling are signs that politicians are pushing back against the principle of protecting scholarly autonomy, or academic freedom. This principle, which has existed for centuries — including in previous civilizations — sits at the heart of modern science.

Today, this principle is taken to mean that researchers who access public funding for their work can expect no — or very limited — interference from politicians in the conduct of their science, or in the eventual conclusions at which they arrive. And that, when politicians and officials seek advice or information from researchers, it is on the understanding that they do not get to dictate the answers. This is the basis for today’s covenant between science and politics, and it applies across a range of research, education, public-policy and regulatory domains.

It is not a perfect system by any means. Some research areas are more autonomous than others, and autonomy can never be a blank cheque: researchers must also be held accountable for their actions, and standards of quality and integrity must be upheld. But protection for autonomy is a long-standing benchmark, the standard to which experts and policymakers aspire. It requires a degree of trust between researcher and politician that each will keep to their word. And when this trust starts to ebb away, the system, too, begins to look vulnerable.

That trust is now under considerable pressure around the world. Cracks have been evident for years in the field of climate change, with a number of politicians ignoring or seeking to undermine the irrefutable evidence showing that humans are the cause. But this lack of trust can now also be seen in other public domains in which verifiable knowledge and research are needed for effective policy-making.

Last year, Brazil’s President Jair Bolsonaro sacked the head of the country’s National Institute for Space Research because the president refused to accept the agency’s reports that deforestation in the Amazon has accelerated during his tenure. In the same year, more than 100 economists wrote to India’s prime minister, Narendra Modi, urging an end to political influence over official statistics — especially economic data — in the country.

And just last week, in Japan, incoming Prime Minister Yoshihide Suga rejected the nomination of six academics, who have previously been critical of government science policy, to the Science Council of Japan. This is an independent organization meant to represent the voice of Japanese scientists. It is the first time that this has happened since prime ministers started approving nominations in 2004.

The pandemic, too, is uncovering examples of political interference in science. In June in the United Kingdom, the statistics regulator wrote to the government, highlighting repeated inaccuracies in its COVID-19 testing data, which the regulator says seem to be aimed at showing “the largest possible number of tests”.

The fields of public-health and infectious-disease research have revealed much about the effects of pandemics and how to curb them. This year, a large volume of work on COVID-19 has illuminated the behaviour of both the virus and the disease. Research has also revealed uncertainties, gaps and errors in our knowledge, as would be expected. But that doesn’t excuse the behaviour we are seeing from politicians around the world, exemplified by Trump’s notorious actions: a chaotic, often ill-informed response, with scientists being attacked and undermined.

The principle that the state will respect scholarly independence is one of the foundations underpinning modern research, and its erosion carries grave risks for standards of quality and integrity in research and policymaking. When politicians break that covenant, they endanger the health of people, the environment and societies.

This is why Nature’s news correspondents will redouble their efforts to watch and report on what is happening in politics and research worldwide. It is why authors of our expert commentaries will continue to assess and critique developments; and why the journal is looking to publish more primary research in political science.

And, in these editorial pages, we will continue to urge politicians to embrace the spirit of learning and collaboration, to value different perspectives, and to honour their commitment to scientific and scholarly autonomy.

The conventions that have guided the relationship between science and politics are under threat, and Nature cannot stand by in silence.

Nature Biotechnology
Volume 38 Issue 10, October 2020
https://www.nature.com/nbt/volumes/38/issues/10

SARS-CoV-2 detection
In this issue, several groups report their findings on the development of methods to detect SARS-CoV-2 in patients and in the community, and benchmark assays to detect SARS-CoV-2-specific antibodies.

The conventions that have guided the relationship between science and politics are under threat, and Nature cannot stand by in silence.

Comment | 06 October 2020
COVID-19 vaccines: how to ensure Africa has access
History must not repeat itself — global and continental cooperation are essential.
John N. Nkengasong, Nicaise Ndembi[…] & Tajudeen Raji

Nature Biotechnology
Volume 38 Issue 10, October 2020
https://www.nature.com/nbt/volumes/38/issues/10

Editorial | 24 September 2020
Trumping science
The scientific integrity of US government agencies is under attack from the Trump administration. Agency senior executives and industry leaders need to continue pushing back.

Nature Biotechnology
Volume 38 Issue 10, October 2020
https://www.nature.com/nbt/volumes/38/issues/10

Comment | 14 September 2020
Artificial intelligence, drug repurposing and peer review
Can traditional computational analysis and machine learning help compensate for inadequate peer review of drug-repurposing papers in the context of an infodemic?
Jeremy M. Levin, Tudor I. Oprea[…] & Alex Zhavoronkov

Nature Biotechnology
Volume 38 Issue 10, October 2020
https://www.nature.com/nbt/volumes/38/issues/10

Q&A | 28 September 2020
Whither COVID-19 vaccines?
Nature Biotechnology convenes a group of experts to provide their insights into SARS-CoV-2 vaccines in development.
Laura DeFrancesco

Nature Biotechnology
Volume 38 Issue 10, October 2020
https://www.nature.com/nbt/volumes/38/issues/10

Patents | 05 October 2020
Pledging intellectual property for COVID-19
Voluntary pledges to make intellectual property broadly available to address urgent public health crises can overcome administrative and legal hurdles faced by more elaborate legal arrangements such as patent pools and achieve greater acceptance than governmental compulsory licensing.
Jorge L. Contreras, Michael Eisen[…] & Frank Tietze

New England Journal of Medicine
October 8, 2020 Vol. 383 No. 15
http://www.nejm.org/toc/nejm/medical-journal

Editorials
Dying in a Leadership Vacuum
The Editors
[See Featured Journal Content above for full text]

PLoS One
http://www.plosone.org/

Research Article
Epidemiological impact and cost-effectiveness of universal meningitis b vaccination among college students prior to college entry
Grace S. Chung, David W. Hutton
Research Article | published 09 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239926

PLoS One
http://www.plosone.org/

Comparing covariation among vaccine hesitancy and broader beliefs within Twitter and survey data
Sarah A. Nowak, Christine Chen, Andrew M. Parker, Courtney A. Gidengil, Luke J. Matthews
Research Article | published 08 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239826

PLoS One
http://www.plosone.org/

Improving quality and use of routine health information system data in low- and middle-income countries: A scoping review
Seblewengel Lemma, Annika Janson, Lars-Åke Persson, Deepthi Wickremasinghe, Carina Källestål
Research Article | published 08 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0239683

PLoS One
http://www.plosone.org/

Characteristics of academic publications, preprints, and registered clinical trials on the COVID-19 pandemic
Silvia Gianola, Tiago S. Jesus, Silvia Bargeri, Greta Castellini
Research Article | published 06 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240123

PLoS One
http://www.plosone.org/

COVID-SCORE: A global survey to assess public perceptions of government responses to COVID-19 (COVID-SCORE-10)
Jeffrey V. Lazarus, Scott Ratzan, Adam Palayew, Francesco C. Billari, Agnes Binagwaho, Spencer Kimball, Heidi J. Larson, Alessia Melegaro, Kenneth Rabin, Trenton M. White, Ayman El-Mohandes
Research Article | published 06 Oct 2020 PLOS ONE
https://doi.org/10.1371/journal.pone.0240011

PLoS Pathogens
http://journals.plos.org/plospathogens/
[Accessed 10 Oct 2020]

Review
Preparedness needs research: How fundamental science and international collaboration accelerated the response to COVID-19
Cormac M. Kinsella, Pauline Dianne Santos, Ignacio Postigo-Hidalgo, Alba Folgueiras-González, Tim Casper Passchier, Kevin P. Szillat, Joyce Odeke Akello, Beatriz Álvarez-Rodríguez, Joan Martí-Carreras
| published 09 Oct 2020 PLOS Pathogens
https://doi.org/10.1371/journal.ppat.1008902
Abstract
The first cluster of patients suffering from coronavirus disease 2019 (COVID-19) was identified on December 21, 2019, and as of July 29, 2020, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections have been linked with 664,333 deaths and number at least 16,932,996 worldwide. Unprecedented in global societal impact, the COVID-19 pandemic has tested local, national, and international preparedness for viral outbreaks to the limits. Just as it will be vital to identify missed opportunities and improve contingency planning for future outbreaks, we must also highlight key successes and build on them. Concomitant to the emergence of a novel viral disease, there is a ‘research and development gap’ that poses a threat to the overall pace and quality of outbreak response during its most crucial early phase. Here, we outline key components of an adequate research response to novel viral outbreaks using the example of SARS-CoV-2. We highlight the exceptional recent progress made in fundamental science, resulting in the fastest scientific response to a major infectious disease outbreak or pandemic. We underline the vital role of the international research community, from the implementation of diagnostics and contact tracing procedures to the collective search for vaccines and antiviral therapies, sustained by unique information sharing efforts.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

6 Oct 2020
Seroprevalence of SARS-CoV-2 IgM and IgG antibodies in an asymptomatic population in Sergipe, Brazil
Original research | English |
Rojas-Cortés
Abstract
Objective.
To assess all the incidents of substandard, falsified and unregistered medicines in 2017 and 2018 in Latin America, determining the types of products affected, stages of the supply chain in which incidents were detected, quality deviations identified in tested samples, and regulatory measures taken by authorities.
Methods.
A comprehensive search of the websites of the Latin American national regulatory authorities was conducted, identifying all eligible incidents during 2017-2018. Standardized values were collected from each incident for pre-determined variables: country, year, type of incident, therapeutic group, supply chain, regulatory measures and laboratory data.
Results.
A total of 596 incidents in 13 countries were included (236 substandard, 239 falsified, 116 unregistered and 5 stolen). The therapeutic categories with the highest incidents were: anti-infectives, medicines for pain/palliative care, hormones/contraceptives, medicines for the respiratory tract, and medicines for mental/behavioural disorders. The most common places where incidents were detected were commercial establishments, pharmacies, health services and manufacturers. The most recurrent quality deviations were failure in parameters (appearance or physicochemical), incorrect labelling, different quantity of active pharmaceutical ingredient, presence of unknown particles, and microbiological contamination. The most frequent regulatory measures identified were alerts, withdrawals, seizures, and prohibition of marketing/distribution/use.
Conclusions.
In Latin America, substandard, falsified and unregistered medicines persist as a highly prevalent problem. An advanced degree of regulatory development in countries is associated with higher incident detection/reporting rates and a more comprehensive set of measures. The pharmaceutical supply chain is more vulnerable in its final node. Quality deviations identified in tested samples pose serious risks to public health.

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

6 Oct 2020
Financing of integrated health service networks
Opinion and analysis | Spanish |

Revista Panamericana de Salud Pública/Pan American Journal of Public Health (RPSP/PAJPH)
https://www.paho.org/journal/en

Latest articles
6 Oct 2020
Substandard, falsified and unregistered medicines in Latin America, 2017-2018
Original research | English |

Science
09 October 2020 Vol 370, Issue 6513
http://www.sciencemag.org/current.dtl

In Depth
A call to test new vaccines head to head, in monkeys
By Jon Cohen
Science09 Oct 2020 : 154-155
Proposed comparison study could clarify safety and which vaccines work best.
Summary
Primate researchers in the United States have banded together in a push for an ambitious monkey study that would do head-to-head comparisons of the leading COVID-19 vaccine candidates. Although 10 candidates are already undergoing large-scale tests in people, proponents of the monkey plan say those clinical trials may not deliver the comprehensive data needed to choose the safest and most effective vaccines. The comparison trial in monkeys, in contrast, could shed light in a matter of weeks on how the candidates stack up on measures including potential side effects, the strength of immune responses they trigger, and how well they protect against infection and disease.