Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 21 Nov 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 21 Nov 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 21 Nov 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 21 Nov 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 21 Nov 2020]
https://carb-x.org/
News
11.18.2020  |
CARB-X is funding Clarametyx Biosciences to develop an innovative immune-enabling antibody therapy targeting serious biofilm-associated infections
CARB-X is awarding up to US$2.42 million to Clarametyx Biosciences to develop a new treatment for serious bacterial biofilm infections, including those such as pneumonia caused by antibiotic-resistant ESKAPE pathogens and polymicrobial biofilms.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 21 Nov 2020]
http://cepi.net/
Latest News
CEPI creates new collaborative taskforce to assess impact of emerging viral strains on effectiveness of COVID-19 vaccines
8 November 2020, Oslo, Norway – To rapidly monitor the emergence of new COVID-19 viral strains and evaluate their impact on vaccine candidates in development, CEPI, the Coalition for Epidemic Preparedness Innovations, has today announced the launch of a first-of-its-kind collaboration with the GISAID Initiative, Public Health England (PHE) and the National Institute for Biological Standards and Control (NIBSC) to further strengthen real-time global tracking and testing of SARS-CoV-2 sequences– the virus behind COVID-19. The announcement follows recent attention to a mutant strain of the virus detected in mink and human populations in Denmark…
Dr. Richard Hatchett, Chief Executive Officer, CEPI: “This joint collaboration between CEPI, GISAID, Public Health England, and the National Institute for Biological Standards and Control, fills a key gap in the global outbreak response through acting as a mechanism to both monitor and test emerging viral strains and evaluate whether these circulating strains may impact COVID-19 vaccine development. Through this effort we can provide information to support continuing global efforts to develop effective COVID-19 vaccines and bring an end to this pandemic as quickly as possible.”

CEPI welcomes Moderna announcement of positive interim data from Phase III trial of COVID-19 vaccine candidate
16 Nov 2020

 

EDCTP [to 21 Nov 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
No new digest content identified.

 

Emory Vaccine Center [to 21 Nov 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 21 Nov 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Update on remdesivir – EMA will evaluate new data from Solidarity trial
Last updated: 20/11/2020
EMA is aware that the World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis…
EMA has requested the full Solidarity data from WHO and the marketing authorisation holder. Once the data are available, EMA will assess the evidence, together with other relevant data, to see if any changes are needed to the marketing authorisation of Veklury (remdesivir) in the EU…

 

 

News: HMA/EMA statement on approval of vaccines
Last updated: 20/11/2020
Development and deployment of safe and effective vaccines is seen as an essential element in the management and solution of the COVID-19 pandemic. There are no COVID-19 vaccines approved yet in the European Union, but due to the urgency posed by this health crisis, different mechanisms are in place to expedite the development of such vaccines in order to make them available as soon as possible while safeguarding the mandatory requirements of quality, safety and efficacy.
According to EU legislation (Regulation 726/2004) most COVID-19 vaccines fall under the scope of the centralised procedure since they are produced by biotechnological processes for which the centralised procedure is mandatory (as listed in Annex 1 to the Regulation). For other types of vaccines currently under development, such as those composed of whole-inactivated virus or live attenuated virus, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) network encourage marketing authorisation holders to submit their applications through the centralised procedure in order to ensure that those vaccines reach all Member States at the same time, with no unfair access in the Union. This is possible according to Article 3.2 of the above-mentioned Regulation:
“Any medicinal product not appearing in the Annex may be granted a marketing authorisation by the Union in accordance with the provisions of this Regulation, if:
(a) the medicinal product contains a new active substance which, on the date of entry into force of this Regulation, was not authorised in the Union; or
(b) the applicant shows that the medicinal product constitutes a significant therapeutic, scientific or technical innovation or that the granting of authorisation in accordance with this Regulation is in the interests of patients or animal health at Union level.”
In such a procedure, EMA’s Committee for Medicinal Products for Human Use (CHMP), which is composed of national experts, carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be authorised or not. This procedure, subsequently finalised by the European Commission’s decision, gives all EU Member States, as well as those in the European Economic Area, the possibility of access to thoroughly and effectively evaluated medicines at the same time and ensures centralised safety monitoring across their life cycle.
In accordance with predefined standards for quality, safety and effectiveness that adequately protect  EU patients and all people who receive medicines or vaccines, EMA in close cooperation with NCA experts in scientific committees, uses accelerated procedures to speed up the process. The goal is to deliver assessments of high-quality applications in the shortest possible timeframes while ensuring robust scientific opinions. Therefore, COVID-19 vaccine applications should be assessed via the centralised procedure and, in addition to the centralised procedure itself, EMA’s scientific advice mechanism should be used whenever necessary, to advise developers on the quality, safety and efficacy requirements that must be met to enter the European market.

 

 

News: EMA organises public meeting on COVID-19 vaccines
Last updated: 19/11/2020
EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring…
The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
The agenda of the event is available on the EMA website.

 

 

News: EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.).
The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies 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.
The Committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). Large-scale clinical trials involving several thousands of people are ongoing, and results are expected shortly. These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once submitted to the agency. All the available data on the safety of the vaccine as well as its pharmaceutical quality (such as its ingredients, the way it is produced, stability and storage conditions) will also be reviewed as they become available.
The rolling review will continue until enough evidence is available to support a formal marketing authorisation application

 

European Vaccine Initiative [to 21 Nov 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 21 Nov 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
November 20, 2020 – Coronavirus (COVID-19) Update: November 20, 2020
:: The FDA, yesterday, issued an EUA for the drug baricitinib (Olumiant), in combination with remdesivir (Veklury) for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
:: The FDA has updated a webpage, Vaccine Development – 101, to provide an overview of the vaccine development process.
:: In a new webpage, Emergency Use Authorization for Vaccines Explained, the FDA offers answers to questions about EUAs, in general, and more specifically, about EUA requests for a vaccine intended to prevent COVID-19.

November 20, 2020 – Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.
“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted.  While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible. A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”…

November 19, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

November 17, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

November 17, 2020 – Coronavirus (COVID-19) Update: November 17, 2020
:: Today, the FDA reaffirmed its commitment to transparency around the EUA process and shared updates on its plan to provide more information about the agency’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines, as part of our COVID-19 response

November 17, 2020 – COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response. We have already posted some scientific review documents, for instance for an EUA revocation as well as an EUA authorization, and we are committing to continuing to post these documents moving forward…

November 16, 2020 – Coronavirus (COVID-19) Update: November 16, 2020
:: Today, FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture the plasma consistent with the EUA.
:: The agency also today published a new webpage, A Closer Look at COVID-19 Diagnostic Testing, to provide health care providers and other public health professionals, including those who might purchase COVID-19 tests, more technical information and resources.

 

FDA – COVID-19 Vaccines [to 21 Nov 2020]
www.fda.gov/covid19vaccines
Upcoming Events
11/20/2020
Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

11/20/2020
The FDA published new information about the vaccine development and review process:
:: Vaccine Development 101
:: Emergency Use Authorization for Vaccines Explained
:: The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization (PDF-723KB)

11/19/2020
FDA and Vaccinate Your Family Talk COVID With Minority Community LeadersExternal Link Disclaimer
FDA leaders participate in a virtual meeting with racial and ethnic minority community members about FDA’s COVID-19 vaccine work.

11/17/2020
COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
Statement reaffirming FDA’s commitment to transparency around the EUA process and updates on FDA’s plan to provide more information about decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.

 

Fondation Merieux [to 21 Nov 2020]
http://www.fondation-merieux.org/
News, Events
Mérieux Foundation co-organized event
7th Meeting of the GTFCC Working Group on Oral Cholera Vaccine Webinars
November 19 – December 10, 2020 – Webinars

 

Gavi [to 21 Nov 2020]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 21 Nov 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 21 Nov 2020]
https://www.theglobalfund.org/en/news/
News
Opportunity for Evaluation of Selected Medicines
20 November 2020
The Global Fund, Stop TB Partnership Global Drug Facility and Unitaid are inviting manufacturers of antiretroviral (HIV/AIDS), antihepatitis B and C, antituberculosis and antimalarial medicines to submit an expression of interest to have their products evaluated by the Expert Review Panel for Pharmaceutical Products.

COVID-19 must transform the definition of global health security
19 November 2020
By Peter Sands, Executive Director
The recent announcements that multiple new coronavirus vaccines are showing strong results provide hope that life will eventually return to normal and the catastrophic death toll will end – good news we all desperately need right now.
But despite this truly astonishing scientific achievement, the stark reality is that the COVID-19 pandemic is getting worse, with accelerating infections, and a weekly death toll of around 50,000. Even if vaccines are approved quickly, they will not be available in large volumes in countries where the Global Fund invests until late 2021 at best. It is therefore vital that the progress on vaccines is not used to justify backing off from current efforts to contain the pandemic and mitigate its devastating consequences on health systems and economies worldwide. On the contrary, we need to step up the global response. We can now see the light at the end of the tunnel; let’s get there as fast as we can and minimize the damage on the way…

Lao PDR aims to achieve universal health coverage with new Global Fund, Government of Australia and World Bank investment
18 November 2020
The first co-financing investment under a new agreement between the Global Fund to Fight AIDS, Tuberculosis (TB) and Malaria, and the World Bank, will support the Government of the Lao People’s Democratic Republic’s goal of achieving universal health coverage by 2025.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 21 Nov 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 21 Nov 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 21 Nov 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
COVID-19 Vaccines: What’s Next?
Interview with Margaret Hamburg, M.D.
Former Commissioner, U.S. Food and Drug Administration
Margaret Hamburg is a former Commissioner of the U.S. Food and Drug Administration (FDA), having served in this post from 2009-2015. A physician-scientist and public health expert, she recently completed a term as Chair of the Board/President of the American Association for the Advancement of Science (AAAS). HVP Editor Kristen Jill Abboud recently spoke with Hamburg about the regulatory issues concerning the eventual licensure of COVID-19 vaccines. These issues are particularly relevant given recent reports that indicate vaccine candidates being developed by Pfizer/BioNTech and Moderna are highly effective.

An edited version of the conversation appears below.
What do you think about the potential risk of politics influencing the licensure of COVID-19 vaccines?
Developing a vaccine is a very big scientific challenge that requires enormous focus and attention on conducting the right studies, ensuring that they are sufficiently rigorous to determine safety and efficacy, and making sure that they are designed and structured ethically. Those issues are generally taken for granted, but in this highly charged political environment there have been concerns raised about the chance that either there will be corners cut in the effort to accelerate vaccine development, or that political pressure will lead regulators to make decisions without adequate and complete information. In my view, it is essential that all of the stakeholders come together to support a robust vaccine research and development process, and I think that has been happening. I have enormous confidence and faith in the FDA and in the teams of scientists and experts that are reviewing these candidate vaccines. We need to have COVID-19 vaccines, preferably more than one, and we need them to be safe and effective. But we also need people to have trust and confidence in those vaccines. If they don’t trust these new vaccines, they won’t take them and then they will not serve their intended purpose to help manage, control, and ultimately end this devastating pandemic.

Pfizer/BioNTech and Moderna have both reported that their vaccine candidates are 95% effective against COVID-19. Was this surprising? Do you anticipate that COVID-19 vaccines will far exceed the U.S. FDA’s minimum efficacy level of 50%?

This was very encouraging news. We are all eager to see more data, but these announcements suggest that these vaccines will meet criteria for authorization and their administration in priority, high-risk populations may begin soon. The data also suggest that the SARS-CoV-2 Spike protein is an appropriate vaccine target, and this bodes well for many of the other vaccine candidates in development that are using different approaches, but are using the Spike protein as the antigen.

Many vaccines are not as effective as we would ideally want them to be. The FDA was thinking about COVID-19 vaccines with regard to the experience with influenza vaccines, which range from 40-70% efficacy. The FDA guidance indicated a 50% efficacy as the minimum threshold for authorization/approval, so these results are coming in dramatically higher than initially expected for this respiratory virus.

 

 

Do you suspect these trials will be sufficient to determine the efficacy of COVID-19 vaccines in specific subpopulations such as the elderly?
Determining efficacy across all relevant populations is a problem for vaccine studies, but we are noticing it more acutely now because there is a very wide range of individuals that will ultimately need to be vaccinated against COVID-19. There has been an effort from the beginning to include elderly individuals in the vaccine studies because we know they are a very important target group because of their elevated risk. Other high-risk groups have been included in the vaccine studies as well, including those with comorbidities, but there will probably need to be expanded studies in some key subpopulations as well. One critical group will be pregnant women, who have not been recruited in a targeted way in the ongoing studies. Another important group is children and youth. A couple of the studies, most notably Pfizer/BioNTech’s, have lowered the age cutoff down to include age 12 and up, but we are going to have to do additional work to understand safety and efficacy, as well as appropriate dosing and immunization schedules in younger children, who may not be at the greatest risk of life-threatening disease, but are certainly important in the dynamics of disease transmission. We will want to have COVID vaccines for all of these population groups, and this will require bridging studies to further flesh-out appropriate use of these vaccines in populations that either weren’t included or a large part of the initial studies.

It will be important to have ongoing oversight of vaccines, even as they move out of the research context and into broader use, because we always want to monitor for emerging safety concerns and deepen our understanding of efficacy. It will be particularly important that we learn more about the duration of protection and determine if certain vaccines work better in specific subpopulations. We will learn much more about that over time and with expanded use as we go from controlled studies of tens of thousands of people, to millions, or even billions of people receiving vaccines worldwide.

If the first candidate vaccines are found to be effective, will all future vaccine candidates need to be compared to those in head-to-head trials for them to receive licensure?
That is a hugely important question and one that is being debated as we speak. It is unusual to be developing and testing so many different vaccines for the same disease at one time. The good news is that there are lot of potential COVID-19 vaccines, but this does make the testing scenarios much more complicated, both scientifically and ethically. Some of the best scientific minds and most qualified vaccine researchers are discussing these issues and it will be critically important that a clear strategy is developed. For now, it is still very much under discussion.

 

 

As data from efficacy trials continues to emerge, what are some of the most pressing issues facing regulators?
One of the critical regulatory issues is whether COVID-19 vaccines will receive an Emergency Use Authorization (EUA) or a full approval. I think it’s pretty safe to say that the first candidate vaccines will most likely be authorized using an EUA and that their use will be targeted to a well-defined set of priority groups for vaccination. The EUA allows more flexibility to move a vaccine out in the context of a massive public health crisis. The process of getting a full licensure is a longer one with more specific data and administrative aspects. My guess is that companies that seek an initial EUA will move quickly to a full licensure application, but that the FDA might ask them to collect additional information before full licensure is granted.

One of the regulatory issues related to actually moving vaccines out into larger and larger populations involves the continued need for “pharmacovigilance” as touched on earlier, which is the ongoing monitoring/oversight to detect any emerging safety concerns and to learn more about levels of efficacy and duration across various subpopulations. Another key regulatory focus will concern vaccine scale up and manufacturing. There has been a great deal of attention paid to this early in the development process of COVID-19 vaccines, which is atypical. Because of the urgency of this situation, decisions were made to “manufacture at risk” before the candidate vaccines are authorized or approved. That will significantly speed the ability to get the vaccine out to people who need it, but there will still be a need for robust regulatory oversight of the scale up and manufacturing process to compare different lots of vaccine as it gets manufactured in larger and larger volumes.

From the beginning of this crisis, regulators around the world have tried very hard to work together and I think have done so in important ways, including collaborative activities to look at the science of developing COVID vaccines and accelerating both the research and development efforts and the regulatory process for reviewing these candidates globally.

 

 

What other issues do you think we will face as vaccines become available?
One of the important issues is understanding what having a vaccine will mean. Early on, vaccines will be a huge step forward, but we will still need to follow many of the non-pharmaceutical public health interventions we have come to know so well—wearing masks, social distancing, washing hands, and avoiding large groups. We have to realize that even though there has been a huge push to scale up the manufacturing of vaccines even before authorization or approval, there are still going to be limited quantities in the beginning, and so it could be a while until everyone who wants the vaccines are going to be able to get them. Many of the vaccines that may be available early on are going to require two doses so that limits the supply, and also means it will take longer until you
reach your desired level of protection.

Vaccines differ, and some may reduce the seriousness of the symptoms of disease or the length of the course of disease, but they may not always prevent infection per se, so people can still get sick. And if you can get sick, most likely you can still transmit the virus, so we’re going to have to be mindful of all of that as we move into a world where vaccines are available.

We need to be careful not to convey the message that vaccines are going to be the magic bullet that will turn the COVID crisis around overnight and we can go right back to our normal lives. On the other hand, we need to work much more aggressively to help the public understand why vaccines matter and to encourage use of the vaccines once they are available. It’s been distressing to see the decreasing number of people who are expressing the conviction that they will take the vaccine. We have to ensure that the right message about the safety and efficacy of the vaccines is getting out so that people trust the vaccines. That message shouldn’t just come from the government or companies. We also need to engage a network of communities—and trusted community leaders—to do outreach to help people understand the use of these vaccines and their potential benefits in a way that is meaningful to them. The great tragedy will be if we have vaccines that work and are safe and nobody wants to take them.

Interview by Kristen Jill Abboud

 

IAVI [to 21 Nov 2020]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
No new digest content identified.

 

 

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
IGBA Launches First Global Biosimilars Week (November 2020)
Geneva, November 16, 2020 – Today the International Generic and Biosimilar Medicines Association (IGBA) launched the first ever Global Biosimilars Week, which is aimed at raising the awareness of biosimilar medicines worldwide through a globally aligned educational initiative.

 

 

IFFIm
http://www.iffim.org/
Press Releases/Announcements
The Innovative Humanitarian Financing Forum to develop collaboration with WEF
19 Nov 2020
The Innovative Humanitarian Financing Forum (IHFF), founded by leaders from IFFIm’s Board and the British Red Cross, convened online on 4 November 2020, bringing to the table 33 people from 17 organisations, both returning and new participants, to explore ways to catalyse humanitarian investing initiatives.

 

IFRC [to 21 Nov 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Austria, Europe, Germany, Greece, Italy, Malta, Portugal, Spain
Red Cross expands COVID-19 testing in seven countries with €35.5 million EU support
Budapest/Geneva, 19 November 2020 – As Europe continues to experience a surge in coronavirus cases and deaths, the Red Cross will scale up COVID-19 testing with the announcement of a €35.5 million European Commission partnership. The International Fede …
19 November 2020

Democratic Republic of the Congo
DR Congo: The latest Ebola outbreak is over, but major challenges remain
Goma/Kinshasa/Nairobi/Geneva, 18 November 2020 – The International Federation of Red Cross and Red Crescent Societies (IFRC) joins the people of the Democratic Republic of the Congo (DRC) in celebrating the end of the country’s 11th Ebola outbreak. Thi …
18 November 2020

Global
Climate change: New report shows global response is failing people in greatest need
IFRC’s World Disasters Report 2020: Come Heat or High Water shows that the countries most affected by climate-related disasters receive only a fraction of the funding that is available for climate change adaptation and thus struggle to protect people from the aggravating effects of climate change.
17 November 2020

Asia Pacific, Philippines
Catastrophic floods submerge whole towns in Philippines
Kuala Lumpur/Manila/Geneva, 15 November 2020 – Catastrophic floods have completely submerged entire towns and villages in the northern region of the Philippines, forcing tens of thousands of people from their homes just days after Typhoon Vamco tore th …
15 November 2020

Asia Pacific, Vietnam
Millions brace for dangerous floods as severe storm hits Viet Nam
Kuala Lumpur/Hanoi/Geneva, 14 November 2020 – Millions of people in Viet Nam are bracing themselves for further floods and landslides, as the thirteenth big storm of the year threatens the country’s hard-hit central provinces. Typhoon Vamco has caused …
14 November 2020

 

Institut Pasteur [to 21 Nov 2020]
https://www.pasteur.fr/en/press-area
Press documents
Press Info
16.11.2020
Operation and reliability of RT-PCR tests in the detection of SARS-CoV-2
The National Reference Center (CNR) for Respiratory Viruses at the Institut Pasteur specializes in viruses such as influenza and bronchiolitis in infants. As an expert center in France, the CNR is responsible for monitoring cases of respiratory infections and for epidemic surveillance. When a new virus emerges, like the novel coronavirus in China, the CNR’s task is to do everything it can to detect the novel pathogen.
In response to the crisis caused by COVID-19, as soon as the first cases began emerging at international level, and especially in Europe (in late January 2020), the CNR at the Institut Pasteur developed a diagnostic test to detect the SARS-CoV-2 virus (known at the time as 2019-nCoV) in suspected cases of infection…

 

IRC International Rescue Committee [to 21 Nov 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As Yemen teeters on the brink of famine, IRC urges G20 leaders to fulfil humanitarian commitments at Saudi Arabia summit
November 20, 2020

Press Release
As COVID-19 second waves threaten conflict-affected countries, IRC urges incoming Biden Administration to prioritize pandemic response in humanitarian contexts
November 16, 2020
New IRC report “Catalyzing the U.S. Response to COVID-19 in Humanitarian Settings” outlines failures in U.S. response and calls on Biden administration to commit at least $20 billion to address virus response abroad in first 100 days.

 

IVAC [to 21 Nov 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 21 Nov 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI, Vaccine Innovative Technology ALliance Korea (VITAL-Korea) to partner up for innovative vaccine research and development
11/17/2020
Aim to accelerate R&D and globalization of Korean vaccines to increase contributions to global health     The International Vaccine Institute (IVI) and the Vaccine Innovative Technology ALliance Korea (VITAL-Korea) agreed to join forces to promote vaccine research and development for global health.

 

JEE Alliance [to 21 Nov 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 21 Nov 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
“What Europe is experiencing today, is not a humanitarian crisis, b…
Speech 19 Nov 2020

Democratic Republic of Congo
MSF denounces ongoing violence in Salamabila
Statement 19 Nov 2020

DRC Ebola outbreaks
Improved medical response sees the end of DRC’s eleventh Ebola outbreak
Project Update 19 Nov 2020

Coronavirus COVID-19 pandemic
Governments must support landmark proposal to waive COV…
Press Release 19 Nov 2020
:: In October, India and South Africa proposed to waiver some intellectual property rights on coronavirus tools during the COVID-19 pandemic.
:: The landmark request would allow countries to choose not to grant nor enforce patents on COVID-19 drugs and vaccines.
:: MSF urges all countries to back the proposal, which is already supported by 99 countries, to allow COVID-19 tools to be more affordable and accessible.

Tuberculosis
Step up for TB report 2020
Report 16 Nov 2020

Tuberculosis
MSF calls on governments and donors to speed up TB testing …
Press Release 16 Nov 2020

 

National Vaccine Program Office – U.S. HHS [to 21 Nov 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 21 Nov 2020]
http://www.nih.gov/news-events/news-releases
News Releases
NIH expands research to improve COVID-19 testing among underserved and vulnerable populations
November 20, 2020 — Research designed to rapidly implement testing strategies in populations disproportionately affected by COVID-19.

Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine
November 16, 2020 — An interim review of trial data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults.

 

PATH [to 21 Nov 2020]
https://www.path.org/media-center/
Press Release
No new digest content identified.

 

Sabin Vaccine Institute [to 21 Nov 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 21 Nov 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
20 November 2020
UNAIDS joins partners to call for better testing, treatment and prevention of HIV and TB among children
On World Children’s Day, UNAIDS is joining with partners to call for accelerated access to better tools to prevent, diagnose and treat HIV in children and tuberculosis (TB) in children living with HIV with a joint statement announcing the launch of the Rome Action Plan 2020…
On 5 and 6 November, the Vatican’s Cardinal Turkson convened the virtual Rome Five meeting. This innovative dialogue brought together leaders from the private and public sectors, governments, regulatory authorities, faith-based and community-based organizations and other implementing partners to find solutions to reduce the burden of HIV and TB among children
The meeting resulted in a new Rome Action Plan 2020, a series of ambitious commitments made by participating organizations aimed at overcoming the bottlenecks to HIV and TB services for children. Among the many commitments made by the partner organizations, UNAIDS has committed to supporting governments to collect and report on the burden of HIV and TB among children so that national responses can be targeted to where they are most needed. UNAIDS will set and report on ambitious age-specific global targets for the prevention, testing and successful treatment of HIV in children and TB in children living with HIV. UNAIDS will continue to advocate at the highest political level for increased investment and committed actions at the country level so that the world can get on track to ending AIDS and TB among children living with HIV.

16 November 2020
New faith-based initiative launched in Côte d’Ivoire

16 November 2020
HIV financing gap widening
The funding gap for HIV responses is widening. Momentum established following global agreement on the Millennium Development Goals in 2000 has been lost in the Sustainable Development Goal era. Increases in resources for HIV responses in low- and middle-income countries halted in 2017, with funding decreasing by 7% between 2017 and 2019 (to US$ 18.6 billion in constant 2016 United States dollars).
The total funding available in 2019 for HIV in these countries amounted to about 70% of the 2020 target set by the United Nations General Assembly…

 

UNICEF [to 21 Nov 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
11/20/2020
Presidents, Prime Ministers, UNICEF Goodwill Ambassadors and global businesses unite with children and young people on World Children’s Day

News note
11/20/2020
Geneva Palais briefing note on the situation of Ethiopian children fleeing into Sudan and UNICEF’s response

Statement
11/19/2020
2.3 million children in Tigray region of Ethiopia need humanitarian assistance, as thousands flee across border into Sudan
Statement by UNICEF Executive Director Henrietta Fore

Press release
11/19/2020
UNICEF appeals for US$42.6 million to deliver humanitarian assistance in hurricane-struck Central America

Press release
11/18/2020
UNICEF calls for averting a lost generation as COVID-19 threatens to cause irreversible harm to children’s education, nutrition and well-being
Children and adolescents account for 1 in 9 of reported COVID-19 infections, according to new analysis released ahead of World Children’s Day

Press release
11/18/2020
UNICEF welcomes end of Ebola outbreak in the Equateur Province of the DRC

 

Unitaid [to 21 Nov 2020]
https://unitaid.org/
Featured News
19 November 2020
Unitaid reaffirms its support to the Medicines Patent Pool, a key player for equitable access to life-saving medicines
Geneva – Through the approval of a new $34.3 million grant for the next five years to the Medicines Patent Pool (MPP), Unitaid has reinforced its historic commitment to equitable access to affordable, quality medicines for all.

Founded by Unitaid 10 years ago, MPP has established itself as a key player in global health through facilitating rapid access to medicines for people affected by HIV/AIDS, tuberculosis and hepatitis C in low- and middle-income countries (LMICs).

Since its inception, MPP’s work with pharmaceutical manufacturers and partners has contributed to supplying over 15 billion doses of quality generic treatments for HIV and hepatitis C in LMICs.

Over the past six years, as part of a coalition of partners including the World Health Organization (WHO), the Global Fund to Fight AIDS, Tuberculosis and Malaria, PEPFAR, Unitaid, and countries such as South Africa and civil society, MPP has facilitated the development, scale-up, and roll-out of dolutegravir (DTG) and the DTG combination regimen TLD (tenofovir/lamivudine/dolutegravir). TLD is a more efficient fixed-dose combination that contributes to decreasing the pill burden and increasing adherence to treatment for people living with HIV.

Joint efforts have contributed to making these life-saving drugs available at historically low prices. Countries are now procuring DTG for less than US$ 70 per person, per year — bringing substantial savings that can be reinvested in other areas. Current annual savings are enough to procure treatment for an additional 5 million people every year.

The WHO recommends DTG-based treatment as the preferred first- and second-line regimen for people living with HIV. MPP has also contributed to the development and distribution of different pediatric formulations that are better suited to children, and has played a critical role in enabling affordable access to hepatitis C treatments in many LMICs.

This new grant, that covers the period 2021-2025, will enable MPP to further its work centered around negotiating voluntary licenses and expanding production capacities for HIV, tuberculosis and hepatitis C medicines in order to make them more widely available and affordable for those who need it. The project also includes extending MPP’s scope to long-acting therapeutics, working alongside all Unitaid-funded long-acting projects with the objective to bring simplified treatments to patients and increase adherence. A further area of work targets voluntary licensing of patented medicines on the WHO Model List of Essential Medicines…

17 November 2020
Unitaid supports the WHO’s cervical cancer elimination strategy launch
Geneva – Unitaid is delighted to give its support to today’s launch of the WHO’s Global Strategy to Accelerate the Elimination of Cervical Cancer – the first time the world has ever committed to eliminating a cancer…

Unitaid is now the largest funder of innovative tools to find and treat precancerous lesions in women living in low-resource settings. These investments have laid a firm foundation for the elimination strategy, and Unitaid remains on-target to reach one million women within three years, with an estimated 100,000 additional lives saved over eight years.

Our partnerships with CHAI, Expertise France, Jhpiego and UICC focus on introducing innovation and making it accessible and affordable. Many of the successful techniques for reducing cervical cancer in high-income countries are difficult to transfer over to low-and-middle income countries, so Unitaid’s fresh and targeted approach has transformational potential.
We have already made significant progress towards our ambitious goal of delivering screening and treatment for less than US$1 per woman. Thermal Ablation devices are now available for less than US$900, representing an average price reduction of 50%…

 

Vaccination Acceptance Research Network (VARN) [to 21 Nov 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 21 Nov 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 21 Nov 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
News
Experts Issue Recommendations for Equitable Distribution of COVID-19 Vaccine
–CHOP-led paper outlines five principles that would allow for equity, transparency, accountability, availability and access–
PHILADELPHIA, Nov. 19, 2020 /PRNewswire/ — A group of vaccine experts led by Children’s Hospital of Philadelphia (CHOP) has published recommendations to ensure equitable distribution of a COVID-19 vaccine when it becomes available. The framework, published today in Heath Affairs, focuses on five principles the authors believe would strengthen the current immunization delivery system to ensure equitable access to everyone for whom vaccination is recommended.

“It is critical for the federal government to set policy and provide coordinated guidance and resources to states and localities for meaningful, rapid implementation of a vaccine strategy, so that areas may begin immunizing prioritized populations as soon as they receive vaccine doses,” said lead author Angela K. Shen, ScD, MPH, a visiting research scientist at CHOP’s Vaccine Education Center.

The paper outlines five main principles by which policymakers can implement an equitable COVID-19 vaccine distribution strategy:
[1] Recruit diverse populations to participate in clinical trials for a COVID-19 vaccine to ensure the data reflect the racial, ethnic, age and gender diversity of the US.
[2] Require transparency when it comes to reviewing safety and efficacy data, with approval discussions taking place in the public eye, particularly in the event of an Emergency Use Authorization.
[3] Follow guidance from the Advisory Committee on Immunization Practices (ACIP) and the National Academy of Sciences, Engineering, and Medicine (NASEM) working groups as they identify priority groups and develop recommendations for vaccinating the civilian population.
[4] Ensure access to vaccinations for all individuals, regardless of their ability to pay.
[5] Engage state-level task forces and working groups in discussions about how to distribute vaccines effectively to recommended populations, with a focus on communication strategies and ensuring proper representation of minority voices.

 

Health Affairs Ahead of Print
Analysis
Ensuring Equitable Access To COVID-19 Vaccines In The US: Current System Challenges And Opportunities
Angela K. Shen, Richard Hughes IV, Erica DeWald, Sara Rosenbaum, Amy Pisani, and Walt Orenstein
PUBLISHED:November 19, 2020 Free Accesshttps://doi.org/10.1377/hlthaff.2020.01554
Abstract
There has been a worldwide effort to accelerate the development of safe and effective severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines. When vaccines become licensed and available broadly to the public, the final hurdle is equitable distribution and access for all who are recommended for vaccination. Frameworks and existing systems for allocation, distribution, vaccination, and monitoring for safety and effectiveness are assets of the current immunization delivery system that should be leveraged to ensure equitable distribution and broad uptake of licensed vaccines. The system should be strengthened where possible to address gaps in access to immunization services and to modernize the public health infrastructure. We offer five recommendations as guideposts to ensure that policies and practices at the federal, state, local and tribal levels support equity, transparency, accountability, availability and access to coronavirus disease 2019 (COVID-19) vaccines. [Editor’s Note: This Fast Track Ahead Of Print article is the accepted version of the peer-reviewed manuscript. The final edited version will appear in an upcoming issue of Health Affairs.]

 

Wellcome Trust [to 21 Nov 2020]
https://wellcome.ac.uk/news
Opinion | 20 November 2020
Four reasons why we need multiple vaccines for Covid-19
Charlie Weller, Head of Vaccines Programme, Wellcome
Having a range of Covid-19 vaccines available for people to use around the world will be essential to bringing the pandemic under control. Here’s why.

Explainer | 19 November 2020
Seven vital questions about the RNA Covid-19 vaccines emerging from clinical trials
Preliminary data from phase III clinical trials has shown the Pfizer-BioNTech and Moderna Covid-19 vaccines to be more than 90% effective. They are the first vaccine candidates to produce such positive results, and this is great news.
These vaccines, unlike the vaccines we already use for other diseases, have been developed using ribonucleic acid (RNA) technology. So, how do they work, are they safe, and when will they be available?

Opinion | 16 November 2020
Drug-resistant infections: what we’re doing now to tackle this slow-moving pandemic
Tim Jinks, Head of Drug-resistant Infections Programme, Wellcome
To stop life-threatening infections from escalating, the world must control the spread of drug-resistant infections. Tim Jinks explains Wellcome’s role in the global response to antimicrobial resistance.

 

The Wistar Institute [to 21 Nov 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 21 Nov 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 21 Nov 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
20/11/20
World leaders join forces to fight the accelerating crisis of antimicrobial resistance

 

 

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ARM [Alliance for Regenerative Medicine] [to 21 Nov 2020]
https://alliancerm.org/press-releases/
Press Releases
ARM Statement on the Trump Administration’s Interim Final Rule on Drug Pricing
November 20, 2020 Washington, DC
Cell, gene, and tissue-based therapies are the future of medicine, with the potential to durably treat or even cure the most challenging diseases. The administration’s ‘Most Favored Nation’ Interim Final Rule could threaten innovation in regenerative medicine. If the administration is concerned about clinical outcomes and high expenditures, policymakers should embrace innovative payment models, including outcomes-based agreements that reward scientific investment when therapies work and patients’ conditions improve.

 

BIO [to 21 Nov 2020]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. McMurry-Heath Calls Foreign Price Controls a “Fatally Flawed Regulation” That Will “Endanger Our Most Vulnerable Americans”
Washington, DC (November 20, 2020) – Dr. Michelle McMurry-Heath, president and CEO of the Biotechnology Innovation Organization (BIO), issued the following statement after the Trump administration moved forward with its threat to impose…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 21 Nov 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 21 Nov 2020]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 21 Nov 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Biopharmaceutical representative joins new antibiotic resistance fighting United Nations group to avert looming superbugs public
20 November 2020

Joint Statement On World Antimicrobial Awareness Week
18 November 2020

 

PhRMA [to 21 Nov 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
PhRMA Announces First-Ever, Industry-Wide Principles on Clinical Trial Diversity
WASHINGTON, D.C. (November 17, 2020) – Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced first-ever, industry-wide principles on clinical trial diversity. The principles focus on four main areas: building trust and acknowledging the historic mistrust of clinical trials within Black and Brown communities, reducing barriers to clinical trial access, using real-world data to enhance information on diverse populations beyond product approval and enhancing information about diversity and inclusion in clinical trial participation. These principles were approved by the PhRMA Board of Directors and will take effect in April of 2021.

“The industry’s new clinical trial diversity principles are an important step toward greater health equity,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “We are addressing issues of mistrust and working to reduce systemic issues that deter communities of color from participating in clinical trials, so that those patients who want to participate, can.”
America’s biopharmaceutical companies are committed to learning and leading forward to address systematic racism and stand up to injustice. At the core of this effort is the need for our industry to better serve historically underserved communities, including Black and Brown communities.

Critical to health equity for these communities is clinical trial diversity that better reflects intended treatment populations for different medicines and therapeutics. With the voluntary adoption of these industry-wide principles by PhRMA member companies, we are pledging to work on addressing the systemic issues that deter people from participating in clinical trials.

To view the principles, please visit: https://www.phrma.org/en/Codes-and-guidelines/PhRMA-Principles-on-Conduct-of-Clinical-Trials