Organization Announcements

Organization Announcements

 

Paul G. Allen Frontiers Group [to 30 Jan 2021]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 30 Jan 2021]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.

 

BMGF – Gates Foundation [to 30 Jan 2021]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 30 Jan 2021]
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 30 Jan 2021]
https://carb-x.org/
News
01.27.2021
CARB-X is funding Seattle-based Lumen Bioscience to develop a new oral monoclonal antibody cocktail to prevent serious diarrheal diseases
CARB-X is awarding up to US$5.35 million to Lumen Bioscience, in Seattle, WA, USA, to develop a new immunotherapy to prevent diarrheal diseases caused by two deadly pathogens, Campylobacter jejuni and enterotoxigenic E. coli.

 

Center for Vaccine Ethics and Policy – GE2P2 Global Foundation [to 30 Jan 2021]
https://centerforvaccineethicsandpolicy.net/
News/Analysis/Statements
No new digest content identified.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 30 Jan 2021]
http://cepi.net/
Latest News
29 Jan 2021
CEPI statement on EMA recommending authorisation of Oxford/AstraZeneca COVID-19 vaccine in the EU
“ Statement from Dr. Melanie Saville, Director of Vaccine R&D, CEPI: We welcome today’s (29 Jan) announcement that the European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for the University of Oxford/AstraZeneca COVID-19 vaccine. The EMA has determined that the vaccine is safe and effective in adults over the age of 18 and as such this is an important milestone for vaccination efforts in Europe and beyond.
“With several approved vaccines now available, and more showing encouraging late-stage trial results, the world is in a stronger position to push back against COVID-19. The Oxford/AstraZeneca COVID-19 vaccine can play a crucial role in the world’s response to this pandemic. The evidence of its efficacy is robust, and it has been shown to prevent serious illness and death, which is a priority at this stage in the pandemic. In addition, it is inexpensive to produce, and can be stored at 2-8 degrees Celsius – characteristics that will enhance access and make global distribution easier, especially in low-income and middle-income countries. AstraZeneca’s commitment to sell their vaccine at no profit is also testament to their commitment to ensuring the whole world benefits from these scientific advancements…”

29 Jan 2021
CEPI statement on Novavax’s COVID-19 vaccine Phase III Efficacy Data
CEPI has to date provided up to US $388 million in funding to accelerate the development and manufacture of Novavax’s COVID-19 vaccine candidate.
“Statement from Dr. Richard Hatchett, CEO of CEPI: It is extremely encouraging that the Novavax, NVX-CoV2373, protein-based COVID-19 vaccine candidate has demonstrated 89.3% efficacy in a Phase 3 UK trial and shows good efficacy against the newly identified variant B.1.1.7. The data from South Africa showing lower efficacy of this highly effective vaccine against B.1.351 is the first direct data to confirm the ability of this variant to partially evade our vaccines.  It is good to hear that Novavax has moved so quickly to initiate development of new constructs against the emerging strains to identify candidates for booster or bivalent vaccines.
“I want to congratulate our Novavax partners on the outstanding results in the UK trial.  NVX-CoV2373 will play a significant role in the global struggle against COVID-19…

28 Jan 2021
CEPI funding call launches to rapidly generate additional clinical research on COVID-19 vaccines
:: Launched today, the new CEPI Call will provide up to US $140 million in funding to vaccine developers and other research institutions for rapid complementary clinical data on COVID-19 vaccines.
:: Deliberately kept broad in scope, examples of scientific programmes to be supported through the Call include clinical trials in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, ‘mix and match’ strategies, and dosing intervals.
:: Purpose of Call is to fill in current clinical research and development gaps to expand access to COVID-19 vaccines.
:: As part of their proposal, applicants must show plans to increase equitable access to COVID-19 vaccine being assessed.

Duke Global Health Innovation Center [to 30 Jan 2021]
https://dukeghic.org/
Launch and Scale Speedometer
No new analysis identified.

 

EDCTP [to 30 Jan 2021]
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
No new digest content identified.

 

Emory Vaccine Center [to 30 Jan 2021]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Commission [to 30 Jan 2021]
http://europa.eu/rapid/search-result.htm?query=18&locale=en&page=1
Statement 29 January 2021
Commission statement on the vaccine export authorisation scheme
To tackle the current lack of transparency of vaccine exports outside the EU, the Commission is putting in place a measure requiring that such exports are subject to an authorisation by Member States.
In the process of finalisation of this measure, the Commission will ensure that the Ireland / Northern Ireland Protocol is unaffected. The Commission is not triggering the safeguard clause.
Should transits of vaccines and active substances toward third countries be abused to circumvent the effects of the authorisation system, the EU will consider using all the instruments at its disposal.
In the process of finalising the document, the Commission will also be fine-tuning the decision-making process under the implementing regulation…

Questions and answers 29 January 2021
Questions and Answers: Transparency and authorisation mechanism for exports of COVID-19 vaccines
The objective of this measure is to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU.

Press release 29 January 2021
European Commission authorises third safe and effective vaccine against COVID-19
Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID19 vaccine developed by AstraZeneca, the third COVID-19 vaccine authorised in the EU.

 

European Medicines Agency [to 30 Jan 2021]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU (updated)
Last updated: 29/01/2021
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation.

EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.

The safety of the vaccine has been demonstrated across the four studies. However, the Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.

These showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (64 of 5,258 got COVID-19 with symptoms) compared with people given control injections (154 of 5,210 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-29 January 2021
CHMP, Last updated: 29/01/2021
… The Committee recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca (COVID-19 Vaccine (ChAdOx1-S [recombinant])) to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation. For more information, see the press release in the grid below….

 

 

News: First COVID-19 vaccine safety update published
Last updated: 29/01/2021
Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified.
The safety update reflects data collected and assessed since Comirnaty’s authorisation, including data from EudraVigilance (the EU’s centralised database of suspected side effects) and data received from other sources, including the company’s monthly safety report required for COVID-19 vaccines. EMA will publish monthly safety updates for all authorised COVID-19 vaccines, in line with exceptional transparency measures for COVID-19…

 

 

News: Clarification of Comirnaty dosage interval
Last updated: 28/01/2021
EMA’s human medicines committee (CHMP) has updated the product information for the COVID-19 vaccine Comirnaty to clarify its position on the interval between the first and second dose.
The product information (section 4.2 and package leaflet) now recommends the administration of the second dose 3 weeks after the first dose. Previously, the product information stated that the interval should be “at least 21 days”.
The product information (section 5.1) already states that the participants whose data was used to calculate efficacy received their second dose within 19 to 42 days after their first dose. A sentence has been added with the information that 93.1% of these participants received the second dose 19 to 23 days after the first dose.
There are currently no clinical data on the efficacy of the vaccine when administered beyond intervals used in the clinical trial.
Full information for patients and healthcare professionals is available in the updated product information

 

European Vaccine Initiative [to 30 Jan 2021]
http://www.euvaccine.eu/
Latest News
EVI
World NTD day 2021
Every year on January 30th, the global health and development community comes together to acknowledge World Neglected Tropical Disease (N…

EVI
New report finds PDPs serving neglected communities produced

 

FDA [to 30 Jan 2021]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
January 29, 2021 – Coronavirus (COVID-19) Update: January 29, 2021
:: This week, the FDA added a new frequently asked question (FAQ), “Can the FDA help me get a COVID-19 vaccine,” to our COVID-19 FAQs, under the vaccine section. The answer is no. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the United States. The FDA is not responsible for vaccine distribution. Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam…

January 26, 2021 – Coronavirus (COVID-19) Update: January 26, 2021

 

FDA – COVID-19 Vaccines [to 30 Jan 2021]
www.fda.gov/covid19vaccines
News and Updates; Upcoming Events
No new digest content identified.

 

Fondation Merieux [to 30 Jan 2021]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 30 Jan 2021]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 30 Jan 2021]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 212 with the aim of developing new tools to tackle infectious diseases that
Press Releases
No new digest content identified.

 

Global Fund [to 30 Jan 2021]
https://www.theglobalfund.org/en/news/
News
COVID-19 Situation Report
28 January 2021
Our COVID-19 Situation Reports bring together news about the Global Fund partnership’s response to the pandemic. We publish a new issue when there are developments. The latest issue is available below.
Situation Report – 28 January 2021 download in English

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 30 Jan 2021]
https://www.glopid-r.org/news/
News
GloPID-R observer, CEPI, seeks senior scientific and global health experts for its Scientific Advisory Committee
28/01/2021
GloPID-R observer, CEPI, has launched a call for applications to join its Scientific Advisory Committee (SAC). The CEPI SAC provides…

The work carried out by GloPID-R, its members and partners and the lessons learnt in the response to the COVID-19 pandemic have been featured in three articles published in leading journals
26/01/2021
‘Coordinating research on pandemic preparedness and rapid response’ by GloPID-R Chair, Charu Kaushic and Geneviève Boily-Larouche, CIHR Institute of Infection…

 

Hilleman Laboratories [to 30 Jan 2021]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 30 Jan 2021]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 30 Jan 2021]
https://www.iavi.org/newsroom
PRESS RELEASES/FEATURES
January 26, 2021
IAVI Sees Hope in Findings of Antibody-Mediated Prevention Study
Results illuminate potential way forward for use of broadly neutralizing antibodies to prevent HIV
IAVI congratulates the U.S. National Institutes of Health (NIH) and the HIV Vaccines Trial Network (HVTN) on the successful conduct of the Antibody-Mediated Prevention (AMP) study and commends the contributions the trial participants made toward answering essential scientific questions…

January 21, 2021
TB vaccine candidate being investigated to prevent TB infection in infants in Phase III priMe study
Study sites are in five African countries with high TB and HIV burden.

 

 

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
Press Releases/Announcements
No new digest content identified.

 

 

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

 

IFRC [to 30 Jan 2021]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Africa, Djibouti, Ethiopia, Sudan
The International Red Cross and Red Crescent Movement scales up its humanitarian response to meet urgent needs in Ethiopia, Sudan and Djibouti
Geneva/Nairobi, 28 January 2021 –  The International Committee of the Red Cross (ICRC) is appealing to donors for 20 million Swiss francs to urgently expand its response to the acute humanitarian needs created by the Tigray crisis in Ethiopia, while th …
28 January 2021

Global
IFRC announces expansion of disaster fund ahead of major climate summit
Geneva, 25 January 2021 – The International Federation of Red Cross and Red Crescent Societies (IFRC) announced today a major expansion of one of the world’s only means of channeling international funds directly to frontline disaster responders. The an …
25 January 2021

 

Institut Pasteur [to 30 Jan 2021]
https://www.pasteur.fr/en/press-area
Press release 25.01.2021
COVID-19: progress update on the Institut Pasteur’s scientific response and vaccine candidate research programs
Since early 2020, the Institut Pasteur has been engaged in research in several of its areas of scientific expertise, including virology, diagnostics, pathophysiology, epidemiology, modeling, therapeutic research and vaccine research. A number of research programs to find a vaccine for SARS-CoV-2, the virus responsible for the COVID-19 epidemic, are under way. In light of the intermediate results of its Phase I clinical trial, the Institut Pasteur is stopping development of one of its vaccine candidates, the vaccine based on the measles vaccine virus. The Institut Pasteur will continue to pursue the development of other vaccine candidates which have reached preclinical phase, alongside its concerted scientific efforts to tackle the COVID-19 epidemic.

 

IRC International Rescue Committee [to 30 Jan 2021]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As more contagious COVID-19 variants threaten the world’s most vulnerable, the IRC calls for equitable vaccine distribution
January 29, 2021
“…With billions of people not anticipated to receive a COVID-19 vaccine this year, we continue to urge high-income countries to increase their investments to both the COVAX facility and broader humanitarian assistance that remains every bit as essential, especially given the severity of COVID-19’s secondary impacts. This includes ensuring that refugees and internally displaced people are included in vaccination campaigns…”

Press Release
The IKEA Foundation awards €30 million grant to the International Rescue Committee to support livelihoods development for urban refugees in East Africa
January 28, 2021

 

IVAC [to 30 Jan 2021]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
Webinar: Social Media Interventions and Vaccine Hesitancy
Register: The International Vaccine Access Center (IVAC) on February 9, 2021 at 1:00pm ET will host a 60-minute webinar, “Social Media Interventions and Vaccine Hesitancy.”
Description: Join us for a webinar presentation about how misinformation spreads over social media platforms and creates vaccine hesitancy. The public’s trust in vaccine safety and effectiveness are key to maintaining immunization coverage and protecting at-risk populations from preventable diseases. Immunization and communications experts will discuss what action is needed to prevent anti-vaccine efforts from spreading over social media networks, and what challenges the infodemic poses to public health efforts internationally.
Register here

 

IVI [to 30 Jan 2021]
http://www.ivi.int/
Selected IVI News, Announcements, Events
COVID-19 and NTDs: from setbacks to a new way forward
by Raphaël Zellweger and Aerie Em
… Rising global COVID-19 cases have remarkably coincided with a reduction in other respiratory and gastrointestinal diseases. In Taiwan, for example, infection rates for influenza, pneumonia, enterovirus and scarlet fever were lower in 2020 compared to previous seasons [1]. It is reasonable to attribute this phenomenon to COVID-induced hygiene consciousness and behavioral changes such as handwashing, mask wearing and social distancing. Unsurprisingly, this reduction has not been observed for vector-borne diseases, as their mode of transmission and control typically differ from respiratory illnesses like the flu and COVID-19. For instance, several countries including Singapore, Peru, Brazil and Colombia suffered epidemics of dengue, a virus transmitted by mosquitoes, during the COVID-19 pandemic [2]…

GI-Cell, IVI sign MOU to develop next-generation COVID-19 vaccine
:: To cooperate in clinical development of COVID-19 vaccine candidate
:: GI-Cell aims to prioritize supplying to Korea and developing countries by developing a vaccine that accommodates mass supply, viral mutation response, safety, convenience of patients
January 26, 2021, SEOUL, Korea – GI-Cell, an affiliate of GI-Innovation, a biotechnology company for cell therapy development, signed a memorandum of understanding (MOU) with the International Vaccine Institute (IVI) to develop a COVID-19 vaccine candidate…
Currently, GI-Cell is developing a COVID-19 vaccine GIC-1114/1114m using GI-COV-VAX, its proprietary protein vaccine development platform. GIC-1114/1114m can not only generate neutralizing antibodies but also induce T-cell responses against SARS-CoV-2 that will hopefully provide better protection against future mutant COVID-19 viruses and is designed to significantly increase the duration of protection. A monkey experiment has confirmed that a single dose induces neutralizing antibody and T-cell responses, which is considered advantageous compared to other products in terms of public health benefit, convenience, side-effects and cost…

 

JEE Alliance [to 30 Jan 2021]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

Johns Hopkins Center for Health Security [to 30 Jan 2021]
https://www.centerforhealthsecurity.org/news/center-news/
Center News
New Algorithms Developed to Attribute Origins of Genetically Engineered DNA
altLabs and the Johns Hopkins Center for Health Security Announces Results of Genetic Engineering Attribution Challenge 2020
January 26, 2021 – Every day, genetic engineering techniques are used to solve critical challenges in agriculture, manufacturing, and medicine. However, as the power of genetic engineering increases, so too does the potential for serious negative consequences if the technology is misused. It is often difficult to trace the origins of a genetically engineered product, making it difficult to ensure its creators receive due credit or are held accountable. Better tools are needed to advance our collective ability to connect the products of genetic engineering to their designers—a process known as genetic engineering attribution—to support responsible development of biotechnology.

To advance genetic engineering attribution, altLabs sponsored in partnership with the Johns Hopkins Center for Health Security, the Johns Hopkins University Applied Physics Laboratory, and the iGEM Safety and Security Program the Genetic Engineering Attribution Challenge on the DrivenData competition platform, offering monetary prizes for algorithms that could accurately predict the origin of genetically engineered DNA sequences. More than 300 teams from around the world participated in the competition, and prizes were awarded to 6 winning teams. Given 10 guesses for each sequence, the best teams were able to predict the source lab of an unfamiliar plasmid DNA sequence almost 95% of the time—a marked improvement over the top published score of 85%. These results demonstrate the potential for new machine learning approaches to further improve existing tools and solve the challenges associated with genetic engineering attribution.

“Synthetic biology offers fantastic benefits for society, but its anonymity opens the door for reckless or malicious actors to cause serious harm,” said Will Bradshaw, Competition Director at altLabs. “By removing this anonymity, genetic engineering attribution promises to make everyone safer—while still promoting and rewarding innovation. Thanks to modern machine learning techniques, reliable attribution of real-world engineered sequences is now within reach—as demonstrated by the results of this competition. Given further investment, attribution technology like this could play a key role in the future of synthetic biology.”…

 

MSF/Médecins Sans Frontières [to 30 Jan 2021]
http://www.msf.org/
Latest [Selected Announcements]
Italy
Abandoned at the borders: stories of people on the move during winter
Voices from the Field 28 Jan 2021

Democratic Republic of Congo
South Kivu: An endless flight
Project Update 28 Jan 2021

Coronavirus COVID-19 pandemic
Malawi is overwhelmed by second wave of COVID-19
Interview 27 Jan 2021

Neglected diseases
No more neglected diseases, no more neglected patients
Press Release 27 Jan 2021

Central African Republic
Displaced people in Bouar living amid fear and growing needs
Project Update 26 Jan 2021

Neglected diseases
Overcoming neglect: Finding ways to manage and control NTDs
Report 26 Jan 2021

 

National Vaccine Program Office – U.S. HHS [to 30 Jan 2021]
https://www.hhs.gov/vaccines/about/index.html
Upcoming Meetings/Latest Updates
No new digest content identified.

 

NIH [to 30 Jan 2021]
http://www.nih.gov/news-events/news-releases
News Releases
Janssen Investigational COVID-19 Vaccine: Interim Analysis of Phase 3 Clinical Data Released
Single dose vaccine appears to be safe and effective at preventing moderate and severe COVID-19 in adults.
January 29, 2021 — An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21. The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.
The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66% effective at preventing the study’s combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant. Moderate COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus either one of the following: evidence of pneumonia; deep vein thrombosis; difficulty breathing; abnormal oxygen saturation or a respiratory rate equal to or greater than 20; or two or more signs or symptoms suggestive of COVID-19, such as cough, sore throat, fever or chills. Severe COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus evidence of clinical signs at rest indicative of severe systemic illness, respiratory failure, shock, significant organ dysfunction, hospital intensive care unit admission or death.
Geographically, the level of protection for the combined endpoints of moderate and severe disease varied: 72% in the United States; 66% in Latin American countries; and 57% in South Africa, 28 days post-vaccination. The investigational vaccine was reportedly 85% effective in preventing severe/critical COVID-19 across all geographical regions. No deaths related to COVID-19 were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19. Overall, there were 16 deaths in the placebo group, and 3 deaths in the vaccine group…

Severe COVID-19 in pregnancy associated with preterm birth, other complications
January 28, 2021 — NIH-funded study also suggests mother-to-infant transmission appears to be rare.

NIH launches database to track neurological symptoms associated with COVID-19
January 26, 2021 — The body’s response to COVID-19 infection on the brain, spinal cord, nerves and muscle can be particularly devastating.

Antibody infusions prevent acquisition of some HIV strains, NIH studies find
January 26, 2021 — Results will inform development of long-acting antibody-based HIV prevention tools.

 

PATH [to 30 Jan 2021]
https://www.path.org/media-center/
Press Release
PATH’s statement on the Biden administration’s memorandum reversing the Mexico City Policy
January 29, 2021 by PATH

GSK, PATH, and Bharat Biotech sign product transfer agreement to help ensure long-term supply of RTS,S/AS01E malaria vaccine
January 27, 2021 by PATH
:: Bharat Biotech to produce antigen for world’s first vaccine against Plasmodium falciparum malaria following technology transfer, to help ensure long-term sustainable supply.
:: Transfer builds on GSK commitments to donate up to 10 million vaccine doses to the pilot implementation in regions of Ghana, Kenya, and Malawi and supply up to 15 million doses annually to 2028 if recommended for wider use.
:: Bharat Biotech selected as partner based upon its established experience in development, production, and supply of global health vaccines.

PATH and the U.S. President’s Malaria Initiative launch a $30M global project to advance the use of new and existing tools to fight malaria and save lives
January 26, 2021 by PATH
PATH builds a consortium of partners to implement the five-year PMI Insights for Malaria (INFORM) award.
Seattle, WA, January 26th, 2021 – PATH is pleased to announce that it has been chosen to lead the U.S. President’s Malaria Initiative’s (PMI) new five-year $30 million operational research and program evaluation project to help partner countries ensure they are making the most effective and efficient use of resources to fight malaria and save lives. Through strong collaboration with in-country research institutions, PMI Insights for Malaria (INFORM) will generate evidence and data to inform national malaria programs and the global malaria community of best practices, while strengthening research capacity in PMI-supported countries.

 

Sabin Vaccine Institute [to 30 Jan 2021]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
Sabin Vaccine Institute Statement on the Passing of Sabin Founder and Trustee Philip Russell
Monday, January 25, 2021
Major General (Ret) Philip King Russell, physician, scientist, soldier, family man, and global health advocate who dedicated his life to protecting humans from infectious disease through vaccines, died peacefully on January 21, 2021, just a few months after being diagnosed with cancer and one week before his 89th birthday. Phil’s proudest achievement and greatest joy was his large and ever-expanding family, and after living in the Washington, DC area for more than 40 years, Phil and his wife of 65 years, Constance Rice Russell, moved to the Denver area in 2014 to be closer to their family. Phil passed his final days with Connie and his three children (Katherine Russell Kingsbery, Ellen King Russell Herting and Richard Webster Russell) by his side. He is also survived by six grandchildren, Russell Everette Kingsbery, Kelsey Louise Kingsbery, William Webster Kingsbery, Avery Grace Russell, Peyton Christine Russell, Taylor King Russell and three great grandchildren.

 

UNAIDS [to 30 Jan 2021]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
28 January 2021
Central African Republic: producing HIV estimates in the context of crisis

27 January 2021
New guidance on ethical HIV prevention trials published
UNAIDS and the World Health Organization have published updated guidance on ethical considerations in HIV prevention trials. The new guidance is the result of a year-long process that saw more than 80 experts and members of the public give inputs and is published 21 years after the first edition appeared.
“UNAIDS is committed to working with the people and populations affected by HIV, promoting and protecting their rights,” said Peter Godfrey-Faussett, UNAIDS Science Adviser. “This guidance sets out how to carry out ethical trials on HIV prevention while safeguarding the participants’ rights during scientific research and promoting the development of new HIV prevention tools.”…

27 January 2021
Islamic Republic of Iran bans stigma and discrimination against people living with HIV in health-care settings

25 January 2021
Hand sanitizer donated by Reckitt Benckiser to people living with HIV

25 January 2021
Discriminatory attitudes towards people living with HIV declining in some regions, rebounding in others

 

UNHCR Office of the United Nations High Commissioner for Refugees [to 30 Jan 2021]
http://www.unhcr.org/en-us/media-centre.htmlS
Selected Announcements
Conditions dire as CAR displacement tops 200,000
29 Jan 2021

 

 

UNHCR welcomes Iceland’s decision to join global efforts to end statelessness
29 Jan 2021

 

 

UNHCR warns asylum under attack at Europe’s borders, urges end to pushbacks and violence against refugees
28 Jan 2021

 

 

As Sub-Saharan crises force more to flee, UNHCR calls for stronger Mediterranean route response
27 Jan 2021

 

 

With refugee resettlement at a record low in 2020, UNHCR calls on States to offer places and save lives
25 Jan 2021

 

UNICEF [to 30 Jan 2021]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release 01/27/2021
Nutrition crisis looms as more than 39 billion in-school meals missed since start of pandemic – UNICEF and WFP
School meals, often the one nutritious daily meal that children get, must be prioritized in school reopening plans

Statement 01/27/2021
12 weeks into the conflict, ‘deeply troubling’ situation for children in Tigray
Statement by UNICEF Executive Director Henrietta Fore on the humanitarian situation in Tigray, Ethiopia

Press release 01/26/2021
Up to 90,000 children in central Mozambique urgently need humanitarian assistance in wake of Cyclone Eloise
Region’s children and families still recovering from devastation wrought by Cyclone Idai less than two years ago

 

Unitaid [to 30 Jan 2021]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 30 Jan 2021]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 30 Jan 2021]
http://www.vaccineconfidence.org/
News, Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 30 Jan 2021]
http://www.chop.edu/centers-programs/vaccine-education-center
News
No new digest content identified.

 

Wellcome Trust [to 30 Jan 2021]
https://wellcome.ac.uk/news
News
No new digest content identified.

 

The Wistar Institute [to 30 Jan 2021]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 30 Jan 2021]
https://www.wfpha.org/
Latest News
Operation Vaccination: An Analysis of Global COVID-19 Vaccine Rollout Strategies
Jan 29, 2021 | News
Operation Vaccination: An Analysis of Global COVID-19 Vaccine Rollout Strategies
The COVID-19 pandemic is the greatest public health crisis of our lifetimes. Mass immunization is the best chance we have of conquering the disease, but it presents a fiercely complex challenge for governments, healthcare systems and populations.
This weekly post will explore the policy, logistics, obstacles and controversies involved in procuring and distributing vaccines against COVID-19. Under investigation are 9 countries across 5 continents (Brazil, India, Indonesia, Ireland, Israel, Nigeria, Taiwan, the UK and the US), as well as COVAX, the global vaccine sharing initiative.
These articles are a means for the WFPHA to keep readers up to date with how the COVID-19 vaccine race is developing across the world. Each week will cover a different theme as it applies to each of the countries being covered:
COVAX
Brazil
India
IDN
IRL
Israel
NGA
TW
UK
US

COVID-19 Pandemic in the Amazon – An Urgent Need for International Solidarity
Jan 29, 2021 | News
COVID-19 Pandemic in the Amazon – An Urgent Need for International Solidarity
Amazon, a region with so much natural wealth, is the homeland of amongst the poorest people in the Americas, including a high proportion of Indigenous Peoples. The poor and neglected…

 

World Organisation for Animal Health (OIE) [to 30 Jan 2021]
https://www.oie.int/en/for-the-media/press-releases/2021/
Press Releases
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ARM [Alliance for Regenerative Medicine] [to 30 Jan 2021]
Press Releases – Alliance for Regenerative Medicine (alliancerm.org)
Press Releases
ARM Statement on the Trump Administration’s Interim Final MFN Rule
Washington, DC – January 26, 2021
ARM today called on the Biden administration to withdraw in its entirety the Trump administration’s Interim Final Rule on the Most Favored Nation (MFN) model for Medicare Part B. The MFN approach is particularly misguided for cell, gene, and tissue-based therapies. These durable – and possibly curative – therapies address the root causes of disease and contribute to more sustainable healthcare systems. Furthermore, patient access to the most innovative therapies in the countries upon which the MFN model is based lags considerably behind the US. Even if CMS were to exclude certain cell and gene therapies from the MFN model today, the innovators of tomorrow will face uncertainty. We encourage the Biden administration to instead consider the adoption of innovative payment models that recognize the unique promise of regenerative medicine, including by tying reimbursement to patient outcomes.

 

BIO [to 30 Jan 2021]
https://www.bio.org/press-releases
Press Releases
Supercharging Marketing—the Mission for New Chief Marketing Officer at BIO
January 28, 2021
Washington, DC – The Biotechnology Innovation Organization (BIO) has appointed Melissa von Stauffenberg as Chief Marketing Officer, effective February 1, 2021. The newly created position emerged from a recent reorganization aimed at driving a…

New “100 Days of Innovation” Blueprint Outlines Priorities To End the Pandemic, Build American Resiliency
January 27, 2021
As Congress and the new President lay out their aggressive “100 Day Plans,” The Biotechnology Innovation Organization (BIO) today released a new blueprint highlighting goals to strengthen America’s innovation ecosystem, end the COVID-19 pandemic,…
The blueprint, which can be found here, includes the advocacy organization’s priorities for the first 100 days working with Congress and the Biden Administration. BIO aims to:
[1] Ensure a speedy transition and an expedited Senate confirmation process for agency leadership critical to advancing public health, nutrition, and environmental goals.
[2] Reengage as a leader on the world stage, including rejoining the World Health Organization and the Paris Climate Accords.
[3] Develop and approve more vaccines, therapeutics, and diagnostics to prevent and treat COVID-19.
[4] Promote robust and equitable patient access to COVID-19 vaccines, therapeutics, and diagnostics.
[5] Better prepare for future infectious disease outbreaks.
[6] Drive economic revival and resiliency through Adoption of Advanced Biotechnology Solutions…

New Criteria Set for Political Contributions from BIO
January 27, 2021
The Biotechnology Innovation Organization announced today that it will resume political giving under new criteria for political leaders seeking campaign assistance. Shortly after the violent demonstration three weeks ago at the US Capitol BIO…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 30 Jan 2021]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 30 Jan 2021]
https://internationalbiotech.org/news/
News
No new digest content identified.

 

IFPMA [to 30 Jan 2021]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement on EU COVID-19 Vaccines Supply
28 January 2021
Global supply chains are key to delivering vaccines to protect citizens against COVID-19. The making of a vaccine requires many dozens of ingredients and manufacturing components which come from around the world.
It is vital that any measures proposed by the European Commission and the Member States do not restrict, hold back, or have other negative impacts on exports of vaccines or the import of key vaccine manufacturing supplies. Risking retaliatory measures from other regions at this crucial moment in the fight against COVID-19 is not in anyone’s best interest.
We are deeply concerned by European discussions that could be disruptive of our global efforts to manufacture and deliver billions of vaccines in record time. This is a time for cool heads and finding solutions. Threatening export restrictions is short sighted; and could risk undermining the supply of vaccines in Europe and around the world.
EFPIA statement here.

 

PhRMA [to 30 Jan 2021]
http://www.phrma.org/
Selected Press Releases, Statements
Growing trend: Increased vaccine confidence
January 28, 2021
According to researchers writing in The Lancet, we need a majority of Americans to have the confidence to get vaccinated for COVID-19 if we are going to be effective in moving the United States toward population-level control of viral spread. As Dr. Anthony Fauci has noted, “If you have a vaccine that is highly effective and not enough people get vaccinated, you’re not going to realize the full, important effect of having a vaccine.”
Blog Post

2020 FDA approvals show innovation despite COVID-19 pandemic challenges
January 26, 2021
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to innovative medicines that are approved through FDA’s Center for Biologics Evaluation and Research—which include for example, cell therapies, gene therapies, vaccines and other biologic medicines.
Blog Post