Emerging Infectious Diseases
CDC expands monkeypox testing capacity with shipments to five commercial lab companies
Working through the Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (HHS) began shipping monkeypox tests to five commercial lab companies this week. It aims to boost the nation’s monkeypox testing capacity at large, with assistance from Aegis... Read More »
Global Fund partners with SC Johnson to address malaria throughout Africa
A new partnership arranged between SC Johnson and the Global Fund this week will focus on resource development for malaria, one of the world’s oldest and deadliest diseases. Together, the pair intend to push for social impact in some of the places malaria has proven most stubborn: Burundi, the... Read More »
FDA issues emergency use authorization for Roche’s cobas SARS-CoV-2 Duo
Roche broke new ground with its cobas SARS-CoV-2 Duo, which this week received U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) to become the first PCR test capable of simultaneously detecting COVID-19 and quantitatively measuring viral load levels. “The test’s... Read More »
Sanofi-GSK next-generation COVID-19 booster vaccine makes strong protective showing against variants of concern
In two trials of a new Sanofi-GSK COVID-19 booster vaccine, strong immune responses were offered to previously vaccinated adults, and solid protection was offered against variants of concern, according to the company’s latest data. This booster is modeled on the Beta variant antigen,... Read More »
BARDA orders extra 500,000 doses of Bavarian Nordic’s JYNNEOS smallpox, monkeypox vaccine
Responding to an increase in global cases of monkeypox, the U.S. Biomedical Advanced Research and Development Authority (BARDA) purchased an additional 500,000 doses of the liquid-frozen JYNNEOS vaccine, a Bavarian Nordic A/S product. JYNNEOS holds the unique position of being the only U.S. Food... Read More »
Moderna’s Omicron-variant booster delivers greater protection against COVID-19 threats
Moderna, Inc. revealed clinical data on its Omicron-containing bivalent COVID booster candidate, mRNA-1273.214, this week, showing that one-month post-administration, a 50 µg dose of the booster provided a superior neutralizing antibody response compared to its predecessor... Read More »
FDA Advisory Committee recommends Novavax COVID-19 vaccine gain Emergency Use Authorization for adults
After considering data from a Phase 3 clinical trial of approximately 30,000 participants, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend the Novavax COVID-19 vaccine gain Emergency Use Authorization... Read More »
WHO highlight need for expedited studies, greater collaboration in addressing monkeypox outbreaks
Following a World Health Organization (WHO) global research consultation, more than 500 experts emphasized that expedited studies, strengthened collaboration from researchers in endemic countries, public health responses, and new clinical studies are needed to address monkeypox. Monkeypox has... Read More »
Bavarian Nordic secures smallpox vaccine supply contract to address monkeypox outbreak
Amid some nervousness over a monkeypox outbreak this year, Bavarian Nordic A/S announced that it has a new supply contract for its smallpox vaccine meant to help those at risk of monkeypox in the short or medium term. The country to benefit from that contract remains unidentified at this time.... Read More »
HHS to invest up to $300M over next 10 years into CARB-X efforts to combat antimicrobial resistant infections
Beginning with $20 million this year, the United States Department of Health and Human Services (HHS) will commit up to $300 million to support antimicrobial resistant (AMR) infection research conducted through the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) over... Read More »
BARDA taps Bavarian Nordic to freeze-dry smallpox vaccine supplies
Beginning in 2023 and 2024, Bavarian Nordic A/S will, for the first time, manufacture and invoice a freeze-dried version of its JYNNEOS smallpox vaccine to the U.S. government. The announcement followed a decision by the Biomedical Advanced Research and Development Authority (BARDA) to exercise... Read More »
NIAID utilizes $577M to establish nine pathogen antiviral drug development centers
Through awards amounting to approximately $577 million, the National Institute of Allergy and Infectious Diseases (NIAID) is working to create nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, working to develop innovative drugs. “The COVID-19 pandemic has... Read More »
AstraZeneca licenses early-stage monoclonal antibodies from RQ Biotechnology for use against COVID-19
In an expansion of its efforts against COVID-19, AstraZeneca announced a new agreement this week with RQ Biotechnology Ltd. that will see it acquire the worldwide license to develop, manufacture, and commercialize monoclonal antibodies against SARS-CoV-2. Developed by the U.K.-based RQ... Read More »
FDA authorizes first non-prescription test for COVID-19, flu and RSV
Broadening testing capabilities and achieving a long-term goal, the U.S. Food and Drug Administration (FDA) this week authorized the first COVID-19 test also capable of detecting flu and the respiratory syncytial virus (RSV) without requiring a prescription. The multifunctional test, the... Read More »
Ugandan preparedness, response to 2018-2020 Ebola outbreaks highlights path for other nations
According to a peer-reviewed analysis from scientists at the Johns Hopkins Center for Health Security and Ugandan colleagues, Uganda’s preparedness efforts during the 2018-2020 Ebola virus disease (EVD) outbreaks in the neighboring Democratic Republic of Congo showed the potential value of... Read More »
Global COVID-19 Summit brings new policy, financial commitments to whole-of-society pandemic preparations
At the second Global COVID-19 Summit last week, governments, including the United States, pledged to provide $3.2 billion in additional funds for COVID-19 and other pandemic preparedness needs and committed to expanding and accelerating testing and vaccine access. This year’s summit was led by... Read More »
Phase 1 trial results of virus-like particle vaccine show promise against encephalitis viruses
A vaccine candidate for eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis virus (VEEV) proved safe, well-tolerated, and robust in antibody response during a Phase 1 clinical trial reported in The Lancet Infectious Diseases. The... Read More »
DoD awards $79.9M contract to Premix to create production capacity of resin for pipette tips
In a push to bolster COVID-19 diagnostic testing, the U.S. Department of Defense (DoD) awarded a $79.9 million contract to Premix, Inc. this week, funding new onshore production capacity for plastic resin used in tests’ pipette tips. This will boost future supply chain demands and other... Read More »
CEPI to provide up to $19.3M for variant-proof COVID-19 vaccine development by Bharat Biotech, University of Sydney and ExcellGene
The Coalition for Epidemic Preparedness Innovations (CEPI) backed efforts at developing a "variant-proof" COVID-19 vaccine this week, announcing that it will provide up to $19.3 million to an international consortium consisting of Bharat Biotech International Ltd., the University of Sydney and... Read More »
Biobot Analytics selected to expand CDC’s National Wastewater Surveillance System
As part of a pandemic preparedness push, the United States Center for Disease Control and Prevention (CDC) announced this week that it chose Biobot Analytics to handle an expansion of the National Wastewater Surveillance System (NWSS). While not a household name, the NWSS works with public... Read More »
BARDA announces new partnerships to develop diagnostics for respiratory RNA virus
The Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, announced Tuesday it had partnered with a number of industry and academic organizations to advance next-gen diagnostics to detect respiratory viruses in a single test.... Read More »
BARDA and Lumen Bioscience developing intranasal antibody treatment for COVID-19
As part of Biomedical Advanced Research and Development Authority’s (BARDA) Beyond the Needle program, Lumen Bioscience is working to create a new antibody cocktail for treatment of SARS-CoV-2, delivered intranasally. Beyond the Needle, managed by the Division of Research Innovation and... Read More »
Positive data reported for Valneva, Pfizer’s Lyme disease vaccine candidate for children
A Lyme disease vaccine candidate for adults and children at least 5 years old produced strong immunogenicity, safety and overall positive results this week in a Phase 2 trial conducted by its developers, Valneva SE and Pfizer Inc. This marked the first clinical study where VLA15, as the... Read More »
WHO recommends Paxlovid as treatment for high risk COVID-19 patients, but warns of roadblocks
While adding Paxlovid – nirmatrelvir and ritonavir – to its list of recommended treatments for mild and moderate COVID-19 patients at risk of hospital admission, the World Health Organization (WHO) noted that lack of price transparency at Pfizer Inc. and testing demands before administration... Read More »
ASPR celebrates construction of new research and development facility for production of prefilled injectors
The U.S. Office of the Assistant Secretary for Preparedness and Response (ASPR) celebrated the completion of the initial design and construction last week for a new ApiJect Technology Development Center that promises greater manufacturing capacity for prefilled injectors used to administer vaccines... Read More »
Bavarian Nordic begins phase 3 clinical trial of MVA-BN RSV vaccine for older adults
A global, Phase 3 trial of approximately 20,000 older adult volunteers for the Bavarian Nordic A/S MVA-BN RSV vaccine candidate began this week and is expected to produce results by mid-2023. The randomized, double-blind test will gather those aged 60 years and older in both the United States... Read More »
Moderna’s bivalent COVID-19 booster platform effective against Beta, Delta and Omicron variants
New clinical data from Moderna, Inc. this week showed that a month after using a bivalent COVID-19 booster candidate, mRNA-1273.211, superior vaccination efficacy was maintained against all variants of concern, including Beta, Delta, and Omicron. These results stemmed from 50 µg booster doses,... Read More »
Emergex enters preclinical development for a tularemia vaccine
Utilizing its synthetic, CD8+ T cell Adaptive Vaccine platform, Emergex Vaccines Holding Ltd. began preclinical development last week of a new medical countermeasure against tularemia. Tularemia is caused by francisella tularensis, an exceptionally virulent intracellular bacterial pathogen. The... Read More »
FDA extends review of REGEN-COV for use on non-hospitalized and prophylaxis COVID-19 patients by three months
Due to discussions between the U.S. Food and Drug Administration (FDA) and Regeneron Pharmaceuticals, Inc. over pre-exposure prophylactic use, the FDA will extend the review of a Biologics License Application (BLA) for REGEN-COV as a COVID-19 treatment for three months. Regeneron seeks to use... Read More »
FDA grants emergency use authorization to first breath-based COVID-19 diagnostic test
A new avenue of testing for COVID-19 opened last week, with emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the InspectIR COVID-19 Breathalyzer, a diagnostic capable of detecting SARS-CoV-2 infection from breath samples. In less than three minutes, the... Read More »
U.S. Sens. Cassidy, Duckworth and Brown introduce bill authorizing research into COVID-affiliated mental illnesses
U.S. Sens. Bill Cassidy (R-LA), Tammy Duckworth (D-IL), and Sherrod Brown (D-OH) introduced a bill this week to fund research on the COVID-19 impacts on mental health and brain function. “The pandemic showed us the need to prioritize mental health and support those suffering,” Cassidy... Read More »
CEPI to help NEC Corporation develop broad protection betacoronavirus vaccine with $4.8M
Japan’s NEC Corporation gained seed funding of up to $4.8 million from the Coalition for Epidemic Preparedness Innovation (CEPI) this week to help its Norway-based subsidiary with the initial development of broadly protective betacoronavirus vaccine candidates. NEC OncoImmunity AS (NOI)... Read More »
Bipartisan group of senators introduce Preventing Future Pandemics Act to counter zoonotic disease spread
By supporting conservation in other nations, a bipartisan group of senators has proposed – through the Preventing Future Pandemics Act of 2022 (S.4074) – that the risk of zoonotic disease transmission could be reduced for humans. As introduced, the bill would authorize the U.S. government to... Read More »
NIAID awards four grants for new Tuberculosis Research Advancement Centers
The National Institute of Allergy and Infectious Diseases (NIAID) this week awarded four grants totaling approximately $4.3 million of investment over the first year alone to launch new Tuberculosis Research Advancement Centers (TRACs) across the country. These grants will last five years,... Read More »