Emerging Infectious Diseases
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded up to $18 million to GSK Biologicals and its affiliate GSK Vaccines Institute for Global Health (GVGH) to develop new vaccines for two different illnesses.
One is a vaccine for Group A streptococcus... Read More »
The National Institutes of Health (NIH) has earmarked funding totaling nearly $33 million over four years for five University of California San Diego Rapid Acceleration of Diagnostics (RADx) projects.
The RADx initiative seeks to expedite the development, commercialization, and implementation of... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) recently partnered with LightDeck Diagnostics to create a six-minute SARS-CoV-2 antigen test usable without the need for a full diagnostic laboratory.
This point of care test could be used for on-site screening of suspected... Read More »
The U.S. Food and Drug Administration (FDA) granted emergency use authorization Monday for the Quidel QuickVue At-Home COVID-19 Test.
An antigen test, QuickVue will allow users suspected of having COVID-19 by their healthcare provider within the first six days of symptom onset to quickly collect... Read More »
U.S. Rep. Tom Reed (R-NY) introduced a $163 billion bill to funds efforts to mitigate the effects of COVID-19.
The Crush The Virus Act (H.R. 1371) provides $163 billion in funding to increase the distribution and administration of COVID-19 vaccines, boost access to COVID-19 testing throughout... Read More »
The U.S. Food and Drug Administration (FDA) announced this week that undiluted frozen vials of the Pfizer-BioNTech COVID-19 vaccine will now be allowed to be transported and stored at conventional pharmaceutical freezer temperatures for up to two weeks.
While the preferred storage for this... Read More »
The United States will now benefit from the rollout of a third COVID-19 vaccine, following last week’s emergency use authorization (EUA) of the Janssen vaccine by the U.S. Food and Drug Administration (FDA).
That decision came in the wake of recommendations from an advisory panel known as the... Read More »
A new report from Johns Hopkins Center for Health Security found that emergency departments in New York City hospitals were overwhelmed and struggled to maintain conventional standards of care during the COVID-19 pandemic.
The report, “Crisis Standards of Care: Lessons from New York City... Read More »
Regeneron Pharmaceuticals is making changes to the Phase 3 trial of its Regen-COV treatment for outpatients with COVID-19.
The changes come at the recommendation of the Independent Data Monitoring Committee (IDMC), which said to no longer use a placebo group in the trial. IDMC found clear... Read More »
Pfizer Inc. and BioNTech announced the beginning of an evaluation into the safety and immunogenicity of a third dose of their COVID-19 vaccine last week to study the effects of a booster vaccine against emerging SARS-CoV-2 variants.
This will be offered to up to 144 participants from the phase... Read More »
The Food and Drug Administration (FDA) is holding an advisory committee meeting on Friday during which the committee is expected to recommend a single-dose Johnson & Johnson (J&J)-Janssen Biotech SARS-CoV-2 vaccine to become the third COVID-19 vaccine available for emergency use to... Read More »
The first 600,000 doses of the AstraZeneca/Oxford COVID-19 vaccine allocated to the COVAX Facility have been delivered to Ghana, with further deliveries expected to reach Cote d’Ivoire later this week.
It marks the beginning of a global rollout long in the planning and the first COVAX vaccine... Read More »
According to a new study from the National Cancer Institute (NCI), at least a few months of protection may be granted against reinfection to those with SARS-CoV-2.
As part of the National Institutes of Health, NCI worked with healthcare data analytics companies HealthVerity and Aetion, Inc. and... Read More »
A Phase 1B clinical trial of Lassa fever vaccine INO-4500, developed by INOVIO, began dosing its first patient this week in Ghana.
The vaccine is a first on several fronts: the first candidate for Lassa fever to begin human trials and the first to have trials conducted in West Africa, where the... Read More »
A pair of monoclonal antibodies (mAbs) developed by Regeneron have shown promising signs against the coronavirus that causes Middle East respiratory syndrome (MERS) in a phase one clinical trial that marked the first such test conducted on people.
In all, the National Institute of Allergy and... Read More »
Specialty vaccine company Valneva has initiated a Phase 3 study for its single-shot chikungunya vaccine candidate, VLA1553.
VLA1553 is the only chikungunya vaccine candidate in Phase 3 clinical trials. Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV).... Read More »
Department of Homeland Security (DHS) Science and Technology Directorate (S&T) personnel said the agency is aiding the scientific community and government decision-makers in proactive African Swine Fever approaches.
“Just because a disease isn’t currently present in the United States,... Read More »
New guidance from the U.S. Food and Drug Administration (FDA) released this week reaches out to medical product developers to address effective means of modifying various medical products to meet the threats posed by new variants of SARS-CoV-2.
SARS-CoV-2, the virus that causes COVID-19, has... Read More »
In an effort to meet global supply demands, Sanofi has agreed to support the manufacturing of a COVID-19 vaccine made by Janssen Pharmaceutical NV and Janssen Pharmaceuticals, Inc., both of which are part of Johnson & Johnson.
The Janssen candidate has been submitted to the U.S. Food and Drug... Read More »
Five COVID-19 vaccine manufacturers assured Congress Tuesday that they are closely watching the emergence of new variants of COVID-19 and are optimistic the two vaccines currently approved in the United States and a third poised for approval will treat those new variants that have emerged in the... Read More »
U.S. Sens. Jon Tester (D-MT) and Jerry Moran (R-KS) are urging President Joe Biden to add the Secretary of the Department of Veterans Affairs (VA) to the Defense Production Act Committee (DPAC).
The DPAC advises the President on the most effective use of the Defense Production Act (DPA) to... Read More »
Following positive results from preclinical testing at the University of Alabama at Birmingham last year, the Altimmune Inc. COVID-19 vaccine candidate AdCOVID is set to start a phase one clinical trial this week.
Efforts will begin with patient enrollment, now that the U.S. Food and Drug... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) and Luminex Corporation announced a collaboration on advanced development support of a single test to rapidly detect and differentiate between COVID-19, influenza, and respiratory syncytial virus (RSV).
Prevalent pathogens all,... Read More »
With money appropriated by Congress last year, President Joe Biden pledged a total of $4 billion to the global COVAX initiative to get poorer nations access to COVID-19 vaccines.
The announcement, made during a virtual G7 Summit, also encouraged partners within that group of wealthy nations to... Read More »
Federal agents with Homeland Security Investigations (HSI) have seized approximately 11 million counterfeit 3M N95 respirator masks in recent weeks.
The effort resulted from a collaboration between the U.S. Department of Homeland Security (DHS) and manufacturer 3M.
“These seizures... Read More »
In tests conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), a new screening technology from Smiths Detection broke new ground in efforts to find and contain COVID-19: the capability to detect the virus SARS-CoV-2 in the air.
The BioFlesh Biological... Read More »
Building off a 2020 research and development agreement for coronavirus therapies, GlaxoSmithKline plc (GSK) and Vir Biotechnology, Inc. announced a binding agreement this week to expand that collaboration into new therapies for flu and other respiratory viruses.
The pair will work together on... Read More »
The U.S. Department of Defense awarded a $1.4 million grant to scientists at West Virginia University (WVU) to develop therapeutics to treat infections prone to antibiotic resistance.
Mariette Barbier of the WVU School of Medicine will lead the research effort. Barbier and her team will present... Read More »
Following the World Health Organization (WHO) emergency use listing of the AstraZeneca/University of Oxford COVID-19 vaccine this week, the COVAX initiative announced it intends the bulk of the first deliveries to occur in March.
COVAX is finalizing the first and second quarter allocations of... Read More »
A new report from the Johns Hopkins Center for Health Security addresses the status of SARS-CoV-2 surveillance, sequencing, and the three emerging variant strains, establishing four policy recommendations to identify and manage them.
“Staying Ahead of the Variants: Policy Recommendations to... Read More »
Leading health and public health organizations in the United States are seeking $4.5 billion in additional annual funding for states, localities, tribes, and territories to support public health infrastructure and workforce.
Representatives from 316 organizations sent a letter to Congressional... Read More »
U.S. Sen. Susan Collins (R-ME) is urging the Secretary of Defense to review the modular pressure mobile containment systems that can offer a Military Treatment Facility (MTF) or hospital the capability to treat patients with COVID-19 symptoms.
In a letter to Secretary of Defense Lloyd Austin,... Read More »
Another four COVID-19 therapeutics for those with mild to moderate symptoms moved further up the pipeline this week, with the announcement of enrollment for Phase 2/3 testing in the National Institute of Allergy and Infectious Diseases (NIAID) ACTIV-2 trial.
ACTIV, or the Accelerating COVID-19... Read More »
The World Health Organization (WHO) formally approved emergency authorization for AstraZeneca’s COVID-19 vaccine, allowing two versions of it to be distributed through the global COVAX program.
AstraZeneca-SKBio is producing the two vaccines in the Republic of Korea and the Serum Institute of... Read More »
U.S. Rep. Brad Schneider (D-IL) and David McKinley (R-WV) introduced a bill to address shortages of personal protective equipment (PPE) and testing supplies.
The Protecting Providers Everywhere (PPE) in America Act would boost domestic PPE and testing supply production. It would also promote a... Read More »
