Moderna, Inc. dosed the first participant this week for its Phase 2 study of a COVID-19 booster vaccine tailored to the omicron variant, mRNA-1273.529, kicking off a two cohort trial that will span the United States.
In all, approximately 300 participants will be enrolled in each cohort. One... Read More »
Drawing from a $200 million program meant to stimulate the development of vaccines with broad betacoronavirus protection, the Coalition for Epidemic Preparedness Innovations (CEPI) announced a $16.9 million award this week for development efforts by BioNet.
BioNet, a French-Thai vaccine... Read More »
Trying to bolster U.S. public health and medical preparedness and response systems after COVID-19 exposed their flaws, U.S. Sens. Patty Murray (D-WA) and Richard Burr (R-NC) have released a discussion draft of a new bill calling for overhaul across the board.
Known as the Prepare for and Respond... Read More »
In a move that prompted backlash from Florida in particular, the United States Food and Drug Administration (FDA) this week announced revised and restricted authorizations of bamlanivimab/etesevimab and REGEN-COV for COVID-19 treatment.
While the two had been available before this, Dr. Patrizia... Read More »
Formerly only used for patients hospitalized with COVID-19, the Gilead Sciences Inc. drug veklury – also known as remdesivir – was expanded by order of the U.S. Food and Drug Administration (FDA) last week to include treatment for mild to moderate cases as well.
Both non-hospitalized adults... Read More »
The Coalition for Epidemic Preparedness Innovations’ (CEPI) 100 Days Mission to reduce the vaccine development timeline received a $300 million investment from the Bill & Melinda Gates Foundation and Wellcome.
While a fraction of the organization’s overall fundraising goal of $3.5 billion,... Read More »
Citing the surge in Omicron cases nationwide, U.S. Rep. John Katko (R-NY) urged President Joe Biden to use research and technology from academic medical centers in Central New York, like SUNY Upstate Medical University, to guide the nation’s public health response and to improve testing.
In a... Read More »
Under a long-term agreement with the United Nations Children’s Fund (UNICEF) announced this week, Merck and Ridgeback Biotherapeutics have agreed to provide 3 million courses of COVID-19 oral antiviral molnupiravir for use in low and middle-income countries.
Distribution will occur throughout... Read More »
The Coalition for Epidemic Preparedness Innovations (CEPI) and Institut Pasteur de Dakar (IPD) recently collaborated to advance COVID-19 vaccine manufacturing in Africa.
CEPI seeks to develop vaccines against future epidemics, while IPD is a non-profit public interest foundation located in... Read More »
A new partnership between governmental, military, and academic scientists seeks to collaboratively develop a vaccine over the next five years capable of protecting against tularemia, melioidosis, and plague from a single source.
Aided by a $10 million grant for the Defense Threat Reduction... Read More »
In the latest effort to get ahead of future medical equipment shortages, U.S. Rep. Josh Gottheimer (D-NJ) announced plans for the Medical and Health Stockpile Accountability Act last week, proposing a new tracking system and data sharing guidelines, and more.
While building greater resilience... Read More »
Expanding options for individuals with COVID-19, the World Health Organization (WHO) last week recommended two additional drugs for treatment: the oral inhibitor known as baricitinib and the monoclonal antibody drug sotrovimab.
Baricitinib is meant for use by those with severe or critical... Read More »
The U.S. Department of Defense (DoD) has coordinated with the Department of Health and Human Services (HHS) to purchase 380 million over-the-counter COVID-19 test kits.
Contracts were awarded to Orlando, Florida-based Abbott Rapid Dx North America, LLC; Mountain View, California's iHealth Lab... Read More »
U.S. Sens. Richard Burr (R-NC) and John Hickenlooper (D-CO) this week introduced a bipartisan bill that would increase the National Institutes of Health’s (NIH) collaboration efforts surrounding research and development of countermeasures for pathogens with pandemic potential.
“Two years... Read More »
In response to the Chinese government's refusal to allow a comprehensive investigation into the origins of COVID-19, a collection of Republican senators introduced the Coronavirus Origin Validation, Investigation and Determination (COVID) Act this week.
The bill seeks to authorize sanctions... Read More »
The U.S. Department of Defense (DoD) announced Monday that it had awarded contracts to Atlantic Trading, LLC, of Austin, Texas and Medea, Inc., of Pleasanton, Calif., that would purchase a combined total of 27 million over-the-counter COVID-19 test kits.
The contracts will support President Joe... Read More »
In a letter to President Joe Biden this week, a collection of more than 40 sitting members of Congress led by U.S. Sen. Bernie Sanders (I-VT) and U.S. Rep. Adam Schiff (D-CA) urged administration action to expand access for and increase the supply of COVID-19 rapid tests.
Demanding more... Read More »
According to GlaxoSmithKline plc (GSK) and Vir Biotechnology, Inc., the United States government this week agreed to purchase another 600,000 doses of the COVID-19 antibody treatment sotrovimab, which will be distributed in this first quarter of 2022.
The arrangement stems from an amendment to... Read More »
Amid rising breakthrough cases of COVID-19, largely fueled by the spread of the omicron variant, the U.S. Food and Drug Administration (FDA) last week shortened the time between primary and booster vaccination with a Moderna COVID-19 vaccine to five months.
This revised timeline was reflected in... Read More »
U.S. Sen. Kirsten Gillibrand (D-NY) joined U.S. Reps. Brian Higgins (D-NY) and Chris Jacobs (R-NY) in urging the U.S. Department of Homeland Security to keep the U.S.-Canada border open for vaccinated individuals.
Citing the economic livelihoods of New York businesses, as well as supply chain... Read More »
As part of President Joe Biden’s pledge to provide 500 million free at-home COVID-19 tests throughout the United States, the Department of Defense (DoD) has awarded a $51.6 million contract to Goldbelt Security, LLC for delivery of test kits.
Kits will be provided over the counter at no cost... Read More »
Three Republican representatives recently forwarded correspondence to President Joe Biden seeking an accounting of existing COVID-19 funding in anticipation of the administration requesting additional dollars.
House Budget Committee Republican Leader Jason Smith (R-MO), House Energy & Commerce... Read More »
While Cue Health already has a COVID-19 test on the market capable of detecting the widespread omicron variant, the organization announced that it will work with the Biomedical Advanced Research and Development Authority (BARDA) to create a point-of-care test specifically focused on rooting out... Read More »
In a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra, U.S. Sens. Richard Burr (R-NC) and Roy Blunt (R-MO) requested explanations for the nation’s COVID-19 testing shortages amid rising omicron variant infection cases.
Specifically, they blasted the Biden... Read More »
Through an amendment (H.R. 4350) to the National Defense Authorization Act (NDAA) passed last week, U.S. Sens. Tina Smith (D-MN), Elizabeth Warren (D-MA), and Bill Cassidy (R-LA) guaranteed a new federal study for the logistics of distributing COVID-19 doses abroad and ensuring vaccine... Read More »
Johnson & Johnson (J&J) released news from the South African Phase 3b Sisonke study of its COVID-19 booster vaccine, which demonstrated 85 percent effectiveness against COVID-19 induced hospitalization, even in a region dominated by the omicron variant.
The results were preliminary, conducted by... Read More »
Following an accelerated review process, the U.S. Food and Drug Administration (FDA) last week approved two new over-the-counter COVID-19 tests in a two-month turnaround time, opening the market to millions of new Roche and Siemens tests.
"Increasing Americans' access to easy-to-use, reliable... Read More »
The Independent Allocation of Vaccines Group (IAVG), a manager of needs-based allocations for the global COVAX initiative, criticized rich nations last week for hoarding COVID-19 vaccines and issued steps to achieve a new goal of 70 percent immunization coverage by mid-2022.
“As the overall... Read More »
As the number of Omicron variant cases of COVID-19 grows, the Centers for Disease Control and Prevention (CDC) has issued updated guidance for healthcare workers regarding their isolation and quarantine times after being infected.
Additionally, the CDC updated its guidance for contingency and... Read More »
The United States Food and Drug Administration (FDA) bestowed emergency use authorization (EUA) to Roche’s COVID-19 at-home test last week, expanding over-the-counter options for those concerned about SARS-CoV-2 and its variants.
As a result, the test will now be available for self-use by... Read More »
The United States authorized the first two pill-based treatments for COVID-19 last week, with the Food and Drug Administration (FDA) granting emergency use authorization to both Pfizer Inc.’s paxlovid and Merck & Co. Inc.’s molnupiravir.
Taking the honor of first approval was paxlovid.... Read More »
The Coalition of Epidemic Preparedness will award up to $50 million in expanded support to SK bioscience as the company pursues a variant-proof vaccine candidate for sarbecoviruses, a group of viruses from which SARS-CoV-2 emerged.
“The rapid spread of the Omicron variant serves as a stark... Read More »
In an effort to close health disparities brought to light and exacerbated by the COVID-19 pandemic, the United States Department of Health and Human Services (HHS) announced this week that it has banded together with 15 digital health startups in the 2022 PandemicX Accelerator.
“PandemicX will... Read More »
In preliminary showings, a third dose of Moderna Inc’s COVID-19 vaccine increased antibody levels against the Omicron variant currently sweeping the world, painting the company’s strategy forward even as a years-long pandemic continues to evolve.
The report followed news that omicron, which... Read More »
Worried by rising COVID-19 variants and the threats of future pandemics, a collection of United States lawmakers last week dispatched a letter to the Senate and House Appropriations Committees asking for further funding in the Fiscal Year 2022 appropriations bill to support global... Read More »