Emerging Infectious Diseases
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 »
The fight against COVID-19 earned another contender last week with the granting of an emergency use listing from the World Health Organization (WHO) to NVX-CoV2373, a vaccine created by Novavax and the first protein-based COVID-19 vaccine to earn that listing.
Better known as COVOVAX, as... Read More »
With a growing body of evidence that novel coronaviruses will continue to infect animals to afflict humans anew, top scientists from the National Institutes of Health (NIH) have called for collaboration in pursuit of a universal coronavirus vaccine.
Drs. Anthony Fauci, Jeffery Taubenberger, and... Read More »
A growing, immediate need exists to accelerate global coronavirus vaccination efforts to help ensure America’s continued economic recovery, experts testified during a Dec. 14 hearing held by the House Select Subcommittee on the Coronavirus Crisis.
To date, nearly eight billion coronavirus... Read More »
With recommendations from an independent Data Safety Monitoring Board (DSMB) and positive antibody and safety showings from preliminary studies, Sanofi and GSK announced this week that their COVID-19 vaccine booster candidate will continue its Phase 3 trial.
So far, the DSMB has identified no... Read More »
With as many as 40 percent of medical device manufacturing facilities refusing to submit records when asked by the U.S. Food and Drug Administration (FDA), U.S. Sens. Tammy Baldwin (D-IL) and Bill Cassidy (R-LA) have proposed a bill that would encourage compliance.
The requests were made between... Read More »
A new report released by the Johns Hopkins Center for Health Security this week determined that the failure to incorporate primary care providers into the frontline response to COVID-19 and the larger public health system could have improved care, testing, and vaccination acceptance.
In... Read More »
Results came in this week from a Phase 2/3 trial of Pfizer Inc.’s COVID-19 oral antiviral treatment, and the data showed a drug capable of cutting risks of hospitalization or death by 89 percent among high-risk adults, when given within a few days of their first symptoms.
The final data from... Read More »
Seeking broader protection against SARS-CoV-2 variants and other betacoronaviruses, the Coalition for Epidemic Preparedness Innovations (CEPI) announced this week that it would invest up to $4.5 million into development of a vaccine candidate based on Affinivax, Inc.’s Multiple Antigen Presenting... Read More »
On Friday, Moderna, maker of one of the FDA-approved COVID-19 vaccines, announced it will amend its contract with Gavi, the vaccine alliance, to accelerate the supply of 20 million doses of the vaccine to COVAX by the end of the year.
The total number of vaccines supplied to COVAX in 2021 now... Read More »
More than 100 COVID-19 experts called on Congressional leaders Thursday to pass bipartisan legislation to create a COVID-19 Commission.
The legislation, introduced by U.S. Sens. Dianne Feinstein (D-CA), Roger Marshall (R-KS), Kirsten Gillibrand (D-NY), Joni Ernst (R-IA), and Richard Blumenthal... Read More »
Pfizer and BioNTech officials recently provided an update regarding the Omicron variant, noting results of an initial laboratory study demonstrating serum antibodies via BNT162b2 neutralize the variant after three doses.
“Although two doses of the vaccine may still offer protection against... Read More »
The U.S. Food and Drug Administration (FDA) approved this week an emergency use authorization (EUA) for AstraZeneca’s Evusheld, authorizing the use of monoclonal antibodies to reduce specific COVID-19 risk.
Evusheld is tixagevimab co-packaged with cilgavimab and administered together to... Read More »
The Bipartisan Commission on Biodefense announced launched a public awareness campaign Wednesday to support the Apollo Program for Biodefense, a project that aims to eliminate pandemics in ten years and reduce other biological threats.
The campaign, similar in scope and importance to landing... Read More »
A new report from the Nuclear Threat Initiative has found that nations around the world remain “dangerously unprepared” to meet future epidemic and pandemic threats,
The report – the 2021 Global Health Security (GHS) Index -- measured the capacities of 195 countries to prepare for... Read More »
Members of the U.S. House Foreign Affairs Committee expressed support for a proposed initiative that would create an international organization aimed at detecting and preventing new biological threats, either unintentionally developed or intentionally introduced by rogue actors, like terrorists or... Read More »
With a new disease variant come further questions of vaccine viability and new tests, and this week, the Coalition for Epidemic Preparedness Innovations (CEPI) announced an expansion of a vaccine agreement with Gritstone bio Inc. to test its mRNA COVID-19 vaccine against the Omicron variant.... Read More »
The U.S. Agency for International Development (USAID) announced Monday it was creating a new whole-of-government effort, the Initiative for Global Vaccine Access (Global VAX), to accelerate efforts worldwide to provide COVID-19 shots and overcome access barriers to vaccines, with a priority on... Read More »
