News
Clinical trials begin in four potential COVID-19 vaccine candidates
Clinical trials on four potential vaccine candidates to prevent infection with the virus that causes COVID-19 disease. The first U.S. patients have been dosed in a clinical trial conducted by Pfizer and BioNTech. They are being held at the NYU Grossman School of Medicine and the University of... Read More »
Rep. Higgins to introduce bill establishing new pandemic agency within HHS
U.S. Rep. Brian Higgins (D-NY) will introduce a bill that would create a new agency within the Department of Health and Human Services, the National Medical Command (NMC). This new independent agency would be charged with preparing for, monitoring, and responding to pandemics. Further, it would... Read More »
FEMA pushes increased COVID-19 testing, community testing sites and reimbursement
One of the areas the United States has struggled with during the COVID-19 pandemic is testing capacity, but now, the Federal Emergency Management Agency (FEMA) is moving to expand testing, testing sites and supplies, and federal reimbursement efforts. All of this is meant to be in line with the... Read More »
New CEPI funding opportunity aims to speed up COVID-19 vaccine production
The search for potential COVID-19 vaccines continues, and the Coalition for Epidemic Preparedness Innovations (CEPI) has issued a call for proposals that could put funds in the hands of organizations with plans to boost development, manufacturing and geographic reach of vaccine candidates. The... Read More »
Healthcare industry receives cybersecurity alerts
Security agencies from the United States and the United Kingdom are warning healthcare policymakers and researchers to be on the lookout for cybersecurity threat campaigns amid the COVID-19 response. Officials representing the U.S. Cybersecurity and Infrastructure Security Agency (CISA) and the... Read More »
CBP Rochester seizes counterfeit COVID-19 test kits
Customs and Border Protection (CBP) officials said the recent inspection of express-consignment shipments at the Rochester New York Airport yielded seizure of counterfeit COVID-19 test kits. “I’m proud of the continued efforts of our CBP officers here in Rochester,” Rochester Port Director... Read More »
Sen. Sanders, Rep. Khanna introduce bill to fund increased production of healthcare supplies in COVID-19 fight
Sen. Bernie Sanders (I-VT) and Rep. Ro Khanna (D-CA) introduced legislation to fund the increased production of health care equipment in the fight against COVID-19. The Emergency Medical Supplies Procurement Act would provide $75 billion for the Trump administration to purchase or manufacture... Read More »
Congress members call on Trump administration to extend Iran arms embargo
An overwhelming bipartisan majority in the U.S. House of Representatives is calling on the Trump Administration to extend the United Nations arms embargo on Iran. The embargo is set to expire in October of this year. A group of 387 members of Congress -- including Reps. Brian Fitzpatrick... Read More »
North Arizona University research initiative aids COVID-19 projections
Northern Arizona University researchers have developed computer modeling systems designed to predict outcomes of the regional spread of the SARS-CoV-2 virus, which causes COVID-19. The approach is being implemented across Coconino, Navajo, Apache, and Mohave counties in response to the Flagstaff... Read More »
GAO issues recommendations for FEMA preparedness
The Government Accountability Office has issued a series of recommendations to the Federal Emergency Management Agency (FEMA) regarding efforts to strengthen national preparedness. The GAO indicated while FEMA uses several scenarios, including pandemic influenza similar to COVID-19, to allow... Read More »
Mayo Clinic, BARDA push expanded access to convalescent plasma for COVID-19 patients
The Biomedical Advanced Research and Development Authority (BARDA) is collaborating with the Mayo Clinic on an expanded access program that will get patients hospitalized with COVID-19 access to convalescent plasma. Convalescent plasma’s use is built on the idea that those who recover from... Read More »
Pfizer, BioNTech dose first US patients for COVID-19 vaccine trial
The first American participants in the Phase 1/2 clinical trial of the BNT162 vaccine program, created by Pfizer Inc. and BioNTech SE, have been dosed as the companies ramp up manufacturing capabilities to meet 2020/2021 capacity needs. That vaccine is meant to treat COVID-19, the disease that... Read More »
FDA issues emergency use authorization for new Roche COVID-19 antibody test
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Roche for its Elecsys Anti-SARS-CoV-2, or COVID-19, antibody test. The test is designed to help determine if a patient has been exposed to the virus and if the patient has developed antibodies against... Read More »
Reps. Brooks, Eshoo introduce Prescription for American Drug Independence Act
U.S. Reps. Susan Brooks (R-IN) and Anna Eshoo (D-CA) introduced legislation that would establish a committee of experts to analyze the impact of U.S. dependence on the foreign manufacturing of lifesaving drugs. The Prescription for American Drug Independence Act would require the National... Read More »
Bipartisan lawmakers advocate United States leads global vaccine effort
Reps. Ami Bera (D-CA) and Ted S. Yoho (R-FL) recently forwarded correspondence to Secretary of State Mike Pompeo, stating that America should participate in and lead global initiatives to coordinate COVID-19 vaccine production and distribution. “The U.S. should consider participating in the... Read More »
Bill to fund COVID-19 testing, tracing
Rep. Bobby L. Rush (D-IL) introduced Friday legislation initiating a $100 million grant program administered by the Centers for Disease Control and Prevention (CDC) to mobilize coronavirus testing and contact tracing. COVID-19 Testing, Reaching and Contacting Everyone (TRACE) Act grantees would... Read More »
CDC launches viral genomics consortium to strengthen national efforts to map SARS-CoV-2
The Centers for Disease Control and Prevention (CDC) recently launched a national viral genomics consortium to better map the genome of SARS-CoV-2, the virus behind the COVID-19 pandemic. The SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES)... Read More »
FDA approves remdesivir for potential, emergency treatment of COVID-19
Following the results of two clinical trials for the experimental antiviral drug remdesivir, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) last week, opening it to use as a treatment for those with severe cases of COVID-19. “Based on evaluation of the... Read More »
Senators call on leadership to approve $8B for contact tracing of COVID-19
A group of 14 Democratic U.S. senators is calling on Congress to include $8 billion in new funding for contact tracing to fight the COVID-19 virus. Contact tracing is the process of tracking infected people to find out who they have been in contact with to stop the spread of the virus.... Read More »
BARDA expands contracts with Bavarian Nordic on smallpox vaccine
The U.S. Biomedical Advanced Research and Development Authority (BARDA) placed a new order under the contract awarded in 2017 to Bavarian Nordic for the manufacturing and supply of Jynneos, a smallpox and monkeypox vaccine. The new award is for $202 million. It is in addition to the existing... Read More »
Bill seeks to bolster supply of personal protective equipment
Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) recently introduced a measure designed to increase the nation’s supply of personal protective equipment (PPE) and other medical supplies. The COVID-19 Emergency Manufacturing Act authorizes the federal government to manufacture... Read More »
Lockheed Martin secures more than $6B Army missile contract
Global security and aerospace company Lockheed Martin has secured a $6.07 billion Army contract to produce Patriot Advanced Capability-3 (PAC-3) Missile Segment Enhancement (MSE) interceptors and associated equipment. "This contract demonstrates our customer's continued confidence in our ability... Read More »
CEPI funding helps INOVIO, Richter-Helm expand manufacturing of COVID-19 DNA vaccine
Thanks in part to another $1.3 million of funding granted by the Coalition for Epidemic Preparedness Innovations (CEPI), an agreement between INOVIO and Richter-Helm BioLogics will expand to support large-scale manufacturing of investigational COVID-19 vaccine INO-4800. INOVIO originally made... Read More »
Senate Democrats increase investigative pressure over removal of BARDA’s director
Among Senate Democrats, concerns are growing that political influence and interference at the Department of Health and Human Services (HHS) played a role in the removal of Dr. Rick Bright from the helm of the Biomedical Advanced Research and Development Authority (BARDA) earlier this month. In a... Read More »
Senate Democrats introduce bill to set framework for federal COVID-19 response
Senate Democrats introduced legislation that lays out a framework for a coordinated federal response to the COVID-19 pandemic. The Medical Supply Transparency and Delivery Act requires the president to utilize all available authorities under the Defense Production Act to mobilize a federal... Read More »
Bipartisan group in Congress urge action on antibiotic resistance
Several Congressional leaders in the U.S. House of Representatives are urging federal government officials to take action on the recommendations made by the Government Accountability Office (GAO) on the problem of antibiotic resistance. Antibiotic resistance occurs when germs develop the ability... Read More »
Mosquito-derived disease guidance issued
A group of organizations jointly released guidance concerning mosquito-based diseases. The International Atomic Energy Agency (IAEA), the Food and Agriculture Organization of the United Nations (FAO), the Special Programme for Training and Research of Tropical Diseases (TDR) and the World Health... Read More »
NIH launches $1.5B national initiative meant to hasten COVID-19 tests
The National Institutes of Health (NIH) recently launched the $1.5 billion Rapid Acceleration of Diagnostics (RADx) initiative, to infuse funding into innovative technologies aimed at speeding innovation, development, and commercialization of reliable COVID-19 tests. Those technologies need... Read More »
Entos, EpiVax partner on development of pan-coronavirus DNA vaccine
Biotechnology companies Entos Pharmaceuticals and EpiVax, Inc. announced a partnership this week dedicated to the development of a pan-coronavirus DNA vaccine. "We are excited to be working with the exceptional team at EpiVax, whose computational approach to optimizing vaccine design is second... Read More »
ICE launches web page to help combat COVID-19 fraud
U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) launched a new web page with information on COVID-19 related fraud schemes. The web site -- called Operation Stolen Promise -- will also highlight the investigative efforts the agency is taking to counter... Read More »
Congressional Democrats seek answers from ATF on efforts to track “ghost guns”
A group of Democrats in Congress are asking the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) about measures the agency has taken to keep homemade firearms – or ghost guns -- from falling into the wrong hands during the COVID-19 pandemic. “While the surge in firearm sales from... Read More »
HHS funds target rural COVID-19 resources
The Department of Health and Human Services (HHS) said nearly $165 million has been earmarked to help rural communities combat the COVID-19 pandemic. The funding allotment via the Health Resources and Services Administration (HRSA) seeks to assist 1,779 rural hospitals while providing additional... Read More »
IDSA develops antibody testing primer for SARS-CoV-2
The Infectious Diseases Society of America (IDSA) has released a primer regarding SARS-CoV-2 serology antibody testing, as well as the research and policy questions the effort raises. “As serological testing for SARS-CoV-2 advances, there are multiple issues that need to be addressed, from... Read More »
Phase 3 trials of Gilead’s remdesivir show promise on COVID-19 patients treated early
The Phase 3 SIMPLE trial of Gilead Sciences Inc’s antiviral drug remdesivir has reached its primary endpoint, supplying positive data that COVID-19 patients administered the drug early fared better than those treated later. From 397 patients, the study revealed that 62 percent of patients... Read More »