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The Biden administration announced an agreement with Pfizer Inc. last week that will provide 10 million courses of the company’s COVID-19 oral antiviral Paxlovid, pending Emergency Use Authorization or approval by the United States Food and Drug Administration (FDA).
“This promising... Read More »
U.S. Sens. Dianne Feinstein (D-CA), Michael Bennet (D-CO), and Mike Crapo (R-ID) introduced this week an amendment that would formally authorize the National Guard’s Fireguard program and alter its year-by-year approval structure to a more certain, five-year authorization.
The senators argued... Read More »
According to updates from AstraZeneca, the company and its partners managed to provide 2 billion doses of its COVID-19 vaccine to more than 170 countries within 11 months of its first approval and a little more than 18 months after AstraZeneca partnered with Oxford University on... Read More »
The United Nations-backed Medicines Patent Pool (MPP) gained access to Pfizer Inc.’s COVID-19 oral antiviral treatment candidate PF-07321332 this week, enabling the organization to produce and distribute the drug to generic sub-licensers for greater global access.
MPP intends to increase... Read More »
Ronapreve, a Roche and Regeneron-developed drug cocktail of casirivimab and imdevimab, gained marketing authorization from the European Commission last week for treatment of COVID-19 cases before hospitalization among adults and adolescents at least 12 years old.
Ronapreve can now be used in... Read More »
Data from the latest global survey on implementation of the Global Action Plan on addressing antimicrobial resistance (AMR) showed that more countries than ever are determined to fight AMR, but also major setbacks caused by the COVID-19 pandemic.
Of the 163 countries that responded to the survey... Read More »
President Joe Biden on Nov. 12 announced he will nominate cardiologist Dr. Robert Califf to be the next commissioner of the U.S. Food and Drug Administration (FDA), a key role as the government continues to combat the ongoing coronavirus pandemic. Current Acting FDA Commissioner Janet Woodcock’s... Read More »
A new effort by the COVAX Facility -- the COVAX Humanitarian Buffer -- received a shot in the arm this week through a new agreement with Johnson & Johnson, which will bring its single-shot COVID-19 vaccine to bear to help approximately 167 million displaced people around the world.
COVAX -- the... Read More »
The U.S. Department of Health and Human Services announced on Wednesday that it would be investing $650 million from the American Rescue Plan to strengthen the manufacturing capacity for quality diagnostic testing through rapid point-of-care molecular tests and increase Americans’ access to them.... Read More »
For at least eight months following a single dose, the REGEN-COV COVID-19 drug cocktail developed by Regeneron Pharmaceuticals, Inc. could provide affiliated risk reductions of 81.6 percent, according to a new analysis of a Phrase 3 trial.
That trial, jointly run by Regeneron and the National... Read More »
Reckoning with the more the 750,000 Americans killed by the COVID-19 pandemic, the failures that stalked response, and the threat of future outbreaks, a bipartisan collection of four senators introduced a new bill last week to build a 9/11-style commission charged with investigating the outbreak... Read More »
Last week, U.S. Reps. Ami Bera (D-CA), M.D. and Don Young (R-AK) introduced a bill to reauthorize a national tuberculosis strategy, authorize grants for state health departments to focus on TB in high-risk populations, and promote interagency coordination in containing the disease.
Despite the... Read More »
The antiviral Molnupiravir became the first oral treatment for COVID-19 to receive authorization this week, winning approval from the U.K.’s Medicines and Healthcare Products Regulatory Agency for treatment of mild-to-moderate COVID-19 cases in adults.
Specifically, users must have had at... Read More »
Republican U.S. senators took aim at the Biden administration’s ongoing response to the COVID-19 epidemic during a Thursday hearing, criticizing the new mandate on vaccinations and blaming federal policies for shortages of therapeutics, testing and other critical materials.
“Cases and... Read More »
A Q2 Solutions Co., Ltd. lab facility in Beijing, China, became the first East Asian lab to join the Coalition for Epidemic Preparedness Innovations’ (CEPI) centralized COVID-19 lab network this week.
“I am delighted to today welcome Q2 Solutions’ facility in Beijing to this group of... Read More »
The failures, successes, and lessons learned from the rollout of COVID-19 vaccines should be incorporated immediately into future pandemic vaccine planning if the world hopes to avoid the delays and pitfalls of the modern ecosystem, according to a new report from the Johns Hopkins Center for Health... Read More »
Last week, the U.S. Food and Drug Administration (FDA) notified Moderna, Inc. that an assessment of an emergency use authorization request for its COVID-19 vaccine to be used on adolescents may not be completed before January 2022.
The delay was due to a stated necessity to evaluate recent... Read More »
The Access to COVID-19 Tools (ACT) Accelerator released a new strategic plan last week that seeks $23.4 billion from international investors by September 2022 to patch inequalities in access to COVID-19 tests, treatments, vaccines, and personal protective equipment.
This is particularly... Read More »
According to a new report from the Global Preparedness Monitoring Board (GPMB), the world is broken in its inequality, division, and lack of accountability, making a health emergency ecosystem incapable of ending the COVID-19 pandemic or preventing another.
The opportunity for reform is... Read More »
With the investment of $26 million announced this week, the Centers for Disease Control and Prevention (CDC) hopes to modernize the science of infectious disease prediction and analytics.
The first investments from CDC’s Center for Forecasting and Outbreak Analytics (CFA) -- which is expected... Read More »
Legislation from U.S. Reps. Lori Trahan (D-MA) and David B. McKinley (R-WV) will be considered in an upcoming hearing hosted by the House Energy and Commerce Committee’s Health Subcommittee, the legislators said Monday.
The Bolstering Infectious Outbreaks (BIO) Preparedness Workforce Act... Read More »
The Biden-Harris administration has reprioritized global health security at the top of America’s national security agenda in efforts to end the COVID-19 pandemic and bolster health systems worldwide by improving preparation, prevention, detection, and response to the next public health... Read More »
In recent weeks, the U.S. Department of Health and Human Services (HHS) has invested more than $562 million into U.S. companies to boost domestic manufacturing of COVID-19 tests and supplies.
These funds, pulled from the American Rescue Plan Act, have benefited supplies such as pipette tips,... Read More »
Lawrence Livermore National Laboratory (LLNL) announced it had joined the international Human Vaccines Project (HVP) Thursday, bringing its expertise and computing resources to the project to aid the development of a universal coronavirus vaccine and to improve understanding of immune response.... Read More »
Recognizing the delays that have plagued low-income countries at nearly every aspect of the COVID-19 pandemic, the Bill & Melinda Gates Foundation announced this week a pledge of up to $120 million to accelerate access to the antiviral drug molnupiravir among low-income nations.
Molnupiravir is... Read More »
The U.S. House of Representatives on Wednesday voted 397-22 to approve a bipartisan bill that aims to reform how the Strategic National Stockpile (SNS) is administered and managed. The legislation now heads to the U.S. Senate for consideration.
The Strengthening America’s Strategic National... Read More »
U.S. Sen. Rob Portman (R-Ohio), the ranking member of the Senate Homeland Security and Governmental Affairs Committee, grilled Tucson Police Chief Chris Magnus, President Joe Biden’s nominee for Commissioner of the U.S. Customs and Border Protection (CBP), on the need for enhanced border security... Read More »
Fed up with the dangers of an unprepared and underfunded public health system, U.S. Sen. Patty Murray (D-WA) voiced support this week for a fiscal year 2022 bill that would increase Centers for Disease Control and Prevention (CDC) funding by $1.85 billion.
The bill, released by the Labor, Health... Read More »
The World Health Organization (WHO) reported last week that tuberculosis (TB) deaths rose for the first time in more than a decade as COVID-19 continues to impact the world.
According to WHO, approximately 1.5 million people died as a result of TB in 2020. The organization noted that fewer... Read More »
On Thursday, the U.S. Department of Homeland Security (DHS) Science and Technology Directorate (S&T) announced it would be joining several agencies in New York City to conduct above-ground and below-ground air sampling studies.
The studies will help urban areas prepare for and recover from... Read More »
The all-star team of government officials, scientists and industry executives who tackled COVID-19 made great strides in the development of an effective vaccine against the novel virus, but that is no guarantee that the United States will be ready for the next pandemic that rears its head, speakers... Read More »
Shortly after the terrorist events of Sept. 11, 2001, letters containing deadly anthrax spores arrived at locations across the country, killing five Americans and sickening 17 others. Twenty years after these incidents, considered the worst biological attacks in U.S. history, the federal government... Read More »
In a letter to high-ranking members of the Biden Administration’s COVID-19 response efforts, three Democratic senators and representatives this week urged a cautious review of the United States Health and Human Services (HHS) contract with Moderna, Inc. and called for efforts to expand global... Read More »
Through exercise of an option with Moderna, Inc., Gavi, the Vaccine Alliance will purchase another 176.5 million doses of the company’s COVID-19 vaccine in an effort to help low income countries over the course of the next year, through the COVAX Facility.
With this purchase, COVAX will have... Read More »
A group of United States senators last week reintroduced an effort to update the Volunteer Protection Act of 1997 and extend legal protections for medical volunteers working in federally-recognized disaster relief efforts.
Authored by U.S. Sens. Marsha Blackburn (R-TN), Bill Cassidy (R-LA) and... Read More »
