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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 »
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 »
The Centers for Disease Control and Prevention (CDC) announced Tuesday that it has awarded $22 million to nearly 30 organizations across the globe to combat antimicrobial resistance (AR) and other healthcare threats.
The CDC also established two new networks – the Global Action in Healthcare... 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 »
Clinical stage biopharmaceutical company Heat Biologics, Inc. recently unveiled a new cellular vaccine platform that it says is designed to allow quicker manufacturing, greater stockpiling and customizability suited to combating a wide range of biological threats.
The emergence of the Omicron... Read More »
Preliminary results from a Phase 2 mix and match trial of the Johnson & Johnson COVID-19 booster vaccine are in, and they determined that administered six months after a vaccination routine of BioNTech and Pfizer’s BNT162b2, both antibody and T-cell responses rise.
The independent study,... Read More »
As part of a trial co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and Medigen Vaccine Biologics Corp. (MVC), researchers will mix and match COVID-19 boosters focusing on combinations of MVC’s vaccine candidate and others.
“As we strive to stay one step ahead of... Read More »
U.S. Sens. Gary Peters (D-MI), Rob Portman (R-OH), and Alex Padilla (D-CA) introduced legislation Wednesday that would increase the transparency in what the federal government spends money on when it comes to disasters and emergencies – including pandemics, wildfires, and flooding.
The... Read More »
A 13-10 vote by the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) set the stage for recommending Emergency Use Authorization of the Merck and Ridgeback Biotherapeutics oral COVID-19 antiviral molnupiravir this week.
The narrow backing followed a... Read More »
As the world continues to realign its approach and expectations in the wake of the emergence of the Omicron variant of COVID-19 in South Africa last week, U.S. Rep. Raja Krishnamoorthi (D-IL) took the opportunity to renew calls for expanding U.S. vaccine aid to other nations.
“The emergence of... Read More »
Moderna announced last week a strategy for addressing the new Omicron variant of COVID-19, including a new booster vaccine and studies of boosters that have already anticipated its mutations.
The rushed strategy announcement came in the wake of closing borders and the World Health... Read More »
Federal agencies, Congress and the White House must jointly foster improved research and development for pandemic preparedness and response, experts said during a recent webinar hosted by the Capitol Hill Steering Committee on Pandemic Preparedness & Health Security.
“Over the last two... Read More »
In facing down a future of potential biological dangers, a new report from authors at NTI | bio recommended concrete action at the national and international level, from new oversight agencies to process overhauls and funding, to improve prevention and response.
In “Strengthening Global... Read More »
With COVID-19 daily emphasizing how critical health care workers are to modern society, a collection of U.S. senators this week proposed a student loan repayment program to drive recruitment and retention in the field of public health.
The BIO Preparedness Workforce Act was introduced by U.S.... Read More »
A bicameral effort from United States Rep. Rosa DeLauro (D-CT) and Sen. Edward Markey (D-MA) rebirthed the Flu Vaccine Act last week, which proposes a $1 billion investment into the National Institutes of Health (NIH) for research of a universal flu vaccine.
Such a vaccine would theoretically... Read More »
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 »