Emerging Infectious Diseases
Adults at least 18 years old could soon gain access to a Johnson & Johnson COVID-19 vaccine booster shot if the U.S. Food and Drug Administration (FDA) agrees with the unanimous recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Last week, in a 19-0 vote,... 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 »
The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative split $77.7 million among 12 new contract awards last week for potential, rapid SARS-CoV-2 diagnostic tests.
Part of the RADx Tech program, which gathered a panel of technical, regulatory and business... Read More »
Food and Drug Administration (FDA) officials said the agency will conduct a Nov. 30 meeting via its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss a COVID-19 oral treatment.
The FDA indicated the effort would focus on Merck and Ridgeback’s request for an emergency use authorization... Read More »
Following two successful Phase 3 trials of more than 6,000 patients, the United States Food and Drug Administration (FDA) last week accepted the Regeneron Pharmaceuticals, Inc. anti-COVID-19 cocktail known as REGEN-COV for priority review.
REGEN-COV is a mix of the antibodies casirivimab and... 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 »
The first participant in a new trial phase recently received a dose of a vaccine candidate against chikungunya disease that is being developed by Emergent BioSolutions Inc.
“Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine... Read More »
The threat detection and security screening technology firm Smiths Detection recently confirmed its BioFlash air sampler detects a series of SARS-CoV-2 variants.
Officials said the detected variants include the Alpha variant, Beta variant, Gamma variant, the Kappa variant and the Delta and Delta... Read More »
The World Health Organization (WHO) has whittled down a list of more than 700 applicants to 26 proposed members to act as expert advisors on its new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO).
These experts will advise WHO as it develops a global framework for defining... 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 National Institutes of Health (NIH) study has determined vaccinated persons with substance use disorders are more susceptible to SARS-CoV-2.
“First and foremost, vaccination is highly effective for people with substance use disorders, and the overall risk of COVID-19 among vaccinated people... Read More »
Moderna officials said the company is slated to build a messenger RNA (mRNA) facility in Africa, producing up to 500 million vaccine doses annually at the 50 microgram dose level.
“Since Moderna’s founding in 2010, our mission has been to make a transformative impact on human lives through... Read More »
VE303, an oral treatment developed by Vedanta Biosciences for patients at high risk of recurrent C. difficile infections (CDI), will get a Phase 3 clinical evaluation trial, thanks to support from the Biomedical Advanced Research and Development Authority (BARDA).
Support from the U.S. government... Read More »
The World Health Organization (WHO) has recommended the first vaccine to treat malaria in children, a mosquito-borne disease that kills more than 260,000 children under the age of five annually in sub-Saharan Africa, in what public health officials have called a historic development.
“The... Read More »
Although its COVID-19 vaccine was never authorized for use in the United States, AstraZeneca submitted a request with the U.S. Food and Drug Administration (FDA) this week seeking emergency use authorization (EUA) for its long-acting antibody (LAAB) combination for use against symptomatic... Read More »
Ending speculation, Johnson & Johnson (J&J) this week officially submitted data to the United States Food and Drug Administration (FDA) to request emergency use authorization (EUA) for a booster version of its COVID-19 vaccine among patients at least 18 years old.
Recent data showed that the J&J... Read More »
The Department of Homeland Security (DHS) completed Operation Allies Welcome (OAW), a nationwide vaccination campaign focused on Afghan evacuees temporarily housed at eight domestic military installations.
As part of the initiative, 49,000 evacuees have been immunized for measles, mumps, rubella... Read More »
The United States Department of Defense (DoD) awarded an agreement worth approximately $22 million to the biopharmaceutical developer Dynavax Technologies Corporation this week, giving it two and a half years to develop an adjuvanted recombinant plague vaccine.
That vaccine will be adjuvanted with... Read More »
According to an announcement from the United States Food and Drug Administration (FDA) last week, two upcoming meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be held next week to address the newest COVID-19 vaccine data.
These meetings will be... Read More »
Results of an interim analysis for the Phase 3 trial of molnupiravir, an investigational oral antiviral for COVID-19 produced by Merck and Ridgeback Biotherapeutics, showed the drug capable of cutting hospitalization or death risk approximately in half.
For the purposes of the trial, over the... Read More »
Safe and effective: this was the verdict of Phase 3 trial results for Regeneron Pharmaceuticals, Inc.’s REGEN-COV COVID-19 treatment, as published in the New England Journal of Medicine earlier this week.
That trial reportedly met both its primary and secondary endpoints, inducing... Read More »
U.S. Reps. Cathy McMorris Rodgers (R-WA), House Energy and Commerce Committee Republican Leader; Brett Guthrie (R-KY), Subcommittee on Health Republican Leader; and Morgan Griffith (R-VA) Subcommittee on Oversight and Investigations Republican Leader, have asked information on breakthrough cases of... Read More »
Reckoning with the dangers of further viruses like SARS-CoV-2, the National Institute of Allergy and Infectious Diseases (NIAID) this week awarded approximately $36.3 million to three academic institutions to help research into vaccines for coronaviruses and their variants.
The end goal is to... Read More »
In a letter dispatched to Congress this week, 24 stakeholder organizations urged Congressional leaders to back the $16 billion funding level for pandemic preparedness advanced by the House Energy and Commerce Committee earlier this year.
That funding was attached as part of the Build Back Better... Read More »
The U.S. Food and Drug Administration (FDA) remains without permanent leadership during the nation’s ongoing battle against the COVID-19 pandemic.
“It's of top concern that President Biden still has not nominated someone to serve as permanent FDA commissioner,” a House Energy and Commerce... Read More »
The World Health Organization (WHO) approved Regeneron Pharmaceuticals’ drug cocktail of casirivimab and imdevimab for use on COVID-19 patients last week, but that endorsement came with a caveat: it urged lower prices, patent releases and equitable distribution.
The Regeneron antibody... Read More »
Several Senate Republican leaders recently expressed “growing concern” over the nation’s stalled progress in fighting the ongoing COVID-19 pandemic and requested details on how the Biden administration plans to move forward during the coming months.
U.S. Senate Minority Leader Mitch... Read More »
At the United States-hosted Global COVID-19 Summit last week, world leaders recommitted to guaranteeing equitable vaccine access for all countries through COVAX, and pledged a mix of funds, doses and supply chain aid to ensure it.
“Science has made huge progress in the fight to save lives,... Read More »
A cooperative effort was enacted against zoonotic diseases this week, with an agreement reached between the International Atomic Energy Agency (IAEA) and France’s Preventing Zoonotic Disease Emergence (PREZODE) initiative.
Members of the IAEA’s Zoonotic Disease Integrated Action (ZODIAC)... Read More »
The Mexican government approved biotechnology company INOVIO to begin a Phase 3 efficacy trial of its COVID-19 DNA vaccine candidate, INO-4800, this week alongside its partner Advaccine Biopharmaceuticals Suzhou Co., Ltd.
This Mexican trial is part of a larger, worldwide Phase 2/3 trial known as... Read More »
The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association (HIVMA) announced that it supports the Biden Administration’s movements in making the COVID-19 vaccines accessible around the world, but said more could be done to achieve vaccine equity.
In a letter to the... Read More »
While falling short of the full authorization Pfizer Inc. and BioNTech SE have clamored for, the United States Food and Drug Administration (FDA) has amended existing emergency use authorization (EUA) for the companies’ COVID-19 vaccine to allow a single booster dose for certain... Read More »
In a letter drafted in advance of the COVID-19 international summit being hosted by President Joe Biden, a group of United States senators and representatives pressed the president this week to commit resources to advancing vaccination efforts worldwide.
The urging from members of Biden’s own... Read More »
The Nuclear Threat Initiative (NTI) commended President Joe Biden for hosting a Global COVID-19 Summit and encouraged those participating in the summit to commit to stemming the impacts of the pandemic around the world.
NTI -- a nonprofit, nonpartisan global security organization focused on... Read More »
