Emerging Infectious Diseases
The U.S. Food and Drug Administration (FDA) granted this week marketing authorization of the BioFire Respiratory Panel 2.1, allowing it to become the first SARS-CoV-2 diagnostic able to be marketed past the ongoing COVID-19 pandemic.
BioFire Respiratory Panel 2.1 is a test by BioFire Diagnostics... Read More »
Moderna announced Tuesday that it has started its study of the COVID-19 vaccine in children.
Called the KidCOVE study, Moderna began Phase 2/3 of its study by administering the vaccine in children from 6 months to less than 12 years of age. The study is being done in collaboration with the... Read More »
Roche recently announced the launch of a new cobas SARS-CoV-2 Variant Set 1 Test to detect and differentiate between viral variants, recognizing the growing prevalence of SARS-CoV-2 variants, such as those first seen in the United Kingdom, South Africa, and Brazil.
“Viruses naturally evolve... Read More »
AstraZeneca announced plans this week to supply up to 500,000 additional doses of AZD7442, an under-development, long-acting antibody combination meant for use against COVID-19, modifying an existing agreement with the U.S. government.
Specifically, the agreement was reached with the Departments... Read More »
Sens. Susan Collins (R-ME) and Bob Menendez (D-NJ) are advocating legislation that would create a COVID-19 Commission modeled after a similar panel that examined the Sept. 11, 2001, terror attacks.
The National Coronavirus Commission Act of 2021 would establish an independent, non-partisan... Read More »
Sanofi Pasteur and Translate Bio launched a Phase 1/2 clinical trial last week for an mRNA COVID-19 vaccine candidate known as MRT5500, hoping for interim results in the third quarter of 2021.
The united efforts of the vaccine and mRNA therapeutics companies include parallel preclinical studies... Read More »
The first candidates were dosed this week as part of a phase one study of mRNA-1283, a new mRNA COVID-19 vaccine from Moderna, Inc.
Unlike its predecessor, which has proved highly effective against the original strain of the virus, this new vaccine candidate is meant to solve a major hiccup to... Read More »
Drugmaker AstraZeneca defended the safety of its COVID-19 vaccine after three more European countries said they would suspend the use of the vaccine.
Over the weekend, Germany, Ireland, and The Netherlands announced they would stop using the vaccine temporarily over concerns about the vaccine's... Read More »
World Health Organization (WHO) officials recently touted the progression of the ACT- Accelerator, noting the initiative has driven progress to accelerate the end of the COVID-19 pandemic.
The initiative was initiated in April 2020 by the WHO, the European Commission, France, and The Bill &... Read More »
Results are in from the latest trials of NVX-CoV2373, Novavax, Inc.’s COVID-19 vaccine candidate, and while it only provided 55.4 percent efficacy in a region beset by the South African variant, it displayed 96.4 percent efficacy against the original strain and 86.3 percent against the United... Read More »
In a study funded by the Mayo Clinic and published in the journal Clinical Infectious Diseases last week, researchers determined that after two doses of mRNA vaccines for COVID-19, asymptomatic patients are less likely to be infected and unknowingly spread the virus.
After two doses of mRNA... Read More »
The single-shot Johnson & Johnson COVID-19 vaccine will be available in more places worldwide now, thanks to a conditional marketing authorization granted by the European Commission and emergency use authorization from the World Health Organization (WHO).
The decisions followed similar approval... Read More »
The National Institutes of Health (NIH) is espousing the benefits of an AEG 12 mosquito protein study authorities said could help develop treatments to combat life-threatening viruses.
Researchers at the NIH's National Institute of Environmental Health Sciences (NIEHS) used X-ray crystallography... Read More »
A study focused on determining whether patients would benefit from a booster for the Moderna, Inc. COVID-19 vaccine has enrolled and dosed its first participants this week.
Moderna’s mRNA COVID-19 vaccine is currently in use across the U.S. and has shown high efficacy against the original... Read More »
Building on its efforts during the ongoing COVID-19 pandemic, the Coalition for Epidemic Preparedness Innovations (CEPI) has proposed a $3.5 billion plan to reduce or eliminate future pandemic and epidemic risk through preparedness investment over the next five years.
The organization has sought... Read More »
A professor from Johns Hopkins Center for Health and Security testified before the Maryland General Assembly on the certification of gene synthesis providers and manufacturers of gene synthesis equipment.
Dr. Gigi Gronvall -- senior scholar at the Johns Hopkins Center for Health Security and... Read More »
Research and development company Battelle announced Tuesday that it had developed a microneutralization assay that uses live SARS-CoV-2 virus to analyze the neutralizing response against the virus in human serum samples.
The assay allows the company to test samples from vaccine clinical trials.... Read More »
CARB-X could award up to $3.5 million, plus up to $18.5 million for successful development milestones, to Affinivax for a vaccine for Staphylococcus aureus bacterial infections, for which treatment options are currently limited.
No vaccine presently exists for S. aureus, despite the high threat... Read More »
U.S. Sen. Jacky Rosen (D-NV) recently co-sponsored legislation to fund the Prevention and Public Health Fund (PPHF), which includes programs aimed and preventing and responding to pandemics.
The Public Health Funding Prevents Pandemics Act would ensure the PPHF, part of the Affordable Care Act,... Read More »
Valneva and Pfizer are getting set to launch a new Phase 2 study on VLA-15, their vaccine candidate for Lyme disease.
The study, VLA15-221, builds on previous positive Phase 2 studies. It incorporates new dose regimens and is anticipated to be the final Phase 2 study before deciding to progress... Read More »
According to a new report from the U.S. Centers for Disease Control and Prevention (CDC) and the University of Utah, the costs of antibiotic resistance among diseases are growing, leading to billions of dollars in health care costs and increasing rates of infections.
According to “National... Read More »
A new deal reached between Baxter BioPharma Solutions and Moderna, Inc. this week will see Baxter handle fill/finish services for Moderna’s COVID-19 vaccine in the United States, ultimately providing between 60-90 million doses this year.
Baxter’s Indiana facility will handle the... Read More »
A molecular test for COVID-19 can now be used at home without a prescription, following the U.S. Food and Drug Administration’s (FDA) granting of emergency use authorization (EUA) to the Cue COVID-19 Test for Home and Over the Counter (OTC) Use.
A molecular nucleic acid amplification test... Read More »
The preliminary results of a Phase 2a randomized, double-blind trial of the Merck and Ridgeback Biotherapeutics-created oral antiviral for the treatment of COVID-19, molnupiravir, have shown the ability to quickly decrease the infectious virus among patients.
While full results are pending, this... Read More »
Through a deal between the World Health Organization and others with GSK, a rotavirus vaccine will be available to more children living in low-income nations facing humanitarian crises.
The agreement makes use of the multi-partner Humanitarian Mechanism, launched in 2017, where manufacturers... Read More »
New research from the Washington University School of Medicine in St. Louis seemingly confirms scientists' and health experts' worst fear that all three of the prominent, fast-spreading variants of COVID-19 can resist vaccines and antibodies currently effective against their forebear.
Published... Read More »
Under a new agreement, Novartis will manufacture the mRNA and bulk drug product for CureVac’s CVnCoV vaccine candidate for COVID-19, with a goal of up to 50 million doses by the end of 2021.
“I am very pleased that with Novartis, we have found another highly experienced partner to support... Read More »
Research from Battelle shows that wastewater analysis can pinpoint neighborhoods that are hotspots for viral outbreaks of COVID-19.
A preliminary report was preprinted on Feb. 20 in the MedRxIv found that by testing wastewater for the presence of SARS-COV-2 and other pathogens, they were able... Read More »
In a new study published on bioRxiv, Soligenix, Inc. reported that its CiVax COVID-19 vaccine demonstrated rapid, broad-spectrum, neutralizing antibody and immunity onset in preclinical studies.
The head stable vaccine used full-length Spike protein antigens to do its work, and at least in... Read More »
The Biomedical Advanced Research and Development Authority (BARDA) and Hologic, Inc. are working together to develop the Panther Fusion SARS-CoV-2/Flu/RSV assay, intended to be able to simultaneously detect and differentiate a variety of viruses from a single sample.
While SARS-CoV-2 is a major... Read More »
The biopharmaceutical company AstraZeneca said it has initiated steps to provide broad and equitable access to the COVID-19 vaccine, noting doses have begun arriving globally in low and middle-income countries.
“These first steps towards fulfilling our broad, equitable, and no-profit emergency... Read More »
A team, including GE Research, the Broad Institute, DNA Script, MEDInstill, Molecular Assemblies, and the University of Washington, has been awarded a five-year, up to $41 million contract from the Defense Advanced Research Projects Agency (DARPA) to create a new, quicker vaccine production... Read More »
The COVID-19 pandemic has hit a critical stage, according to the Infectious Diseases Society of America (IDSA), and as such, the $1.9 billion American Rescue Plan touted by the Biden Administration and advanced by the House last week represents a welcome boost.
“This legislation represents... Read More »
In what Johnson & Johnson CEO Alex Gorsky called a great example for the larger pharmaceutical industry, the company has reached a deal with fellow pharmaceutical giant and oft-rival Merck that will unite the pair’s resources to produce Johnson & Johnson’s new COVID-19 vaccine.
Faced... Read More »
The Biden administration helped forge a deal between Merck and Johnson & Johnson (J&J) to expand production of J&J’s COVID-19 vaccine, which is expected to help the company deliver 100 million doses by the end of May instead of its previous June goal.
The collaboration between the... Read More »
