Emerging Infectious Diseases
International organizations, vaccine manufacturers agree to intensify vaccine delivery
Leaders of several international organizations including the International Monetary Fund, World Bank Group, the World Health Organization and the World Trade Organization met with the CEOs of leading vaccine manufacturing companies to discuss way to improve low- and lower-middle income countries’... Read More »
New clinical data shows Moderna COVID-19 vaccine still highly effective against variants
According to new data from clinical trials highlighted by Moderna, Inc. this week, its debut COVID-19 vaccine, mRNA-1273, continues to be highly effective against COVID-19, providing 96 percent efficacy against hospitalization and 87 percent against infection. The data -- from a study at Kaiser... Read More »
DOD funds earmarked for additional monoclonal antibodies doses
Regeneron Pharmaceuticals, Inc. and Eli Lilly and Company have secured Department of Defense (DOD) contracts to produce additional doses of monoclonal antibodies to block the infectivity of SARS-CoV-2. Authorities indicated the $3.2 billion total allotment is in coordination with the Department... Read More »
WHO, global health leaders in plea for accelerated vaccination efforts in Africa and abroad
Vaccine equity is in need of a boost globally, and in Africa in particular, and unless that changes, World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus and other health leaders said this week the COVID-19 pandemic may never end. Cooperation is the key to ending the... Read More »
BARDA taps procurement option for approximately $112.5 million of SIGA oral smallpox treatment
Through a contract with SIGA Technologies, Inc., the Biomedical Advanced Research and Development Authority (BARDA) has exercised a procurement option to obtain approximately $112.5 million worth of the oral TPOXX smallpox treatment this year. TPOXX is an orally administered and IV formulation... Read More »
Emergent BioSolutions, Providence Therapeutics sign development, manufacturing agreement for COVID-19 vaccine
Gaithersburg, Md.-based Emergent BioSolutions Inc. and Canadian vaccine company Providence Therapeutics said on Tuesday they have entered into a $90 million, five-year development and manufacturing agreement to support Providence’s COVID-19 messenger RNA (mRNA) vaccine candidate. Already... Read More »
Biden plans global COVID response summit as lawmakers call for increased vaccine aid
The Biden administration seeks an international summit on COVID-19 pandemic responses and to form a united global front for vaccination efforts, a proposal that could impact vaccine manufacturing, supply chains and even the upcoming United Nations General Assembly. Closer to home, though, U.S.... Read More »
Novavax launches Phase 1/2 trial to chart immunogenicity, safety of combo-COVID-19 and flu vaccine
Novavax, Inc. began enrollment last week of the first participants for a Phase 1/2 clinical trial to assess the safety and immunogenicity of a combination vaccine formed from the company’s seasonal influenza and COVID-19 vaccines. Each vaccine has already been tested in solo clinical trials up... Read More »
Moderna signs multi-year COVID-19 vaccine manufacturing agreement with National Resilience
Under the terms of a new, multi-year agreement reached this week between Moderna and National Resilience, National Resilience will produce mRNA for Moderna’s COVID-19 vaccines at its Mississauga, Ontario facility. “Moderna’s COVID-19 vaccine has saved countless lives, and we’re excited... Read More »
COVAX predicts 2 billion doses of COVID-19 vaccine in first quarter 2022, calls for further support
In its latest Supply Forecast, the multilateral vaccine equity program COVAX announced expectations of 1.425 billion doses of COVID-19 vaccines available this year, with 2 billion doses available for delivery in the first quarter of 2022 -- a milestone, but still a lagging figure. Resulting from... Read More »
Caucus targets U.S.-spearheaded global vaccination effort
A group of lawmakers launched the COVID-19 Global Vaccination Caucus, which they said would advocate for vaccines as a means of ending the COVID-19 pandemic. Reps. Raja Krishnamoorthi (D-IL), Pramila Jayapal (D-WA), Tom Malinowski (D-NJ), Mark Pocan (D-WI) and Jake Auchincloss (D-MA) along with... Read More »
DoD uses option to acquire 200,000 doses of Valneva’s Japanese encephalitis vaccine
As part of a contract signed with Valneva SE last year, the United States Department of Defense (DoD) has decided to utilize an option that will increase supply of the company’s Japanese encephalitis vaccine, IXIARO, to a minimum of 200,000 doses. Japanese encephalitis is a deadly infectious... Read More »
Bipartisan Commission on Biodefense lauds Biden’s Pandemic Preparedness Plan, but urges more funding
The Bipartisan Commission on Biodefense last week applauded the Biden Administration’s work on a new $65.3 billion American Pandemic Preparedness Plan for investments to combat the next biological threat, though it argues that greater funding is necessary to make sufficient plans. The White... Read More »
Argonne National Lab collaborations yield better understanding of SARS-CoV-2 proteins
Thanks to collaborations with commercial and academic research partners alike, the Argonne National Laboratory has published new research showing the capabilities of artificial intelligence and simulation workflows to provide insight to the SARS-CoV-2 viral genome and potentially fuel drug... Read More »
Phase 3 trial begins for SK bioscience and GSK COVID-19 vaccine candidate
Approximately 4,000 people from all over the world will be enrolled in a Phase 3 trial of a combined SK bioscience and GlaxoSmithKline plc (GSK) adjuvanted COVID-19 vaccine candidate beginning this week. The trial will combine the SK COVID-19 vaccine candidate GBP510 with GSK’s pandemic... Read More »
DOD awards contracts for COVID-19 test kits and pipette tips
The Department of Defense (DOD) has awarded $194.5 million across two contracts for COVID-19 test kits and pipette tips. The awards, made in conjunction with the Department of Health and Human Services (HHS), were funded via the American Rescue Plan Act (ARPA) to support domestic industrial base... Read More »
DOD grants $6.5 million award for polyester-tipped swab production
U.S. Cotton, LLC has secured a $6.5 million Department of Defense (DOD) contract to increase domestic production of polyester-tipped swabs used in COVID-19 home test kits. The effort, in accordance with the Department of Health and Human Services, would also aid COVID-19 mass testing... Read More »
BARDA program seeks to expand development of digital health tools and at-home diagnostic tests
Thinking up ways to better address future public health emergencies, the Biomedical Advanced Research and Development Authority’s (BARDA) Division of Research, Innovation and Ventures (DRIVe) has expanded a partner program focused on technology development to include digital health tools and... Read More »
CDC issues health advisory over risks and mounting illnesses linked to Ivermectin as COVID-19 treatment
Although a United States Food and Drug Administration (FDA)-approved prescription medication, the Centers for Disease Control and Prevention (CDC) issued a warning last week that the drug ivermectin is not meant to be used for prevention or treatment of COVID-19. Failing to heed that warning... Read More »
NIH begins study of extra COVID-19 vaccine dose effects on people with autoimmune disease
The National Institutes of Health (NIH) began a Phase 2 clinical trial last week to investigate any antibody response generated by an extra dose of authorized/approved COVID-19 vaccines among patients with autoimmune disease who experienced no response from a previous vaccine regimen. The... Read More »
Pandemic Action Network proposes financing global pandemic preparedness through UN-run fund
A new policy brief released this month by the advocacy group Pandemic Action Network (PAN) calls on world leaders to create a 100-day action plan toward creating a new financing mechanism at the United Nations General Assembly capable of bolstering pandemic preparedness by at least $10 billion... Read More »
Phase 3 trial for INOVIO COVID-19 vaccine candidate authorized to proceed in Brazil
INOVIO received the green light for phase three of its INNOVATE Phase 2/3 clinical trial of INO-4800 last week, allowing it to proceed with efficacy evaluation of its COVID-19 DNA vaccine candidate in Brazil. Alongside its partner, Advaccine Biopharmaceuticals Suzhou Co., Ltd., INOVIO intends to... Read More »
Zalgen to supply Lassa Fever antibody testing kits for CEPI study in West Africa
The largest ever Lassa Fever study in West Africa secured the means of testing this week, thanks to a contract between the Coalition for Epidemic Preparedness Innovations (CEPI) and Zalgen Labs LLC, which will supply antibody testing kits for up to 7,000 participants. Zalgen, a biotechnology... Read More »
Trial data shows Johnson & Johnson COVID-19 booster shot provides sizeable antibody uptick
New data released by Johnson & Johnson this week showed that using its single-shot COVID-19 vaccine as a booster for the previously vaccinated could provide as much as a nine-fold increase in antibodies for patients at least 18 years old. The news follows interim reports from July, published in... Read More »
House Republicans press NIH and NIAID for further details on Wuhan Lab biosafety concerns
Republican leaders on the House Energy and Commerce Committee this week queried the director of the National Institutes of Health (NIH), Dr. Francis Collins, with more questions in the saga of the Chinese Wuhan Institute of Virology, its research and the origins of COVID-19. Writers included... Read More »
Emergent BioSolutions’ candidate part of federal trial for out-patient COVID-19 treatment
A plasma-derived COVID-19 candidate from Emergent BioSolutions Inc. is part of a late-stage federal study that will test the therapy as a potential outpatient treatment for people who are at high risk of developing severe disease, including adults 55 and older and those who are... Read More »
Phase 2/3 trial launched for Chikungunya vaccine in Costa Rica
Vaccination has begun for a Phase 2/3 trial of Bharat Biotech International Ltd’s (BBIL) Chikungunya vaccine candidate, through a partnership with the International Vaccine Institute (IVI) in Costa Rica. The Costa Rican trial of BBV87, the official name for the candidate, marks the... Read More »
BARDA accepting partners to create diagnostic assays for respiratory RNA viral pathogens
The Biomedical Advanced Research and Development Authority (BARDA) placed a call for partners this week to aid the organization in developing new sequencing-based, agnostic diagnostic tests better capable of detecting respiratory RNA viruses. Potential partners will be able to help guide the... Read More »
Moderna applies for full U.S. licensure of its COVID-19 vaccine following Phase 3 study success
With data from its Phase 3 COVE study showing a COVID-19 vaccine with 93 percent effectiveness, Moderna, Inc. has officially filed for a biologics license application (BLA) to the United States Food and Drug Administration (FDA) that would lead to full licensure. It’s an important step, which... Read More »
Soligenix demonstrates filovirus vaccine platform capabilities for multiple heat stable candidates
Through publication of data in Vaccine, this week Soligenix showcased the capabilities of its filovirus vaccine platform to formulate and provide heat stabilization for multiple antigen combinations of vaccine candidates: monovalent, bivalent, and trivalent. The single-vial platform project was... Read More »
Bavarian Nordic begins Phase 2 clinical trial of COVID-19 booster vaccine
A 210-person Phase 2 clinical trial for the COVID-19 vaccine candidate, ABNCoV2, began this week to determine its potential as a booster vaccine for those who have either caught the disease previously or been otherwise vaccinated. Licensed by Bavarian Nordic A/S and developed by AdaptVac, the... Read More »
Astra-Zeneca COVID-19 antibody therapeutic shows promise in Phase 3 trial
Results of a Phase 3 clinical trial have shown that AstraZeneca’s antibody combination for COVID-19, AZD7442, cuts the risk of symptomatic COVID-19 cases by 77 percent for at least three months. That is dependent on the treatment being taken prior to infection. However, the antibodies used in... Read More »
WHO forms new advisory group on origins of novel pathogens
With the formation of a new Scientific Advisory Group for the Origins of Novel Pathogens (SAGO), the World Health Organization (WHO) is calling for experts to lend their knowledge on the origins of pathogens with wide-reaching potential. This multidisciplinary group will consist of up to 25... Read More »
FDA grants first full COVID-19 vaccine approval to Pfizer-BioNTech
The United States Food and Drug Administration (FDA) on Monday granted full approval to Pfizer-BioNTech’s COVID-19 vaccine for use among patients 16 years and older, making it the first of the disease’s vaccines to cross beyond conditional use. Since Dec. 11, 2020, the mRNA-based vaccine had... Read More »