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UNICEF recently confirmed that more than 550,000 doses of a World Health Organization (WHO)-recommended malaria vaccines arrived in the Republic of Sierra Leone.
Malaria burden is significant in Sierra Leone as it accounts for over two million hospital visits per year, of which children under five years of age account for one million of these cases.
This vaccine-preventable disease accounts for about 25% of child deaths in this West African country.
These vaccinations are essential as exposure to malaria parasites does not confer lifelong protection, unlike other mosquito-transmitted diseases.
Announced on December 15, 2023, this shipment, worth $ 5.5 million, follows the shipment of over 330,000 doses to Cameroon. These shipments signal the scale-up of vaccination against malaria across the highest-risk areas on the African continent.
As of December 24, the WHO and the European Medicines Agency recommended the Mosquirix™ (RTS,S/AS01) and R21 / Matrix-M™ malaria vaccines. These vaccines have been added to the WHO's list of prequalified vaccines.
These malaria vaccines are not yet available in the Region of the Americas, which includes the United States.
Following the discovery of Human Immunodeficiency Virus (HIV) as a causative agent of AIDS, multiple vaccine-candidate clinical trials have been conducted over the past 35 years.
According to the authors of a new study published in the journal Science, future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to stimulate the immune system further.
These researchers wrote on December 14, 2023, that the potential of an HIV vaccine might be better judged by measuring how it affects CD8+ T-cell function and sensitivity in addition to just assessing the number of CD8+ T cells generated, which has been the usual practice.
These findings build on decades of research by the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation to better understand the immune response to HIV.
The insights from this study may help guide future preventive and therapeutic HIV vaccine design and development and HIV immunotherapy approaches.
Mark Connors, M.D., chief of the HIV-Specific Immunity Section of NIAID’s Laboratory of Immunoregulation, is available to discuss this research via e-mail at [email protected].
As of December 23, 2023, there are no approved HIV vaccines.
Barinthus Biotherapeutics plc today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of the VTP-500 vaccine candidate for the prevention of Middle East Respiratory Syndrome (MERS) Coronavirus (CoV).
This new project intends to take this MERS vaccine through Phase II clinical trials and, if successful, on into the development of an investigational ready reserve of 100,000 doses.
The three-way partnership has awarded up to $34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford.
VTP-500 has already completed Phase I clinical trials in Britain and Saudi Arabia, and the University of Oxford is now conducting a Phase Ib trial in the UK to assess vaccination of older adults, the age group most in need of this vaccine.
The VTP-500 development program was awarded PRIME designation in December 2023 by the European Medicines Agency.
This program is essential, as no vaccines targeting MERS have been licensed.
“We are thrilled to be working with the University of Oxford and CEPI on developing this important vaccine candidate,” commented Bill Enright, Barinthus Bio’s Chief Executive Officer, in a December 21, 2023 press release.
MERS is a severe respiratory infection caused by MERS-CoV, a coronavirus first identified in 2012 in Saudi Arabia. It has caused more than 2,600 human infections in at least 27 countries. MERS has a case-fatality rate of more than 35%.
The World Health Organization wrote on August 29, 2023, that it expects additional MERS-CoV cases to be reported from the Middle East and/or other countries where MERS-CoV is circulating in dromedaries.
Barinthus Bio, formerly Vaccitech plc, is a clinical-stage biopharmaceutical company developing novel T-cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
HOOKIPA Pharma Inc. today announced that Gilead Sciences has purchased 15 million shares of the company's common stock for approximately $21.25 million, for $1.4167 per share.
This transaction closed on December 20, 2023, indicating Gilead's total ownership in HOOKIPA's Common Stock is approximately 19.4%.
In addition, HOOKIPA has other transaction rights.
Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on December 21, 2023. "Together, we have made meaningful progress in finding a potential functional cure for Human Immunodeficiency Virus (HIV)."
"Most recently, we received clearance from the U.S. Food and Drug Administration of our Investigational New Drug application for HB-500 and are excited to begin our Phase 1 trial in the first half of 2024."
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine that is being evaluated as part of a potential curative regimen for HIV.
One vector is based on lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.
Both encode the same HIV antigens.
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial. Gilead has the exclusive right to assume further development of the program thereafter.
As of December 22, 2023, there are several HIV vaccine candidates conducting research, but none have been approved. According to the U.S. National Institutes of Health, HIV vaccine candidates can not cause an HIV infection.
Merck today announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for V116, a 21-valent pneumococcal conjugate vaccine candidate specifically designed to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults.
The FDA grants priority review to medicines and vaccines that, if approved, would significantly improve the safety or effectiveness of the treatment or prevention of a serious condition. The FDA has set a Prescription Drug User Fee Act of June 17, 2024.
The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older.
Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, commented in a press release on December 19, 2023, "If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed to address the serotypes that cause most adult invasive pneumococcal disease."
"We look forward to discussing the data that support our filing with the FDA and are urgently working to bring this potential new preventative measure to adult patients."
Merck says V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, responsible for approximately 30% of invasive pneumococcal disease in individuals 65 and older.
The Novo Nordisk Foundation today announced it is committing up to $260 million to establish a state-of-the-art research and vaccine development initiative.
The aim is to create new or improved vaccines for some of the deadliest respiratory diseases, including tuberculosis, influenza, and Group A Streptococcus.
This is the first vaccine initiative globally to focus solely on understanding how to generate immunity in the airway. This is a potentially revolutionary means to block infection and prevent airborne diseases from spreading between humans.
The research arm – the Novo Nordisk Foundation Center for Vaccines and Immunity – is funded via an eight-year grant and anchored in the Department of Immunology and Microbiology at the University of Copenhagen, which has gained global recognition for its expertise in infectious disease, immunology, and technological innovation.
“Basic research carries great importance when it comes to the health and well-being of the world’s population – both present and future,” says Dean Bente M. Stallknecht from the Faculty of Health and Medical Sciences, University of Copenhagen, in a press release on December 18, 2023.
“Vaccines and knowledge of immunology is a key part of that. Boosting excellent basic research within this field of research will pave the way for discoveries and hold the potential to make a huge difference to so many people globally.”
A key partner in the initiative will be Denmark’s Statens Serum Institut.
GeoVax Labs, Inc. today announced that it has amended a previously executed Patent and Biological Materials License Agreement with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in support of GeoVax's development of a vaccine against the SARS-CoV-2 betacoronavirus that causes COVID-19.
The NIAID amendment expands GeoVax's commercial license to include the mpox and smallpox orthopoxviruses as additional indications.
The License Agreement, as amended, enables the creation of preventive Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccines that prime and/or boost the immune system against COVID-19, as well as mpox and/or smallpox.
David Dodd, GeoVax President and CEO, commented in a press release on December 19, 2023, "...The addition of the Mpox and smallpox indications to our NIAID License Agreement complements GeoVax's license agreement with City of Hope National Medical Center for GEO-CM04S1."
Mr. Dodd continued, "We anticipate that adding the Mpox/Smallpox indication to an MVA-vectored COVID-19 vaccine is a viable regulatory pathway and may be an important product differentiator from other competitors."
"For those regions/populations where Mpox and/or smallpox may be of a concern, we believe our COVID-19 vaccine will be a better choice."
Modified Vaccinia Ankara (MVA) is the vaccine currently used and stockpiled in the U.S. Strategic National Stockpile for immunization against the Mpox (JYNNEOS) and smallpox (ACAM2000) viruses.
GeoVax Labs, Inc. is a clinical-stage biotechnology company. The unedited press release is available at this link.
According to several health agencies, the global risk assessment related to dengue virus outbreaks increased in late December 2023.
The European Centre for Disease Prevention and Control reported that as of November 2023, over 4.5 million cases and over 4,000 dengue-related deaths have been reported from 80 countries/territories globally.
For example, the U.S. CDC reissued Level 1 - Practice Usual Precautions, Travel Health Notices on December 14, 2023, for countries located in Africa, Asia, the Americas, the Middle East, and the Pacific Islands.
In the Americas, the Pan American Health Organization (PAHO) confirmed that 2023 is the year with the highest historical record of dengue cases, registering more than 4.1 million new infections, exceeding 2019, when about 3.1 million cases were reported.
Several factors are associated with the increasing risk of dengue epidemics, such as the changing range in elevation of Aedes aegypti mosquitoes, especially in previously dengue native areas, stated the PAHO on December 12, 2023.
Because mosquito bites spread dengue, all travelers to these areas, including southeast Florida and Puerto Rico, are at risk.
Since dengue can become severe within a few hours, usually requiring hospitalization, prevention options are essential.
In addition to avoiding mosquito bites, dengue is a vaccine-preventable disease.
As of late 2023, two approved dengue vaccines and several vaccine candidates are in development. These vaccines have limited availability, based on which country you are located in.
