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In Canada, most influenza surveillance indicators are increasing but remain within expected levels typical of this time of year.
From August 27, 2023, to December 9, 2023, 163 laboratory-confirmed influenza outbreaks have been reported in Canada.
From an age-group perspective, adults 65 and older have accounted for 42% of recent flu-related hospitalizations.
On December 21, 2023, Canada confirmed its recommendation for seniors to get a flu shot for the 2023-2024 season.
Canada's National Advisory Committee on Immunization (NACI) preferentially recommends adults 65 years of age and older preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose, and recombinant vaccines.
This included CSL Seqirus's FLUAD® Influenza vaccine (surface antigen, inactivated, adjuvanted with MF59®).
"The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems," said Bertrand Roy, Ph.D., Country Head Medical Affairs Canada at CSL Seqirus, in a press release on December 21, 2023.
The NACI's new recommendation is based on data from studies showing that all approved enhanced influenza vaccines effectively reduce the risk of influenza-related hospitalization and medical encounters.
Influenza causes an average of 12,200 hospitalizations and approximately 3,500 deaths each year in Canada, with the majority occurring in adults over 65 years of age.
Canadians over 65 accounted for 76% of the reported influenza-associated deaths during the 2022/23 flu season.
Vaxart, Inc. today announced that it has completed enrollment and dosing in the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate focused on lactating mothers.
There is no U.S. Food and Drug Administration-approved vaccine against norovirus.
Outbreaks sickens approximately 21 million people in the United States annually, and 15% of children under age five contract norovirus annually.
Approximately 3 million sets of parents are forced by this virus to miss work, 2.2 days on average, to care for their children. The annual disease burden from norovirus is $10.6 billion in the U.S. alone.
“This is an important step forward as we drive toward a vaccine candidate that may make it possible for mothers to protect their children against this highly contagious – and potentially lethal -- virus. We look forward to announcing topline data from this study by the end of 2024,” commented Dr. James F. Cummings, Vaxart’s Chief Medical Officer, in a press release on December 21, 2023.
“We are very proud of our clinical team for completing enrollment of this trial within our planned timeline.”
The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study (VXA-NVV-108) is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age.
As of late December 2023, several norovirus vaccine candidates are conducting clinical research.
Children located in a few African countries now have access to a second malaria vaccine, the R21/Matrix-M™ malaria vaccine.
As of December 21, 2023, the World Health Organization (WHO) has added this malaria vaccine to its list of prequalified vaccines, which increases access to vaccines procured by UNICEF and funding support for deployment by Gavi, the Vaccine Alliance.
In October 2023, WHO recommended that Oxford University's developed and Serum Institute of India manufactured R21/Matrix-M to prevent malaria in children following the advice of the WHO Strategic Advisory Group of Experts on Immunization and the Malaria Policy Advisory Group.
R21/Matrix-M integrates Novavax Inc.'s Matrix-M djuvant.
The initial malaria vaccine, Mosquirix™ RTS, S/AS01, obtained WHO prequalification status in July 2022.
"Today marks a huge stride in global health as we welcome the prequalification of R21/Matrix-M, the second malaria vaccine recommended for children in malaria-endemic areas, said Dr. Kate O'Brien, Director of WHO's Department of Immunization, Vaccines and Biologicals, in a press release on December 21, 2023.
"This is another step toward ensuring a healthier, more resilient future for those who have lived for too long in fear of what malaria could do to their children. Together with our partners, we are united in pursuing a malaria-free future, where every life is shielded from the threat of this disease."
Malaria is a mosquito-borne disease causing a high burden on children in the African Region, where nearly half a million children die from the disease each year. Globally, in 2022, there were an estimated 249 million malaria cases and 608,000 malaria deaths across 85 countries.
In the United States, about 2,000 malaria cases are detected in international travelers annually. However, local malaria cases in the U.S. (Arkansas, Florida, Maryland, Texas) were detected in 2023.
These WHO-prequalified malaria vaccines are not available in the U.S.
With approved Ebola vaccines and monoclonal antibody therapies available in Africa, a safe and effective treatment option is now the goal for researchers.
RedHill Biopharma Ltd. today announced that its two novel, oral host-directed investigational drugs, opaganib and RHB-107 (upamostat), demonstrated robust synergistic effect when combined individually with Veklury®, significantly improving viral inhibition while maintaining cell viability in a new U.S. Army-funded and conducted Ebola virus disease in vitro study.
Jeffrey Kugelman, Ph.D., Major(P), U.S. Army MSC, Branch Chief Synthetic Biology & Surveillance, Molecular Biology Division, U.S. Army Medical Research Institute of Infectious Diseases, who led the bioinformatics analysis of the study, commented in a press release on December 20, 2023, "The results suggest that opaganib and upamostat may have potential or use in combination with direct antiviral agents, such as Veklury, to improve treatment outcome, increasing efficacy while maintaining safety."
Opaganib (ABC294640) is a proprietary investigational host-directed and potentially broad-acting drug and is a first-in-class, orally administered sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory, and antiviral activity, targeting multiple potential diseases.
"Opaganib is believed to be the first host-directed molecule to show activity in Ebola virus disease, and these results add to a recent U.S. Army Ebola virus study in which opaganib delivered a statistically significant increase in mice survival time in vivo," added Reza Fathi, Ph.D., RedHill's SVP R&D.
RHB-107 (upamostat) is a proprietary, first-in-class, once-daily orally administered investigational antiviral that targets human serine proteases in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease.
There are two types of Ebola causing outbreaks in Africa.
The initial Zaire Ebolavirus disease outbreak was confirmed in 1976 in South Sudan and the Democratic Republic of Congo.
African countries have endured Zaire Ebolavirus outbreaks between 2014, 2016, 2018, and 2022. Over 29,000 people were infected, and more than 11,000 died.
Separately, there have been five Sudan Ebolavirus outbreaks.
The World Health Organization issued new guidelines (August 2023) on Ebola infection prevention and control.
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.
Uvax Bio, LLC today announced acknowledgment from the Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in Australia.
The two vaccines being tested are based on Uvax Bio's proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimized (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms (UVAX-1197 and UVAX-1107, respectively).
Uvax Bio's HIV-1 vaccines are combined with Dynavax's CpG 1018® adjuvant and aluminum hydroxide.
Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024.
Previously, in a preclinical toxicology study, UVAX-1107 & 1197 combined with CpG 1018® and aluminum hydroxide were safe with no serious adverse events.
In a second preclinical immunogenicity study, immunization with Uvax Bio's HIV-1 vaccine candidates elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.
Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.
"The body of evidence from our preclinical studies and GMP manufacturing runs was instrumental in facilitating this authorization to begin preparation for our first Phase 1 trial," commented Ji Li, Ph.D., Uvax Bio CEO, in a press release on December 19, 2023.
"Our clinical team will begin preparing to initiate this trial in January 2024."
As of December 20, 2023, the U.S. Food and Drug Administration, Japan's National Institute of Infectious Diseases, the European Medicines Agency, and the United Kingdom had not approved an HIV prevention vaccine.
Researchers recently wrote in an original research article that getting an annual flu shot is highly recommended. Still, influenza vaccines do not work as well in older adults due to the aging of their immune systems.
One approach to improving influenza vaccine efficacy is the addition of an adjuvant to the vaccine to boost an individual's immune response.
Published on December 19, 2023, this new study evaluated an adjuvanted vaccine compared to an unadjuvanted vaccine for preventing cardiorespiratory hospitalizations and hospitalization costs.
The Original Research's findings demonstrated that the adjuvanted flu vaccine, compared to the unadjuvanted vaccine, prevented more hospitalizations and significantly reduced associated hospital costs.
The study included 715,807 aIIV3 and 320,991 IIV4e recipients in the 2018–19 and 844,169 aIIV3 and 306,270 IIV4e recipients in the 2019–20 influenza seasons.
aIIV3 vaccination was significantly more effective than IIV4e in preventing cardiorespiratory disease (2018–19 rVE = 6.2%; and 2019–20 rVE = 6.0%) and respiratory disease (2018–19 rVE = 8.9%; and 2019–20 rVE = 10.1%).
During the 2018–19 flu season, cardiorespiratory hospitalization cost savings for the aIIV3 population were $392 million and $ 221 million for the 2019–20 season.
Respiratory hospitalization cost savings for the aIIV3 population were $145 million and $97 million, respectively.
As of December 20, 2023, over 153 million influenza vaccines (nasal, egg-based, cell-based) were distributed this flu season in the U.S. These vaccines are generally available at clinics and local pharmacies.
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.
The World Health Organization (WHO) today announced that COVAX will close at the end of 2023.
The WHO stated on December 19, 2023, COVAX, a multilateral mechanism for equitable global access to COVID-19 vaccines launched in 2020, will close on December 31, 2023, having delivered nearly 2 billion vaccines to 146 economies.
COVAX's end-to-end efforts helped lower-income economies achieve a COVID-19 two-dose coverage of 57%, compared to the global average of 67%.
In 2024 and 2025, low- and lower-middle-income economies will continue to receive COVID-19 vaccines and delivery support from Gavi, the Vaccine Alliance.
Most of COVAX's advance purchase supply agreements will have been completed or terminated by the end of 2023, except one, where a modest volume of supply will continue into the first half of 2024. So far, 58 lower-income economies have requested 83 million doses in 2024.
"COVID-19 has been the greatest health challenge of our time, and it was met with innovation and partnership on an equally unprecedented scale," said José Manuel Barroso, Chair of the Board of Gavi, the Vaccine Alliance, in a WHO press release.
"COVAX's impact has been historic, as are the insights it has generated on how, concretely, the world can do better next time."
"As we transition COVID-19 into Gavi's routine programming, we do so with deep gratitude for the passion, dedication, and sacrifice of so many around the globe who fought tirelessly for three years to try and create a more equitable world – and with an unwavering commitment to improving by transforming learnings into tangible action."
COVAX was a historic effort co-led by Gavi, the Coalition for Epidemic Preparedness Innovations, and the WHO. As of the end of 2023, the WHO has Listed twelve different COVID-19 vaccines.
