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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.
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.
Novavax Inc. announced today that its updated protein-based COVID-19 vaccine is now available in France to prevent COVID-19 in individuals aged 12 and older.
As of December 19, 2023, the updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601), is intended for adults and adolescents aged 12 and over, regardless of their vaccination history, but is not recommended for pregnant women pending further data, according to the National recommendation of France's General Directorate of Health.
France's Ministry of Health provides the new protein-based vaccine in hospitals (December 7, 2023) and retail pharmacies (December 14, 2023).
As outlined in French vaccination recommendations, 'a diverse vaccine portfolio with both mRNA and non-mRNA options is critical to helping to protect communities across France against COVID-19 this vaccination season and in future.'
In the United States, the Food and Drug Administration amended the EUA on October 3, 2023, of the Novavax COVID-19 Vaccine, Adjuvanted, for use in individuals 12 and older, to include the 2023-2024 formula.
As of December 19, 2023, Novavax's protein-based vaccine is the only non-mRNA COVID-19 vaccine available in the U.S.
Invivyd, Inc. today announced positive initial results from the ongoing CANOPY Phase 3 pivotal clinical trial of VYD222, a broadly neutralizing, half-life extended monoclonal antibody (mAb) candidate for the prevention of symptomatic COVID-19.
Results showed that the safety and tolerability profile of VYD222 remains favorable, with no study drug-related serious adverse events reported to date.
The company also reported on December 14, 2023, that in vitro pseudovirus testing shows VYD222 has potency against various SARS-CoV-2 coronavirus variants currently circulating, such as HV.1, BA.2.86, XBB.1.5.10/EG.5, and HK.3.
Importantly, VYD222 continues to show neutralizing activity against variants with the F456L mutation found in most variants in the U.S.
Currently, no mAb is authorized or approved in the U.S. to prevent symptomatic COVID-19.
"We are pleased to share positive initial topline results from CANOPY, which bolster our belief that VYD222 holds the potential to provide vulnerable people, particularly the immunocompromised (IC), with meaningful protection from COVID-19," said Dave Hering, Chief Executive Officer of Invivyd, in a press release.
"VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the IC cohort, essentially replicating the titer levels observed in our Phase 1 clinical trial of VYD222 in healthy volunteers."
"We are also encouraged by the potential early signal of strong clinical protection from symptomatic COVID-19 in the CANOPY clinical trial to date, which would be expected given the high VYD222 sVNA titer levels and dose selected."
"We look forward to continued engagement with the FDA on these promising results, and we intend to submit a request for Emergency Use Authorization as soon as practicable."
Globally, there are millions of immunocompromised people, with more than 9 million in the U.S. alone who may not adequately respond to COVID-19 vaccination.
