Vaccine News

ImmunityBio today announced the recent publication of preclinical data in the online issue of Science, First Release. The data indicate that combination therapy with N-803, an IL-15 superagonist, and broadly neutralizing antibodies may potentially enable the immune system to manage human immunodeficiency virus (HIV) without the need for antiretroviral treatment.

The preclinical non-human primate study funded by the National Institutes of Health and the U.S. National Institute of Allergy and Infectious Diseases demonstrated that using N-803, in combination with broadly neutralizing antibodies (bNAbs), led to sustained viral control after discontinuation of antiretroviral therapy (ART) in ART-suppressed rhesus macaques infected with simian-human immunodeficiency virus AD8 (SHIV-AD8).

Treatment with N-803 and bNAbs led to immune activation and transient viremia but only limited reductions in the SHIV reservoir.

Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.

“The viral reservoir in people with HIV is established within the first few days of infection and cannot be eliminated by the body’s immune system or currently available treatments, representing a significant obstacle in curing an established HIV infection,” said James B. Whitney, M.D., study author and researcher at the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Harvard Medical School, in a press release on March 6, 2024.

“When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy.”

Following on from and directly attributable to these preclinical results, two clinical trials were designed to investigate the ability of N-803 and bNAbs to reduce viral loads in HIV-infected individuals on antiretroviral therapy.

As of March 2024, these clinical studies are actively enrolling participants.

CSL Seqirus today announced that it is fully equipped to deliver its influenza vaccine portfolio for the 2024-2025 U.S. season.

The new vaccine will be based on the trivalent strains recommended by the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC), which confirmed the viral strain selection in a March 5, 2024 meeting.

Furthermore, CSL Seqirus has already received FDA approval for its U.S. trivalent influenza vaccines. 

"CSL Seqirus applauds the VRBPAC's commitment to providing a clear, evidence-backed recommendation to the FDA so that the composition of seasonal influenza vaccines for the upcoming season will be formulated to match projected circulating strains, based on the WHO's ongoing surveillance," said Gregg Sylvester, CSL Seqirus's Chief Health Officer and Head of Medical Affairs, in a press release.

"In addition to implementing this change, we are committed to working with our partners in public health to reverse the alarming decline in immunization rates and vaccine confidence that we have seen over the past two flu seasons."

The strain selection for the 2024/25 influenza season reflects the removal of B/Yamagata, which will not be included in the vaccines manufactured and delivered by CSL Seqirus. 

This selection is in accordance with the February 2024 World Health Organization recommendations and is identical to the Southern Hemisphere 2024 flu season, which usually occurs between April and September.

On March 4, 2024, the WHO published Influenza Update N° 466, confirming influenza detections have recently decreased in the Northern Hemisphere.

"This strain consistency across hemispheres will support both speed and efficiency, as CSL Seqirus has experience manufacturing these recommended strains," commented Dave Ross, Vice President of North America Commercial Operations, CSL Seqirus. 

Across the globe, CSL Seqirus is collaborating with regulatory bodies and public health authorities on an appropriate transition timeline for each country, which aims to ensure a smooth transition, increase vaccine confidence, and improve immunization rates.

CSL Seqirus is one of the largest influenza vaccine providers in the world. It utilizes egg, cell, and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries worldwide.

As of late February 2024, the U.S. CDC reported over 158 million flu vaccines had been distributed during the 2023-2024 season.

Various flu shots remain available at most pharmacies in the U.S.

A leading global vaccine developer has announced that their investigational vaccine candidate for Herpes Simplex Virus (HSV) is undergoing a phase 1/2 clinical trial for the first time in Europe, England, and the United States.

GlaxoSmithKline plc. (GSK), known for its extensive range of vaccines for various conditions, including RSV, meningitis, and shingles, is conducting an innovative study to evaluate the safety, immune response, efficacy, and reactogenicity of HSV-targeted immunotherapy (HSVTI).

This multi-country research study is recruiting 332 healthy participants aged 18-40 years or those aged 18-60 years with recurrent genital herpes.

Known as GSK3943104A, GSK Study #215336 is forecasted to conclude in May 2026.

This HSVTI study will explore different formulations and be conducted in two parts:

Part I assesses different formulations of the HSVTI in healthy participants;

Part II assesses the two formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.

In 2023, the World Health Organization estimated 3.7 billion people under the age of 50 have a HSV infection. Genital herpes is a sexually transmitted infection (STI) passed on through vaginal, anal, and oral sex.

There are approved vaccines to prevent STIs, such as mpox and HPV.

Currently, there's no cure or preventive vaccine for genital herpes.

However, in addition to GSK, companies such as Moderna Inc and BioNTech SE are conducting HSV vaccine research as of March 5, 2024.

Vaxcyte, Inc. today announced it has completed enrollment for its Infant Phase 2 clinical study evaluating VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) engineered to prevent invasive pneumococcal disease (IPD).

The primary three-dose immunization series is expected to produce topline safety, tolerability, and immunogenicity data by the end of the first quarter of 2025. And the booster dose results will be announced by the end of 2025.

These results will be crucial in demonstrating the effectiveness of VAX-24 and its potential to protect humankind from bacterial diseases.

"Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under," said Jim Wassil, Executive Vice President and Chief Operating Officer of Vaxcyte, in a press release on March 4, 2024.

Vaxcyte's carrier-sparing PCV franchise candidates include VAX-24 and VAX-31, the Company's next-generation 31-valent PCV currently being evaluated in a Phase 1/2 study, are being studied to prevent IPD. 

Escherichia coli (E. coli) is a harmful bacteria that poses a severe threat to newborns, causing neonatal sepsis infections that can be life-threatening. Given the underdeveloped immune systems of newborns, they are particularly vulnerable to such infections.

The risk of death from neonatal sepsis increases by 7.6% every hour a treatment is delayed.

However, there is currently no vaccine available for pregnant women to prevent this medical issue.

In an attempt to fill this void, the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has taken an assertive stance by announcing $467k funding for GlyProVac to develop a maternal vaccine (GPV02) that targets E. coli.

This strategic move will help combat this bacterial species and save the lives of many newborns at risk of these severe infections.

GPV02 uses a selected bacterial protein, naturally decorated with small sugar molecules, to trigger an immune response for protection. This approach differs from previous attempts to develop protein-based bacterial vaccines since it involves specific natural sugar modifications previously undiscovered.

GlyProVac uses BEMAP technology to ensure that GPV02 correctly imitates E. coli, thus preparing the immune system to recognize the bacterium when an infection occurs.

Erin Duffy, Ph.D., R&D Chief of CARB-X, commented in a press release on February 29, 2024, "Because newborns at risk for neonatal sepsis are too young to be immunized, the vaccine would be administered to expectant mothers and target bacteria that cause neonatal bloodstream infections in babies."

"The vaccinated mothers would pass antibodies on to their babies in utero and through breastmilk after birth to strengthen their newborns' immune systems, helping them ward off infections."

The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the most significant burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics.

GlyProVac is a research and development company from the University of Southern Denmark in Odense committed to reducing bacterial infections and antimicrobial resistance worldwide.

The global measles outbreak continued to impact people in England during late February 2024. Over the past decade, the uptake levels of childhood vaccines offered in England have been falling across all vaccines, including measles.

Data show more than 3.4 million children in England are either unprotected or not fully protected and at risk of catching completely preventable diseases.

According to the UK Health Security Agency, 69 additional laboratory-confirmed measles cases have been confirmed in England since one week ago.

As of March 1, 2024, the total number of measles cases confirmed since October 2023 is now 650.

Sixty-three percent (410 of 650) of these measles cases have been in the West Midlands, 15% in London, and 7% in Yorkshire and The Humber. The remaining cases were reported in other regions of England.

To change the trajectory of this measles outbreak, the UKHSA is launching a Childhood Immunisations national marketing campaign on March 4, 2024.

Professor Dame Jenny Harries, Chief Executive of UKHSA, said in a media release, "We need an urgent reversal of the decline in the uptake of childhood vaccinations to protect our communities. Through this campaign, we particularly appeal to parents to check their children's vaccination status and book appointments if their children have missed any immunizations."

"The ongoing measles outbreak we are seeing is a reminder of the very present threat."

"Unless uptake improves, we will start to see the diseases vaccines protect against re-emerging and causing more serious illness."

The UKHSA is co-ordinating its national marketing campaign with an operational measles, mumps, and rubella (MMR) catch-up campaign to counter this decline.

Areas with low uptake will be a focus for support and parents of children aged six to 11 years will be contacted directly and urged to make an appointment with their child's GP practice for any missed MMR vaccines.

In 2023, two million texts, emails, and letters were sent to parents and carers of 1-5-year-olds who were unvaccinated, and thanks to those efforts, 165,000 doses of MMR vaccine were delivered.

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that individuals aged 65 and older receive an additional dose of 2023-2024 Formula COVID-19 vaccine four months after receiving the last dose.

According to a Novavax Inc. press release on February 28, 2024, while today's recommendation focuses on protection for older adults at increased risk of COVID-19, information shared at this ACIP meeting also reinforces the ongoing benefit of vaccination for all eligible.

Data from clinical trials continue to show broad long-lived neutralization responses to currently circulating forward-drift variants, including JN.1 and JN.4, for Novavax's protein-based non-mRNA COVID-19 vaccine while maintaining a favorable side effect profile.

Peer-reviewed real-world effectiveness data that shows the immune responses seen in our trials translate into COVID-19 prevention in the real world is being published.

Those interested in a non-mRNA protein-based vaccine should ask their pharmacists about the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) at major retail pharmacies nationwide, including, but not limited to, Albertsons, CVS Pharmacy and Rite Aid.

Vaccine doses can also be located at us.novavaxcovidvaccine.com or vaccines.gov.

Novavax's Nuvaxovid™ XBB.1.5 is one of 13 COVID-19 vaccines the World Health Organization listed as of early 2024.