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Influenza Vaccine Candidates 2024

Influenza Vaccine Candidates 2024

A report indicates over 110 influenza vaccine candidates are under development in 2024.

A mosaic influenza nanoparticle vaccine (FluMos-v1) is unique in that it is designed to co-display four recently circulating haemagglutinin (HA) strains. A phase 1 clinical study demonstrates that FluMos-v1 nanoparticles are predominantly quadrivalent. Imaging by TIRFM allowed direct visualization of the co-localization of HA trimers from multiple strains, and imaging of more than 10 thousand nanoparticles revealed individual nanoparticles with four, three, two, and one color.

CSL sa-mRNA bicistronic influenza vaccine candidates produced a potent, cross-reactive immune response against pandemic and seasonal influenza strains A(H5N1) and A(H1N1). In addition, the mRNA platform recently reported results from a significant Phase III vaccine study, meeting its primary and secondary endpoints of infection prevention and severe disease with a favorable safety and tolerability profile.

Cidara Therapeutics's CD388 is a highly potent long-acting antiviral immunotherapy in phase 1 study, designed to deliver universal seasonal and pandemic influenza prevention.

CureVac's second-generation mRNA influenza vaccine candidate, CVSQIV, was developed with GSK. An extended preliminary phase 1 data from Joint COVID-19 and Flu mRNA Vaccine Development Programs was launched on May 8, 2023. The Phase 1 study's best-performing candidate providing broad antigen coverage against WHO-recommended flu strains selected for Phase 2, following positive data from Phase 1 interim analysis. Dosing of the first Phase 2 participant is anticipated in Q4 2023.

The Emergex universal influenza vaccine candidate is designed to induce CD8+ T cells specific to highly conserved parts of the influenza virus from both the positive and negative sense reading frames. 

Flu-v Influenza Vaccine is a synthetic universal flu vaccine candidate that offers protection across a broad influenza spectrum forcing 1+NP forcing vaccine candidate consisting of MVA, a replication-deficient pox viral vector safely tested in thousands of patients, generates strong immune reaction against Matrix 1 Nucleoprotein influenza antigens. 

NasoVAX is a recombinant intranasal vaccine developed for both seasonal and pandemic use.

NanoFlu is a quadrivalent recombinant hemagglutinin (H.A.) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses H.A. amino acid protein sequences similar to the recommended wild-type circulating virus H.A. sequences. In addition, NanoFlu contains Novavax's patented saponin-based Matrix-M™ adjuvant. CD388 (drug-Fc conjugate) is a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Cidara Therapeutics intends to initiate a Phase 1 study in healthy volunteers in 2022.

The U.S. NIH's BPL-1357 is a whole-virus vaccine candidate comprising four non-infectious, chemically inactivated, low-pathogenicity avian flu viruses conducting a phase 1 study.

Novavax investigational influenza (qNIV) vaccine is our quadrivalent nanoparticle vaccine candidate, targeting seasonal flu. qNIV is designed using our recombinant technology, with four forms of wild-type hemagglutinin (H.A.) protein from the influenza virus as antigens. Antigens are organized into distinct nanoparticle complexes recognized by the immune system, working in concert with our Matrix-M™ adjuvant.

Osivax' OVX836 targets the nucleoprotein (N.P.), a highly conserved internal antigen. Unlike surface antigens, the N.P. is much less likely to mutate, alleviating the need for annual vaccination updates. The latest results from the Phase 2a dose-optimization study (OVX836-003) found that OVX836 maintained an excellent safety profile at all doses and provided protective efficacy in reducing PCR-confirmed influenza-like illnesses by 78%. Topline results from both studies are anticipated in the first half of 2023. 

Sinovac Biotech Ltd.'s two-dose inactivated quadrivalent influenza vaccine is conducting a phase 3 study with children in Chile.

Revelation Biosciences Inc. intranasal REVTx-99a is for the preventive treatment of H3N2 influenza (influenza A and B) infection in healthy humans, parainfluenza, rhinovirus, respiratory syncytial virus, and SARS-CoV-2 including its variants.

Redeeflu (M2SR) is a nasal vaccine candidate utilizing a proprietary M2 deleted, single replication influenza virus.

Vaxess Technologies, Inc. MIMIX-Flu Vaccine Patch is conducting Phase I Clinical Trial, a first-in-man trial of VX-103. On June 5, 2023, the Company stated the MIMIX-Flu vaccine patch elicited robust, durable, and broadly protective immune responses. And titers did not differ significantly for the two dose levels, indicating a fractional dose can be delivered without substantially impacting immunogenicity.

PDS Biotechnology Corporation's investigational universal influenza vaccine PDS0202 demonstrated active neutralization across multiple influenza viruses. 

The universal influenza vaccine candidate FluMos-v2 (VRC- FLUMOS0116-00-VP, start date: 2023-08-09) was designed by researchers at NIAID's Vaccine Research Center (VRC) and is conducting a phase 1 clinical trial. FluMos-v2 is intended to induce antibodies against various influenza virus strains by displaying part of the influenza virus hemagglutinin (H.A.) protein in repeating patterns on self-assembling nanoparticle scaffolds (SAPNs). Exposure to these harmless fragments of virus proteins prepares the immune system to recognize and fight the virus. When tested in animals, the experimental vaccine resulted in robust antibody responses. It is an adaptation of an earlier U.S. NIH universal flu vaccine candidate, FluMos-v1, which began first-in-human testing in 2021 and is still undergoing clinical trials.

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Monday, February 26, 2024 - 11:35
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Influenza Vaccine Candidates under development in 2024
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Influenza
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Curevo Vaccine today announced positive data from a Phase 2 trial of amezosvatein (a non-mRNA, adjuvanted subunit vaccine also known as CRV-101) head-to-head versus the U.S. FDA-approved Shingrix® vaccine.

According to the Company's press release on January 7, 2024, Amezosvatein met all primary endpoints in the randomized, controlled, observer-blind Phase 2 trial, including demonstrating non-inferiority to Shingrix as measured by humoral immune response.

Amezosvatein also exhibited lower rates of solicited local and systemic adverse events. Amezosvatein was engineered to have a best-in-class safety profile.

Like Shingrix, amezosvatein uses a subunit protein antigen called glycoprotein 'E' (gE).

Targeting the gE antigen is proven to elicit a long-term, protective immune response to prevent shingles.

Also, like Shingrix, amezosvatein uses an adjuvant targeting the TLR4 pathway to boost the immune response to the gE antigen.

"Fewer than 5% of eligible adults in most European countries and China have received both doses of Shingrix," noted George Simeon, Curevo's Chief Executive Officer, "and two-thirds of adults in the USA still need to be immunized against shingles.

As of January 8, 2024, various shingles vaccines are available in over 30 countries.

Based upon these clinical study results, Curevo will advance amezosvatein into global Phase 3 trials in 2024 to address a market for shingles vaccination currently exceeding $4 billion. 

Virtually all adults have been exposed to the varicella-zoster virus, and around 30% will develop shingles at least once in their lifetime. 

Also called 'herpes zoster,' shingles occur when the varicella-zoster virus causing childhood chickenpox re-emerges from sensory ganglion nervous system cells where the virus lies dormant after initial exposure.

Vaccine Treats: 
Shingles
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Image Caption: 
by Alexandra Koch
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Seattle
Vaccine: 
Amezosvatein CRV-101 Shingles Vaccine
RSV antibody 2024

Immunize Infants with Beyfortus As Quickly As Possible

Updated CDC Guidance regarding using Nirsevimab Beyfortus to protect young children from RSV
January 5, 2024
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The Philadelphia Department of Public Health reported today that there is a cluster of measles among unvaccinated residents.

As of January 4, 2024, in addition to an index case, three locally acquired cases have been confirmed, with two of those cases being hospitalized and released.

Furthermore, there are at least two more possible cases that have been hospitalized.

If you visited any of these sites on the days listed at this link, you may have been exposed to measles.

These measles cases are connected with the notice issued on December 23, 2023.

Health Commissioner Dr. Cheryl Bettigole commented in a press release, “Unfortunately, we are seeing cases of measles that have spread to vulnerable individuals, including young children, due to people declining vaccination and also failing to adhere to quarantine recommendations."

The Health Department is strongly recommending that anyone who may have been exposed to measles should quarantine themselves by staying home and away from others.

Additionally, people who have not received both doses of a Measles, Mumps, and Rubella (MMR) vaccine should talk with their healthcare provider about getting caught up.

Vaccine Treats: 
Measles
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Image Caption: 
by Heather Anne Norbury
Live Blog Update Author: 
Don Hackett
Location Tags: 
Philadelphia
Vaccine: 
Priorix MMR Vaccine
Dengue cases 2023

Mass Vaccinations Target Brazil's Dengue Outbreak

Qdenga dengue vaccine has limited availability in 2024
January 5, 2024
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AstraZeneca and Sanofi recently announced China's National Medical Products Administration approved Beyfortus™ (Nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).

Beyfortus is the first approved single-dose (50mg) preventive option to protect infants born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease entering or during their first RSV season.

Beyfortus is anticipated to be available in China during the upcoming 2024-2025 RSV season. Its administration can be timed to the start of the local RSV season.

RSV is the most common cause of LRTD in infants, including bronchiolitis and pneumonia, and is also a leading cause of hospitalisation in all infants. China ranks among countries with a high prevalence of RSV infections.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, commented in a press release on January 2, 2024, "Beyfortus  represents the first opportunity to prevent serious respiratory disease due to RSV for all infants in China."

"We look forward to making Beyfortus available for the 2024/25 season."

While Beyfortus was approved in the United States in 2023, its availability has been limited. As of December 14, 2023, the manufacturers committed 1.4 million doses for delivery in the U.S. before February 2024.

Canada, the European Union, and the United Kingdom have also approved Beyfortus.

Vaccine Treats: 
Respiratory Syncytial Virus (RSV)
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Image Caption: 
by Christel SAGNIEZ
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
China
Vaccine: 
Beyfortus (Nirsevimab) RSV Antibody
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Pfizer Canada announced the Health Canada approved its bivalent Respiratory Syncytial Virus (RSV) vaccine ABRYSVO™ Vaccine.

ABRYSVO is indicated for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older by active immunization, and the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant women.

"Vaccines are considered to be the most effective tool in public health for preventing illness and can help reduce the stress on our healthcare system and professionals, including nurses, doctors, and others on the frontline," said Dr. Darine El-Chaâr, Maternal Fetal Medicine physician at The Ottawa Hospital, in a press release on January 4, 2024. 

"Vaccines administered through maternal immunization can also help play a critical role in decreasing the gap of vulnerability in the first few months of an infant's life, as well as helping to protect their mothers, who may be at increased risk of severe disease compared with non-pregnant women."

RSV is a common respiratory virus that causes mild disease with cold-like symptoms in the fall and winter months.

In more vulnerable populations, like adults 60 and over, an RSV infection can be severe, especially among those with underlying respiratory or cardiac conditions.

For infants, RSV infection can result in respiratory distress, especially in those less than six months of age and those with higher risk factors such as congenital heart or lung disease or prematurity.

Pfizer Canada is currently assessing the availability timeline for ABRYSVO and is committed to bringing a supply of this vaccine to Canadians as quickly as possible.

As of January 5, 2024, RSV vaccines and monoclonal antibody therapy that deliver passive immunization to infants are approved for use in the United States.

Vaccine Treats: 
Respiratory Syncytial Virus (RSV)
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Image Caption: 
by Cornelia Schneider-Frank
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Canada
Vaccine: 
ABRYSVO RSVpreF RSV Vaccine
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The Walgreens Flu Index® recently rendered updated information regarding influenza activity compiled using retail prescription data for antiviral medications used to treat influenza across Walgreens pharmacy locations. 

As of December 30, 2023, the Index identified the top ten cities impacted by the flu last week:

  1. Columbus-Tupelo-West Point-Houston, Miss.
  2. Lafayette, La.
  3. El Paso, Texas (Las Cruces, N.M.)
  4. Beaumont-Port Arthur, Texas
  5. Chattanooga, Tenn.
  6. Monroe, La.-El Dorado, Ark.
  7. Montgomery-Selma, Ala.
  8. Knoxville, Tenn.
  9. New Orleans, La.
  10. Shreveport, La.

Previously, the U.S. CDC reported seasonal influenza activity was elevated in most parts of the country.

As of December 29, 2023, outpatient respiratory illness was above baseline for the eighth consecutive week and in all 10 HHS Regions.

From a prevention perspective, the CDC encourages most people to get an annual flu shot.

And for those who catch the flu, prescription antiviral drugs that treat influenza are available at most pharmacies in the U.S.

Vaccine Treats: 
Influenza
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Image Caption: 
Walgreens Flu Index map Dec. 30, 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Chicago
Vaccine: 
Fluzone High-Dose Quadrivalent Influenza Vaccine
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Sanofi Canada recently announced the National Advisory Committee on Immunization's annual Statement on Seasonal Influenza Vaccine for 2024-2025 continues to recommend Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines to protect adults 65 years of age and older against influenza.

Delphine Lansac, General Manager, Vaccines Canada, Sanofi, commented in a press release on January 3, 2023, "This long-standing recommendation as a preferential influenza vaccine for adults 65 years of age and older speaks to the science that Fluzone® High-Dose Quadrivalent is built on and demonstrates our continued leadership in vaccines."

"It's been a groundbreaking year, where over 50% – more than one in two – seniors who received influenza vaccines in Canada were immunized with Fluzone® High-Dose Quadrivalent Influenza Vaccine."

Fluzone® High-Dose Quadrivalent Influenza Vaccine is designed to protect seniors with four times the active component dosage of a standard flu shot.

To date, Fluzone® High-Dose is available in more than 20 countries, including the United States, Canada, and Germany.

As of December 23, 2023, over 155 million flu shots had been distributed in the U.S. this season. 

Vaccine Treats: 
Influenza
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Image Caption: 
by Mariam P.
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Toronto
Vaccine: 
Fluzone High-Dose Quadrivalent Influenza Vaccine
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Invivyd, Inc. today announced that it has requested Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for VYD222, a broadly neutralizing, half-life extended monoclonal antibody (mAb) candidate, for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents.

This is essential news since about 9 million people in the U.S. may not adequately respond to current COVID-19 vaccines.

Initially authorized in late 2020, there are no mAbs currently authorized by the FDA targeting COVID-19. mAb treatments are effective when they block the SARS-CoV-2 beta coronavirus that causes COVID-19 from entering cells in the human body.

"We are tremendously pleased by the fact that VYD222 continues to demonstrate in vitro neutralization activity against the latest dominant variant, JN.1, as well as other prevalent SARS-CoV-2 strains," said Dave Hering, Chief Executive Officer of Invivyd, in a press release on January 3, 2023.

"We believe that the demonstrated durability of VYD222 is reflective of our strategy to select antibody candidates that target conserved epitopes to achieve our stated goal of keeping pace with viral evolution." 

The EUA submission was based on positive initial results from the CANOPY Phase 3 pivotal clinical trial of VYD222 and ongoing in vitro neutralization activity against relevant variants such as JN.1.

Previous COVID-19 mAb news is posted by Precision Vaccinations.

Vaccine Treats: 
COVID-19
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Invivyd 2024
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Boston