Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations

Dec 8, 2023 • 4:45 pm CST
WHO map of Zambia anthrax outbreak Dec. 8, 2023

The ongoing anthrax outbreak in the Republic of Zambia has recently become a multi-country concern.

The World Health Organization (WHO today announced that as of November 20, 2023, 684 suspected human cases, including four deaths, have been reported in 2023.

This unprecedented anthrax outbreak marks the first significant occurrence spanning nine out of 10 country provinces. The last large-scale outbreak reported in Zambia occurred in 2011, with 511 suspected cases, wrote the WHO on December 8, 2023.

The risk of the outbreak spreading within Zambia is assessed to be high, and at the regional level is also considered high due to the frequent movement of both animals and people between Zambia and its neighboring countries, such as Angola, Botswana, the Democratic Republic of the Congo, Malawi, Mozambique, Namibia, Tanzania, Uganda, and Zimbabwe.

International travelers to anthrax-endemic countries should be aware of the current health risk, says the WHO. In 2021, about 554,000 tourists visited Zambia, formerly known as Northern Rhodesia, reported WorldData.

However, the WHO advises against implementing travel or trade restrictions with Zambia based on the current information on this event.

In addition to anthrax, the U.S. CDC has included Zambia in Travel Health Advisories in 2023 regarding measles and polio.

Humans usually acquire the infection after exposure to infected animals, carcasses, or animal products. More than 95% of human anthrax cases take the cutaneous form and result from handling infected carcasses or hides, hair, meat, or bones from such carcasses.

Anthrax is a zoonotic disease caused by Bacillus anthracis that typically affects ruminants (cows, sheep, and goats). The bacteria produce highly potent toxins responsible for the symptoms, causing a high lethality rate in the pulmonary form.

Humans can develop the disease from infected animals or through contaminated animal products. Hospitalization is required for all human cases identified. Vaccines are available for livestock.

However, humans have access to a limited supply.

From a prevention vaccination perspective, Emergent BioSolutions Inc. recently announced that the U.S. Biomedical Advanced Research and Development Authority awarded a $75 million contract option to acquire the newly licensed anthrax vaccine CYFENDUS™.

Deliveries of the two-dose vaccine are expected to begin in the U.S. in 2023 and be completed in the late first quarter of 2024. These vaccines are unavailable to the general public.

Dec 8, 2023 • 11:16 am CST
US CDC Influenza map Dec. 8, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced seasonal flu activity continues to increase in most parts of the country, with the southeast and south-central areas of the country reporting the highest levels of activity.

As of December 8, 2023, outpatient respiratory illness is above baseline nationally for the fifth week and is at or above baseline in all 10 HHS Regions. 

Furthermore, the National Center for Health Statistics (NCHS) Mortality Surveillance data available on December 7, 2023, indicates that 0.2% of the deaths (48) that occurred during Week #48 were due to influenza.

Last week, in #47, there were 61 flu-related deaths and 2,373 pneumonia-related deaths.

Specifically, there were four influenza-associated pediatric deaths reported during Week #48, bringing the 2023-2024 season total to 12 pediatric deaths.

Last flu season, about 182 children died from influenza.

From a prevention perspective, the CDC recently confirmed that over 151 million flu shots had already been distributed in the U.S.

These influenza vaccines are generally available at clinics and pharmacies, 

Dec 8, 2023 • 9:17 am CST
by Elías Alarcón

The journal Nature Medicine recently asked researchers to name their top clinical trial picks for 2024, from base editing and a vaccine against human immunodeficiency virus (HIV).

On December 7, 2023, Carrie Arnold and Paul Webster wrote ...with so many rollercoaster years since the start of the pandemic, it is impossible to predict exactly what the biomedical world will deliver in 2024.

Experts identified which trials will likely have an outsized impact on medicine in 2024.

One expert, Carey Hwang, a senior vice president and head of clinical research at Vir Biotechnologycommented, highlighted VIR-1388, a cytomegalovirus (CMV) vector vaccine that induces strong, unique, and sustained T cell responses that can potentially prevent the acquisition of HIV.

The HIV Vaccine Trials Network is conducting a clinical trial at ten sites in the U.S. and two sites in South Africa, with support from the U.S. National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation.

From a public health perspective, having a vaccine against HIV would have a tremendous impact, commented Hwang.

As of December 8, 2023, the U.S. FDA has not approved any HIV vaccine candidates.

Dec 8, 2023 • 4:31 am CST
US CDC mpox outbreak map in the DRC December 7, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced a Health Alert Network (HAN) Health Advisory about the occurrence, geographic spread, and sexually associated human-to-human transmission of Clade I Monkeypox virus (MPXV) in the Democratic Republic of the Congo (DRC).

Since January 2023, the DRC has reported 12,569 suspected mpox cases and 581 related deaths from 22 regions.

The new HAN says cases of Clade I MPXV have not been reported in the United States as of December 7, 2023. The global outbreak of Clade II MPXV was initially reported in May 2022.

However, clinicians should be aware of the possibility of Clade I MPXV in travelers who have been in DRC. 

Third-party data indicate that the number of tourists arriving in the DRC was about 460,880 in 2021.

The CDC recently issued a Travel Health Notice (Level 2 - Practice Enhanced Precautions) for people traveling to DRC. Furthermore, there are no direct commercial passenger flights from DRC to the U.S. as of December 2023.

U.S. FDA-approved vaccines (JYNNEOS, ACAM2000) are expected to be effective for both Clade I and II MPXV infections.

Vaccination or prior MPXV infection should provide antibodies that will provide cross-protection to other orthopoxviruses, including Clade I MPXV, says the CDC.

However, clinical verification is under review.

The CDC recommends clinicians encourage vaccination for eligible patients.

Eligible patients who have only received one dose of Bavarian Nordic JYNNEOS® (MVA-BN®, IMVAMUNE®) vaccine, which is based on a live, attenuated vaccinia virus, should receive the second dose as soon as possible, regardless of the time that has elapsed since the first dose.

Mpox vaccines have limited availability in the U.S.

Furthermore, clinicians should notify their state health department if they have a patient with mpox-like symptoms and should submit lesion specimens for clade-specific testing for these patients.

Dec 7, 2023 • 7:04 pm CST
WHO Report #9, Dec. 7, 2023

The World Health Organization (WHO) announced today's preliminary 2023 data, indicating that the number of cholera cases reported this year has surpassed that recorded in 2022.

As of December 7, 2023, over 610,000 cholera cases and 3,500 related deaths have been reported by 29 countries.

The WHO confirmed that given the extensive number of outbreaks, their widespread distribution, and the current shortage of oral cholera vaccines (OCV), the WHO continues to assess the risk at the global level as very high.

At the end of November 2023, around 65 million OCV doses have been requested, with 45% being approved and allocated to 12 countries.

The global OCV stockpile is 4.5 million doses, available but not yet allocated. 

There are three WHO pre-qualified OCVs: Dukoral®, Shanchol™, and Euvichol®.

In the current outbreak context, only one-dose courses have been validated and implemented in these reactive campaigns, says the WHO.

Since the beginning of 2023, 24 reactive vaccination campaigns have been implemented in 12 countries facing cholera outbreaks: Ethiopia (4), Mozambique (4), Kenya (3), Somalia (2), Northwest Syria (2), Cameroon (2), Sudan (2), the Dominican Republic (1), Democratic Republic of Congo (DRC) (1), Haiti (1), Malawi (1), and Zambia (1).

From an OCV availability perspective, the U.S. Food and Drug Administration recommends OCV for specific conditions in countries undergoing outbreaks.

However, vaccination against cholera is not generally recommended because most U.S. travelers do not visit cholera outbreaks. 

In August 2023, the U.S. Centers for Disease Control and Prevention published Cholera Vaccine Recommendations, highlighting the Vaxchora® vaccine.

All OCVs require two doses for complete protection against cholera for up to three years, while a single dose provides short-term protection. 

Dec 7, 2023 • 6:23 pm CST
from Pixabay

 Anixa Biosciences, Inc. today announced new and updated positive results from the Phase 1 clinical trial of its breast cancer vaccine.

The data were presented by G. Thomas Budd, M.D., a staff physician at Cleveland Clinic Cancer Institute and principal investigator of the study, in a poster entitled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC."

Patients who had been curatively treated for TNBC received three vaccinations given once every two weeks. IFNγ and IL-17, which are T cell immune response indicators (cellular immunity), and antibody production (B cell humoral immunity) were measured to evaluate the vaccination effect.

Data from the 16 patients treated to date showed that:

Most patients developed ELISpot (T-cell) responses that met the rigorous protocol-specified definition of an immune response, with a measurable but lesser magnitude of response noted in the remaining patients.

12 (75%) of the women had antigen-specific IFNγ and/or IL-17 ELISpot responses at all dose levels, while ELISA antibody responses at Dose Level 2 and higher.

A statistically significant (P = 0.03) increase in IFNγ over baseline (Day 0) was observed by Day 56, while a significant (P = 0.0001) increase in IL-17 over baseline was observed by Day 14.

Among the doses studied, Dose Level 1 (10 mcg α-lactalbumin/10 mcg zymosan) was determined to be a usable immunologic dose and the maximum tolerated dose (MTD).

No significant side effects were observed at the MTD besides irritation at the injection sites. No myalgias, flu-like symptoms, or aberrant laboratory values were noted.

Anixa and Cleveland Clinic plan to investigate additional intermediate dose levels and continue studying the vaccine's safety and immunologic effects in two additional patient cohorts.

The first cohort, which opened for enrollment in August 2023, is evaluating the combination of the Company's breast cancer vaccine with Keytruda® (pembrolizumab) in post-operative patients found to have residual disease following neoadjuvant chemo-immunotherapy.

The second cohort will investigate the safety and immunologic effects of the vaccine in patients who are BRCA1, BRCA2, or PALB2 mutation-positive and are planning prophylactic risk-reducing mastectomies.

"The data from our Phase 1 trial has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, in a press release on December 7, 2023.

"We look forward to reviewing additional data as the trial continues to completion, and we are in the planning stages of the Phase 2/3 studies of this vaccine."

"Our goal is to initially evaluate the vaccine's ability to prevent recurrence of cancer in survivors and continue with extension studies to eventually determine its effectiveness in preventing the initial onset of TNBC."

Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology invented at Cleveland Clinic, the site of the Phase 1 trial. The U.S. Department of Defense grant was made directly to the Cleveland Clinic.

Dec 7, 2023 • 10:12 am CST
Walgreens Dec. 7, 2023

As the United States heads into the winter months that typically coincide with peak respiratory illness season, Walgreens provides in-store and at-home testing and treatment options to help everyone stay healthy and feel better faster if they are experiencing symptoms.

"Respiratory illness activity and hospitalizations are picking up in many parts of the U.S., and these numbers are likely to continue increasing in the coming months," said Anita Patel, PharmD, Vice President of Pharmacy Service Development at Walgreens, in a press release on December 7, 2023.

"In addition to staying up to date on your vaccinations, getting tested, seeking treatment promptly, and practicing good respiratory etiquette are all important steps to protect yourself and your loved ones this winter, especially if you are feeling sick or planning to travel and gather for the holidays."

Walgreens stated testing is the best way to know if you have a specific respiratory virus so you can take appropriate precautions and get the proper relief or treatment immediately.

With influenza, RSV, and COVID-19 viruses circulating, visiting a local pharmacist in 2023 may be just what the doctor ordered.

Flu and RSV vaccines are covered by most insurance plans with a $0 copay and by Medicare and Medicaid in certain states. 

Dr. Patel added, "People are increasingly relying on pharmacies as a one-stop destination for these services and deepening their relationships with their community pharmacists, who work tirelessly to provide the care and information they need all season long."

"As the nature of respiratory illness season continues to evolve post-pandemic, we remain focused on being a trusted partner in keeping our communities healthy."

As of December 2, 2023, the Walgreens Flu Index listed the top three states indicating influenza outbreaks:

  1. Louisiana
  2. Mississippi
  3. Texas

With nearly 9,000 retail locations across America, Puerto Rico, and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving almost 10 million customers daily. 

Various types of flu shots are available as of December 7, 2023.

Dec 7, 2023 • 4:38 am CST
by Gerd Altmann

The approval of yet another RNA-based vaccine might not seem momentous, wrote Elie Dolgin in an article published by the journal Nature.

But the endorsement last week by Japanese authorities of a jab against the SARS-CoV-2 coronavirus constructed using a form of RNA that can make copies of itself inside cells — the first 'self-amplifying' RNA granted full regulatory approval anywhere in the world — marks a pivotal advance.

The December 6, 2023, article is posted at this link.

In late November 2023, CSL and Arcturus Therapeutics announced that Japan's Ministry of Health, Labor, and Welfare approved ARCT-154, a self-amplifying Messenger RNA COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

Dec 6, 2023 • 5:31 pm CST
PAHO dengue case 5 year trend as of December 2023

The Pan American Health Organization (PAHO) issued an Epidemiologic Alert confirming a significant increase in dengue during the second half of 2023 in several countries of the Region of the Americas, especially in Central America and the Caribbean.

As of December 5, 2023, the Americas set a new record number of dengue cases with over 4.1 million patients.

According to the seasonal pattern of dengue and the current rainy season, the PAHO called for the intensification of preparedness actions within healthcare services to facilitate access and proper management of patients ahead of the Southern Hemisphere's peak season.

In 2023, through week #45, 1,954 dengue-related deaths were reported in the Region of the Americas (case fatality rate [CFR]: 0.048%).

The most significant number of dengue cases were reported in Brazil, with 2,909,404 cases.

Of the 6,340 severe dengue cases reported in 2023, the highest numbers were recorded in Brazil with 1,474 cases, Colombia with 1,390, Mexico with 1,142, Peru with 1,065, and Bolivia with 640 cases.

In addition, a notable increase in the notification of locally transmitted cases has been observed in places such as The Bahamas and the state of Florida.

Given this situation, the PAHO / World Health Organization urges Member States to implement appropriate actions at the level of patient care services, including triage, diagnosis, and timely and proper treatment of dengue cases and other arboviruses such as Zika.

As of December 2, 2023, the PAHO indicated 31,780 Zika cases across the Americas this year.

From a protection perspective, two dengue vaccines have been authorized in various countries since October 2022.

Dec 6, 2023 • 10:52 am CST
US CDC COVIDVaxView Dec. 6, 2023

The U.S. CDC's Weekly COVID-19 Vaccination Dashboard estimates vaccinations and intent for vaccination using various data sources, including surveys, healthcare claims, electronic medical records, and immunization information systems data.

As of December 6, 2023, category highlights include the following data:

As of November 25, 2023, 6.9% (95% Confidence Interval: 6.0%-7.9%) of children were reported to be up-to-date with the 2023-24 COVID-19 vaccine.

About 17.3% of children had a parent who reported they planned to get their child vaccinated. Additional COVID-19 vaccination data for children by demographic characteristics at the national level and overall estimates by jurisdiction are available at this CDC link.

For pregnant women, 8.9% had received the updated 2023-24 COVID-19 vaccine.

Vaccination coverage was highest among non-Hispanic Asian (15.2%) women and lowest among non-Hispanic Black (2.7%) pregnant women.

And for adults, about 16% reported having received an updated 2023-24 COVID-19 vaccine since September 14, 2023. Vaccination coverage increased by age and was highest among adults 65 and older [33.3%, (31.2%-35.3%)].

From a geography perspective, the District of Columbia reported the most significant number of vaccinated adults, with about 30.7%.

COVID-19 vaccination coverage estimates among all adults are based on CDC's National Immunization Survey–Adult COVID Module data.

Dec 6, 2023 • 5:26 am CST

Recent Highly Pathogenic Avian Influenza (HAPI) outbreaks in Europe have led France to issue a 'high' alert, forcing poultry farms to keep birds indoors as of December 5, 2023.

The French government wrote, 'continuing strong dynamic of HPAI virus infection recorded in Europe, while the first contamination of a farm had been detected a few days ago in France, has now led the public authorities to place all of the territories at high-risk levels with of HPAI.'

The French Ministry of Agriculture and Food Sovereignty launched a vaccination campaign in October 2023 to reduce the spread of HAPI. The mandatory vaccination of domestic ducks applies to all of Metropolitan France (except Corsica Island).

To better inform the public, the Ministry has published 'Ten Things to Remember About HAPI Vaccination' (posted in French) on November 17, 2023.

Avian influenza, known as bird flu, is harmless in cooked food and spreads among various types of birds, mammals, and even to humans.

Furthermore, the World Health Organization report #907 confirmed sporadic influenza A(H5N1) clade virus detections in humans. 

On September 29, 2023, the U.S. government announced that it restricted the import of poultry from France and its European Union trading partners following France's decision to vaccinate meat ducks against HPAI.

Additionally, the U.S. Centers for Disease Control and Prevention (CDC) published a Technical Report in 2023 that confirmed the overall risk to human health associated with the ongoing outbreaks of highly pathogenic A(H5N1) viruses remains low.

From an outbreak protection perspective, the CDC confirmed in June 2023 that about 20 million H5N1 and 12 million H7N9 vaccines for humans were available in the U.S. National Strategic Stockpile.

Note: This article was updated on Dec. 7, 2023.

Dec 6, 2023 • 4:18 am CST
Health Canada COVID-19 case map December 5, 2023

Novavax, Inc. today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals aged 12 and older.

The Public Health Agency of Canada's National Advisory Committee on Immunization recommended XBB COVID-19 vaccines that target more recent, immune-evasive virus variants.

The expanded authorization was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16, and XBB.2.3 variants.

Additional non-clinical data demonstrated that Novavax's vaccine-induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1, and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6.

These data indicate that Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

In Canada, recombinant XBB sub-lineages remain dominant, representing 93% of sequences in the past month. HV.1, HK.3, and BA.2.86 (including JN.1) are the major lineage groups demonstrating consistent growth in Canada.

Health Canada's latest COVID-19 numbers were updated at this link as of December 5, 2023, 8 am ET.

"Today's expanded authorization will support the Canadian government's strong commitment to provide its citizens with effective options, such as our protein-based non-mRNA vaccine, in the campaign against currently circulating COVID-19 variants," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on December 5, 2023.

Novavax's updated COVID-19 vaccine is also authorized in the U.S. and Europe by the World Health Organization and is under review in other markets.

Dec 5, 2023 • 9:22 am CST
US CDC 2023

Vaxcyte, Inc. today announced the publication of the results from the VAX-24 vaccine candidate's pneumococcal disease (PD) proof-of-concept study in the journal The Lancet Infectious Diseases.

This phase 1/2 clinical trial evaluated the safety, tolerability, and immunogenicity of Vaxcyte's investigational 24-valent, carrier-sparing pneumococcal conjugate vaccine (PCV) compared to the current standard-of-care, Prevnar 20® (PCV20, APEXXNAR), for the prevention of invasive pneumococcal disease (IPD) in healthy adults.

The study results showed that VAX-24 demonstrated a safety and tolerability profile comparable to PCV20 at all doses studied and an immunogenicity profile that met or exceeded established regulatory immunogenicity standards for all 24 serotypes at the conventional 2.2 mcg dose.

"The results from the proof-of-concept study provided the first look at the safety and immunogenicity profile of VAX-24 in adults, giving us confidence in the 2.2 mcg dose we plan to advance into Phase 3," said Dr. Jakub Simon, Chief Medical Officer of Vaxcyte, in a press release on December 4, 2023.

"We look forward to initiating our Phase 3 pivotal, non-inferiority study, designed to further establish the clinical potential of VAX-24, and announcing topline data, which we expect in 2025."

PD is an infection caused by Streptococcus pneumoniae bacteria, says the U.S. CDC.

It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis.

People can get pneumococcal disease more than once. A previous pneumococcal infection will not protect you from future infection. Therefore, CDC recommends pneumococcal vaccination even if someone has had pneumococcal disease in the past.

In the United States, approximately 320,000 people get pneumococcal pneumonia each year, which is estimated to result in about 150,000 hospitalizations and 5,000 deaths.

Pneumococci also cause over 50% of all cases of bacterial meningitis in the U.S.

As of December 2023, several approved pneumococcal vaccines are available at clinics and pharmacies in the U.S.

Dec 5, 2023 • 5:05 am CST
from Pixabay

Osivax today announced that it has received a grant of over $1.5 million from the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The grant will support preclinical studies evaluating the breadth of protection and immune response induced by OVX836 against pandemic influenza strains.

OVX836 is a first-in-class influenza vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response.

OVX836 will be evaluated against two pandemic influenza A-strains in preclinical models: the once pandemic but now seasonal, pH1N1, and the highly pathogenic variant with pandemic potential, H5N1.

Osivax’s oligoDOM® technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses.

OVX836 has been tested in 5 clinical trials with 1200 participants, showing promising safety, immunogenicity, and efficacy read-outs. 

“Receiving this grant from the NIAID will support our progress in developing OVX836 to provide broad-spectrum protection against influenza, which remains a perennial pandemic threat,” commented Alexandre Le Vert, Co-Founder and CEO of Osivax, in a December 5, 2023 press release.

“We believe that by generating these additional data against pandemic influenza strains, we will be able to bolster the positive results generated by OVX836 against seasonal strains, placing us on a strategic path toward future regulatory approval.”

Osivax also recently published the results of a Phase 2a dose-optimization study (OVX836-003) in The Lancet Infectious Diseases, showing efficacy in humans against seasonal strains.

Dec 4, 2023 • 4:56 pm CST
US CDC Lyme disease map 2021

With the winter months ahead, most hikers are not focused on catching Lyme disease. However, once the snow melts, millions of people will once again not have access to a vaccine.

There are currently no approved human vaccines for Lyme disease.

To address this significant health risk, Pfizer Inc. and Valneva SE today announced that they have completed recruitment for the Phase 3 clinical trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) for Lyme disease vaccine candidate VLA15.

The VALOR trial, initiated in August 2022, has enrolled 9,437 participants five years of age and older at sites where Lyme disease is highly endemic across the U.S., Europe, and Canada.

As part of the primary vaccination series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year and one booster dose approximately one year after completion of the primary immunization.

The trial builds on previous positive Phase 1 and 2 trial results and includes adult and pediatric participants to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.

"Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long-lasting consequences," said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer, in a press release on December 4, 2023.

"If approved, a vaccine could prevent the disease and ease the burden of acute, severe, and sometimes persistent consequences in adults and children."

"We look forward to progressing the trial with the goal of submitting a Biologics License Application to the U.S. Food and Drug Administration and Marketing Authorization Application to the European Medicines Agency in 2026, subject to positive data."

VLA15 is an alum-adjuvanted formulation administered intramuscularly and has demonstrated a strong immune response and a satisfactory safety profile in pre-clinical and clinical trials.

This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease.

OspA is a surface protein the bacteria expresses when present in a tick. Blocking OspA inhibits the bacterium's ability to leave the tick and infect humans.

The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species prevalent in North America and Europe.