Vaccine News

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Sep 10, 2024 • 2:33 pm CDT

RSV Vaccinations Protect Older Seniors

US NIH 2024

According to a new modeling study published by the Canadian Medical Association Journal, targeting respiratory syncytial virus (RSV) vaccinations to older adults (70+) with underlying health conditions is the most cost-effective way to reduce disease.

Published on September 9, 2024, this study found RSV vaccinations based on age plus risk for RSV-related complications were projected to avert a median of 20% to 31% of outpatient cases, 38% to 42% of hospital cases, and 39% to 42% of related fatalities.

“Strategies focused on adults with underlying medical conditions that place them at increased risk of RSV disease are more likely to be cost-effective than general age-based strategies,” wrote Dr. Ashleigh Tuite, the Centre for Immunization Programs at the Public Health Agency of Canada and the Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, with coauthors.

“We found that vaccination of older adults may be less costly and more effective than no vaccination and that vaccinating people aged 70 years and older with chronic medical conditions is likely to be cost-effective based on commonly used cost-effectiveness thresholds.”

Three approved RSV vaccines are available in the United States for the 2024-2025 season. These vaccines are generally available at clinics and pharmacies in the United States.

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Karen McClorey Hackett

Sep 10, 2024 • 7:19 am CDT

69% Overall Response Rate in Cancer Vaccine Candidate Phase 2 Study

by Ernesto Eslava

Evaxion Biotech A/S today announced new clinical phase 2 data for its lead compound EVX-01. The data show that 11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate, and 15 out of the 16 patients had reduced tumors.

This topline data is part of a one-year interim analysis of the ongoing phase 2 trial assessing EVX-01 in combination with Merck & Co., Inc. anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.

EVX-01 is a personalized peptide-based neoantigen cancer vaccine/therapy (immunotherapy) for the first-line treatment of multiple advanced solid cancers. This combo therapy is tailored to target each patient's unique tumor profile and immune characteristics. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

"A huge unmet medical needs remain in the field of melanoma, and we believe that EVX-01 could be an improved treatment option for patients. We look forward to presenting the complete one-year dataset at ESMO, discussing the data with potential partners, and advancing the phase 2 trial towards its completion next year,” says Christian Kanstrup, CEO of Evaxion, in a press release on September 9, 2024.

In the completed Phase 1/2a clinical trial, vaccine-induced T cells were detected in all patients.

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Karen McClorey Hackett

Sep 10, 2024 • 5:15 am CDT

Global Phase 3 Study Launches for Second-Line Non-Small Cell Lung Cancer Vaccine

US NIH

OSE Immunotherapeutics SA today announced the launch of its international Phase 3 clinical trial (Artemia) of Tedopi®, the ‘off-the-shelf’ neoepitope-based therapeutic cancer vaccine, in second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC).

Tedopi® (immunotherapy activating tumor-specific T-cells, off-the-shelf, neoepitope-based) is the most advanced therapeutic cancer vaccine in development.

This pivotal study, accepted in 14 countries by international health agencies (Canada, Europe, U.K., U.S.), supports the registration of the product Tedopi® in parallel with the companion diagnostic for HLA-A2 positive patients.

Nicolas Poirier, CEO of OSE Immunotherapeutics, said in a press release on September 10, 2024, “This international registration trial is now on track, and we look forward to confirming the therapeutic benefit of Tedopi® for metastatic cancer patients."

"Tedopi® is the most advanced therapeutic cancer vaccine in clinical development and the first treatment option to address the high unmet medical need and largely untapped market in advanced and metastatic second-line NSCLC. “

NSCLC accounts for 85% of all lung cancers, and the HLA-A2 phenotype represents about 45% of the population.

Each year, more people die of lung cancer in the U.S. than of colon, breast, and prostate cancers combined. Lung cancer accounts for about 20% of all cancer deaths.

The American Cancer Society (ACS) estimates for lung cancer cases for 2024 are:

About 234,580 new cases of lung cancer (116,310 in men and 118,270 in women),
About 125,070 deaths from lung cancer (65,790 in men and 59,280 in women).

On a positive note, the ACS says the number of deaths from lung cancer continues to decrease due to fewer people smoking and advances in early detection and treatment.

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Don Ward Hackett

Sep 9, 2024 • 5:20 pm CDT

Pregnant Women Should Avoid Visiting Oropouche Virus Outbreaks

PAHO Sept. 2024

Since 2023, outbreaks of Oropouche virus disease have been primarily reported in South America but have recently been reported throughout the Region of the Americas.

Published on September 6, 2024, the Pan American Health Organization (PAHO) Epidemiological Update Oropouche in the Americas disclosed that 9,852 confirmed cases, including two deaths, have been reported this year.

Confirmed cases were reported in eight countries: Bolivia (356), Brazil (7,931, including two deaths), Canada (1 imported case), Colombia (74), Cuba (506), the Dominican Republic (33), Peru (930 cases), and the United States (21 imported cases, in 3 states).

The PAHO reiterated its recommendations on diagnosis and clinical management, laboratory diagnosis, prevention, and vector control of Oropouche virus disease. The disease is spread to people by the bites of infected biting midges, and some mosquitoes can also spread the virus.

The likelihood of Oropouche spreading widely in the continental U.S. is low because of differences in climate, types of biting midges, and mosquitoes. However, public health authorities have assessed the risk to human health in the Americas as very high.

The U.S. CDC Level 2 Travel Health Notice says Oropouche cases have been traced to vertical infection causing congenital malformation or fetal death associated with infection. Investigations on vertical transmission and malformation risk remain under assessment in various countries.

Therefore, the CDC recommends that pregnant women avoid non-essential travel to areas with reporting Oropouche cases.

The clinical presentation of Oropouche virus disease is commonly mistaken for other arboviruses, such as dengue and chikungunya.

Diagnosis of Oropouche virus disease can be challenging. It requires a positive RT-PCR result from blood samples collected within six days of symptom onset. After this period, serology could be diagnostic, but commercial kits for the Oropouche virus are currently unavailable.

While preventive vaccines for chikungunya (IXCHIQ®) and dengue available, no Oropouche vaccine is available in 2024.

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Karen McClorey Hackett

Sep 9, 2024 • 1:01 pm CDT

Without a Lyme Disease Vaccine, the U.S. CDC Offers Information Toolkit

US CDC Lyme disease state based map 2022

The American Medical Association (AMA), in partnership with the U.S. Centers for Disease Control and Prevention (CDC), today announced it has developed a new toolkit to help clinicians offer better care for patients with prolonged, non-specific symptoms and concerns about Lyme disease.

The CDC has scheduled a COCA Call for September 19, 2024, when presenters will share a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients.

If you cannot attend the live COCA Call, the recording will be available on the webpage. The slide set will be available on the day of the call under Call Materials on the COCA Call webpage.

According to recent data, Lyme disease has continued spreading in the United States from the northeast into the upper midwest. And in various Euopean countries.

About 329,000 persons annually are diagnosed with Lyme disease in the U.S.

While most patients recover fully after treatment, but about 5 to 10% can have prolonged symptoms such as fatigue, pain, and difficulty thinking.

As of September 9, 2024, there are no Lyme disease approved vaccines.

However, Valneva SE's VLA15 vaccine candidate has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

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Karen McClorey Hackett

Sep 9, 2024 • 11:22 am CDT

mRNA-based Gonorrhea Vaccine Found Protective in Pre-Clinical Setting

by Betty Verheij

Evaxion Biotech A/S today announced new pre-clinical data demonstrating the ability of its novel EVX-B2 mRNA gonorrhea vaccine candidate to eliminate gonorrhea bacteria by triggering a targeted immune response.

This new data provides strong Proof-of-Concept (PoC) for the mRNA-based version of EVX-B2 in a pre-clinical setting.

EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate for which pre-clinical PoC has already been obtained. The novel pre-clinical data for the mRNA-version of the vaccine substantiates that AI-Immunology™ identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities.

“In the case of gonorrhea, no vaccine exists today, so we have an opportunity to develop a potentially groundbreaking treatment. Further, the data confirms that our platform is delivery modality agnostic, which is a very strong value proposition towards existing and new partners,” said Christian Kanstrup, CEO of Evaxion, in a press release on September 9, 2024.

While there are no approved gonorrhea vaccines, off-table use of existing vaccines has been found to offer some protection.

A systematic review published in July 2024 evaluated the evidence of vaccine effectiveness (VE) of meningococcal B (MenB) outer membrane vesicle (OMV) vaccines against gonorrhea and a non-OMV-based vaccine (MenB-FHbp). This study concluded that 4CMenB and MenB-OMV vaccines show moderate VE against gonorrhea infection.

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Karen McClorey Hackett

Sep 9, 2024 • 4:49 am CDT

Mpox Vaccines Arrive in Africa

from Pixabay

The Africa Centres for Disease Control and Prevention (Africa CDC) and United Nations Children’s Fund (UNICEF) recently announced the arrival of the first shipment of 99,100 doses of the JYNNEOS® (MVA-BN®) mpox - smallpox vaccine.

On September 5, 2024, the Bavarian Nordic A/S produced vaccines were officially received by the Minister of Health of the Democratic Republic of Congo (DRC), Samuel Roger Kamba, alongside others.

Additional shipments to the DRC are planned for a total of more than 250,000 vaccines.

Since the start of 2024, DRC has reported over 4,901 confirmed mpox clade 1 cases, with more than 629 associated deaths, representing a sharp escalation in both infections and fatalities compared to previous years.

According to the Africa CDC, introducing the two-dose JYNNEOS vaccine is a decisive action to mitigate further spread and protect the most at-risk populations.

The U.S. government has confirmed that two doses provide robust protection against disease, and booster doses (3rd) are not endorsed. As of September 2024, JYNNEOS is commercially available in the U.S.; however, routine immunization against mpox is not recommended for the general public.

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Don Ward Hackett

Sep 8, 2024 • 5:26 pm CDT

Costa Rica Confronts Chikungunya, Dengue, and Zika Outbreaks in 2024

Costa Rica Dept of Health Sept. 2024

When visiting the Republic of Costa Rica in 2024, international guests may be exposed to mosquito-transmitted diseases such as chikungunya, dengue, or zika.

This health concern has not fazed international travelers, as about 2.4 million people arrived in 2023, a 16% increase over 2022.

On September 6, 2024, the Costa Rica Ministry of Health published Epidemiological Bulletin No. 34, highlighting various health risks, such as the following:

There have been 28 chikungunya infections reported this year. In 2023, there were 82 chikungunya cases confirmed. From a prevention perspective, Valneva SE's IXCHIQ® vaccine is now approved in various countries, including the U.S.

Costa Rica has been included in the U.S. Centers for Disease Control and Prevention's (CDC) latest Travel Health Advisory, which confirmed that dengue fever is classified as high risk and is a year-round health risk. Over 19,900 dengue cases were confirmed in Costa Rica in 2024, and 24,914 were reported in 2023.

Takeda's QDENGA® dengue vaccine is available in various countries in 2024.

This Central American country has also reported 23 Zika cases in 2024, with 40 cases confirmed in 2023. No Zika vaccines are available anywhere in 2024.

Furthermore, as the 2024-2025 respiratory season approaches, Costa Rica is launching a vaccination campaign against influenza and rhinovirus. The Tico Times reported the country plans to administer 1.5 million vaccines.

To alert travelers of these health risks, Canada, the United Kingdom, and the U.S. CDC have issued travel advisories and vaccine recommendations for Costa Rica.

The CDC recommends checking its recommended travel vaccine list and seeing a healthcare provider at least a month before visiting Costa Rica.

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Karen McClorey Hackett

Sep 7, 2024 • 10:03 am CDT

Ontario Confirms First Rabies Case this Century

WHO Rabies case map 2022

The Brant County Health Unit (BCHU) has received confirmation of a human case of rabies in a resident of Brantford-Brant, Ontario, Canada.

As of September 6, 2024, the individual was hospitalized. As a precaution, family members and other close contacts are being assessed and offered post-exposure prophylaxis, as needed.

While the suspected exposure of the case was from a bat in the Gowganda area of the Timiskaming region, bats in all areas of Ontario are known to carry rabies. Bats, skunks, foxes, and raccoons are the most common to spread the rabies virus in Canada.

Ontario’s last domestic case of human rabies occurred in 1967, and there have been 26 human cases in Canada since 1924.

The World Health Organization (WHO) states that dogs spread most rabies cases globally. To date, there has never been a documented case of human-to-human transmission of rabies virus.

Once the virus infects the central nervous system and clinical symptoms appear, rabies is fatal in 100% of cases. There are an estimated 59,000 deaths from rabies annually. However, due to underreporting, documented case numbers often differ from the estimate, says the WHO.

Even though rabies is well-controlled in the United States, over 4 million Americans report animal bites each year, with 800,000 seeking medical attention.

In 2022, 54 U.S. jurisdictions reported 3,579 animal rabies cases. However, only ten people die from rabies infection annually in the U.S.

Rabies is a viral infection that causes brain and spinal cord inflammation. It is typically spread to humans through direct contact with saliva or mucous of an infected animal, such as through a bite or scratch. Even tiny bites or scratches, which can be challenging to see, can transmit the virus.

Effective rabies vaccines are available to immunize people before and after potential exposures.

As of 2024, three WHO pre-qualified human rabies vaccines, RABIVAX-S, VaxiRab N, and VERORAB, are available globally. In the United States, rabies vaccines are generally offered at travel clinics and pharmacies.

Note: This news article was updated on Sept. 28, 2024.

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Don Ward Hackett

Sep 6, 2024 • 12:34 pm CDT

Polio Travel Advisory Issued for 37 Countries

GPEI Sept 2024

According to this week's Global Polio Eradication Initiative (GPEI) report, various countries confirmed poliovirus detections and vaccination efforts.

As of early September 2024, a two-round polio vaccination campaign was launched in the Palestinian territory, providing more than 640,000 children with two drops of novel oral polio vaccine type 2 (nOPV2) vaccine.

Additionally, new polioviruses cases and positive environmental isolates were detected in the following countries as of September 4, 2024:

Afghanistan: 1 WPV1 case

Pakistan: 8 WPV1-positive environmental samples

Côte d’Ivoire: 1 cVDPV2-positive environmental sample

DR Congo: two cVDPV2 cases

Egypt: 1 cVDPV2-positive environmental sample

Indonesia: 3 cVDPV2 cases

Niger: 2 cVDPV2 cases and 3 cVDPV2-positive environmental samples

Nigeria: 7 cVDPV2 cases and 1 cVDPV2-positive environmental sample

South Sudan: 2 cVDPV2-positive environmental samples

Sudan: 1 cVDPV2-positive environmental sample

To alert international travelers of their potential polio risk, the U.S. Centers for Disease Control and Prevention (CDC) reissued a Global Polio Alert - Level 2, Practice Enhanced Precautions Travel Health Notice on August 20, 2024, regarding polio outbreaks and poliovirus detections in 37 countries.

The CDC says that before traveling to any destination listed, adults who have previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.

Polio vaccination services are generally available to local clinics and community pharmacies in the U.S.

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Karen McClorey Hackett

Sep 6, 2024 • 12:13 pm CDT

Lassa Fever Vaccine Could Save Millions

WHO Lassa Fever outbreak map 2024

New research by modeling experts shows that vaccinating against Lassa Fever—a viral disease—would prevent millions of people from falling ill.

Lassa fever is found in parts of West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria, where the first documented case occurred in 1969.

According to modeling by the Universities of Oxford and Liverpool and the Liverpool School of Tropical Medicine, deploying an effective Lassa vaccine across 15 countries of continental West Africa could save nearly 3,300 lives over ten years, wrote the Coalition for Epidemic Preparedness Innovations (CEPI).

The model was published on August 28, 2024, and predicted 2.7 million (95% uncertainty interval: 2.1–3.4 million) Lassa virus infections annually. However, due to limited access to diagnostics and healthcare, Lassa’s true disease burden could be much higher than reported.

They also model the emergence of ‘Lassa-X’—a hypothetical pandemic Lassa virus variant—and project impacts of achieving 100 Days Mission vaccination targets.

The results showed that around 5,500 lives could be saved and 33,000 hospitalizations avoided throughout a two-year outbreak if safe and 70% effective Lassa X vaccines were given to 40% of people per year starting within 100 days.

Overall, the most effective vaccination strategy was a population-wide preventive campaign targeting WHO-classified ‘endemic’ districts.

Richard Hatchett, CEO of CEPI, commented in a press release, “This study demonstrates the urgent need for a vaccine to protect people from this debilitating and sometimes deadly disease. Lassa fever has been a priority for CEPI since our launch in 2017, and we are proud to be one of the world’s leading Lassa vaccine R&D funders.”

CEPI is one of the world’s leading Lassa vaccine candidate R&D funders. To date, it has invested in six potential vaccine candidates, of which four have progressed into human testing.

One of CEPI’s partners, IAVI, has launched the first-ever Phase II clinical trial of a Lassa vaccine in Abuja, Nigeria.

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Karen McClorey Hackett

Sep 6, 2024 • 10:38 am CDT

Massachusetts and New Hampshire Confirm Additional Eastern equine encephalitis and West Nile virus Cases

US CDC WNV case map September 3, 2024

In the northeastern section of the United States, concerns about the impact of Eastern equine encephalitis (EEE) and West Nile virus (WNV) have continued into September 2024.

The Massachusetts Department of Public Health (DPH) announced on September 5, 2024, one additional human case of EEE and one additional human case of WNV in Massachusetts this year.

The total number of EEE cases in Massachusetts this year is three, with seven WNV cases.

WNV risk levels in the following communities are being raised to high: Stoneham and Wakefield in Middlesex County.

Throughout the U.S., 38 states have reported WNV cases in 2024.

The last outbreak of EEE occurred in 2019-2020 and resulted in 17 human cases and seven deaths. In 2023, there were six human cases of WNV.

As of September, EEE risk levels have been raised to high in Acton, Ayer, Boxborough, Carlisle, Littleton in Middlesex County, and Harvard in Worcester County. The following communities are being raised to moderate: Bedford, Billerica, Chelmsford, Concord, Framingham, Groton, Lincoln, Shirley, Stow, Tyngsborough, Wayland, and Westford in Middlesex County; and Berlin, Bolton, Clinton, and Lancaster in Worcester County.

Public Health Commissioner Robbie Goldstein, MD, PhD., commented in a press release, “It is essential that residents continue to use mosquito repellent with an EPA-registered active ingredient every time they are outdoors. We also strongly recommend that residents and towns in high-risk areas for EEE reschedule their evening outdoor events to avoid peak mosquito biting hours.”

EEE and WNV are transmitted to humans through the bite of an infected mosquito.

“Mosquito behavior starts to change in September,” said State Epidemiologist Dr. Catherine Brown. “They will be less active during cooler temperatures. However, during warmer weather, such as being forecast for the end of next week, mosquitoes will be out and looking for their next meal.”

To the north of Massachusetts, the New Hampshire Department of Health and Human Services reported on September 4, 2024, that ten mosquito batches tested positive for EEE this year, with one fatal human case.

The last reported human cases of EEE in New Hampshire were in 2014 when three cases were identified. Two of those patients died.

As of September 6, 2024, no vaccines are available for people to protect themselves against EEE or WNV.

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Don Ward Hackett

Sep 6, 2024 • 5:32 am CDT

Japan Approves Protein-based COVID-19 Vaccine

US CDC Japan 2024

Novavax Inc. announced on X today that its updated 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) has received Marketing Approval from Japan’s Ministry of Health, Labour and Welfare.

As of September 6, 2024, Novavax's vaccine is the only non-mRNA, protein-based COVID-19 vaccine available in the U.S. following the Food and Drug Administration (FDA) granting emergency use authorization.

John C. Jacobs, President, and Chief Executive Officer, Novavax, commented in a recent press release, "Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."

Since August 2020, Novavax and Takeda Pharmaceutical Company Limited have partnered to develop, manufacture, and commercialize Novavax’s COVID‑19 vaccines.

Before visiting Japan, the U.S. CDC recommends travelers speak with a healthcare provider one month before departure about their vaccination options.

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Don Ward Hackett

Sep 5, 2024 • 3:30 pm CDT

Puerto Rico Battles Dengue Outbreak Without a Vaccine

from Pixabay

During the global dengue virus outbreak in 2024, Puerto Rico was the most impacted area in the United States. The U.S. CDC says that Dengue is endemic in Puerto Rico, cases are increasing, and it issued a Dengue travel advisory earlier in 2024.

As of week #32 in August 2024, Puerto Rico reported 2,704 dengue cases, with San Juan reporting over 950 cases.

The local health department's report for August 2024 indicates that 1,234 dengue-related hospitalizations and two dengue-related deaths occurred this year.

Last year, 1,242 dengue cases were reported in Puerto Rico.

Since 2019, the U.S. Food and Drug Administration (FDA) has approved the Dengvaxia vaccine for certain people with laboratory evidence of a previous dengue infection and living in areas where Dengue is endemic, such as Puerto Rico.

However, in late August 2024, Puerto Rico's Health Department issued a Notice of Discontinuation regarding access to Dengvaxia.

This announcement indicates that millions of visitors to Puerto Rico in 2024 will be unable to access a Dengue-preventive vaccine.

The FDA may approve various dengue vaccines in the coming months and once again become available throughout the U.S.

Additionally, diseases such as Chikungunya have been transmitted to people by the Aedes aeqypti mosquito.

The good news is that Valneva SE's IXCHIQ® single-dose chikungunya vaccine is available in the U.S. at travel clinics and pharmacies.

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Don Ward Hackett

Sep 5, 2024 • 10:01 am CDT

RSV Vaccination Protects Seniors From Hospitalization

by Franz Bachinger

When the U.S. Centers for Disease Control and Prevention (CDC) recommended respiratory syncytial virus (RSV) vaccination for seniors in 2023, prelicensure trials were not powered to assess efficacy against RSV-associated hospitalization, excluded immunocompromised patients, and underrepresented other groups at increased risk of severe RSV disease, including adults aged 75 years and older.

A recent real-world study published by The JAMA Network Research Letter on September 4, 2024, evaluated the effectiveness (VE) of the RSV vaccine against RSV-associated hospitalization during the first season of use.

These researchers concluded VE against RSV-associated hospitalization was 75% (95% confidence interval (50% to 87%).

As of May 2024, the CDC RSVVaxView estimated that 24.4% of adults 60 and older received an RSV vaccine.

As of September 2024, three RSV vaccines are authorized for use in the United States and are readily available at most clinics and pharmacies before the 2024-2025 RSV season intensifies during the winter months.

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Karen McClorey Hackett