Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Apr 16, 2024 • 10:50 am CDT
by Liza Trinidad

The U.S. FDA has set February 14, 2025, as the action date for a GSK MenABCWY combination vaccine candidate that protects against the five most common groups of bacteria causing invasive meningococcal disease.

GSK’s 5-in-1 MenABCWY vaccine candidate combines the antigenic components of its two vaccines with demonstrated efficacy and safety profiles, Bexsero® (MenB-4C) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine).

Combining the protection offered by these U.S. FDA-approved vaccines with fewer shots will reduce and simplify the number of injections.

In the U.S., while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunization rates have remained low overall due in part to a complex vaccination schedule.

As of April 16, 2024, there are various approved meningococcal vaccines and candidates conducting clinical research.

Apr 16, 2024 • 9:34 am CDT
UT MD Anderson Houston, Texas

A global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”) announced today a co-development and licensing agreement with The University of Texas MD Anderson Cancer Center to develop novel mRNA-based cancer vaccines.

CureVac N.V. stated in a press release on April 16, 2024, that the collaboration creates strong synergies between its unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development, and clinical research.

The collaboration will focus on developing differentiated cancer vaccine candidates in selected hematological and solid tumor indications with high unmet medical need.

Following the selection of the most promising validated vaccine candidates and the completion of Investigational New Drug approvals, Houston, Texas-based MD Anderson will be responsible for conducting initial Phase 1/2 studies in appropriate clinical indications.

“We look forward to collaborating with the team at MD Anderson to push the boundaries of mRNA technology and develop impactful therapeutic options for patients in need,” commented Dr. Alexander Zehnder, Chief Executive Officer of CureVac.

“By combining our respective expertise, we believe we can go further and faster in developing novel, off-the-shelf, mRNA-based cancer vaccines that have the potential to improve patient outcomes significantly.”

Both parties will contribute to identifying differentiated cancer antigens based on whole genome sequencing, combined with long- and short-read RNA sequencing and cutting-edge bioinformatics. 

Apr 16, 2024 • 8:24 am CDT
by Pete Linforth

A newly approved vaccine option for protecting adults from hepatitis B (HepB) reported positive news.

Today, VBI Vaccines Inc. provided a business update that included the PreHevbrio™ (PreHevbri®, Sci-B-Vac®) vaccine and announced financial results for the year that ended December 31, 2023.

The U.S. sales volume totaled approximately 65% of the 2023 full-year volume.

The Company stated preliminary 2024 PreHevbrio U.S. sales demonstrate a substantial outpacing of 2023 on a volume basis through early March 2024.

Market segment contracting platforms continue to see growth across large hospital systems, national and regional pharmacy networks, multiple extensive military and federal facilities, prisons, and independent and public health clinics:

A top-five national health system converted to PreHevbrio in early 2024, with contracting efforts underway to secure additional partners

Retail usage is supported by strong ordering from national chains, including Walmart and regional pharmacy networks

Additionally, PreHevbrio is also available for purchase through the CDC Adult Vaccine Contract

“Over the last 12 months, we’ve seen continued progress across all of our lead programs – with increased use of PreHevbrio and an ever-expanding access and distribution network in place, as well as positive clinical data announcements from all lead pipeline programs, we are helping to make great strides in the fight against GBM, hepatitis B, and coronaviruses,” said Jeff Baxter, VBI’s President and CEO, in a press release on April 16, 2024.

As of April 2024, PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of HepB approved for use by the FDA in the United States

 

Apr 15, 2024 • 3:13 pm CDT
BMC Journal Malaria map

Despite the expenditure of over $3 billion to fight malaria outbreaks since 2021, the world still witnessed an estimated 600,000 malaria deaths and 247 million clinical malaria cases.

To address malaria outbreaks in Africa, new vaccines have recently been deployed.

The Mosquirix™ RTS,S/AS01E malaria vaccine (RTS,S) was introduced in 2019 by national immunization programs in Ghana, Kenya, and Malawi. Researchers aimed to address questions about feasibility and impact, as well as assess safety signals observed during the phase 3 clinical trial.

In a prospective evaluation published by The Lancet on April 4, 2024, the three primary doses were effectively deployed during the first two years of implementation of RTS,S.

There was no evidence of the safety signals that had been observed in the phase 3 trial, and the introduction of the vaccine was associated with substantial reductions in hospital admissions with severe malaria.

This evaluation continues to assess the impact of four doses of Mosquirix.

This study was funded by Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and Unitaid. No industry conflicts were disclosed.

In addition to RTS,S, the R21/Matrix-M™ malaria vaccine, co-produced by scientists at the University of Oxford, Novavax AB, and Novavax Inc., has been offered in Africa in 2024.

As of April 2024, the U.S. Food and Drug Administration had not approved either malaria vaccine.

Apr 15, 2024 • 8:50 am CDT
WHO Marburg disease case map 2024

Soligenix, Inc. announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the active ingredient in MarVax™, the subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for "the prevention and post-exposure prophylaxis against MARV infection."

MARV is a member of the Filoviridae family, which also includes Sudan and Zaire ebolaviruses. MARV outbreaks were first recognized in 1967 In Germany and Serbia, and continue in 2024.

MarVax was developed with Dr. Axel Lehrer at the University of Hawaiʽi at Mānoa.

In addition to providing a seven-year term of market exclusivity upon final FDA approval, orphan drug designation also positions Soligenix to be able to leverage a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a Biologics License Application, and certain tax credits.

The U.S. Orphan Drug Act assists companies in developing safe and effective therapies for treating rare diseases and disorders that affect fewer than 200,000 people in the U.S.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, commented in a press release on April 15, 2024, "Elements of this subunit vaccine platform... indicate its broad applicability."

"We have also demonstrated the ability to package more than one vaccine antigen in a single vaccine, particularly against MARV and Sudan ebolavirus where there are currently no available vaccines."

"The FDA's decision to grant orphan drug designation to both the MARV and Sudan ebolavirus vaccine candidates signifies an important step for Soligenix as we continue to advance the program and adds significantly to the existing patent estate surrounding this novel technology and the filovirus program." 

As of April 2024, several MARV vaccine candidates are conducting early-stage clinical studies.

Apr 14, 2024 • 8:43 am CDT
GPEI polio case map April 2024

According to the latest weekly update by the Global Polio Eradication Initiative (GPEI), Afghanistan reported its second wild poliovirus type 1 (WPV1) case of 2024.

This polio patient is from Nuristan province in the eastern part of the country.

Five WPV1-positive environmental samples were reported: four in Nangarhar and one in Kandahar.

As of April 14, 2024, Afghanistan is one of the two countries in the Middle East where WPV1 is still endemic.

The total number of WPV1 cases reported in 2023 remains six.

During 2024, various countries deployed the type 2 novel oral polio (nOPV2) vaccine produced by Indonesia's Biofarma.

This oral polio vaccine (OPV) has been 'triple-locked' using genetic engineering to prevent it from becoming harmful and producing a gut reaction. As a result, nOPV2 is reported to be more genetically stable than approved OPVs, with a lower risk of reversion to neurovirulence and less likely to mutate and cause paralysis.

Over the past two years, about 1.1. billion nOPV2 vaccines have been administrated worldwide. The GPEI says international travelers should speak with a healthcare provider about their polio vaccine options, including booster doses.

The inactivated polio vaccine is offered in the United States at various clinics and pharmacies.

Apr 14, 2024 • 8:13 am CDT
US CDC Yellow Book 2024 African Meningitis Belt map

Nigeria has made history by becoming the first country to introduce a new vaccine called Men5CV, which the World Health Organization (WHO) has recommended.

On April 12, 2024, the WHO confirmed Men5CV is effective against five strains of the meningococcus bacteria, and it is being used to protect people in Nigeria.

Nigeria is one of Africa's 26 meningitis hyper-endemic countries, situated in the area known as the African Meningitis Belt. Last year, there was a 50% jump in annual meningitis cases reported across Africa.

In Nigeria, a recent outbreak of Neisseria meningitidis (meningococcus) serogroup C outbreak led to 1,742 suspected meningitis cases, including 101 confirmed cases and 153 deaths in seven of 36 Nigerian states.

"Meningitis is an old and deadly foe, but this new vaccine holds the potential to change the trajectory of the disease, preventing future outbreaks and saving many lives," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.

"Nigeria's rollout brings us one step closer to our goal to eliminate meningitis by 2030."

Meningitis is a severe infection that leads to the inflammation of the membranes (meninges) surrounding and protecting the brain and spinal cord. The WHO says there are multiple causes of meningitis, including viral, bacterial, fungal, and parasitic pathogens.

Bacterial meningitis is the most serious, can also result in septicemia, and can seriously disable or kill within 24 hours those that contract it. 

In a single shot, the new vaccine offers a powerful shield against the five major strains of the meningococcal bacteria (A, C, W, Y, and X).

Gavi, the Vaccine Alliance, is funding the vaccine and emergency vaccination activities. The alliance supports lower-income countries with routine vaccination against meningitis and also funds the global meningitis vaccine stockpile.

Apr 14, 2024 • 7:52 am CDT
Walgreens Flu Index map April 6, 2024

Nationally, weekly flu hospital admissions have been decreasing since January 2024, but small outbreaks continued to be reported in April 2024.

On April 12, 2024, the U.S. Centers for Disease Control and Prevention (CDC) reported outpatient respiratory illness declined and is below baseline for the first time since late October 2023, while HHS regions 1, 5, and 7 remain above their region-specific baselines.

From a local perspective, the Walgreens Flu Index™ - Week Ending April 6, 2024, identified these ten Designated Market Areas with Flu Activity:

  1. Omaha, Neb.
  2. Lincoln & Hastings-Kearney, Neb.
  3. El Paso, Texas (Las Cruces, N.M.)
  4. Davenport, Iowa-Rock Island-Moline, Ill.
  5. Lansing, Mich.
  6. Oklahoma City, Okla.
  7. Columbus-Tupelo-West Point-Houston, Miss.
  8. Ft. Smith-Fayetteville-Springdale-Rogers, Ark.
  9. Harlingen-Weslaco-Brownsville-McAllen, Texas
  10. Knoxville, Tenn.

The CDC's Weekly U.S. Influenza Surveillance Report also confirmed that five influenza-associated pediatric deaths occurring during the 2023-2024 season were reported to the CDC during Week 14, bringing the season total to 138 pediatric deaths.

Furthermore, the CDC recommends people speak with a healthcare provider about late-season flu shot options. Various egg, cell, and nasal-based influenza vaccines remain available at community pharmacies in the U.S.

Note: The Walgreens Flu Index displays information regarding flu activity compiled using retail prescription data for antiviral medications used to treat influenza.

Apr 12, 2024 • 12:02 pm CDT
by Gerd Altmann

It has become clear that Brazil is currently facing its largest dengue fever outbreak. While two dengue vaccines have been approved for use in the country, each one has its own set of issues.

As of April 12, 2024, vaccine producers are focused on protecting more Brazilians against the virus over the next year.

Sanofi Pasteur's Dengvaxia vaccine is meant for individuals aged 9-45 who already have dengue. It requires three doses and pre-administration testing.

On the other hand, Takeda's second-generation QDENGA® (TAK-003) two-dose vaccine is also approved for use, but it has already sold out its production for 2024. 

As of January 2024, the Ministry of Health forecasted that 5.2 million doses will be delivered in 2024. Unfortunately, that amount will leave millions of people unprotected this year.

Furthermore, an article published by The New England Journal of Medicine in January 2024 stated that the Butantan-DV single-dose vaccine candidate offers protection against all four dengue virus serotypes without regard to dengue baseline serostatus and across a wide age range.

In addition to the logistical and economic benefits, Butantan-DV rapid protection may be necessary if Brazil's dengue outbreak accelerates.

The development of this novel tetravalent dengue vaccine began at Butantan Institute in 2010, using a formulation created by researchers affiliated with the U.S. NIH.

Based on recent phase 3 clinical trial results, Butantan Institute plans to submit a report to ANVISA in 2024, applying for the vaccine's registration. 

"The cost of dengue in Brazil is absurd," virologist Maurício Lacerda Nogueira said in a press release in February 2024.

"The (Butantan-DV) vaccine is expected to reduce mortality and hospitalizations due to the disease, so the Brazilian government's investment of several hundred million reais in developing an indigenous vaccine will have a huge impact on public health."

Apr 12, 2024 • 8:05 am CDT
Costa Rica Health Alert April 2024

Costa Rica's Ministry of Health (MOH) and the Caja Costarricense del Seguro Social have begun investigating a potential outbreak of Bordetella pertussis (whooping cough) in the district of Tibas, located north of San Jose.

This is the same area in Costa Rica where the MOH has reported chikungunya, dengue, malaria, and Zika cases in 2024.

As of April 11, 2024, given the contagious nature of whooping cough and its severity in children and unvaccinated populations, the U.S. Embassy urges heightened awareness and vaccination verification for U.S. citizens in Costa Rica.

Before visiting Costa Rica in April 2024, the U.S. CDC advises international travelers to speak with a travel vaccine expert regarding their options one month ahead of departure.

In the Boston, Massachusetts, area, travel vaccination services are offered at Destination Health Travel Clinic.

Apr 11, 2024 • 2:47 pm CDT
PAHO dengue trend chart April 2024

According to the Pan American Health Organization (PAHO) Situation Report No. 12, the dengue fever outbreak in 2024 is setting unfortunate records. 

Twenty-two countries and territories in the Region of the Americas reported the circulation of dengue serotypes. Brazil, Costa Rica, Guatemala, Honduras, Mexico, and Panama report the simultaneous circulation of all four dengue subtypes.

Between epidemiological weeks 1 and 11 of 2024, 3,665,589 suspected cases of dengue were reported in the Americas.

This figure represents an increase of 286% compared to the same period in 2023.

In the Southern Cone subregion. 410,296 new suspected dengue cases were reported last week, representing an increase of 342% compared to the same week in 2023.

While Brazil has reported the most dengue cases, Argentina presented a 67% increase in cases compared to the four previous epidemiological weeks.

The Caribbean is also reporting a significant increase in dengue cases this year.

As of April 11, 2024, there is good news regarding dengue protection. Both approved dengue vaccines are available in the Americas.

The second-generation dengue vaccine QDENGA® is available in Argentina, Brazil, and other countries, but not the United States.

Apr 11, 2024 • 1:03 pm CDT
by Nitish Patel

The latest report on measles cases in England shows a steady increase in numbers and a shift in geographical distribution.

According to the April 11, 2024 update from the U.K. Health Security Agency (UKHSA), 89 laboratory-confirmed cases have occurred in the past week, bringing the total number of confirmed cases since October 2023 to 1,023.

While the outbreak in the West Midlands initially caused the surge in measles cases, the latest data reveals that London now has the highest number of newly confirmed cases.

There have been 195 measles cases in the last month, 35% of which (69 cases) were reported in London and 32% (62 cases) in the West Midlands.

In a press release, Dr. Rob Verrecchia, UKHSA Health Protection Consultant, said, "We are continuing to see measles cases right across the country, with cases particularly high in London and the West Midlands."

"Measles is completely preventable with vaccination, but many thousands of children around the country are still not fully vaccinated and are at risk of serious illness or life-long complications."

England is not alone in the measles outbreak of 2024. 

The U.S. CDC has identified measles outbreaks in 49 countries over the past year.

Additionally, the CDC recommends international travelers be fully immunized against measles. In the U.S., measles vaccines are available in clinics and community pharmacies in 2024. 

Apr 11, 2024 • 9:38 am CDT
US CDC yellow fever case map April 2024

Recent reports indicate that the yellow fever (YF) virus, which is transmitted by mosquitoes, will continue to have a severe impact on human health in 2024.

According to the U.K.'s Travel Health Pro reporting on April 4, 2024, in South America, there have been seven confirmed cases of YF, out of which four have been fatal, including three in Colombia and two in Guyana and Peru, respectively.

In Brazil, six cases of yellow fever, including four deaths, have been confirmed this year in Minas Gerais, Espírito Santo, and São Paulo.

While vaccination for YF is one of the most successful public health interventions to prevent the disease, most international travelers remain unprotected.

Public health leaders in the United Kingdom, the United States, and the World Health Organization recommend pre-trip yellow fever vaccination for all travelers aged nine months and above who are visiting areas with a risk of yellow fever unless the vaccine is not advised for medical reasons.

In 2017, the U.S. Centers for Disease Control and Prevention expanded its yellow fever vaccine recommendations for travelers to Brazil because of a large outbreak in multiple states.

As of April 11, 2024, the YF-VAX® vaccine is offered at certified clinics and pharmacies in the U.S. Internationally, the Stamaril vaccine is offered in various countries.

These vaccine providers also offer travel-related vaccination services for diseases such as dengue, influenza, measles, and polio.

Apr 10, 2024 • 11:59 am CDT
by Nicholas_Demetriades

The World Health Organization (WHO) has issued Disease Outbreak News (DON513) after confirming Timor-Leste's first fatal human case of rabies by its Ministry of Health and Ministry of Agriculture, Fishery and Forestry.

As of late March 2024, 29 suspected rabies cases in humans exposed to dogs had been reported in Oecusse Municipality this year.

The public health response is ongoing and includes dog vaccination and ensuring the availability of rabies vaccines and human rabies immunoglobulin. 

As of April 10, 2024, the available information suggests a high risk of rabies at the national level, whereas the risk at regional and global levels is low, according to the WHO's assessment.

The WHO noted that Oecusse is an enclave of Timor-Leste located within Indonesia East Nusa Tenggara province (NTT), where six human rabies deaths have been recorded.

In 2023, a total of 30 human rabies deaths were reported from NTT province.

Rabies is a vaccine-preventable, zoonotic, viral disease affecting the central nervous system. The WHO procured 1,000 doses of human rabies vaccines and distributed them to Timor-Leste hospitals and health clinics.

In the United States, various rabies vaccines have been approved. 

Furthermore, a rabies vaccine candidate (PIKA Rabies Vaccine) reported very positive results from a phase 3 clinical study.

 

Apr 10, 2024 • 8:54 am CDT
US CDC measles outbreaks 2024

As the world battles the resurgence of measles outbreaks, most vaccination campaigns are reactive.

According to an announcement by Ginkgo Bioworks, an AI-enabled measles forecasting model may soon empower proactive public health measures, such as immunization campaigns.

Announced today, Ginkgo's epidemiological modeling experts and Northeastern University researchers were awarded a grant from the Bill & Melinda Gates Foundation to develop a forecasting model to assess the risk of measles outbreaks and inform decision-making for timely interventions.

This innovative model will draw upon traditional and non-traditional data, including public health reports, travel patterns, economic activity, and other factors, and utilize AI approaches such as machine learning and deep learning to structure and analyze a multitude of data sources to produce actionable insights.

Matt McKnight, General Manager for Biosecurity at Ginkgo Bioworks, commented in a press release on April 10, 2024, "If we wait until large pockets of measles show up in hospital systems to launch public health responses, we are missing a critical window to act and slow the spread of this debilitating and highly contagious disease."

"Modern data and AI tools can shift the biosecurity and public health paradigm from reactive to proactive by helping global health leaders make more timely, effective decisions to prevent outbreaks from happening in the first place."

Measles is a highly contagious and often severe disease that most commonly affects children. While the widespread availability of measles vaccines has dramatically reduced the disease burden over the past several decades, cases are on the rise in the U.S. in 2024.

The majority of measles cases imported into the United States occur in unvaccinated residents who become infected during international travel, says the U.S. CDC.

For example, a substantive, ongoing measles outbreak has occurred in Chicago, Illinois, over the past two months.