Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Sep 27, 2023 • 11:34 am CDT
by ParentiPacek

The Minnesota Health Department today confirmed that Beyfortus™ (Nirsevimab) is available to order via the Minnesota Vaccine for Children (MnVFC).

Beyfortus is the first U.S. FDA-approved extended half-life monoclonal antibody offering passive immunization to infants to prevent lower respiratory tract infections caused by the respiratory syncytial virus (RSV).

Even though Beyfortus is not a vaccine, the VFC program voted to include it in the VFC available vaccines to help ensure that all MnVFC-eligible children can access it at no cost.

Many Minnesota hospital pharmacies are enrolled in the MnVFC program because they manage vaccines for their co-located clinics.

These hospitals can provide inpatient Beyfortus as part of this program. Still, they may need to adjust their practices to include monitoring inpatient unit refrigerator temperatures and documenting MnVFC eligibility in their records.

Nationwide, Beyfortus is part of the U.S. Vaccines For Children program and will be available for the 23-24 RSV season.

The U.S. CDC says administration will start in early October 2023.

Note that babies born between April and September will receive doses early in fall 2023, in addition to babies born during the RSV season, which runs into 2024.

Sep 27, 2023 • 9:17 am CDT
US CDC Group B Streptococcus 

A company developing polysaccharide conjugate vaccines against serious bacterial threats announced today it received a grant award of up to $3 million for developing a Group B Streptococcus (GBS) vaccine.

The U.S. National Institute of Allergy and Infectious Diseases issued the grant to Omniose, whose research operations were established at BioGenerator Labs in St. Louis, MO. The company was previously known as VaxNewMo.

Timothy Cooke, CEO, commented in a press release on September 27, 2023, “GBS infections are an important health problem globally, and there is a broad consensus for a vaccine solution.”

Omniose aims to develop a GBS vaccine with the highest efficacy using a vastly simplified production process.

The Omniose platform uses synthetic biology with enzymatic rather than chemical methods to produce GBS polysaccharide conjugate vaccines.

The one-step enzymatic process occurs in a single re-engineered E. coli cell and retains 100% of sialic acid residues on the polysaccharide for each capsular polysaccharide conjugate.

Retention of sialic acid residues has been shown to be critical for eliciting optimal functional antibody responses towards certain GBS serotypes post-vaccination.

Conventional chemical methods are complex and lead to reduced levels of sialic acid residues through oxidation, which can have a negative impact on protection, says the company.

Group B Streptococcus is a leading cause of invasive bacterial infections in neonates and older adults in the U.S. It causes an estimated 90,000 infant deaths and 46,000 stillbirths worldwide, according to the U.S. CDC. There are currently no vaccines to prevent GBS. 

 

Sep 27, 2023 • 5:45 am CDT

The September KFF COVID-19 Vaccine Monitor recently asked the public about their intention to get an influenza vaccine, new respiratory syncytial virus (RSV) vaccines, and the updated COVID-19 vaccine during the 2023-2024 respiratory season.

A “tripledemic” scenario in which all three viruses peak together could impact millions of people simultaneously.

According to the KFF poll announced on September 27, 2023, most adults (58%), including three-quarters of adults 65 and older, say they will get a flu shot this year.

And about half of adults say they either will “definitely get” (23%) or “probably get” (23%) the new vaccine for COVID-19 that was approved on September 12.

In addition, 58% of adults 60 and older say they will either “definitely get” or “probably get” the new RSV vaccine recommended for their age group.

The U.S. Centers for Disease Control and Prevention (CDC) recently recommended that most people get vaccinated this year.

From a trust perspective, this poll offered good news for healthcare providers.

Healthcare providers were ranked as the most trusted sources of information about vaccines again, as most adults (68%) say they usually keep up-to-date with the vaccines their provider recommends.

Unfortunately, government sources of vaccine information like the CDC, local public health departments, and the U.S. FDA fare much lower.

The complete KFF poll results are linked here.

This article's headline was updated on Sept. 28, 2023.

Sep 26, 2023 • 5:30 pm CDT
US CDC dengue map September 25, 2023

Some countries are reporting increased dengue outbreaks in Central and South America, Mexico, and the Caribbean during 2023. Dengue can become severe within a few hours. Severe dengue is a medical emergency, usually requiring hospitalization.

The U.S. Center for Disease Control and Prevention (CDC) issued a Level 1 Travel Health Notice on September 25, 2023, to alert international travelers of this mosquito-transmitted health risk.

According to the CDC, dengue is endemic in about 125 countries. 

The countries listed below have recently reported higher-than-usual dengue cases, and travelers visiting these countries may be at increased risk of catching this serious disease.

Argentina

Colombia

Cuba

Guadeloupe

Guatemala

Jamaica

Martinique

Nicaragua

Panama

Peru

In the U.S., 44 jurisdictions have reported about 880 dengue cases in 2023. The majority of these dengue cases were detected in Florida and Puerto Rico.

Since October 2022, two dengue vaccines have been authorized in various countries.

Sep 26, 2023 • 9:44 am CDT
US CDC rabies sources 2023

A novel rabies vaccine candidate designed to produce a more robust immune response in an accelerated timespan compared to existing rabies vaccines today announced it has progressed to late-stage clinical research.

YS Biopharma Co., Ltd. confirmed on September 26, 2023, that it has enrolled the first subject in its Phase 3 clinical trial of the PIKA Rabies Vaccine candidate.

The trial will assess the safety, immunogenicity, and lot-to-lot consistency of the PIKA Rabies Vaccine and is expected to include an estimated 4,500 subjects.

Dr. Muhammad Ahmad, the Principal Investigator at Central Park Teaching Hospital in Lahore, Pakistan, where the first subject has been enrolled, commented in a press release, "This marks an important step forward in our collective efforts to develop a novel and powerful vaccine which leverages recent immunological advancements."

"We are optimistic that these results will help shape the future of vaccine interventions and aid in treating a pressing global public health issue."

This experimental vaccine may add clinical value to the currently approved rabies vaccines as sporadic breakthrough infections (i.e., rabies cases in people vaccinated) have been reported, according to The Lancet Infectious Disease in December 2022.

Rabies is a viral disease characterized by an almost 100% mortality rate upon the onset of clinical symptoms.

The virus is responsible for approximately 59,000 human fatalities annually in over 150 countries, primarily in Asia and Africa. 

In the U.S., bites from bats, not dogs, are the leading source of rabies infections.

The U.S. CDC says before visiting high-risk rabies destinations, discuss vaccination options with a healthcare provider.

Sep 26, 2023 • 4:04 am CDT
US CDC TB program 2023

The World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, recently launched the TB Vaccine Accelerator Council to facilitate the development, licensing, and using new Tuberculosis (TB) vaccines.

The 100-year-old Bacille Calmette-Guérin (BCG) is the only licensed TB vaccine, with over ten versions available globally.

While it provides moderate efficacy in preventing severe forms of TB in infants and young children, it does not adequately protect adolescents and adults, who account for the majority (>90%) of TB transmission globally, said the WHO on September 22, 2023.

In a press release, Dr. Tedros Adhanom Ghebreyesus commented, "Today, we have knowledge and tools they could only have dreamed of."

"The political declaration countries approved today, and the targets they have set, are a commitment to use those tools, and develop new ones, to write the final chapter in the story of TB."

The Council aims to identify innovative sustainable financing, market solutions, and partnerships across public, private, and philanthropic sectors. It will leverage various agencies to strengthen commitment and actions for novel TB vaccine development and access.

The U.S. Centers for Disease Control and Prevention (CDC) reported that TB outbreaks increased by 5% in 2022, with 60 U.S. states, the District of Columbia, and territories provisionally reporting 8,300 TB cases last year.

According to the CDC, TB is caused by Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any body part.

As a result, two TB-related conditions exist: latent TB infection and TB disease. If not treated properly, TB disease can be fatal.

In the U.S., Merck's TICE BCG vaccine has limited availability.

Sep 25, 2023 • 4:38 pm CDT
Outbreak Analytics and Disease Modeling Network September 2023

The U.S. Centers for Disease Control and Prevention (CDC) recently announced it had granted 13 funding awards to establish a first-of-its-kind national network, the Outbreak Analytics and Disease Modeling Network (OADMN).

The OADMN's goal is to improve speed, accuracy, and use of data & analytics during health emergencies, which is an important step towards ensuring Americans have the information they need to keep themselves and their families safe during outbreaks.

Many of these awardees are leading a consortium of collaborators to design, prototype, test, and scale up advances in data modeling tools and technology that can be used to support public health decision-makers at all levels of government.

"The collaboration with our public health, private, and academic partners over the last year to advance the science of disease forecasting and deliver decision support to leaders has been instrumental in improving outbreak response," said Dr. Dylan George, Director, Center for Forecasting and Outbreak Analytics, in a press release on September 22, 2023. 

The grantees will be organized into three categories of performance, supporting three priority program actions:

  • Innovators: these grantees will develop methods, tools, technologies, and other products to support emergency response.
  • Integrators: these grantees will take lessons learned and techniques from Innovators and test them in small-scale deployments.
  • Implementors: these grantees will take tested best practices and scale up to larger jurisdictions and partners.

The funding 13 recipients comprising OADMN in September 2023 include:

Emory University

Northeastern University

The University of North Carolina at Chapel Hill

Kaiser Permanente Southern California

Carnegie Mellon University

University of Michigan School of Public Health

University of California, San Diego

University of Minnesota

Clemson University

University of Utah

International Responder Systems

The University of Texas at Austin

The Johns Hopkins University

Note: The OADMN effort is in addition to the U.S. government's Disease X initiative.

Sep 25, 2023 • 1:40 pm CDT
by Mercy Hass

During last week's Advisory Committee on Immunization Practices (ACIP) meeting, an updated adult, adolescent, and infant vaccination schedule was presented.

On September 22, 2023, the CDC's Sarah Schillie, MD, MPH, MBA CAPT, US Public Health Service, presented a draft Addendum to the 2023 Immunization Schedules.

This Addendum contains ACIP recommendations that occurred after the 2023 schedule was published earlier this year.

For 2023, two separate vaccination schedules with multiple sections summarize and aid in implementing the approved ACIP policy.

This is the most up-to-date vaccine recommendation for COVID-19, RSV, Influenza, pneumococcal, polio, and Mpox vaccines.

The CDC plans to release 2023 Immunization Schedules with Addenda this week. With this addition, all ACIP recommendations will formally be part of the Immunization Schedules.

Sep 25, 2023 • 9:22 am CDT
by Deyson Ortiz

BioArctic AB and Eisai announced today that LEQEMBI® Intravenous Infusion had been approved in Japan as a treatment for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD).

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody (mAbs) directed against aggregated soluble and insoluble forms of Aβ.

LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.

Japan is the second country to approve LEQEMBI, following the Food and Drug Administration (FDA) approval in the U.S. in July 2023.

"The approval of LEQEMBI in Japan is another important step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic, in a press release on September 25, 2023.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic has the right to commercialize lecanemab in the Nordic region, and currently, Eisai and BioArctic are preparing for joint commercialization in the region.

According to the Alzheimer's Association, AD is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia.

As of September 2023, The U.S. FDA, the European Medicines Agency, and the United Kingdom's NHS have not authorized preventive AD vaccines.

Sep 25, 2023 • 7:46 am CDT
U.S. CDC JE infection cycle 2023

A specialty vaccine company today announced the signing of a $32 million contract with the United States (U.S.) Department of Defense (DoD) for the immediate supply of its Japanese encephalitis (JE) vaccine, IXIARO®.

Under this new one-year contract with Valneva SE, the DoD can purchase additional doses for the next twelve months.

IXIARO® is the only JE vaccine approved for adults by the U.S. Food and Drug Administration (FDA).

Dipal Patel, Chief Commercial Officer of Valneva, commented in a press release on September 25, 2023, "We are excited to continue our long-term relationship with the DoD."

"The U.S. military has trusted IXIARO® for over ten years to help protect military personnel, their families, civilian government service personnel, and government contractors from this potentially deadly disease."

Japanese encephalitis is a deadly infectious disease found mainly in Asia. The disease is endemic in Southeast Asia, India, and China, a region with more than three billion population. 

About 70,000 cases of JE are estimated to occur in Asia each year.

JE is fatal in approximately 30% of those who show symptoms, leaving half of the survivors with permanent brain damage.

In the U.S., Valneva markets and distributes IXIARO® directly to the military and private travel market.

IXIARO / JESPECT® is licensed for adults in Australia, New Zealand, Europe, Canada, Switzerland, Hong Kong, Singapore, Israel, Norway, Liechtenstein, Iceland, Singapore, Japan, the United Kingdom, and the Republic of Korea. In all other licensed territories, IXIARO/JESPECT is indicated for use by adults aged 18 years or older.

Sep 24, 2023 • 11:36 am CDT
Walgreens Flu Index September 16, 2023

When comparing data from the past few influenza seasons, it appears the 2023-2024 flu season is starting slowly.

Globally, the World Health Organization's Influenza Update N° 454 confirmed influenza detections remained low. In the temperate zones of the northern hemisphere, indicators of influenza activity were reported at low levels or below the seasonal threshold in most reporting countries.

Within the United States, the Centers for Disease Control and Prevention (CDC) reported on September 22, 2023, that seasonal flu rates last week were low nationally, with 315 (0.8%) positive specimens reported.

Last week, 820 patients with laboratory-confirmed influenza were admitted to a hospital, an increased number since the previous report.

Separately, the U.S. National Center for Health Statistics mortality surveillance data published on September 21, 2023, confirmed 13 additional influenza-related deaths.

The FluView week #37 report confirmed two additional children died from flu-related illness. A total of 176 influenza-associated pediatric fatalities were reported during the 2022-2023 flu season. 

The previous high was during the 2019-2022 flu season when 199 children died from influenza infections.

From a local perspective, the Walgreens Flu Index market-specific information indicates the top cities for influenza were led by the following:

1. Harlingen-Weslaco-Brownsville-McAllen, Texas
2. El Paso, Texas (Las Cruces, N.M.)
3. Columbus-Tupelo-West Point-Houston, Miss.
4. Corpus Christi, Texas
5. Puerto Rico

The CDC's new Director, Mandy K. Cohen, MD, MPH, recently posted a video on Instagram encouraging people to speak with a healthcare provider about flu shot options and when to be protected during the new flu season.

As of late September 2023, most pharmacies offer influenza vaccination appointments and walk-in services.

Sep 23, 2023 • 4:18 pm CDT
The Jenner Institute 2023

Since August 2023, the Indian state of Kerala has been experiencing its fourth Nipah virus outbreak.

Over the past two decades, the Nipah virus has spilled into humans in Bangladesh, India, Malaysia, the Philippines, and Singapore.

While no approved Nipah virus vaccines exist, several candidates are conducting clinical trials.

“The Nipah virus outbreak is a reminder of the increased risk of zoonotic diseases as the world population expands and encroaches into wild habitats. We have the technology to rapidly develop next-generation mRNA vaccines that will effectively fight against these new viruses”, commented Pascal Brandys, co-founder and CEO of Phylex BioSciences, in a press release on September 22, 2023.

“Our mRNA vaccine encoding for a highly immunogenic nanoparticle provides a flexible platform for rapid development of a new Nipah virus vaccine and will be of great value in combatting Nipah virus and other similar viruses.”

Phylex BioSciences published last year the proof-of-principle of its second-generation nanoparticle mRNA vaccine. The same technology is directly applicable to the development of a Nipah virus vaccine.

The second generation mRNA vaccine candidate encodes for a nanoparticle displaying 60 copies of the antigen-based upon the head domain of the G protein of the Nipah virus.

The anticipated advantages of the nanoparticle vaccine are superior immune response, long-term protection from cell-mediated immunity, and protection against virus dissemination in the brain.

Globally, an estimated two billion people worldwide are at risk for bat-borne Nipah virus outbreaks. The Nipah virus has a fatality rate exceeding 40%.

Sep 22, 2023 • 7:19 am CDT
U.S. CDC travel alerts and WHO diphtheria vaccination map Sept. 22, 2023

While Diphtheria is a vaccine-preventable disease, recent health alerts indicate various countries have under-vaccinated populations.

As of September 22, 2023, the U.S. Centers for Disease Control and Prevention (CDC) issued Travel Health Notices for Diphtheria outbreaks in the Republics of Guinea and Nigeria in Africa and Vietnam in East Asia.

As an example of recent outbreaks, during July and August 2023, a total of 5,898 suspected Diphtheria cases were reported from Local Government Areas in eleven Nigerian states.

The CDC says if you travel to any affected area, you should be up to date with your diphtheria vaccines. The U.S. agency recommends vaccinating everyone two months and older to protect against Diphtheria.

And if you have immunization questions, discuss the need for a booster dose with your healthcare professional before traveling abroad.

Diphtheria is a serious infection caused by strains of Corynebacterium diphtheriae bacteria that make a toxin that can cause people to get very sick.

This bacteria spread from person to person through respiratory droplets, like from coughing or sneezing, and from touching open sores or ulcers of people sick with Diphtheria.

For some people, respiratory Diphtheria can lead to death. Even with treatment, about 1 in 10 patients with respiratory Diphtheria die. Without treatment, up to half of patients can die from the disease, says the CDC.  

Globally, Diptheria cases have been declining since 2019, when 22,986 cases were reported by the World Health Organization (WHO). In 2022, 5,856 cases were confirmed. 

Furthermore, the WHO's current vaccination data indicates a high percentage for most countries, including the United States.

Sep 21, 2023 • 4:19 pm CDT
by P T from Pixabay

During the ongoing mpox outbreak, older smallpox vaccines were used to prevent infection and reduce disease severity in those at increased risk for infection.

However, the effectiveness of smallpox vaccination against mpox was unknown.

On September 21, 2023, the New England Journal of Medicine published a Correspondence that stated previous vaccination at a median of 13 years earlier with either a first- or second-generation smallpox vaccine reduced the likelihood of testing positive for orthopoxvirus, including mpox, among current or former military personnel for whom vaccination data were available.

The estimated vaccine efficacy was 72% for Dryvax (1st generation) and 75% for ACAM2000 (2nd generation).

Among the participants who tested positive for orthopoxvirus, 121 (41%) had been diagnosed with HIV infection (odds ratio, 2.34; 95% CI, 1.65 to 3.35).

Within the VA portion of the study, 19 of 186 participants (10%) required hospitalization; there were no deaths from mpox, and all the participants had an uneventful recovery.

The Department of Defense electronic laboratory data and the Veterans Affairs Corporate Data Warehouse identified eligible participants. The study was approved by the institutional review board of Emory University and was granted an exemption for consent.

Sep 21, 2023 • 11:27 am CDT
TB case map in the USA - 2021

The 2019 Lancet Commission on Tuberculosis laid out an optimistic vision for how to build a tuberculosis-free world through smart investments based on sound science and shared responsibility.

Since then, several significant strides have been made toward ending tuberculosis, according to a Review published by The Lancet on September 13, 2023.

With excellent short-course preventive regimens and several late-stage vaccine candidates, tuberculosis prevention is also on the cusp of a revolution.

These clinical tools are needed as more than 7 million people worldwide have died of tuberculosis in the past five years.

Still, much more can be done to implement the Commission's recommendations fully.

For example, the Bill and Melinda Gates Foundation and Wellcome pledged $550 million to support late-stage clinical trials for a new tuberculosis vaccine. The M72/AS01E (M72) subunit vaccine candidate is conducting phase 3 clinical research.

And in the United States, the 100-year-old BCG vaccine is considered for people who meet specific criteria.

According to the U.S. Centers for Disease Control and Prevention, BCG vaccination is considered for children under specific conditions.

The CDC reported in March 2023 that TB cases increased by 5% in 2022, with 60 U.S. states, the District of Columbia, and territories provisionally reporting 8,300 TB cases.