Travel Vaccine Breaking News

An independent committee of vaccine experts unanimously endorsed removing one influenza virus strain from future influenza vaccines.

On October 5, 2023, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to eliminate the influenza B/Yamagata lineage viruses since it has not been detected for about three years.

The VRBPAC vote follows the World Health Organization's recent announcement that it endorsed eliminating the influenza B/Yamagata/16/88 lineage component from the 2024 Southern Hemisphere flu shot formulation.

Flu seasons in the Southern Hemisphere usually occur between April and September, while the Northern Hemisphere's is generally between October and May.

This change should not impact the effectiveness of flu shots.

A recent U.S. CDC report found the adjusted vaccine effectiveness against severe acute respiratory infection hospitalization associated with any influenza virus during the 2023 Southern Hemisphere flu season was 51.9% (95% Confidence Interval 39.2%–62.0%).

For the 2023-2024 flu season in the U.S., there should be ample supply of vaccines at health clinics and pharmacies. According to a report by the Global Healthy Living Foundation and IQVIA, about 60% of vaccinations during the 2022 flu season took place at pharmacies in the U.S.

Vaccine manufacturers have projected to supply as many as 156.2 million to 170 million doses of influenza vaccines for the 2023-2024 season.

As of September 23, 2023, the CDC says about 100 million doses had been distributed in the U.S. All influenza vaccines are quadrivalent for this flu season, such as FLUMIST® and FLUCELVAX®.

While there is currently no cure for cat allergy, a prevalent, life-long condition, an innovative therapeutic vaccine for humans has begun clinical trials.

Angany Inc. today announced that it has received clearance from U.K.'s Medicines and Healthcare Products Regulatory Agency for the first clinical study to be conducted on its vaccine candidate ANG-101 to treat human allergy to cats.

ANG-101 is a therapeutic vaccine that provides a disruptive disease-modifying approach for treating cat allergy.

Derived from its proprietary eBioparticle-Potentiated Immunotherapy™ technology, ANG-101 active immunotherapeutic ingredient is a unique 140 nm enveloped bioparticle (eBioparticle™) that mimics a virus in shape and size with its surface covered with thousands of copies of cat major allergen Fel d 1.

This clinical study is a first-in-human, open-label, and single-site evaluation of the new vaccine's safety, allergenicity, and immunogenicity in adult patients allergic to cat dander.

This early-stage clinical trial will be conducted under the guidance of Professor Stephen Durham and Dr Guy Scadding, two leading clinical allergy experts from Imperial College London.

Professor Durham commented in a press release on October 5, 2023, "The potential treatment of cat allergy using an auto-adjuvanted vector builds upon its known ability to induce strong allergen-specific IgG antibody responses, as observed in animal models."

Unlike prophylactic vaccines, Angany’s therapeutic vaccines are a new generation of immunotherapy biologics used to treat established pathologies.

They are meant to restore or boost natural immune mechanisms and create sustainable immune protection and vigilance.

Human allergies to cats and dogs affect 10 to 20% of the world’s population, says the Asthma and Allergy Foundation of America.

When you have a pet allergy, you are not allergic to the pet’s hair, fur, or feathers but to the protein found in the pet’s dander, saliva, and urine.

Across both prepandemic and pandemic years, the respiratory syncytial virus (RSV) outbreaks in the United States began in Florida, the southeast, and later in the north and west regions. 

Florida's RSV season is longer than the rest of the U.S. and has distinct regional patterns, says the U.S. Centers for Disease Control and Prevention (CDC).

The Florida Department of Health reported as of week #39, September 30, 2023, RSV activity was increasing with higher test positivity, hospital admissions, and emergency room rates, with three previous outbreaks but no current RSV outbreak. 

Furthermore, NREVSS data show Florida's PCR positivity 3-week moving average was about 7.7% as of September 28, 2023.

Globally, the World Health Organization (WHO) Influenza Update N° 454 indicates RSV activity was found to be generally low, except in some parts of Western Australia and some Central and temperate South American countries.

Additional WHO and CDC RSV outbreak data are posted at Precision Vaccinations.

As of October 4, 2023, RSV vaccines and monoclonal antibody therapies are available in the U.S.

With the World Health Organization's (WHO) recent recommendation of a second dengue vaccine, this increased access may help reduce dengue outbreaks globally. About 4 billion people live in areas with a risk of dengue. 

In the United States, the CDC confirmed that 44 U.S. jurisdictions had reported about 997 dengue cases as of September 27, 2023.

During the summer of 2023, dengue outbreaks have been reported by the U.S. CDC in Florida, New Jersey, New York, and Puerto Rica.

In Florida, the Department of Health issued a statewide mosquito-borne illness advisory in June 2023. 

As of September 30, 2023, 38 locally acquired dengue cases have been reported this year, primarily in Miami-Dade County. Additionally, 334 travel-associated dengue fever cases were reported, primarily in people arriving from Cuba and Brazil. 

Over one thousand miles to the north, New York has reported 74 dengue cases, and New Jersey has confirmed 35 this year.

In the Caribbean Sea, the U.S. territory of Puerto Rica has reported 442 cases.

Anyone who lives in or travels to dengue-endemic areas is at risk for infection. According to the CDC, the four dengue viruses are spread to people through the bite of an infected Aedes species mosquito.

The CDC has issued various Travel Health Advisories regarding dengue outbreaks in 2023. Before visiting the areas, the CDC suggests discussing dengue vaccination options with a healthcare provider.

Malaria vaccines have been in development since the 1960s, with substantial progress in the last decade, says the World Health Organization (WHO). Today, the WHO announced it has recommended a second vaccine, R21/Matrix-M, for preventing malaria in children.

As of October 2023, the R21 vaccine is the second malaria vaccine recommended by WHO, following the Mosquirix™ (RTS,S/AS01) vaccine, which received a WHO recommendation in 2021.

Demand for malaria vaccines is unprecedented in 2023. However, the available supply of RTS,S is limited.

The addition of R21 to the WHO's recommended malaria vaccine list is expected to result in sufficient vaccine supply in various countries.

The following steps for R21/Matrix-M, include completing the ongoing WHO prequalification and enabling international vaccine procurement for a broader rollout in malaria outbreak countries.

The WHO's Director-General endorsed the recommendation following its regular biannual meeting on 25-29 September 2023.

"As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two," commented Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release on October 2, 2023.

"Demand for the RTS,S vaccine far exceeds supply, so this second vaccine is a vital additional tool to protect more children faster and to bring us closer to our vision of a malaria-free future."

The R21 vaccine has been shown to reduce symptomatic malaria cases by 75% during the 12 months following a 3-dose series. A fourth dose given a year after the third maintained efficacy. 

This efficacy is similar to that demonstrated when RTS,S is given seasonally. 

The WHO says that at US $2 – US $4 per dose, the cost-effectiveness of the R21 vaccine would be comparable with other recommended malaria interventions and other childhood vaccines.

Malaria is a disease caused by four species of protozoan parasites of the genus Plasmodium and is transmitted to people by Anopheles mosquitoes. 

According to the WHO's recent World Malaria Report, the global number of malaria cases reached about 240 million, with over 600,000 related fatalities.

As of October 2023, neither malaria vaccine is available in the United States.

Without an approved Alzheimer's disease vaccine available, several bipolar disorder (BD) candidates are following U.S. Food and Drug Administration (FDA) policies to accelerate clinical research.

In the U.S., about 2.8% of the population is estimated to be affected by BD during the past year, says the U.S. NIH.

For example, Alzamend Neuro, Inc. today announced receipt of a “Study May Proceed” letter from the U.S. FDA for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1.

AL001 is a novel lithium-delivery system that has the potential to deliver benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium, a chemical entity well known for efficacy in BD type 1. 

Alzamend’s goal is to revive the utility of lithium treatment by importantly improving the benefit-to-risk relationship of lithium treatment in clinical practice. 

“Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option for BD type 1,” said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on Octobe 2, 2023.

“If we are able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the seven million Americans afflicted with BD."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024"

Based on the favorable safety profile observed in the recently completed study and extensive safety data on the drug’s constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.

BD is a mood disorder characterized by periods of depression and periods of abnormally elevated happiness.

The condition is classified as BD Type 1 if there has been at least one manic episode, with or without depressive episodes.

And can be classified as BD Type 2 if there has been at least one hypomanic episode (but no full manic episodes) and one major depressive episode.

As of October 2023, there are several Alzheimer's disease vaccines and therapies conducting clinical trials which are seeking participants. 

Recent research assessed whether the off-label use of meningococcal group B vaccines (MBV) was associated with subsequent lower gonorrhea prevalence.

A Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded the outer membrane vesicle OMV-based MBV was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29 years.

These results are consistent with other study findings that OMV-based vaccines offered 31% (95% CI 21-39) protection against gonorrhea.

Two meningococcal vaccines are available in the U.S.: MenB-4C (OMV-based) and MenB-FHbp.

This study's finding is good news since gonorrhea infection rates increased by about 4%, reaching 710,151 in 2022. 

As of September 30, 2023, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency have not approved vaccines for preventing gonorrhea infection.

However, the FDA recently granted Fast Track designation for GSK's Neisseria gonorrhea investigational vaccine (NgG) candidate.

GSK announced on June 27, 2023, that Phase II of an ongoing study aims to demonstrate Proof of Concept by assessing the NgG vaccine's efficacy in healthy adults at risk of gonorrhea.

This study started in November 2022 in the U.S., UK, France, Germany, Spain, Brazil, Philippines, and South Africa.

According to the U.S. Centers for Disease Control and Prevention, gonorrhea is now the second most common sexually transmitted infection (STI) in the U.S. Most women infected with gonorrhea do not have any symptoms. 

Other STI vaccine news (herpes, syphilis, HPV, mpox) is posted at this link.