Vaccine News

While West Nile Virus (WNV) has been detected in thirty-six states in 2023, Colorado is experiencing its worst outbreak in five years.

As of September 1, 2023, the Colorado Department of Public Health and Environment (CDPHE) reported that 13 people have died this year from WNV infection.

Additionally, 113 people have been hospitalized with WNV.

In 2022, Colorado reported 20 WNV deaths. 

The abundance of the disease-carrying Culex mosquitoes in 2023 is likely due to the high level of precipitation last winter and spring.

“The trends we are seeing in our West Nile virus tracking data are unprecedented,” said Dr. Rachel Herlihy, state epidemiologist, CDPHE, in a press release on August 4, 2023.

While most people infected with West Nile virus don’t have symptoms, some can develop a serious, potentially deadly illness. People aged 60 and older and those with certain medical conditions are at greater risk of serious disease.

Dr. Michelle Barron, senior medical director of infection prevention and control for UCHealth, offered messages for people who are spending time outdoors and for those who may be feeling sick.

Protect yourself to avoid getting mosquito bites.

And, if you are feeling sick and suspect you might have West Nile virus, seek help from a doctor immediately.

“If your infection progresses to the point where you are having persistent headaches, confusion, any kind of muscle weakness, numbness or tingling, you need to be seen by a doctor as quickly as possible,” Barron said.

Barron offered answers to questions about WNV on September 1, 2023.

As of August 29, 2023, 455 human WNV cases and 315 Neuroinvasive Human Disease (meningitis or encephalitis) patients have been confirmed by the U.S. CDC. Furthermore, there are no approved West Nile virus vaccines in 2023.

Last year’s flu season began earlier than expected in the United States, and many children were not protected from influenza.

To better understand this health risk, the U.S. Centers for Disease Control and Prevention (CDC) Clinician Outreach and Communication Activity webinar on August 31, 2023, presented an update on 2023-2024 influenza recommendations for non-adults.

This digital presentation revealed on slide #42 that influenza vaccination coverage in children six months to 17 steadily decreased during 2019-2023.

During 2019-2022, 62.2% of children got an annual flu shot.

In 2022-2023, only 55.1% of children received an annual flu shot.

Furthermore, the CDC reported that influenza-associated pediatric deaths during the 2022-2023 season have reached 172, a three-year high.

The CDC says annual flu shots for most people over six months of age are the most effective way to prevent influenza illness and associated complications. 

From a protection perspective, the CDC says over 65% of influenza-vaccinated children were protected from flu-related hospitalization during 2023.

A clarification for this flu season is people with egg allergy may receive any influenza vaccine (egg-based or non-egg-based) that is otherwise appropriate for their age and health status; additional safety measures are no longer recommended.

And multiple vaccines can be administered along with a flu shot.

Additionally, coincident with National Immunization Awareness Month in August, the American Academy of Pediatrics released an updated policy statement and technical report on August 29, 2023, with recommendations for preventing and controlling influenza in children for the 2023-’24 influenza season.

The World Health Organization (WHO) recently announced the initiation of the second round of polio vaccinations in six provinces within the Islamic Emirate of Afghanistan.

The WHO's goal is to ensure every child in the selected provinces.

These vaccinations are essential since five wild poliovirus type 1 cases were confirmed in Afghanistan in August 2023.

Although the number of positive samples in Afghanistan increased in 2023 compared to the year 2022, this was partly due to more intensive surveillance in the country, stated the WHO on August 25, 2023.

The WHO's International Travel and Health also recommends that all travelers to polio-affected areas be fully vaccinated against polio.

Residents (and visitors for more than four weeks) from infected areas should receive an additional dose of OPV or inactivated polio vaccine within four weeks to 12 months of travel.

As of September 2023, the Global Polio Eradication Initiative is focusing on reaching every last child in Afghanistan with vaccines, strengthening surveillance, and maintaining political commitment, financial resources, and technical support at all levels.

Influenza remains a serious threat to children due to its potential to cause severe morbidity and mortality during the 2023-2024 flu season, says the U.S. Centers for Disease Control and Prevention (CDC).

The CDC has scheduled a Clinician Outreach and Communication Activity call on August 31, 2023, to update Pediatric Providers regarding the 2023-2024 influenza recommendations.

The CDC says annual flu shots are the most effective way to prevent influenza illness and associated complications. And clinicians play a critical role in immunizing children, their family members, and caregivers.

As of late August 2023, over 100 million flu shots have been distributed in the U.S.

The webinar/call is from 2:00 PM – 3:00 PM ET on August 31, 2023, and is available from this CDC webpage.

 Alzamend Neuro, Inc. today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for Bipolar Disorder (BD).

Alzamend believes this program may qualify for the 505(b)(2) pathway for FDA approval, which is available to new formulations of an approved drug.

Once the IND is cleared by the FDA, Alzamend intends to initiate the Phase IIA study to determine relative increased lithium levels in the brain compared to a marketed lithium salt in BD patients, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treated with AL001.

Alzamend's goal is to replace a 300 mg TID lithium carbonate dose for the treatment of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient.

"This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline," commented Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on August 30, 2023.

"Being able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring (TDM) could positively impact the 7 million Americans afflicted with BD."

Lithium is a commonly prescribed drug for manic episodes in BD type 1 and maintenance therapy of BD in patients with a history of manic episodes. 

AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

Results from Alzamend's recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's and healthy patients identified a maximum tolerated dose ("MTD"), as assessed by an independent safety review committee.

This MTD, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily, is designed to be unlikely to require TDM.

Moreover, this dose is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts, thereby avoiding clinical disadvantages.

BD, previously known as manic depression, is a mood disorder with three types, according to the U.S. NIH.

In the U.S., about 3% of the population is estimated to be affected by BD at some point in their life.

BD is among the top 20 causes of disability worldwide, leading to substantial societal costs. Other mental health issues, such as anxiety and substance use disorders, are commonly associated with BD.

The FDA has not approved an Alzheimer's Disease or BD vaccine candidate as of August 30, 2023.

Gavi announced today that the Republic of Kenya Kenya surpassed its target of vaccinating 1.59 million people during a 10-day oral cholera vaccine (OCV) campaign conducted in early August 2023.

Speaking in Nairobi on August 28, 2023, the Acting head of the Health Ministry's Disease Surveillance and Response Unit, Dr. Emmanuel, said in a media statement the OCV campaign was in response to a Kenyan cholera outbreak, which was first reported in October 2022 and has so far resulted in 11,872 cases and 196 deaths across Kenya.

"The case fatality rate of the cholera outbreak stands at 1.7%, underscoring the severity of the situation," he said.

However, recent cholera epidemics in different parts of the world have far exceeded that standard, with the average case fatality rates across outbreaks in 2021 standing at 1.9% globally and 2.9% in Africa.

The World Health Organization calls for access to adequate life-saving treatment to maintain case fatality rates below 1%, achievable when appropriate interventions are deployed.

The U.S. Centers for Disease Control and Prevention has confirmed a recent, unprecedented global increase in cholera outbreaks, such as in Haiti. However, nearly all cholera cases reported in the U.S. are acquired during international travel.

Valneva SE today announced that Health Canada has completed screening validation of the Company's regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review.

Based on Health Canada's performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It could become the first licensed chikungunya vaccine to address this unmet medical need if approved. 

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a press release on August 29, 2023, "Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers."

"This threat continues to grow as shown by the recent epidemiological alert issued by the Pan American Health Organization."

"No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to make VLA1553 available in different territories as quickly as possible."

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus transmitted by Aedes mosquitoes. Infection leads to symptomatic disease in up to 97% of humans after four to seven days following the mosquito bite.

While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash, and chronic arthralgia. Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.

As of July 2022, more than three million cases have been reported in the Americas, and the economic impact is considered significant.

There are no preventive vaccines or effective treatments available, and, as such, chikungunya is considered to be a major public health threat.

This vaccine was granted PRIority MEdicine designation by the European Medicines Agency in 2020 and also received FDA Fast Track, Breakthrough Therapy, and Priority Review designations in 2018, 2021, and 2023, respectively.

Other Chikungunya vaccine candidates are also seeking approval.