Vaccine News

 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.

CSL Seqirus today announced it was selected by the Biomedical Advanced Research and Development Authority (BARDA) to deliver one bulk lot of H5N8 A/Astrakhan antigen to the U.S. government.

This acquisition of a bulk lot will increase BARDA's stockpile of vaccines to support rapid response in an associated influenza pandemic.

CSL Seqirus has been working with BARDA in a longstanding partnership for over a decade, including numerous R&D and manufacturing activities and awards supporting BARDA's pandemic preparedness objectives.

Confirmed on August 28, 2023, this is the third award CSL Seqirus has received from BARDA in the last two years related to the ongoing outbreak of HPAI in the United States.

As of August 2023, the Pan American Health Organization reported H5N1 viruses (clade 2.3.4.4b) had been detected in 15 countries in Latin America, the Caribbean, the United States, and Canada over the past 18 months.

This award follows the February 2022 award to produce an H5N8 A/Astrakhan virus vaccine seed and the subsequent October 2022 announcement of the selection of CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study.

While the likelihood of sustained human-to-human transmission of bird flu is "low," according to the U.S. Centers for Disease Control and Prevention (CDC) and World Health Organization, there have been reported a small number of human cases of avian influenza A(H5), including one in the U.S. in April 2022, a case in Ecuador in January 20235 and Chile in March 2023.

"While human cases are rare, sporadic, and isolated, consistent detection of bird and mammalian cases demands vigilance," commented Marc Lacey, Executive Director, Pandemic Response Solutions, CSL Seqirus, in a press release.

"Ongoing surveillance and preparedness efforts are critical to minimize the public health risk."

CSL Seqirus used its cell-based influenza vaccine technology, as utilized for FDA-approved AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), to manufacture the H5N8 A/Astrakhan bulk vaccine at the company's Holly Springs, North Carolina, facility, which was built in partnership with BARDA.

CSL Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.

This $46.3 million project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50122D00004.

Valneva SE today reported positive initial Phase 3 safety data in adolescents for its single-dose chikungunya virus (CHIKV) vaccine candidate VLA1553.

On August 28, 2023, Valneva announced the initial safety data generated in the ongoing trial VLA1553-321, Valneva's first clinical trial in an endemic area (Brazil) and with individuals previously infected with CHIKV, showed that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection.

In this study, 754 individuals were vaccinated in trial VLA1553-321, and the present analysis includes safety data up to Day 29. An independent DSMB has continuously evaluated safety data during the trial and identified no safety concerns.

Overall, the adverse event profile is consistent with the profile observed in Valneva's pivotal Phase 3 trial in adults, reported in March 2022.

Immunogenicity data for this new trial are expected in November 2023.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "These new safety data in a younger population and individuals previously infected with the chikungunya virus confirm the safety profile we previously observed in adults and the elderly."

"Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus is endemic, it is, therefore, our objective to make this vaccine available to all age groups, especially as no vaccine or specific treatments are currently available for this debilitating disease."

Funded by the Coalition for Epidemic Preparedness Innovations and conducted in collaboration with Brazil's Instituto Butantan, the VLA1553-321 adolescent trial is intended to support label extension in this age group following a potential initial regulatory approval in adults from the U.S. Food and Drug Administration. The trial is also expected to support the vaccine's licensure in Brazil, which would be the first potential approval for use in endemic populations.

The present safety analysis will also enable regulatory submission to the European Medicines Agency in 2023.

If licensed, this would be the first CHIKV vaccine candidate approved.

Since dengue outbreaks cause about 400 million infections yearly, the Pan American Health Organization (PAHO) and other agencies continue issuing health alerts for this deadly disease.

In the Americas, the total number of dengue cases reported was 2,997,097 through July 2023. Additionally, 1,302 deaths were reported in the Region.

To limit these deaths, two dengue vaccines have been approved and deployed in 2023.

According to a new study published in the journal Vaccines on August 22, 2023, the effectiveness of these vaccines varies.

Dengvaxia® has shown an efficacy of 60.8 % (95 % CI, 52.0–68.0) against symptomatic, virologically confirmed dengue (VCD) caused by any of dengue's four serotypes more than 28 days after the third dose in Asia (2 to 14-year children), and Latin America (9 to 16-year children) [15], respectively.

While QDENGA® has shown around 80.2 % (95 % CI, 73.3–85.3) efficacy.

And during a phase 1 clinical trial, the efficacy against VCD at 28 days after a single dose of a U.S. NIH-developed vaccine candidate was 79.6 %.

This study assessed the safety and immune response regarding nAbs induced by the SII Dengue vaccine in healthy adults in Australia.

The study showed the vaccine was safe and highly immunogenic in adults, primarily seronegative at baseline.

In the vaccine group, 59.0 % of participants showed DENV vaccine viremia post-vaccination.

This vaccine (Dengusiil) was formulated at Serum Institute of India Pvt. Ltd. (SII) to contain DENV 1, DENV 3, and DENV 4 serotypes at not less than 2.5 log10 PFUs and DENV 2 at not less than 3 log10 PFUs per single dose of 0.5 mL.

SII executive director Rajeev Dhere recently informed the TOI, "The Phase-I trial was conducted in Australia as we needed participants who had not been exposed to dengue previously."

"India has a significant proportion of people with dengue antibodies, so it was essential to test the vaccine's safety and effectiveness on individuals who were not already immune to the disease."

As of August 27, 2023, Dengvaxia is approved in the U.S., but availability requires pre-admission testing.

During 2023, the state of Florida and Puerto Rico have reported locally acquired and travel-related dengue cases.

Pfizer Inc. recently announced in a press release that the European Commission (EC) has granted marketing authorization for ABRYSVO™, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults.

ABRYSVO is the first licensed vaccine designed and studied explicitly for maternal immunization. Now, a single dose of the vaccine could be administered in the EU between weeks 24 and 36 of gestation.

In addition, ABRYSVO has been studied in adults 60 and older.

"The approval of ABRYSVO in Europe marks significant progress in the scientific community's efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults," commented Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer on August 24, 2023.

"Last year's significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases. The approval of the vaccine for both older adults and infants through maternal immunization is a triumph for public health, and we hope to see a tremendous impact for future (RSV) seasons."

This authorization is valid in all 27 EU member states, plus Iceland, Liechtenstein, and Norway.

RSV is a contagious virus and a common cause of respiratory illness worldwide. 

In the EU, approximately 245,000 yearly hospital admissions were associated with RSV in children younger than five. 

The disease burden for older adults is also significant. Each year, the virus causes more than 270,000 hospitalizations and about 20,000 deaths in individuals and older.

The virus can affect an infected individual's lungs and breathing passages, potentially causing severe illness or death.

As of August 26, 2023, two RSV vaccines are approved for seniors and available at clinics and pharmacies in the United States.