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The U.S. Centers for Disease Control and Prevention (CDC) vaccine advisory committee today presented an overview of a successful childhood vaccination program.

Mona Marin, M.D., with the CDC Advisory Committee on Immunization Practices, presented '25 Years of Varicella Vaccination Program in the United States: Health and Economic Impact during 1995–2019' on February 23, 2023.

Historically, varicella was considered a disease of little consequence, too mild to warrant prevention.

However, Varicella is an illness with a characteristic maculopapular, vesicular rash.

During the pre-vaccine era, varicella infected almost everyone during childhood, who accounted for more than 90% of the cases, two-thirds of the hospitalizations, and about half of the deaths, wrote researchers in a related article.

Varicella, known as chickenpox, is also highly infectious, with 61% and 100% secondary attack rates among susceptible household contacts, says the CDC.

As other causes of infectious disease burden in children in the U.S. were controlled through vaccination (e.g., measles, diphtheria, poliomyelitis), varicella assumed more importance as a preventable cause of mortality and morbidity.

Based on a documented continuing disease, the U.S. was the first country to implement a routine varicella vaccination program following the licensure of the live, attenuated varicella vaccine (VARIVAX®, Merck & Co, Inc) in 1995.

Expansion of the U.S. vaccination program to include a second VARIVAX dose led to further declines in disease incidence, outbreaks, hospitalizations, and deaths.

Twenty-five years after the introduction of the varicella vaccine, the disease has declined overall by about 97%.

An additional benefit of the varicella vaccination program is the impact on HZ.

Recent data show a lower HZ risk among healthy and immunocompromised children. This is reflected in stepwise declines in HZ incidence at the population level as the age groups became dominated by persons born during the varicella vaccination program.

Moreover, the decline in HZ incidence in children provides tentative reassurance that, over time, HZ rates will decline as vaccinated children age.

The Journal of Infectious Diseases published the unedited article in November 2022.

Note: Varivax and the HZ-prevention vaccines (Shingrix) are generally available at clinics and pharmacies in the U.S.

Vaccine Treats: 
Varicella Zoster
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U.S. CDC ACIP Feb. 23, 2023
Live Blog Update Author: 
Karen McClorey Hackett
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Atlanta
Vaccine: 
Varivax Varicella Vaccine
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In a review article recently published in Vaccines Journal referenced over 25 studies and discussed multiple injection delivery methods, including PharmaJet's needle-free precision delivery systems.

This study found that needle-free delivery enhanced the clinical performance of DNA-based vaccines.

Currently, 250 vaccine programs are invested in DNA vaccines and therapeutics because of their potential benefits.

"We are enthused to see that pre-clinical results have translated into more effective clinical responses in human trials," said Chris Cappello, President and CEO of PharmaJet, in a press release on February 23, 2023. 

"We currently have eighty-three studies ongoing with novel pharmaceuticals focusing on nucleic acid technology and other new vaccine technology platforms."

"We believe that our precision delivery devices have the potential to increase the performance and therefore the probability of regulatory success of many of these candidate vaccines."

Several DNA candidate vaccines in combination with PharmaJet devices are in development, including for a COVID-19 bivalent booster, HIV, Zika, influenza, poxvirus, hantavirus, and dengue infections.

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PharmaJet Systems Feb. 2023
Live Blog Update Author: 
Don Hackett
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Denver
Polio infected countries 2023

Adults Can Consider Polio Boosters

Poliovirus spreads from people to people and is detected in wastewater
February 23, 2023
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Gilead Sciences, Inc. today announced data evaluating lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab as a potential long-acting HIV treatment regimen with twice-yearly dosing.

Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV.

At Week 26, 90% of participants receiving the complete study regimen (n=18/20) maintained virologic suppression (HIV-1 RNA ≤50 copies/mL). 

“Novel long-acting HIV treatment options will drive the next chapter in care and may help meet the therapy needs and preferences of people living with HIV. In this study, we found that lenacapavir and bNAbs in a combination approach may have a significant role to play in the future treatment of HIV,” said Dr. Joseph Eron, MD, lead study investigator and the Chief of the Division of Infectious Diseases at the University of North Carolina School of Medicine, in a press release on February 21, 2023.

“As a clinician who strives to support the people living with the virus under my care, it will be exciting to continue evaluating the combination regimen as a potential twice-yearly long-acting HIV treatment option.”

The combination of lenacapavir with teropavimab and zinlirvimab will advance to a Phase 2 study later in 2023 in virologically suppressed people living with HIV.

Lenacapavir is being developed as a foundation for future HIV therapies to offer long-acting oral and injectable options with several dosing frequencies, combined with other antiretroviral agents for treatment or as monotherapy for prevention, that help address individual patient needs and preferences.

Sunlenca® (lenacapavir), alone or in combination, is not approved by any regulatory authority outside the United States, United Kingdom, Canada, or the European Union for any use.

Note: bNAbs are not preventive vaccines. Furthermore, the U.S. FDA has not approved any HIV vaccine candidate.

Vaccine Treats: 
HIV
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by Fernando Zhiminaicela
Live Blog Update Author: 
Don Hackett
Location Tags: 
California
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The U.S. Centers for Disease Control and Prevention (CDC) today announced it had renewed and expanded its Alert - Level 2, Practice Enhanced Precautions focused on polio outbreaks and the continued detections of poliovirus.

On February 21, 2023, the CDC stated some international destinations have circulating poliovirus.

At present, only two countries remain with the indigenous transmission of wild poliovirus type 1, Afghanistan and Pakistan. 

And before traveling to any at-risk destination, the CDC recommends that adults who previously completed the routine polio vaccine series receive a single, lifetime booster dose of polio vaccine.

Furthermore, children should also be up to date on their routine polio vaccines.

Polio is a crippling and potentially deadly disease that affects the nervous system. 

Because the virus that causes polio lives in the feces of an infected person, people infected with the disease can spread it to others. People can also be infected if they drink water or eat food contaminated with infected feces.

In 2022, poliovirus was detected in wastewater systems in travel hotspots, including New York, London, Canada, and Israel.

In rare cases, polio infection causes permanent loss of muscle function. And polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.

Polio is a vaccine-preventable disease, says the CDC.

Approved polio vaccines are generally available in the U.S. at travel clinics and pharmacies.

Vaccine Treats: 
Polio
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U.S. CDC polio alert Feb. 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Atlanta
Vaccine: 
nOPV2 Polio Vaccine
Bacterial vaccine funding

£1 Million Supports Bacterial Vaccine Development

Bacterial vaccines fight against antimicrobial resistance
February 22, 2023
CDC center in Atlanta

Which Flu Shot is Most Effective

Influenza vaccination recommended for most at risk populations
February 22, 2023
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LinKinVax today announced the interim results of a double-blind, Phase I clinical trial evaluating CD40.HIVRI.Env, a preventive HIV vaccine candidate.

The ANRS VRI06 study's initial results, published on February 22, 2023, show that the vaccine candidate was safe and induced an early, significant, and sustained immune response.

The vaccine yielded high levels of antibodies directed against the HIV envelope: 

  • 80-100% at Week 6,
  • 100% at Week 26 in all groups (0.3, 1, and 3 mg).
  • These levels remained stable or dropped slightly until Week 48.
  • Antibodies targeting a specific area of the HIV envelope (V1/V2 region) were also produced.

Furthermore, at Week 26, neutralizing antibodies were detected in 50% of subjects in the 0.3 mg group and 100% of subjects in the other two groups.

The observed counts of CD4+ T cells targeting specifically the HIV envelope protein produced after the vaccination remained stable until Week 48.

Prof. Yves Lévy, Executive Director of the Vaccine Research Institute and CMSO of LinKinVax, commented in a press release, "The immune response profile generated by this vaccine (antibody response and activation of polyfunctional CD4+ T cells) was the one associated with a reduced risk of HIV infection in the RV144 trial."

"However.... the efficacy of this vaccine will only be evaluated in the Phase II/III studies."

LinKinVax's vaccine platform is built around a humanized monoclonal antibody, which is merged with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. 

André-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax, added, "We are pleased with these very promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety."

"This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results has been obtained."

"These studies will aim to demonstrate the efficacy of the vaccine, the "Everest of vaccine strategies," which has been the elusive goal of HIV research for the past 40 years."

Other HIV vaccine development news is posted at Precision Vaccinations.

Vaccine Treats: 
HIV
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by Gerd Altmann
Live Blog Update Author: 
Don Hackett
Location Tags: 
Paris

Bladder Cancer Vaccines

Bladder Cancer Vaccines

The U.S. Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Canadia, and the United Kingdom NHS say bacille Calmette-Guerin  (BCG) vaccination has shown positive results against types of bladder cancer, such as nonmuscle-invasive bladder cancer (NMIBC). In the 1970s, the BCG vaccine was approved as an immunotherapeutic treatment for bladder cancer patients. Since then, BCG has been the standard therapy for treating high-risk NMIBC patients to avoid the recurrence and progression of the disease.

With intravesical therapy for Bladder Cancer, a liquid drug (BCG) is inserted into your bladder through a tube (urinary catheter rather than giving it by mouth or injecting it into your blood, says Cancer.org. Drugs administered directly into the bladder affect the cells lining the inside of the bladder and have little to no effect on cells elsewhere. This means that intravesical therapy doesn't treat cancer cells outside the bladder lining, including those that have grown deeply into the bladder wall.

An abstract presented at the European Association of Urology 2022 Annual Meeting reported BCG vaccination nearly halved the risk of progression among patients with NMIBC compared with transurethral resection of the bladder, but only among those at high risk.

A report published in February 2023 estimates that more than 8,300 patients a year are not receiving full BCG treatments for their bladder cancer. Notably, 20% of the organizations reported being unable to provide BCG to patients eligible for therapy.

Bladder Cancer Vaccine Availability

Manufacturing changes in the production of BCG vaccines have resulted in worldwide shortages. Therefore, BCG constraints have had a clinical impact on Bladder Cancer treatment. Because of this situation, NMIBC patients might have received fewer doses of BCG than those recommended, might have received instillations of different BCG substrains depending on the BCG availability in each region, might have received a reduced length of standard maintenance therapy, and so forth. 

On July 24, 2023, the BCG vaccine manufactured by the Serum Institute of India began to be exported to Canada for immunotherapy to treat bladder cancer.

In Australia, intravesical immunotherapy BCG is approved.

Bladder Cancer Vaccine Candidates

ImmunityBio's Anktiva™ N-803 Plus BCG vaccine is a therapy to treat adults with NMIBC carcinoma in situ with or without Ta/T1 papillary disease.

Bladder Cancer Treatments

On November 30, 2023, Astellas Pharma Inc. and Seagen Inc. announced that the U.S. Food and Drug Administration accepted for priority review a supplemental Biologics License Application for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. On December 15, 2023, Reuters reported  Astellas Pharma's Padcev, in combination with Keytruda, was approved for a type of bladder cancer.

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Robert Carlson, MD
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Saturday, December 16, 2023 - 05:20
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Bladder cancer can potentially be prevented by BCG vaccination in 2023.
Condition: 
Bladder Cancer
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Icosavax, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) virus-like particle (VLP) vaccine candidate, in older adults 60 years of age and above.

Niranjan Kanesa-thasan, Chief Medical Officer of Icosavax, commented in a press release on February 21, 2023, "IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults."

In October 2022, Icosavax initiated a Phase 1, randomized, observer-blinded, placebo-controlled, multicenter study of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®, in up to 120 healthy older adults aged 60 to 75 years.

Icosavax anticipates announcing topline interim results from this Phase 1 trial in mid-2023, with subjects after that followed through 12 months after vaccination.

The company plans to initiate a Phase 2 trial for IVX-A12 in the second half of 2023.

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

As of February 21, 2023, the FDA has not approved any RSV vaccine candidates conducting late-stage studies. Furthermore, the FDA has approved and is reviewing RSV monoclonal antibody therapies.

Vaccine Treats: 
Respiratory Syncytial Virus (RSV)
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by Vlad Vasnetsov
Live Blog Update Author: 
Don Hackett
Location Tags: 
Seattle