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Moderna Inc. president Stephen Hoge commented at a conference on healthcare on March 6, 2023, indicating it would accelerate the approval pathway for its personalized cancer vaccine candidate mRNA-4157/V940.

"At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval," Hoge said, according to EndPoint News.

"It's too early to say, but we are hopeful that the data will mature that way."

On December 13, 2022, mRNA-4157/V940, combined with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with a high risk of recurrence following complete resection.

An advantage of Moderna's mRNA platform is that it allows for investigational medicines that combine several different approaches to activate the immune system to attack cancer in a single mRNA therapy.

The U.S. Food and Drug Administration has already issued breakthrough therapy designation for mRNA-4157/V940 ahead of a potential Phase 3 study for the treatment expected in 2023 for adjuvant melanoma, a type of skin cancer.

In 2019, the latest year for which incidence data are available, 88,059 new cases of melanoma of the skin were reported, and 8,092 people died of this cancer in the U.S. Cancer is the second leading cause of death in the U.S., exceeded only by heart disease, says the U.S. CDC.

The CDC's real-time cancer dashboard is available at this link.

Vaccine Treats: 
Skin Cancer
Image: 
Image Caption: 
by Peter W.
Live Blog Update Author: 
Don Hackett
Location Tags: 
Cambridge
Vaccine: 
mRNA-4157 Cancer Vaccine
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The Annals of Internal Medicine today published a systematic review and meta-analysis of three randomized clinical trials in adults with prediabetes.

The U.S. Centers for Disease Control and Prevention (CDC) says prediabetes is a serious health condition where blood sugar levels are higher than normal but not high enough to be diagnosed as type 2 diabetes (T2D). 

Published on March 7, 2023, this analysis concluded vitamin D usage effectively decreased the risk of developing TD2.

This data found vitamin D use reduced the risk for diabetes by 15% (hazard ratio, 0.85 [95% CI, 0.75 to 0.96]) in adjusted analyses, with a 3-year absolute risk reduction of 3.3% (CI, 0.6% to 6.0%).

Among participants assigned to the vitamin D group who maintained an intratrial mean serum 25-hydroxyvitamin D level of at least 125 nmol/L (≥50 ng/mL) compared with 50 to 74 nmol/L (20 to 29 ng/mL) during follow-up, cholecalciferol reduced risk for diabetes by 76% (hazard ratio, 0.24 [CI, 0.16 to 0.36]), with a 3-year absolute risk reduction of 18.1% (CI, 11.7% to 24.6%).

And Vitamin D increased the likelihood of regression to normal glucose regulation by 30% (rate ratio, 1.30 [CI, 1.16 to 1.46]).

Furthermore, there was no evidence of a difference in the rate ratios for adverse events (kidney stones: 1.17 [CI, 0.69 to 1.99]; hypercalcemia: 2.34 [CI, 0.83 to 6.66]; hypercalciuria: 1.65 [CI, 0.83 to 3.28]; death: 0.85 [CI, 0.31 to 2.36]).

This study's limitations included 'people with prediabetes do not apply to the general population.'

The CDC says approximately 96 million American adults have prediabetes. However, more than 80% of those with prediabetes don't know they have it. 

This study had no external funding, and the researchers did not disclose any industry conflicts of interest.

In May 2022, the U.S. Food and Drug Administration approved Eli Lilly's Mounjaro injection to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise. Mounjaro is not indicated for use in patients with type 1 diabetes. 

As of March 7, 2023, no FDA-approved vaccine prevents diabetes.

Vaccine Treats: 
Diabetes 2
Image: 
Image Caption: 
from Pixabay
Live Blog Update Author: 
Don Hackett
Location Tags: 
United States of America
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Oliver Rich, Special Agent in Charge of the San Antonio Division of the Federal Bureau of Investigation (FBI), announced today that the FBI is seeking the public’s assistance in identifying the person(s) responsible for the assault and kidnapping of four U.S. Citizens, in Matamoros, Tamaulipas, Mexico.

On March 3, 2023, four Americans crossed into Matamoros, Tamaulipas, Mexico. Shortly thereafter, unidentified gunmen fired upon the passengers in the vehicle.  

All four Americans were placed in a vehicle and taken from the scene by armed men.

The US ambassador to Mexico, Ken Salzar, said in a statement that “US law enforcement officials from numerous agencies are working with Mexican authorities at all levels of government to secure the safe return of our compatriots."

The FBI, federal partners, and Mexican law enforcement agencies are investigating, and the FBI announced a reward of $50,000 for the return of the victims and the arrest of those involved.

Previously, the U.S. Department of State has issued its highest level travel advisory for most of Mexico, warning Americans 'do not go.'

 

Image: 
Image Caption: 
U.S. Dept of State Mexico March 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
South Texas
Alzheimer's disease

Pharmacists Effectively Administered Passive Immunizations Too

Passive immunity enhanced with monoclonal antibody therapy
March 6, 2023
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Eisai Co., Ltd. and Biogen Inc. today announced that the U.S. Food and Drug Administration (FDA) had accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBI™, supporting the conversion of the accelerated approval of LEQEMBI to an FDA traditional approval.

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act action date of July 6, 2023.

As of March 6, 2023, the FDA plans to hold an Advisory Committee meeting to discuss this humanized immunoglobulin gamma 1 monoclonal antibody application but has not publicly announced the meeting date.

LEQEMBI was approved under accelerated approval in the U.S. and was on January 18, 2023.

This indication is approved under accelerated approval based on a reduction in amyloid beta plaques observed in patients treated with LEQEMBI.

The accelerated approval was based on data demonstrating that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining AD feature.

Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit.

The FDA has not approved any AD vaccine candidates as of March 6, 2023.

Vaccine Treats: 
Alzheimer’s Disease
Image: 
Image Caption: 
by Nancy Jane P.
Live Blog Update Author: 
Don Hackett
Location Tags: 
Cambridge
Vaccine: 
LEQEMBI Alzheimer's Disease Treatment

ID93 + GLA-SE TB Vaccine

ID93 + GLA-SE TB Vaccine Description

AAHI’s TB vaccine ID93 + GLA-SE combines several proteins from Mycobacterium tuberculosis (Mtb), the bacterium that causes TB, into a fusion protein (“ID93”) with a proprietary immune-stimulating adjuvant (“GLA-SE”) in a freeze-dried formulation that can be stored at elevated temperatures (nearly 100 degrees Fahrenheit) for several months.

ID93 + GLA-SE Indication

ID93 + GLA-SE TB is a new vaccine that is indicated to prevent the world’s second-deadliest infectious disease.

The World Health Organization estimates that nearly 2 billion people across the globe are infected with Mtb. 

ID93 + GLA-SE Clinical Trial

The results of a Phase 1 clinical trial have been published. 

ID93 + GLA-SE elicited a stronger immune response than administration of the same vaccine using separate vials of antigen and liquid adjuvant formulation.

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Manufacturer: 
Access to Advanced Health Institute
Reviewer: 
Robert Carlson, MD
Vaccine: 
ID93 + GLA-SE TB Vaccine
Generic: 
ID93 + GLA-SE
Clinical Trial Phase I: 
Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults
Condition: 
Tuberculosis
Last Reviewed: 
Tuesday, March 7, 2023 - 06:55
Status: 
Candidate
BCG vaccine for TB

Old Tuberculosis Vaccine Gets Energized

Temperature-Stable Tuberculosis Vaccine Candidate found safe
March 6, 2023
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The U.S. Centers for Disease Control and Prevention (CDC) and the Kentucky Health Department recently alerted health officials and the public that there was a significant measles exposure event southwest of Lexington.

Asbury University, located in Wilmore, KY, hosted an on-campus event in mid-February 2023 that included about 20,000 attendees from around the U.S.

A measles case was confirmed on February 24, 2023, in an unvaccinated person who attended this gathering while infectious.

The CDC says that anyone unvaccinated or not fully vaccinated against measles should quarantine for 21 days. And anyone with measles symptoms should isolate and call a health care facility before testing.

With declines in measles vaccination rates, outbreaks are occurring in all World Health Organization Regions.

Significant measles outbreaks have been reported in the European, African, Eastern Mediterranean, and Southeast Asian Regions.

In the U.S., recent measles outbreaks were confirmed in Minnesota and Ohio.

The CDC says measles is a vaccine-preventable disease, with access to measles vaccines at most health clinics and pharmacies in the U.S.

Vaccine Treats: 
Measles
Image: 
Image Caption: 
by Kjrstie from Pixabay
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Lexington
Vaccine: 
Measles Vaccines March 2023
Measles vaccinations

MMRV Vaccines Gain Intramuscular Administration Authorization

Merck MMRV vaccines can be administered intramuscularly
March 6, 2023
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The U.S. Centers for Disease Control and Prevention (CDC) recently issued a Watch - Level 1, Practice Usual Precautions notice regarding the Lassa Fever outbreak in the west African country of Nigeria.

On March 1, 2023, the CDC confirmed there is an outbreak of Lassa fever, an acute viral hemorrhagic fever, in several states in Nigeria.

Visitors to Nigeria should seek medical care immediately if they develop (during or after travel) fever, chills, headache, fatigue, bleeding, trouble breathing, vomiting, facial swelling, or pain in the chest, back, and abdomen.

Before the pandemic, about 5 million people visit Nigeria annually, with Niger and India as the most frequent countries of origin of tourists in Nigeria, reports Statista. 

However, as of March 5, 2023, no Lassa fever vaccines are available.

But treatment with antiviral medicine is most effective during the early stages of illness.

Vaccine Treats: 
Lassa Fever
Image: 
Image Caption: 
U.S. CDC Nigeria March 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Lagos
Vaccine: 
INO-4500 Lassa Fever Vaccine