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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

Old Tuberculosis Vaccine Gets Energized

Temperature-Stable Tuberculosis Vaccine Candidate found safe

March 6, 2023

Fact checked by Robert Carlson, MD

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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

MMRV Vaccines Gain Intramuscular Administration Authorization

Merck MMRV vaccines can be administered intramuscularly

March 6, 2023

Fact checked by Robert Carlson, MD

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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

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Image Caption:

U.S. CDC Nigeria March 2023

Live Blog Update Author:

Don Hackett

Location Tags:

Lagos

Vaccine:

INO-4500 Lassa Fever Vaccine

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According to recent reporting by the Austin Business Journal (ABJ), Elon Musk's car factory and rocket ship companies may become neighbors with significant developments, including a new airport.

The ABJ reported on February 16, 2023, a developer believes this corner of east Austin could soon be called World Trade Center Austin.

Positioned far away from Austin's current weirdness, this ambitious plan includes a mix of Las Vegas, Disney World, and Venice.

This area is also the home to the Circuit of The Americas, which has hosted racing, action sports, and music events since 2012.

Named Greenport Airport, the online information posted as of March 5, 2023, indicates an opening last year.

Austin's current airports include the expanded Austin-Bergstrom International Airport, which offers a vast array of local Austin eateries and relaxing live music.

Additionally, the Austin Executive Airport is a first-class business facility ranked as a top Fixed Base Operator in Texas. And on Austin's western front, the Lakeway Airpark serves various public and private aviation needs.

From a health perspective, there are certified travel vaccination pharmacies in Austin meeting the needs of international travelers.

Vaccine Treats:

Yellow Fever

Image:

Image Caption:

by Achim Thiemermann

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Austin

Vaccine:

YF-VAX Yellow Fever Vaccine

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Carnival Cruise Line recently announced it is expanding its offerings with a fourth ship in Galveston, Texas.

The Carnival Miracle arrival will Texas-size sailings beginning in the fall of 2024 through the spring of 2025.

“We have always offered a great variety of cruises from Galveston, but by adding a fourth Carnival ship to homeport in Galveston and sailing these longer itineraries, we are giving our guests great new choices, especially for those who want to experience a wider variety of beautiful ports of call and more time to enjoy their time at sea,” said Christine Duffy, president of Carnival Cruise Line, in a press release on March 2, 2023.

Carnival Miracle will reposition from San Francisco to Galveston in October 2024 and operate a spectacular Carnival Journeys voyage that visits Cabo San Lucas, Mexico; Puntarenas, Costa Rica; Cartagena, Colombia; and a Panama Canal transit.

Carnival Miracle will further diversify Carnival’s deployment from Galveston by joining:

Carnival Breeze, which offers four- and five-day cruises;
Carnival Dream, which sails primarily six- and eight-day cruises, and
Carnival Jubilee features a rollercoaster, which arrives this December to begin week-long Western Caribbean sailings.

From a health perspective, while the COVID-19 pandemic has faded away in Texas, many cruise ship passengers should remain vigilant about noroviruses.

Norovirus is a very contagious virus that causes vomiting and diarrhea, says the U.S. Centers for Disease Control and Prevention.

In the United States, cases of norovirus occur most frequently during late fall, winter, and early spring.

One of the best ways to prevent the spread of norovirus is by practicing good hand hygiene.

The Norovirus Outbreak Map of confirmed outbreaks in the U.S. was updated in February 2023. And the Vessel Sanitation Program identifies various norovirus outbreaks onboard cruise ships.

Unfortunately, U.S. Food and Drug Administration had not approved a norovirus vaccine as of March 5, 2023.

Vaccine Treats:

Measles

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