Search API | Vax-Before-Travel

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BioArctic AB's partner, Eisai, announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly Leqembi™ intravenous (IV) maintenance dosing.

A Prescription Drug User Fee Act action date is January 25, 2025.

Leqembi (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.

In the U.S., Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).

As of June 10, 2024, Leqembi is approved in Japan, China, and South Korea, and applications have been submitted for review in several countries, including the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

As part of the monthly IV maintenance regimen, patients who have completed the biweekly IV initiation phase, the exact period under discussion with the FDA, would receive a less frequent monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic amyloid beta (Aβ) protofibrils that can continue to cause neuronal injury.

The sBLA is based on the modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE), as well as the Clarity AD study (Study 301) and its OLE study.

Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing after the FDA granted it Fast Track designation in May 2024.

Alzheimer's disease is a progressive disease caused by toxic amyloid proteins. Once established, this pathophysiological process continues throughout the patient's life, so sustained treatment is necessary.

The company says treatment should be initiated early to maximize patient outcomes.

Data from Studies 201 and 301 and their OLEs show that continued therapy with LEQEMBI beyond the 18-month core phase prolongs the benefit as highly toxic protofibrils are continuously removed.

If approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen, which is less burdensome and makes it easier for patients and care partners to continue long-term.

BioArctic is a Swedish research-oriented biopharma company focused on neurodegenerative disorders. It has a broad and well-diversified project portfolio and the potential to improve patients' health.

Vaccine Treats:

Alzheimer’s Disease

Image:

Image Caption:

by Sofia Shultz

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Stockholm

Vaccine:

LEQEMBI Alzheimer's Disease Treatment

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Moderna, Inc. today announced that its Phase 3 clinical trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza and SARS-CoV-2 viruses than licensed flu and COVID vaccines in adults 50 and older, including an enhanced influenza vaccine in adults 65 and older.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on June 10, 2024.

"Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine."

Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference, submit them for publication, and engage regulators on the next steps.

mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Moderna says each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.

Vaccine Treats:

Influenza

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Image Caption:

by Senjin Pojskić

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Cambridge

Vaccine:

Flumist Quadrivalent Influenza Vaccine

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According to the weekly update of the Global Polio Eradication Initiative (GPEI), three countries confirmed additional polio cases.

As of June 5, 2024, Afghanistan and Pakistan each reported one wild poliovirus type (WPV1) case, the fourth WPV1 case for each country in 2024.

And Niger reported its second circulating vaccine-derived poliovirus type 2 (cVDPV2) case this year.

Additionally, the GPEI posted the results of the Strategic Advisory Group of Experts on immunization meeting results from March 2024 at this link.

The U.S. CDC issued an updated Global Polio Alert on May 23, 2024, regarding polio outbreaks and poliovirus detections in 34 countries.

The World Health Organization recently confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension through July 2024. Various vaccines are available worldwide to prevent additional polio cases.

Vaccine Treats:

Polio

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Image Caption:

GPEI polio case map June 4, 2024

Live Blog Update Author:

Don Hackett

Location Tags:

Geneva

Vaccine:

nOPV2 Polio Vaccine

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GSK plc today announced that the U.S. Food and Drug Administration (FDA) has approved Arexvy™ (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.

In the United States, Arexvy is approved for use in adults 60 and older and recommended by the U.S. CDC and its vaccine committee (ACIP) using shared clinical decision-making.

Professor Ann R. Falsey, University of Rochester School of Medicine, said in a press release on June 7, 2024, "I am thrilled that GSK's vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number—an important number, but not the only factor to consider."

GS has also filed regulatory submissions to extend the use of Arexvy in Europe, Japan, and other geographies, with regulatory decisions undergoing review.

Clinical trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to be completed in H2 2024.

As of June 2024, the U.S. FDA has approved three RSV vaccines.

Vaccine Treats:

Respiratory Syncytial Virus (RSV)

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Image Caption:

by Guillermo Gavilla

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

London

Vaccine:

AREXVY RSV Vaccine

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In the Northern Hemisphere, influenza activity was generally low at interepidemic levels in most countries, according to the World Health Organization (WHO) in Influenza Update N° 477.

As of the end of May 2024, the WHO says elevated flu activity continued to be reported in countries in Central America and the Caribbean.

In the United States, the Centers for Disease Control and Prevention (CDC) confirmed on June 7, 2024, that seasonal influenza activity remains low nationally and is forecasted to resume in Fall 2024.

As the Southern Hemisphere winter season accelerates, countries in South America continue to report elevated influenza activity. Influenza A(H1N1)pdm09 and A(H3N2) viruses have been detected.

The WHO forecasts that influenza infections will increase in the coming months.

Both the WHO and CDC recommend international travelers speak with a healthcare provider about flu shot options before departing abroad.

The CDC recently reported that about 158 million flu vaccines were distributed in the U.S. during the 2023-2024 flu season.

Note: The CDC says most known influenza viruses are dissimilar to avian and pandemic influenza viruses; traditional flu shots are not expected to protect people against bird flu or cow flu.

Vaccine Treats:

Influenza

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Image Caption:

US CDC Flu View data June 7, 2024

Live Blog Update Author:

Don Hackett

Location Tags:

Geneva

Vaccine:

Flumist Quadrivalent Influenza Vaccine

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A Short Communication published by the journal Influenza and Other Respiratory Diseases added to the research-based and real-world evidence the respiratory syncytial virus (RSV) can be prevented in most infants receiving a new monoclonal antibody (mAb).

RSV is the #1 cause of hospitalization of infants in most countries. In France, hospitalizations with RSV represent 28% of all-cause hospitalizations in children under the age of one during the RSV season.

This new study found a single dose of the extended half-life Beyfortus™ (nirsevimab) was found to be 75.9% effective against RSV-related hospitalization in France.

This long-duration mAb was also 80.6% (61.6–90.3) and 80.4% (61.7–89.9) effective in two sensitivity analyses.

These real-world estimates confirmed the efficacy observed in RSV clinical studies, wrote these researchers on June 5, 2024.

Sanofi and AstraZeneca recently announced they are producing Beyfortus before the 2024-2025 RSV season in the U.S.

On November 16, 2023, the CDC announced the release of the U.S. FDA-approved Beyfortus to physicians and hospitals through the Federal VFC Program and commercial channels.

Vaccine Treats:

Respiratory Syncytial Virus (RSV)

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Image Caption:

Pixabay 2024

Live Blog Update Author:

Karen McClorey Hackett

Location Tags:

Austin

Vaccine:

Beyfortus (Nirsevimab) RSV Antibody

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The New Jersey Department of Health (NJDOH) today announced a Somerset County resident developed measles following international travel.

As of June 5, 2024, no additional cases have been identified. Secondary cases would be expected to occur no later than June 26, 2024.

This is the second confirmed case of measles reported in NJ in 2024, the first of which was identified in Camden County in January.

In 2019, New Jersey reported a significant travel-related measles outbreak.

The NJDOH urges all residents planning to travel, regardless of destination, to ensure they are current on all routine and travel vaccinations, especially MMR vaccinations.

MMR vaccination services are generally available at travel vaccine clinics and pharmacies in the U.S.

As of June 2024, 52 countries are currently experiencing measles outbreaks, according to the U.S. CDC.

Vaccine Treats:

Measles

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Image Caption:

New Jersey beach - Pixabay 2024

Live Blog Update Author:

Don Hackett

Location Tags:

New Jersey

Vaccine:

Priorix Vaccine

Dengusiil Dengue Vaccine

Serum Institute of India (SII) Pvt. Ltd. Dengusiil tetravalent dengue vaccine live attenuated is conducting clinical research in 2024. The TOI reported Dengusiil was formulated 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 received the vaccine strains from the U.S. National Institutes of Health. Results from a study published in August 2023 reported that the vaccine was highly immunogenic. More than 69% of participants had tetravalent seroconversion, and more than 15 had trivalent seroconversion. These researchers concluded a single dose of dengue vaccine was safe and well tolerated in adults. The vaccine was highly immunogenic, with trivalent or tetravalent seroconversion and seropositivity in most participants.

SII is conducting phase 2 clinical for Dengusiil in 2024. A study published in August 2023 reported that the vaccine was highly immunogenic.

Serum Institute of India is the world's largest vaccine manufacturer in terms of the number of doses produced and sold globally. SII performs high-quality pre-clinical and clinical research in compliance with GLP and GCP guidelines on all its products before they are marketed worldwide. After licensure, diligent pharmacovigilance is maintained as per international norms.

Dengusill Vaccine Availability

SII says Dengusiil intends to be commercialized in India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives, and Sri Lanka.

Dengusill Vaccine Indication

Dengue fever virus is transmitted to humans by infected mosquitoes. In 2024, outbreaks were reported in over 100 countries. Dengue is endemic in India, with an overall seroprevalence of 48·7 % (95 % CI 43·5–54·0).

Dengusill Vaccine Side Effects

The phase 1 clinical trial concluded that Dengusill was safe and well tolerated, and no causally related serious adverse event was reported in the study.

Dengusill Vaccine News

November 27, 2023 - HT reported SII would start Phase I & II dengue vaccine trials in India.

Dengusiil Dengue Vaccine Clinical Trials

The Phase I, double-blind, randomized, placebo-controlled trial on 60 healthy individuals aged 18 to 45 years in Australia to assess the safety and immunogenicity of the Dengusiil tetravalent live-attenuated dengue vaccine. The study was conducted from December 2019 - June 2021. Results: 60 participants were randomized to receive dengue vaccine (n = 40) or placebo (n = 20). Twenty-three participants (59 %) showed DENV vaccine viremia post-vaccination for any of the four serotypes, with the majority on days nine and 11. At baseline, all participants were naïve by dengue PRNT50 for all four serotypes in both the study groups except for four in the dengue vaccine group and two in the placebo group. On day 57, the GMTs of neutralizing antibodies ranged from 66.76 (95 % CI 36.63, 121.69) to 293.84 (95 % CI 192.25, 449.11) for all four serotypes in the dengue vaccine group. On day 181, though the titers declined, they still remained much higher than the baseline. The titers in the placebo group did not change after vaccination. Seroconversion through day 85 ranged from 79.5 % for DENV 1 to 100 % for DENV2, while in the placebo group, no participant showed seroconversion through day 85. Similar trends were noted when PRNT was done using wild DENV serotypes in both vaccine and placebo groups.

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Manufacturer:

Serum Institute of India (SII) Pvt. Ltd

Reviewer:

Robert Carlson, MD

Vaccine:

Dengusiil Dengue Vaccine

VIS:

PDF

Availability:

N/A

Drug Class:

Vaccine, live tetravalent

Clinical Trial Phase I:

A Phase 1 Safety Study of Dengusiil in Healthy Adults

Condition:

Dengue

Last Reviewed:

Thursday, December 5, 2024 - 08:50

Brand:

Dengusill

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

UNII:

DB14764

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According to data published by the U.S. Centers for Disease Control and Prevention (CDC), a UCLA-led multi-site study that included 45% women and 20% children, no mpox cases were reported,

During June–December 2023, among 196 patients in the study, only three mpox cases were identified (1.5%). All cases were among men who reported having sex with multiple men in the month prior and not being vaccinated against mpox.

The CDC's MMWR revealed on June 6, 2024, that clinicians should remain vigilant for mpox virus infections and educate patients about the importance of risk reduction and JYNNEOS® vaccination.

Bavarian Nordic produces the third generation JYNNEOS® (MVA-BN®, IMVAMUNE®), a two-dose vaccine based on a live, attenuated vaccinia virus, Modified Vaccinia Ankara.

A meta-analysis of 16 studies published on April 26, 2024, revealed that the JYNNEOS vaccine effectiveness (VE) for one pre-exposure prophylactic vaccination ranged from 35% to 86%, and VE ranged from 66% to 90% for two doses.

In 2024, JYNNEOS became commercially available in the U.S. Currently, the CDC does not recommend routine immunization against mpox for the general public and has not endorsed JYNNEOS booster doses (3rd).

Vaccine Treats:

mpox

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