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While the U.S. Food and Drug Administration (FDA) has not approved an Alzheimer's disease (AD) vaccine, there is progress in developing monoclonal antibody therapies.
For example, Eli Lilly and Company presented on March 31, 2023, an Interim Analysis from a Phase 1 Study of Remternetug, an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of amyloid-beta peptide that is present only in brain amyloid plaques.
Lilly stated Remternetug demonstrated rapid and robust amyloid plaque reduction in participants with AD.
Furthermore, to determine the safety, tolerability, and pharmacokinetic/pharmacodynamic data, Lilly is conducting a phase 3 trial (NCT05463731).
Separately, Lilly's donanemab is conducting a Phase 3 clinical trial.
Other Alzheimer's vaccine and antibody development news is posted at PrecisionVaccinations.com/Alz.
The Republic of Kenyan health authorities recently launched its first-ever cholera vaccination drive to bolster outbreak control efforts.
This program was strategically needed as Kenya has recorded more than 7,800 cholera cases and 122 related fatalities as of March 26, 2023.
The 10-day vaccination campaign launched with support from World Health Organization targeted 2.2 million people in the four worst-affected areas.
Vaccination teams went door-to-door to provide residents with the vaccine at homes, schools, health centers, markets, and other strategic public spaces.
According to Dr. Emmanuel Okunga with Kenya’s Ministry of Health, the vaccination campaign reached about 99% of the target population.
“It has been very successful,” he commented in a WHO Africa article on March 31, 2023.
“We are now monitoring the impact of the vaccine on the number of cases, and we have already seen a decline across the affected counties.”
Cholera infections are caused by ingesting contaminated food or water, with symptoms including acute watery diarrhea, which can quickly lead to severe dehydration.
The U.S. Centers for Disease Control and Prevention (CDC) published Cholera Vaccine recommendations on September 30, 2022. The CDC currently recommends the Vaxchora® vaccine for adult travelers.
The global supply capacity was 36 million oral cholera vaccine doses in 2022, whereas demand exceeded 70 million.
In the first quarter of 2023, 11.7 million doses have been requested (by six countries), of which 2.2 million doses have been shipped.
Other cholera vaccine news is posted at this link.
Researchers recently published a study in the American Journal of Health-System Pharmacy that concluded pharmacist-led culture follow-up programs to deprescribe antibiotics for patients with negative cultures has the potential to save significant antibiotic exposure.
According to these researchers, there was an opportunity to save a median of five antibiotic days per patient.
Published on March 28, 2023, this peer-reviewed, retrospective, descriptive study reviewed bacterial cultures of adult patients at an emergency department or urgent care in August 2022.
For one month, pharmacists reviewed 398 cultures, of which 208 (52%) were urine cultures or chlamydia tests with negative results.
Fifty patients (24%) with negative results had been prescribed empiric antibiotics.
The median duration of antibiotic treatment was seven days (interquartile range [IQR], 5-7 days), while the median time to culture finalization was two days (IQR, 1-2 days).
Thirty-two patients (15.3%) followed up with their primary care physician within seven days; of these patients, 1 (0.05%) had their antibiotic prescription discontinued by the primary care physician.
Previous studies in 2022 and 2019 also concluded pharmacist interventions deliver measurable, positive results.
Public Health France recently announced an investigation of Mpox cases clustered in the Centre-Val de Loire region, located in the Paris Basin and bisected by the Loire River.
As of March 23, 2023, about 5,000 cases of Mpox had been recorded in France since May 2022.
After the peak of contamination reached the end during June/July, the number of cases fell sharply.
Between January 2023 and March 23, 2023, 17 confirmed male cases were reported in the Centre-Val de Loire region, including 14 since March 1, 2023.
Six of the 17 cases had received no smallpox vaccination.
Unfortunately, Mpox infections can occur in people who have received a complete 2-dose vaccination.
The investigation showed that all these cases concerned men who have sex with men, several of whom reported having had several partners without always being able to identify them.
In addition, no parties or events common to the cases were identified.
The clinical characteristics of these cases remain similar to those previously observed; no case required hospitalization.
In addition, Mpox outbreak news is posted at MpoxToday.
Following assessing the primary endpoints of the Phase II/III study, PharmaJet partner Gennova Biopharmaceuticals Limited has submitted data for its mRNA-based Omicron-specific Covid-19 booster shot for Emergency Use Authorization to the office of the Drug Controller General of India.
This is the first booster in India explicitly targeting the SARS-CoV-2 coronavirus Omicron variant.
GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8 °C, which means it can be distributed through the existing refrigeration supply chain Pan-India and in low- and middle-income countries.
The vaccine, GEMCOVAC-OM, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System.
"Our partnership with Gennova Pharma and their Omicron booster clinical program confirms the value of choosing our widely validated and rapidly scalable Precision Delivery Systems to improve the effectiveness of DNA and mRNA vaccines," said Chris Cappello, President, and CEO, PharmaJet, in a press release on April 3, 2023.
"The Tropis System is already commercially available in India, and we are well-prepared to rapidly support demand for the GEMCOVAC-OM Omicron booster."
"In addition, we look forward to continuing our partnership with Gennova with additional novel vaccines."
For more information, visit Pharmajet's website.
Alzamend Neuro, Inc. today announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat mild to moderate dementia of Alzheimer's Disease.
ALZN002 is a proprietary "active" immunotherapy product, which means each patient's immune system produces it.
This trial aims to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20-30 subjects with mild to moderate morbidity.
"Alzamend's motto is 'Making Alzheimer's just a memory.' There remains a need to develop new therapies that alter the progression of Alzheimer's and prevent, reverse, or slow neurodegeneration and cognitive decline."
"Today, we are on the threshold of importantly advancing the art and science of anti-beta amyloid therapy by treating each Alzheimer's patient's immune system," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on April 3, 2023.
"Intermittent use of our immunotherapeutic vaccine (ALZN002) may be expected to limit the number of infusions needed, may reduce the potential for adverse reactions, and provide more substantive cognitive and functional outcomes to the millions of Americans afflicted with this devastating disease."
The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treating patients with Alzheimer's in a more extensive Phase IIB efficacy and safety clinical trial, which Alzamend expects to initiate within three months of receiving data from the initial trial.
Other Alzheimer's disease vaccine news is posted at this link.
The COVID-19 pandemic fundamentally changed expectations for public health, especially the speed at which credible health information is delivered, wrote the U.S. Centers for Disease Control and Prevention (CDC).
Throughout the pandemic, the CDC has been improving the timeliness, completeness, and quality of critical data for the response.
Through the Data Modernization Initiative, the CDC empowered 'data to move faster than a disease.'
Updated on March 31, 2023, a series of Weekly Review issues coinciding with the end of the COVID-19 public health emergency (May 2023) and what it means for CDC and the data reported.
The first issue was published on February 24, 2023, and the final two issues will publish on April 14 and May 12, 2023.
To view current and historical maps of COVID-19 vaccination by demographics in the U.S. as of April 2, 2023, please visit this webpage: Maps of COVID-19 Vaccinations by Age and Sex over Time.
There are new entry requirements when visiting the Turks and Caicos Islands. The Ministry of Health and Human Services recently announced the COVID-19-related requirements would expire.
This means proof of COVID-19 vaccination will no longer be required for visitors to the Turks and Caicos Islands as of April 1, 2023.
However, persons are strongly encouraged to take general precautions to protect themselves and limit the transmission of the SARS-CoV-2 coronavirus and other respiratory illnesses in circulation.
And eligible persons are strongly encouraged to consider taking COVID-19 vaccine/booster and the flu shot.
These vaccines are available at no cost at all Primary Health Care Clinics. For further information, please visit the Ministry of Health’s website https://www.gov.tc/moh/coronavirus/.
Separately, the U.S. CDC suggests other travel vaccinations when visiting Turks and Caicos in 2023.
Furthermore, there is a risk of dengue in this country, and visitors should avoid mosquito bites, particularly between dawn and dusk.
A British Overseas Territory located southeast of the Bahamas, Turks and Caicos is an archipelago of 40 islands in the Atlantic Ocean. Before the recent pandemic, about 1.5 million people visited the islands in 2019.
Lucira Health, Inc. recently announced the nationwide launch of its Lucira COVID-19 & Flu Home Test in the United States.
The COVID-19 & Flu Home Test is the first and only combination COVID-19 & Flu test granted emergency use authorization by the U.S. Food and Drug Administration for use at home and other non-laboratory sites.
The Lucira COVID-19 & Flu Home Test is a molecular test, not an antigen test, that demonstrated similar performance for COVID-19 and Influenza compared to highly sensitive lab-based PCR tests in clinical trials.
The easy-to-use, all-in-one combination test delivers results in 30 minutes or less from one shallow nasal swab and as of March 28, 2023, can be purchased in the U.S. for $34.99 at www.lucirahealth.com/flu.
