Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Apr 3, 2023 • 10:34 am CDT
by Gerd Altmann

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.

Apr 2, 2023 • 6:39 am CDT
COVID-NET April 2, 2023

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.

Apr 1, 2023 • 10:16 am CDT
U.S. CDC Turks and Caicos Islands April 2023

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.

Apr 1, 2023 • 9:20 am CDT
Lucira Health, Inc. April 2023

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.

Apr 1, 2023 • 9:00 am CDT
GPEI March 29, 2023

The Global Polio Eradication Initiative (GPEI) recently announced it had been two years since the novel oral polio vaccine type 2 (nOPV2) became available.

Approximately 590 million doses of nOPV2 have been administered across 28 countries under its WHO Emergency Use Listing (EUL) to date.

An additional 13 countries have met the EUL requirements for nOPV2 use in the event of a polio outbreak.

As of April 1, 2023, the nOPV2 vaccine is unavailable in the U.S.

GPEI’s nOPV Working Group leaders, Simona Zipursky (World Health Organization) and Ananda S. Bandyopadhyay (Bill & Melinda Gates Foundation), were interviewed on March 29, 2023, on the journey and the vaccine’s performance so far.  

The unedited interview is posted at this link.

Apr 1, 2023 • 8:34 am CDT
by Gerd Altmann

A recent study published in the peer-reviewed journal Science Advances indicates that the protease inhibitor Paxlovid could soon become less effective in treating COVID-19 infections.

This new research shows that simple single amino acid changes in SARS-CoV-2 coronavirus main protease could severely undermine the efficacy of antiviral drugs. 

To lower the risk of resistance, the researchers say protease inhibitors must be carefully designed to avoid simple resistance mutations. 

Announced on March 29, 2023, and conducted by the Midwest Antiviral Drug Discovery Center in Minnesota, this study shows that drug-resistant variants have appeared multiple times independently in different parts of the world, with regional clusters providing evidence for person-to-person transmission.

Further research will likely develop additional next-generation protease inhibitors with different resistance profiles and drugs targeting other viral processes, such as replication or cell entry.

A multi-drug approach—like existing therapies for HIV and Hepatitis C virus — could further help to protect against resistance and cure SARS-CoV-2-infected individuals, wrote these researchers.

Apr 1, 2023 • 8:01 am CDT
by Gerd Altmann

The UK Health Security Agency Week #13 reported COVID-19 activity decreased across most indicators compared with the previous week.

As of March 30, 2023, through Respiratory Datamart, SARS-CoV-2 positivity decreased to 10% compared with 10.9% in the previous week.

Overall, COVID-19 hospitalizations decreased slightly in week #12 and were highest in the 85 and over age group.

Furthermore, the COVID-19 Autumn booster vaccination campaign commenced in September 2022.

By the end of week #10, about 65% of all people aged over 50 and living in England had been vaccinated with an Autumn booster dose.

Mar 31, 2023 • 3:20 pm CDT
from Pixabay

The Region of the Americas has seen a significant surge in dengue cases and, in 2023, “is showing intense dengue transmission,”  stated the World Health Organization on March 23, 2023.

By early March 2023, 342,243 dengue cases, including 86 deaths, were reported in the Americas.

At this pace, 2023 may easily eclipse the results seen in 2022.

In 2022, over 2.8 cases of dengue, including 1,290 deaths, representing a two-fold increase in patients compared with 2021.

Unfortunately, this trend is being realized in the state of Florida.

The Florida Health Department reported as of week #12, there had been 52 travel-associated dengue cases, and one locally acquired dengue case confirmed this year. 

This compares with 903 travel-associated and 68 locally-acquired dengue cases reported in 2022, primarily in southern Florida.

The good news is that dengue is a vaccine-preventable disease, and two vaccines are becoming more available for international travelers in 2023.

Mar 31, 2023 • 1:40 pm CDT
from Pixabay

Resistance to Paxlovid™ is already evident among viral SARS-CoV-2 variants currently circulating globally, indicating that this stand-alone antiviral, known as a protease inhibitor, could soon become less effective in treating COVID-19 patients.

Published on March 29, 2023, this study's conclusion was presented in the peer-reviewed journal Science Advances.

To lower the risk of resistance, the researchers say protease inhibitors must be carefully designed to avoid simple resistance mutations. 

These researchers wrote that these results encourage the monitoring of resistance variants and the development of additional protease inhibitors and other antiviral drugs with different mechanisms of action and resistance profiles for combinatorial therapy.

"Despite Paxlovid's proven success in blunting COVID-19 symptoms, the long-term consequences of its widespread use in speeding up resistance are unknown," commented S. Arad Moghadasi, co-author of the study and a University of Minnesota Medical School graduate student in a press release.

Mar 31, 2023 • 11:04 am CDT
U.S. CDC FluView data March 31, 2023

The U.S. Centers for Disease Control and Prevention (CDC) today announced four additional influenza-associated pediatric fatalities have occurred during the 2022-2023 flu season in the United States.

A total of 138 pediatric flu deaths have been reported so far this flu season.

The good news is the CDC FluView week #12 report confirmed seasonal flu rates were low nationally last week, with outpatient respiratory illness below baseline, and eight of 10 HHS regions are below their respective baselines as of March 31, 2023.

Previously, the World Health Organization published Influenza Update N° 401 on March 20, 2023, stating most indicators of influenza activity decreased to levels similar to or below levels typically observed this time of year in the Northern Hemisphere.

The CDC suggests anyone traveling to the Southern Hemisphere in April 2023 speak with a healthcare provider about potentially getting an additional flu shot for protection.

Flu shots remain available for most people over six months at most clinics and pharmacies in the U.S.

As of March 4, 2023, about 173.37 million influenza vaccines had been distributed during the 2022-2023 flu season. 

Mar 31, 2023 • 8:06 am CDT
from Pixabay

The European Medicines Agency human medicines committee today announced it recommended authorizing the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and older who have previously been vaccinated with an mRNA COVID-19 vaccine.

It is the eighth vaccine recommended in the European Union for protecting against COVID-19 and, together with the vaccines already authorized, will support vaccination campaigns in EU Member States during the pandemic.

An updated listing of COVID-19 vaccines is posted at Coronavirus Today.

Mar 31, 2023 • 7:32 am CDT
by Dom Carver

NSW Health today announced a Western Sydney infant infectious with measles spent time in locations in Parramatta and Westmead on March 27, 2023.

The infant, too young to be vaccinated against measles, acquired the infection in India before returning to Sydney.

NSW Health also confirmed a local measles case in September 2022.

Dr. Christine Selvey, Director of Communicable Diseases, NSW Health, commented in a press release on March 29, 2023, "Measles is a highly contagious infection, and the most vulnerable are infants under 12 months, who are too young to be vaccinated against it, other members of the community who are not fully vaccinated and people with a weakened immune system."

Measles cases increased worldwide by about 80% during 2022 compared with 2021.

Measles is a vaccine-preventable disease that quickly spreads in the air through coughing or sneezing by someone unwell with the disease.

"It can take up to 18 days for symptoms to appear after an exposure, so it is essential to stay vigilant if you've been in the above locations, and if you develop symptoms, please call ahead to your GP to ensure you do not spend time in the waiting room with other patients," Dr. Selvey added.

The U.S. Food and Drug Administration (FDA) recently approved the intramuscular route of administration for M-M-R®II and ProQuad®. In addition, the FDA approved the Priorix vaccine for use in the U.S.

Measles outbreak news for 2023 is posted at Vax-Before-Travel.

Mar 31, 2023 • 3:27 am CDT
by Elena We

The start-up company PathoVax LLC announced that the U.S. Food and Drug Administration had concluded that a Phase 1 clinical trial for its monovalent component- HPV16 RG1-VLP vaccine RGVax may proceed.

This first-in-human, global multicenter Phase 1 clinical study seeks to demonstrate RGVax's safety and immunogenicity responses to HPV16 RG1-VLP in healthy volunteers.

RGVax is a chimeric HPV virus-like particle platform that displays 360 copies of the highly conserved, neutralizing HPV epitope (RG1).

The foundational technology is based on research conducted at the Johns Hopkins University and Medical University Vienna.

Unlike existing HPV vaccines, the RGVax technology and formulation have been shown to provide comprehensive protection against at least 18 high-risk human papillomavirus (HPV) types with immunogenicity lasting over a year without additional boosts in head-to-head studies with existing approved HPV vaccines.

"The world needs more, and particularly broad-based, HPV vaccines. We look forward to globally supporting these efforts in parallel and beyond this Phase 1, especially in Asia-Pacific and other developing countries, where there is a high burden of HPV diseases," said Dr. Kevin Koh, Chairman of PathoVax, in a press release on March 29, 2023.

A National Cancer Institute PREVENT contract funds the initiation of the Phase 1 study. 

As of March 31, 2023, there are various approved HPV vaccines and several vaccine candidates in development. 

Mar 31, 2023 • 2:49 am CDT
by David Mark

The Janssen Pharmaceutical Companies of Johnson & Johnson recently disclosed that after assessing the respiratory syncytial virus (RSV) vaccine landscape, the Company would discontinue its RSV adult vaccine program.

“By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients’ lives,” said Bill Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation and Medical Officer and Interim Head, Janssen R&D., in a press release on March 29, 2023.

The decision to discontinue the RSV adult vaccine program is part of a broader effort to make strategic choices for its investments to focus on medicines with the greatest potential benefit to patients. 

As of March 31, 2023, the U.S. FDA has not approved any RSV vaccine candidate.

However, the FDA previously approved monoclonal antibody therapies for infants.

 

Mar 31, 2023 • 2:30 am CDT
U.S. CDC - lymph gland called a bubo

The peer-reviewed journal Science Advances recently disclosed researchers from Tel Aviv University and the Israel Institute for Biological Research developed the first mRNA-based, lipid nanoparticle (LNP) vaccine effective against a lethal bacteria.

Published on March 8, 2023, this study on mice demonstrated that all vaccinated animals were fully protected against the bacteria that causes the plague.

Humans usually get the plague after being bitten by a rodent flea that is carrying the plague bacterium, says the U.S. CDC.

The most common sign of bubonic plague is the rapid development of a swollen and painful lymph gland called a bubo.

Plague morbidity and mortality rates have substantially decreased since the introduction of antimicrobials.

However, the isolation of Y. pestis strains resistant to multiple therapeutic antibiotics and the concern of a natural or intentional disease outbreak initiated by antibiotic-resistant strains emphasize the need to develop vaccines against the plague.

The researchers wrote, "Our mRNA-LNP vaccine elicited humoral and cellular immunological responses in C57BL/6 mice and conferred rapid, full protection against lethal Y. pestis infection after a single dose."

This study's findings suggest there is a new way of developing vaccines for bacterial diseases, including diseases caused by antibiotic-resistant bacteria.