Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Jan 9, 2023 • 6:23 pm CST
U.S. CDC shingles

SK bioscience today announced that it received a biologics license application approval for the 'SKYZoster™' shingles vaccine from the National Pharmaceutical Regulatory Agency in Malaysia.

SKYZoster is a live vaccine that attenuates the varicella-zoster virus and was initially approved in South Korea in 2017, then in Thailand in May 2020.

A recent Phase III clinical trial showed that SKYZoster is non-inferior compared to the control vaccine (Zostavax).

The cell-mediated immune response was also shown to be at an equal level, proving SKYZoster™ effectively induces immunogenicity against shingles, also known as herpes zoster.

Jaeyong Ahn, CEO of SK bioscience, commented in a press release on January 9, 2023, "It is encouraging that vaccines made by our technology are gradually expanding their influence in the global vaccine market where big pharmaceutical companies mainly dominate."

SKYZoster™ is steadily expanding its market position in South Korea. According to the IMS data, SKYZoster's market share in the third quarter of 2022 reached 56%.

Additionally, SK bioscience plans to submit for SKYZoster Pre-Qualification to the World Health Organization.

Shingles is a vaccine-preventable disease, says the U.S. Centers for Disease Control and Prevention (CDC). 

About 33% of people in the U.S. will develop shingles in their lifetime.

If you've ever had chickenpox, you can get shingles. Even children can get shingles. And your risk of shingles increases with age says the CDC.

In the U.S., the Shingrix® vaccine is the market leader and is generally available at most clinics and pharmacies.

Other approved shingles vaccines and vaccine candidate news are posted at PrecisionVaccinations.com/Shingles.

Jan 9, 2023 • 3:30 pm CST
USDA 2022-2023 Detections of HAPI in Mammals

The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) confirmed today additional highly pathogenic avian influenza (HAPI) H5N1 detections in mammals.

The updated USDA listing as of January 9, 2023, includes skunks, bears, raccoons, and another red fox.

The USDA previously confirmed the Eurasian H5N1 strain first appeared in North America in January 2022.

On January 5, 2023, the StarHeral reported HAPI infections were the cause of death for four animals at the Riverside Discovery Center in Scottsbluff. The Nebraska zoo confirmed a cougar, bear, and two tigers had died.

The release indicates the animals ate local geese with HPAI in their systems.

The U.S. Centers for Disease Control and Prevention (CDC) says although bird flu (HAPI) viruses mainly infect and spread among wild migratory water birds and domestic poultry, some bird flu viruses can infect other animals as well.

While it’s unlikely people would become infected with bird flu viruses, it is possible, says the CDC.

Globally, six human influenza A H5N1 2.3.4.4b infections were reported last year, including a man working with birds in Colorado

Since April 2022, about 110 H5N1 detections in mammals were confirmed during 2022.

The USDA reported HAPI detections had affected 47 states and led to the loss of over 57.8 million birds as of January 4, 2023.

Additional HAPI (bird-flu) news is posted at PrecisionVaccinations.com/Avain.

Jan 9, 2023 • 9:23 am CST
by Joshua Woroniecki

The U.S. Transportation Security Administration (TSA) recently reported great news for the domestic travel industry and new solutions for frustrated air travelers.

As of January 8, 2023, TSA checkpoint travel activity this year surpassed volumes last seen in 2019 before the pandemic curtailed most trips.

While this data is great news for the industry, it also means longer wait times at security checkpoints.

However, the TSA is aggressively deploying new digital solutions to empower quicker check-ins and security clearance.

One of those solutions was very effective last year.

In December 2022, 91% of TSA PreCheck® passengers waited less than 5 minutes.

And when traveling with children 12 and under, they can join a parent/guardian at TSA PreCheck® in the dedicated lanes.

In 2023, more than 200 airports and 85+ airlines will provide TSA PreCheck® services.

For TSA PreCheck eligibility requirements and instructions on accessing TSA PreCheck, visit the Help Center.

Note: You do not need to apply for TSA PreCheck® if you already have Global Entry, NEXUS, SENTRI, or hold an active TWIC® or Commercial Driver’s License with an HME and you meet the TSA PreCheck eligibility requirements.

Jan 9, 2023 • 6:47 am CST
by Christian Hänsel

The Government of Canada confirmed on January 7, 2023, Canadians should exercise a high degree of caution in Mexico due to civil unrest.

And to avoid non-essential travel to various areas due to high crime levels.

For example, Canadians visiting Mexico were recently informed to limit their movements in Mexico's northwest area. Canadian tourists in Mexico's Sinaloa state remained in their hotels for several days after civil unrest was reported.

The Canadian government has released a list of travel advisories for countries like Mexico to avoid similar situations, empowering more informed travel decisions.

"The safety of Canadians abroad is a top priority for the Government of Canada," Marilyne Guèvremont, spokesperson at Global Affairs Canada, told Global News on January 8, 2023.

To alert U.S. citizens of these risks, the in-person consular services at the U.S. Consular Agency in Mazatlan remained suspended on January 9, 2023. 

This is a continuation of the suspension of services previously announced, stemming from the violence across Sinaloa. 

U.S. citizens in need of a passport who plan to fly from Sinaloa to the United States in the next week should email the American Citizen Services unit at the U.S. Consulate General in Hermosillo.

The U.S. Consulates General in Hermosillo and Guadalajara continue to offer in-person consular services.

The U.S. State Department reminds U.S. citizens that Sinaloa is classified as Level 4 – Do Not Travel – in its travel advisory for Mexico.

Please visit travel.state.gov for the entire Mexico Travel Advisory, issued in October 2022, to see state-level summaries and advisory levels for your specific travel destination. 

Jan 8, 2023 • 4:45 pm CST
from Pixabay

Interesting Engineering (IE) reported today that while attending the Consumer's Electronic Show 2023 in Las Vegas, Nevada, it learned the kind of solutions being developed to provide humans food during space flight to Mars.

One solution that stood out was turning plastic into consumable food during the long trip.

NASA says if a spacecraft departs Earth at a speed of about 24,600 mph, the trip to Mars will take about seven months.

To feed inter-galaxy travelers, Columbus, OH-based Beehex is developing deep-space food solutions using various 3D-printed food technologies in microgravity.

"So if you want to create steak out of plastic, the entire mechanism on one side of this container will be able to produce steak out of plastic- or chicken breasts," wrote IE.

Typically, BeeHex's 3D decoration equipment allows bakeries to produce decorated cookies, cakes, cupcakes, and more with high speed and precision.

The full IE article is posted at this link.

As of January 8, 2023, the U.S. CDC has not posted vaccination recommendations for when people visit Mars.

Jan 8, 2023 • 3:28 pm CST
by Ana Jimenez

The U.S. State Department will soon begin correctly spelling the Republic of Turkey as "Türkiye" in formal settings.

According to the U.S. Department of State spokesperson Ned Price, on January 5, 2023, the name change was approved by the U.S. Board on Geographic Names following a request from the Turkish embassy.

In June 2021, President Recep Tayyip Erdogan requested the name change by launching a global rebranding campaign. He asked the rest of the world to embrace his country's original name, not the anglicized version.

"Türkiye is the best representation and expression of the Turkish people's culture, civilization, and values," President Erdogan commented.

Turkish people have called their country Türkiye since 1923, at the end of the Ottoman Empire and when the Turkish Republic was formed.

Data sources indicate Türkiye recorded 16 million tourists in 2020, ranking 15th worldwide.

Türkiye's cosmopolitan capital Ankara is positioned in the central Anatolia region.

While Istanbul, formerly known as Constantinople, is Turkey's largest city and is the gateway between Europe and Asia across the Bosphorus Strait. 

While the U.S. Centers for Disease Control and Prevention does not have an active travel notice, its website says to check the vaccines and medicines list and visit your doctor or pharmacist at least a month before visiting Türkiye to get what is needed for your trip.

And the Department of Stated suggests visitors exercise increased caution when traveling to Türkiye as some areas have increased risk.

The U.S. Embassy in Ankara is located at 1480 Sok No:1 Cukurambar Mah Cankaya 06530, Ankara.

Jan 8, 2023 • 1:16 pm CST
U.S. EMBASSY BOGOTÁ COLUMBIA

The U.S. Embassy in Bogota recently published a Level 3: Reconsider Travel notice with updates to high-risk areas. As of January 5, 2023, Columbia's U.S. Embassy says to exercise increased caution due to civil unrest.

Specifically, U.S. citizens are advised not to visit Arauca, Cauca (excluding Popayán), and Norte de Santander departments. 

And the Colombia-Venezuela border region.

Furthermore, demonstrations occur regularly throughout the country. As a result, road closures may significantly reduce access to public transportation and disrupt travel within and between cities. 

As a result, U.S. government employees are not permitted to travel by road between most major cities. 

And Colombia's land border areas are off-limits to U.S. government personnel unless authorized. 

If you decide to travel to Colombia, the State Department suggests keeping a low profile and enrolling in the Smart Traveler program to receive digital alerts and make it easier to be located during an emergency. 

And U.S. citizens can obtain local assistance at U.S. Embassy in Bogota, at Calle 24 Bis No. 48-50, Bogotá, D.C. Colombia.

From a health perspective, the U.S. Centers for Disease Control and Prevention (CDC) included Columbia in its Dengue outbreak travel advisory.

Furthermore, the CDC suggests various travel vaccinations, such as malaria, measles, and yellow fever, before visiting Columbia.

Travel vaccines are available in the U.S. at certified clinics and pharmacies.

Jan 8, 2023 • 7:29 am CST
New York polio wastewater surveillance report 2023

The New York State Department of Health Wastewater Surveillance's recent report reveals two additional positive poliovirus samples were identified in lower New York. 

As of January 6, 2023, sequencing analysis by the Centers for Disease Control and Prevention (CDC) confirmed the presence of poliovirus in a total of 101 positive samples of concern.

The poliovirus samples were collected in Rockland County, Orange County, Sullivan County, Nassau County, Brooklyn (Kings County), and Queens County.

The CDC says 94 of these samples are genetically linked to a Rockland County, NY, resident who was confirmed with polio (Acute flaccid myelitis) in 2022.

Polio is highly contagious, and people can spread the virus even if they don't know they're sick. However, individuals infected with polio shed viruses in their stools. 

New York says wastewater surveillance is an essential public health tool, providing the early and ongoing detection of polio in communities.

This monitoring helps identify where the virus may be and when, though it does not provide quantitative information about who or how many people or households may be infected.

Furthermore, wastewater collected in sewer systems in New York cannot be a source of polio infection or transmission for the general public. And it does not contaminate New York drinking water, including tap water, streams, and lakes, says the Department of Health.

The CDC says polio is a vaccine-preventable disease, and vaccines are generally available at clinics and pharmacies in New York.

Other polio outbreak news for 2023 is posted at PrecisionVacccinations.com/Polio.

Jan 8, 2023 • 3:23 am CST
by Manuel Alvarez

When BioNTech SE announced that the first person was dosed in a first-in-human Phase 1 clinical trial with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1, there was much enthusiasm generated by millions of people.

BioNTech's placebo-controlled, observer-blinded, two-dose-escalation study was launched on December 8, 2022, and is expected to enroll around 108 healthy adult volunteers.

This first-in-human HSV vaccine study was last updated on January 5, 2023.

However, it is scheduled for a June 2025 completion date.

BNT163 is not the only herpes vaccine candidate conducting early-stage research.

Still, it is the only mRNA vaccine that encodes three HSV-2 glycoproteins to help to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs.

"My colleagues and I are proud to have contributed to the early development and preclinical testing of this exciting new mRNA vaccine candidate that may have the potential to prevent people from contracting the virus," commented Prof. Harvey M. Friedman, M.D., Professor of Infectious Diseases at the University of Pennsylvania's Perelman School of Medicine, in a press release.

Dr. Friedman conducted preclinical and discovery science work on HSV and is the University's principal investigator for the preclinical discovery and enabling studies.

The U.S. Centers for Disease Control and Prevention (CDC) recently estimated that there were 572,000 new genital herpes infections in a year.

Throughout the U.S., about 12% of persons aged 14 to 49 have an HSV-2 infection.

From a herpes treatment perspective, research recently indicated about 15 vendors were participating in the herpes treatment market, which is valued at over three billion dollars annually.

Acyclovir and Valtrex® have significant shares in the pharmacy segment.

And United BioPharma is developing UB-621 as a first-in-class anti-gD monoclonal antibody candidate with demonstrated viral suppression of transmission and recurrence of HSV-1 and HSV-2. 

This HSV antibody candidate's phase 2 study was last updated on May 18, 2022.

Updated herpes vaccine candidates and treatment news are posted at PrecisionVaccinations.com/Herpes.

Jan 7, 2023 • 1:04 pm CST
by Kim Heimbuch

The U.S. Food and Drug Administration (FDA) recently approved Eisai R&D Management Co., Ltd.'s Leqembi for treating Alzheimer's disease.

Leqembi (lecanemab-irmb) is the second of a new category of medications approved for Alzheimer's disease that target the fundamental pathophysiology of the disease.

In July 2021, the FDA approved Aduhelm, an amyloid beta-directed antibody indicated to treat Alzheimer’s disease. 

These medications represent an essential advancement in the ongoing fight to effectively treat Alzheimer's disease.

The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.

The labeling also states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

The FDA granted this application Fast Track, Priority Review, and Breakthrough Therapy designations.

"Alzheimer's disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones," said Billy Dunn, M.D., director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, in a press release on January 6, 2023.

"This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."

The results of a Phase 3 randomized, controlled clinical trial to confirm the drug's clinical benefit have recently been reported, and the agency anticipates receiving the data soon.

Alzheimer's disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.

While the specific causes of Alzheimer's are not fully known, it is characterized by changes in the brain—including amyloid beta plaques and neurofibrillary, or tau, tangles—that result in the loss of neurons and their connections.

These changes affect a person's ability to remember and think.

As of January 7, 2023, the FDA has not approved an Alzheimer's disease vaccine. However, there are several conducting clinical trials.

Disclosure: FDA and NIH announcements were manually curated.

Jan 6, 2023 • 1:43 pm CST
by Anil sharma

Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application for its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine in infants and children six weeks through 17 years of age.

And for preventing otitis media caused by seven of the 20 Streptococcus pneumoniae serotypes in the vaccine.

The Prescription Drug User Fee Act goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023. 

“Today’s regulatory milestone further advances Pfizer’s commitment to the more than 20-year legacy of helping protect infants and children from invasive pneumococcal disease through conjugate vaccination,” said Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a press release on January 6, 2023.

“By offering the broadest serotype coverage by a pneumococcal conjugate vaccine against important serotypes causing pneumococcal disease in U.S. infants and children, 20vPnc, if approved, can help expand the protection for this vulnerable pediatric population.”

The FDA previously approved PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) on June 8, 2021, to prevent invasive disease and pneumonia caused by the 20 pneumococcus serotypes in the vaccine in adults ages 18 years and older.

Jan 6, 2023 • 1:19 pm CST
U.S. CDC Influenza report week #51

The U.S. Centers for Disease Control and Prevention (CDC) today reported seasonal influenza activity remains high in the U.S. but is declining in most areas.

However, influenza-related fatalities have increased.

As of Week #51, the CDC disclosed 74 influenza-associated pediatric fatalities were reported during the 2022-2023 flu season. Unfortunately, 13 of those deaths were recently reported.

Furthermore, the CDC confirmed on January 6, 2023, that among the 2,380 pneumonia, influenza, and/or COVID-19 (PIC) fatalities last week, 303 were influenza-related.

The CDC continues every eligible person to get annual flu shots, which are generally available at clinics and pharmacies in the U.S. 

"An annual flu shot is the best way to protect against influenza," CDC researchers wrote in today's weekly report.

"Vaccination helps prevent infection and can also prevent serious outcomes in people who still get sick with flu."

Jan 6, 2023 • 4:01 am CST
by Anemone P.

BioNTech SE today announced that it signed a Memorandum of Understanding ("MoU") with the Government of the United Kingdom ("UK") focused on personalized mRNA immunotherapies.

The MoU aims to provide personalized cancer therapies for up to 10,000 patients by the end of 2030.

This objective is part of a multi-year collaboration focused on three strategic pillars: cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding BioNTech's footprint in the UK as one of the Company's key markets.

The next steps of the collaboration will be the selection of candidates, trial sites, and the set-up of a development plan to be ready to enroll the first cancer patient in the second half of 2023.

Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech, commented in a press release on January 6, 2023, "Our goal is to accelerate the development of immunotherapies and vaccines using technologies we have been researching for over 20 years."

"The collaboration will cover various cancer types and infectious diseases affecting collectively hundreds of millions of people worldwide."

BioNTech stated it plans to invest in a UK Research and Development ("R&D") hub in Cambridge with an expected capacity of more than 70 highly skilled scientists, the first to commence R&D by the end of the first quarter of 2023. 

Disclosure: Content was manually curated for mobile readers.

Jan 5, 2023 • 9:14 am CST
by Darwin Adalia

Vaxcyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for VAX-24, an investigational 24-valent pneumococcal conjugate vaccine (PCV) candidate for the prevention of invasive pneumococcal disease (IPD), in adults.

PD is an infection caused by Streptococcus pneumoniae bacteria.

With Breakthrough Therapy designation, Vaxcyte will have access to all of the elements of the FDA's Fast Track program.

The company stated the FDA's decision was based on positive topline results from the Phase 1/2 proof-of-concept study, which evaluated the safety, tolerability, and immunogenicity of VAX-24 in adults 18-64 years of age.

Grant Pickering, Chief Executive Officer and Co-Founder of Vaxcyte, said in a press release on January 5, 2022, "Our focus remains on advancing our VAX-24 clinical programs in both adults and infants."

"And we anticipate announcing the topline data from the Phase 2 study in adults 65 and older in the second quarter of 2023."

VAX-24 is intended to improve the standard-of-care PCVs for children and adults by covering the serotypes responsible for most of the pneumococcal disease currently in circulation.

Vaxcyte aims to efficiently create and deliver high-fidelity, broad-spectrum vaccines, such as VAX-24, by using modern synthetic techniques, including advanced chemistry and the XpressCF™ cell-free protein synthesis platform.

In the U.S., approximately 900,000 people get pneumococcal pneumonia each year, which is estimated to result in about 150,000 hospitalizations and 28,000 deaths.

Pneumococci also cause over 50% of all cases of bacterial meningitis, says the U.S. Centers for Disease Control and Prevention.

Antibiotics are used to treat pneumococcal disease, but some strains of the bacteria have developed resistance to treatments. 

As of January 5, 2022, the U.S. FDA has approved various PCV vaccines, and several are conducting late-stage clinical research.

Disclosures: The company and CDC published the data, and this news post is not paid content.

Jan 5, 2023 • 7:59 am CST
Aura Air Inc. RSV air purification system

Aura Air Inc. today announced the findings of an independent study confirming that the company's data-driven air purification devices are highly effective in eliminating the airborne pathogens that contribute to Respiratory Syncytial Virus (RSV).

A recent study by Innovative Bioanalysis Laboratory shows Aura Air's four-stage purification process filters and removes 99.997% of airborne RSV.

According to the U.S. Centers for Disease Control and Prevention, RSV results in approximately 58,000 annual hospitalizations.

Aura Air has partnered with schools, hospitals, and medical associations like the New Jersey Hospital Association (NJHA) to help them combat the spread of RSV, COVID-19, and the flu.

"Hospitals and communities across the country are being hit by an unprecedented surge in patients suffering from RSV, especially very young children," said New Jersey Hospital Association's SVP Michael A. Guerriero in a press release on January 4, 2023.

"Aura Air's advanced air purification and disinfection technology provide a welcome line of defense against these highly contagious viruses."

In addition to RSV, Sheba Medical Center, a leading Israeli medical facility, and Innovative Bioanalysis Laboratory confirmed that Aura Air successfully filters and removes 99.99% of airborne SARS-CoV-2 and 99.98% of Influenza A viruses.

Aura is headquartered in Israel with global offices in the U.S. and India, with distribution in about 87 countries.

Note: As of January 4, 2023, the U.S. FDA has not approved an RSV-preventive vaccine.

Disclosures: This content was sourced from the company and is not paid content.