Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Jan 12, 2023 • 8:50 am CST
by Manuel Alvarez

Health Canada recently approved Enhertu™ for treating adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Patients with hormone receptor-positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.1 

Enhertu (trastuzumab deruxtecan) is a specifically engineered HER2-directed antibody-drug conjugate (ADC) jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The approval by Health Canada on January 6, 2023, was based on the DESTINY-Breast04 Phase III trial results.

"Since the approval of HER2-targeted therapies in breast cancer more than twenty years ago, only patients with HER2-positive disease have been eligible for these therapies – leaving those with tumors with lower levels of HER2 expression with limited effective treatment options," said Dr. Jan-Willem Henning, Medical Oncologist, Tom Baker Cancer Centre, and Clinical Associate Professor, Cumming School of Medicine, University of Calgary, in a press release on January 12, 2023.

"The recent Health Canada approval of Enhertu in the HER2-low patient population is a significant milestone in the treatment of metastatic breast cancer and is the first anti-HER2 molecule to demonstrate efficacy outside of traditional HER2-positive breast cancer.

"Based on the promising data from the DESTINY-Breast04 trial, we're now able to differentiate levels of HER2 expression to redefine how we classify and treat metastatic breast cancer, providing additional patients with the opportunity to benefit from HER2-directed therapy."

In Canada, 10% of newly diagnosed breast cancers are metastatic; for those initially diagnosed with early-stage breast cancer, approximately 30% will progress to metastatic disease.

HER2 expression is currently defined as either positive or negative and is determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.

However, approximately half of all breast cancers are HER2-low, and previously these patients had limited effective treatment options following progression on endocrine (hormone) therapy.

Health Canada reviewed and approved Enhertu for this indication under the Priority Review and Project Orbis FDA collaboration pathways seven months from filing, enabling the timely availability to bring this new treatment option to HER2-low breast cancer patients as quickly as possible.

Note: ENHERTU is U.S. FDA-approved for treating several types of cancer.

Jan 11, 2023 • 3:38 pm CST
by BobSpicer

Situated in the Caribbean Sea, Grand Cayman is the westernmost of the three Cayman Islands. According to residents, three is a magic number.

When two is few and four is much, three islands are always just right, is a local saying.

And based on recent announcements, the U.S., Canadian, and U.K. governments agree with that saying.

For example, on January 10, 2023, the U.S. Department of State issued a low-level travel advisory for the Cayman Islands.

And if U.S. citizens need assistance, they must visit the U.S. Embassy in Kingston, Jamaica.

As the Cayman Islands is a British Overseas Territory, the U.K.'s Foreign Travel Advice recently confirmed there are no government requirements or limits on public gatherings in the Cayman Islands.

Since there's no formal British diplomatic or consular representation, local authorities deal with all requests for emergency assistance.

From a health perspective, the U.S. Centers for Disease Control and Prevention confirmed in November 2022 there are no health notices currently in effect for the Cayman Islands.

Furthermore, all vaccinated and unvaccinated visitors have been permitted to enter the Cayman Islands without additional documents since August 2022.

Travelers are not required to:

  • Apply for a Travel Declaration
  • Present a negative COVID-19 test
  • Show proof of vaccination
  • Wear masks

The Cayman Islands is conveniently about one hour flight south of Florida and is easily accessible via nonstop service from most travel hubs in the U.S., Canada, and the U.K.

George Town is the capital city, helping thousands of visitors enjoy their vacation. Besides seasonal hurricanes, the Cayman Islands is the place to relax in 2023.

Disclosures: This article is not paid content. 

Jan 11, 2023 • 1:30 pm CST
U.S. TSA airport screening

According to today's announcements, World Health Organization (WHO) and European Centre for Disease Prevention and Control (ECDC) officials again recommend airline travelers wear face masks while flying.

During a media briefing, Catherine Smallwood, WHO senior emergency officer for Europe, stated, "Passengers should be advised to wear masks in high-risk settings such as long-haul flights."

"This should be a recommendation issued to arriving passengers where there is widespread COVID-19 transmission."

The ECDC reported today the following recommendations apply with immediate effect for flights arriving in the EU from China: 

  • pre-departure testing for passengers on direct and indirect flights,  
  • wearing of medical face masks or respirators on board the aircraft for both passengers and crew,
  • enhanced cleaning and disinfection of aircraft serving these routes,
  • wherever possible, the vaccination status of crew members should be considered before assignment for duty,
  • random testing may also be carried out on a sample of arriving passengers,
  • wastewater should be monitored at airports with international flights and aircraft arriving from China to monitor the level of infection and detect any new variants.

These ECDC measures were defined in a way that should not introduce any flight delays or compromise flight safety. 

While there is ample debate on the value of wearing face masks in the open air, numerous studies support mask-use when in closed settings, such as an airplane.

And the WHO Director-General's remarks at the media briefing on January 11, 2023, included, "And we continue to call on all people to take appropriate precautions when necessary to protect yourself and others."

"You may not die with this disease (COVID-19), but you could give it to someone else who does."

Globally, nearly 2.9 million new COVID-19 cases and over 11,000 related fatalities were reported for the week ending January 8, 2023.

However, the data represents a reduction in weekly cases and fatalities of 9% and 12%, respectively, reported the WHO today.

Jan 11, 2023 • 12:26 pm CST
U.S. FDA vaccine committee digital meeting

The U.S. Food and Drug Administration (FDA) has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for January 26, 2023.

This digital meeting will start at 8:30 AM and is open to the public via YouTube https://youtu.be/ZjULNuSYfd0.

FDA confirmed it intends to make background material available to the public no later than two business days before the meeting. In addition, materials for this meeting will be available on the VRBPAC main webpage.

Furthermore, interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee using this docket number: FDA-2022-N-2810.

Comments received on or before January 18, 2023, will be provided to the VRBPAC. Comments received after January 18, 2023, and by January 25, 2023, will be considered by the FDA. 

Additional meeting information is available on this FDA webpage.

The VRBPAC reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products intended to prevent, treat, or diagnose human diseases.

And, as required, any other products for which the FDA has regulatory responsibility.

The Committee also considers the quality and relevance of the FDA's research program, which provides scientific support for regulating these products and makes appropriate recommendations to the Commissioner of the FDA.

Jan 11, 2023 • 11:53 am CST
WHO Situation Update Edition 125 Jan. 11, 2023

The World Health Organization (WHO today issued a Rapid Risk assessment regarding the XBB.1.5 coronavirus variant. The XBB.1.5 variant is a sublineage of XBB, which is a recombinant of two BA.2 sublineages.

Based on its genetic characteristics and early growth rate estimates, XBB.1.5 may contribute to increases in case incidence.

As of January 11, 2023, the WHO stated in a media release that the overall confidence in the assessment is low, as growth advantage estimates are only from one country, the United States of America (USA).

From October 22, 2022, to January 11, 2023, 5,288 sequences of the Omicron XBB.1.5 variant have been reported from 38 countries.

Most of these sequences are from the USA (82.2%), the United Kingdom (8.1%), and Denmark (2.2%).

Globally, nearly 2.9 million new COVID-19 cases and over 11,000 related fatalities were reported for the week ending January 8, 2023.

This Edition 125 data represents a reduction in weekly cases and deaths of 9% and 12%, respectively, reported the WHO on January 11, 2023.

Jan 11, 2023 • 11:29 am CST
by Torsten Simon

The U.S. Federal Aviation Administration (FAA) today announced at 0850 EST that normal air traffic operations are resuming gradually across the United States following an overnight outage to the FAA’s Notice to Air Missions (NOTAM) system.

The NOTAM provides safety information to flight crews when flying in the U.S.

Before commencing a flight, pilots are required to consult NOTAMs, which list potential adverse impacts on flights, from runway construction to the potential for icing. 

Furthermore, the FAA is in the process of modernizing the NOTAM system to improve the delivery of safety-critical information to aviation stakeholders.

Earlier on January 11, 2023, the FAA confirmed departures were resuming at Newark Liberty and Atlanta Hartsfield-Jackson airports due to air traffic congestion in those areas.

The AP reported about 21,000 flights were scheduled for departure today.

Jan 11, 2023 • 10:41 am CST
J.P. Morgan Healthcare Conference 2023

Regeneron Pharmaceuticals, Inc. discretely revealed its intentions to expand its Anti-SARS-CoV-2 Monoclonal Antibody offerings at the J.P. Morgan Healthcare Conference on January 9, 2023.

Regeneron's presentation stated that in the U.S. alone, millions of immuno-compromised people will not adequately respond to vaccination.

And antibodies can be dosed prophylactically to prevent infection and severe COVID-19 disease.

On slide #27, the Company stated its 'Next-gen COVID antibody binds outside variable RBD and has demonstrated high neutralization activity against all known variants and lineages and disclosed it anticipates initiating the REGN14287 phase 3 clinical trial in 2023, pending regulatory discussions.

The NCT04425629 study was last updated on July 29, 2022.

Previously Regeneron's first-generation REGEN-COV monoclonal antibody combination (casirivimab and imdevimab) is U.S. Food and Drug Administration-approved and was a market leader in the U.S.

The U.S. NIH stated on December 1, 2022, vaccination remains the most effective way to prevent SARS-CoV-2 infection and should be considered the first line of prevention.

Jan 10, 2023 • 12:11 pm CST
by Markus Winkler from Pixabay

There are several new scientific developments regarding COVID-19 that might be useful to you for navigating the pandemic, wrote Katelyn Jetelina, Ph.D., an epidemiologist trying to make sense of this pandemic world.

All stem from different COVID-19 "story threads" I've written before. So, a quick round-up was posted by Jetelina at this substack link.

Separately, the U.S. CDC's Data Tracker publishes various information that is perpetually updated.

And the WHO publishes weekly epidemiological updates (Jan. 4, 2023) on the ongoing COVID-19 pandemic.

Jan 10, 2023 • 4:52 am CST

The City of Columbus, Ohio, reported yesterday new data regarding the measles outbreak in children that was initially identified in June 2022.

As of January 9, 2023, there have been 82 measles confirmations and 33 related hospitalizations.

About 75% of these children were unvaccinated before being infected with the measles virus.

Columbus's Health Commissioner, Dr. Mysheika W. Roberts, recently stated, "The end of an outbreak isn't declared until 42 days after the last infected person develops a rash."

"If you are interested in scheduling your child's MMR vaccine, you can contact your local healthcare provider or reach out to the Ohio Department of Health," reported SpectumNews1.

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

Additionally, since many measles cases are travel-related, the CDC suggests being fully immunized before traveling abroad, as several countries, such as India, have reported outbreaks in 2023.

In the U.S., measles vaccines are generally available at clinics and pharmacies.

Jan 10, 2023 • 4:41 am CST
by Els Cools

Genexine Inc. recently announced updated results following the completion of its Phase 2 clinical study using GX-188E, its first-in-class proprietary DNA vaccine, in combination with KEYTRUDA® in 65 patients with HPV 16- and/or HPV 18- positive recurrent or metastatic advanced cervical cancer.

GX-188E is a therapeutic DNA vaccine that encodes the E6/E7 fusion protein of HPV subtypes 16 and 18 and is administered intramuscularly by electroporation.

On January 8, 2023, Genexine disclosed the final efficacy analysis of a phase 1/2 clinical trial showed an Objective Response Rate of 35% (21 of 60 patients), indicating that of the 60 patients with advanced cervical cancer, 21 patients saw either over 30% reduction in tumor size or complete remission.

Furthermore, cancer patients with a CPS<1 showed a response rate of 29.2%, while those with a CPS≥1 showed a response rate of 38.9%.

With a disease control rate of 57.0%, this combination therapy was effective in more than half of the patients.

The overall survival was 16.7 months which compares favorably to other agents that have been granted accelerated approval by U.S. Food and Drug Administration in 2nd line cervical cancer treatment.

Neil Warma, President and CEO of Genexine, commented in a press release on January 8, 2023, "... the results ... reinforce our belief that GX-188E could open up new treatment opportunities to all cervical cancer patients, especially PD-L1 negative patients who currently have limited options."

"We also appear to be extending patient survival beyond that of currently marketed drugs which should position us well as we move into larger Phase 3 studies to become a leader in the oncology DNA vaccine market."

Genexine management is presenting these data at the JP Morgan conference on January 9-13, 2023.

'The most important things you can do to help prevent cervical cancer are to get vaccinated against HPV, have regular screening tests, and go back to the doctor if your screening test results are not normal,' says the U.S. Centers for Disease Control and Prevention.

Disclosure: This announcement was curated for mobile readership and is not paid content.

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.