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The Ecuadoran Ministry of Public Health recently announced a nine-year-old girl in the province of Bolivar had been infected with the A-H5 strain of avian influenza after direct contact with infected birds.

This is Ecuador's first human infected with the avian flu strain, as reported by Xinhua on January 11, 2023. "So far, no other (bird flu) cases of human infection have been recorded since an outbreak began in 2022," said the ministry.

Globally, six other human influenza A H5N1 2.3.4.4b infections had been reported in China, Vietnam, the U.K., Spain (2), and Colorado during 2022-2023.  

The Pan American Health Organization/WHO recommended on December 3, 2022, that the Member States strengthen coordination between sectors involved in alerting and responding to zoonotic events and implement the necessary measures to contain emerging pathogens that may put public health at risk. 

Previously, South American countries, such as Belize, Columbia, Mexico, Peru, and Venezuela, confirmed bird flu cases in 2022.

In the U.S., the United States Department of Agriculture's Animal and Plant Health Inspection Service stated the Eurasian H5N1 strain first appeared in North America in January 2022, affecting 47 states, leading to the loss of over 57.8 million birds as of January 11, 2023.

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.

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. 

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.