Travel Vaccine Breaking News

As 2022 ended, about thirty countries reported polio cases and/or poliovirus confirmations.

In response to these serious disclosures, the U.S. Centers for Disease Control and Prevention (CDC) reissued its Level 2 Travel Advisory.

On January 3, 2022, the CDC confirmed various international destinations have circulating poliovirus, such as London, England.

Since polio is a vaccine-preventable disease, the CDC says before any international travel, make sure you are up to date on your polio vaccines.

And the CDC recommends that adults who previously completed the full, routine polio vaccine series receive a single, lifetime booster dose of an authorized polio vaccine.

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

While most people with polio do not feel sick, it can be a crippling and potentially fatal disease that affects the nervous system. 

In reaction to a polio case confirmation in New York, the CDC announced on November 30, 2022, it would expand wastewater testing for poliovirus in select jurisdictions, such as near Detroit and Philadelphia.

As of December 30, 2022, sequencing analysis by the CDC confirmed the presence of poliovirus in a total of 99 positive samples of concern in New York.

Disclosures: Polio data originated from the CDC and NY Dept. of Health.

The U.S. Department of State reissued its Level 4: Do Not Travel advisory for the Republic of Iraq. As of January 3, 2023, this travel alert indicates significant civil unrest and Mission Iraq’s limited capacity to support U.S. citizens.

Furthermore, U.S. citizens in Iraq face high risks to their safety and security.

Due to risks to civil aviation operating in the Baghdad Flight Information Region, the U.S. Federal Aviation Administration (FAA) has extended its Special Federal Aviation Regulation for an additional two years, prohibiting certain flights at altitudes below 32,000 feet.

Because of security concerns, U.S. government personnel in Baghdad are instructed not to use Baghdad International Airport.

U.S. citizens should consult the FAA Prohibitions, Restrictions, and Notices website for more information.

For local assistance, the U.S. Embassy in Baghdad is located at Al-Kindi Street, International Zone, Baghdad, Iraq.

From a health perspective, the U.S. CDC publishes travel vaccine recommendations at this link.

Evaxion Biotech A/S today announced that the U.S. Food and Drug Administration ("FDA") determined that the Company may proceed with its Phase 2b clinical trial of EVX-01.

The study (EVX-01 plus Pembrolizumab 25 MG/ML) was first initiated in Australia in September 2022.

EVX-01 is a peptide-based cancer therapy intended for the first-line treatment of various metastatic and unresectable melanoma.

In November 2022, the Company submitted an Investigational New Drug Application ("IND") along with a Fast Track designation application to the FDA for a

On December 22, 2022, the FDA issued approval for the Company to proceed with its Phase 2b clinical trial of EVX-01 in combination with KEYTRUDA® for treating patients with metastatic melanoma.

"Receiving a green light from the FDA is a tremendous boost for our personalized cancer vaccine program. EVX-01 is already actively enrolling patients in Australia, and the FDA approval expands our ability to move forward quickly with our lead program in malignant melanoma," commented Erik Heegaard, Chief Medical Officer at Evaxion, in a press release on January 3, 2022.

"Moreover, the FDA is a universally recognized national authority, and its endorsement is an important step towards demonstrating a clinically meaningful benefit of our first personalized cancer vaccine,"

The Phase 2b study will be conducted at clinical sites across the U.S., Europe, and Australia. It is carried out in collaboration with Merck, supplying its PD-1 inhibitor KEYTRUDA®.

The U.S. NIH says melanoma is the third most common cutaneous malignancy after basal cell carcinoma and squamous cell carcinoma.

The treatment modalities currently used for metastatic melanoma include surgery, immunotherapy, targeted therapy, and chemotherapy.

The treatment paradigm of metastatic melanoma has changed dramatically within the last few years with the advent of immune checkpoint inhibitors and targeted therapy, says the NIH.

Evaxion Biotech A/S is a clinical-stage biotech company developing AI-powered immunotherapies.