Vaccine News

Health Canada today announced it had issued a Notice of Compliance approving BEYFORTUS™ (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season.

And children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

BEYFORTUS is not a vaccine.

It is an immunizing agent and a long-acting monoclonal antibody (mAB).

The approval on April 24, 2023, was based upon a BEYFORTUS™ clinical development program spanning three pivotal late-stage clinical trials.

Jason Lee, Head of Vaccines Medical Affairs, Sanofi Canada, commented in a press release, "Today is a historical day for RSV prevention as decades of research and development culminate in Canada's approval of the first immunization against RSV disease."

"BEYFORTUS, designed using a long-acting mAB, will help meet a vast unmet need in RSV prevention, providing parents with an option to protect their infants during the first RSV season."

Sanofi stated it is committed to making BEYFORTUS available to newborns and infants for the upcoming 2023/2024 RSV season. 

In the U.S., government agencies are reviewing this mAB for potential authorization this year.

The U.S. Food and Drug Administration (FDA) approved an injectable mAB therapy (Synagis®) in 1998.

RSV is a common and highly contagious seasonal respiratory virus infecting almost all children. It is a leading cause of infant hospitalizations (79%), including infants born at term with no underlying health conditions.

RSV also burdens the health system, with most hospitalized infants needing supplemental oxygen and some requiring ICU admission.

RSV vaccine candidates remain under review in the U.S. and have not been U.S. FDA-approved.

The U.S. Department of State issued a Level 4: Do Not Travel advisory for the Republic of Sudan in northeast Africa.

Announced on April 22, 2023, the travel alert confirmed the U.S. Embassy in Khartoum suspended its operations.

In addition, the State Department ordered the departure of U.S. direct-hire employees and eligible family members from the Embassy in Khartoum due to the continued civil unrest.

Specifically, the U.S. government cannot provide routine or emergency consular services to U.S. citizens in Sudan due to the current security situation.

We are aware of convoys departing Khartoum traveling towards Port Sudan. However, the Embassy cannot assist convoys, and traveling in any convoy is at your own risk, wrote the Embassy.

And if you travel to Sudan, exercise extreme care in all parts of the country, including Khartoum. Unfortunately, Khartoum's airport was closed due to the uncertain security situation.

Additionally, visitors are encouraged to enroll in the Smart Traveler Program to receive Alerts during an emergency.

From a health perspective, the U.S. CDC issued various travel alerts for Sudan's measles, polio, and dengue outbreaks.

Travel vaccination services are offered in Texas at local clinics and community pharmacies.

The U.S. CDC's Weekly U.S. Influenza Surveillance Report published today highlighted negative news regarding influenza-associated pediatric mortality.

During Week #15, two influenza-associated pediatric deaths that occurred during the 2022-2023 season were reported this week.

This data increases the total number of pediatric flu deaths reported during the 2022-2023 flu season to 143.

Throughout the COVID-19 pandemic, there were very few pediatric deaths reported.

Pre-pandemic, during the 2019-2020 flu season, 199 deaths were confirmed by the CDC. 

The positive news posted by the CDC on April 21, 2023, is the majority of influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this flu season's influenza vaccines.

The CDC continues to recommend that everyone ages six months and older get an annual flu vaccine as long as flu activity continues in the U.S.

As of March 4, 2023, the CDC reported that about 173 million flu shots had been distributed this flu season, about the same as 2021-2022. 

And flu shots are advised for those traveling to countries where influenza cases have been reported, such as Brazil, Belize, Guatemala, Peru, and Europe.

The Government of Western Australia (WA) recently confirmed a case of measles was identified in a returned overseas traveler.

According to the Department of Health, on April 20, 2023, this was the first measles case reported in WA in more than three years.

And if you attended the exposure sites during the listed dates, you may have been exposed to this very transmissible virus and should monitor for symptoms.

People with measles typically develop symptoms around ten days after exposure, and rashes usually appear four to five days after symptoms start showing.

Globally, measles cases increased by about 80% last year compared with 2021, says the U.S. Centers for Disease Control and Prevention (CDC).

The CDC's top ten global measles outbreak list is led by India.

To alert international travelers of their measles risk, the CDC reissued its Watch - Level 1, Practice Usual Precautions notice on April 6, 2023.

Vaccination with a measles-containing vaccine is the best way to ensure you are protected, says the CDC. 

For travelers 12 months or older, two doses at least 28 days apart are recommended.

In the U.S., measles vaccines are offered at health clinics and pharmacies in cities such as Austin, Houston, and Lubbock, Texas.

The U.S. Department of State recently reissued its Level 2: Exercise Increased Caution travel advisory for the Dominican Republic, which has realized a post-pandemic in visitors.

In February 2023, about 1 million visitors returned to the eastern half of the island of Hispaniola, located in the Caribbean Sea, according to Travel Path.

On April 17, 2023, the State Department confirmed the development of a professional tourist police corps, the institution of a 911 system, and a concentration of resources in resort areas means these areas are better policed than urban areas like Santo Domingo. 

If needed, the U.S. Embassy Santo Domingo is located at Av. República de Colombia #57.

And this Advisory encourages visitors to avoid demonstrations and enroll in the Smart Traveler Enrollment Program to receive Alerts and make locating during an emergency easier.

From a health perspective, the U.S. CDC has included the Dominican Republic in recent dengue and cholera outbreak alerts.

And yellow fever vaccination is required if traveling from the states of Mina Gerais, Espirito Santo, Sao Paulo, or Rio de Janeiro in Brazil, including if the transit was less than 12 hours in an airport located in any of these states in Brazil.

If you depart from Houston, Texas (77018), travel vaccination clinics and pharmacies are near Bush International Airport.

The U.S. CDC Morbidity and Mortality Weekly Report (MMWR) today announced that during January 2022, the COVIDTests.gov program became available to all U.S. households, which could order free-to-the-user at-home test kits from the federal government.

In a probability sample of U.S. households, both awareness of the COVIDTests.gov program and use of kits were high, with more than 41 million households estimated to have used kits during January–May 2022.

This MMWR concluded the long-term availability of government-supplied test kits appears to have significantly improved access to SARS-CoV-2 virus testing for racial and ethnic minorities, underscoring a critically important element of the U.S. national COVID-19 response.

The World Health Organization (WHO) today published Influenza Update N° 443, confirming flu detections decreased steeply in January 2023 after a peak in late 2022.

After the end of January 2023, global activity increased until a peak around week #10, after which detections decreased.

In the countries of North America, most indicators of influenza activity were at levels typically observed towards the end of the annual flu season.

And as of April 17, 2023, overall influenza detections in Europe decreased, and influenza positivity from sentinel sites decreased to 16% but remained above the epidemic threshold at the regional level.

Of 41 European countries, 13 reported moderate intensity, with the remainder reporting low or below baseline intensity.

Influenza activity was low last week in the Caribbean and Central American countries.

However, increases in influenza activity were reported in Belize and Guatemala, where activity was close to the moderate threshold.

And the tropical countries of South America, influenza remained low, except for Brazil, Peru, and the Plurinational State of Bolivia, which reported high activity.

Since spreading influenza is a year-round health risk, the WHO and the U.S. CDC recommend international travelers speak with a healthcare provider about flu shot options.

For example, the HEB Pharmacy at UT Health in Austin, Texas (78712), located near the Austin Bergstrom International Airport (AUS), offers pre-departure travel vaccination advice and services.