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GlaxoSmithKline (GSK) Pharmaceuticals Ltd today announced the launch of its Shingrix® vaccine to prevent shingles (herpes zoster) and post-herpetic neuralgia in adults aged 50 years and above in India.
PTI reported Shingrix can provide at least ten years of protection against shingles, which is caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox, GSK said in a statement on April 24, 2023.
In the U.S., the CDC's Morbidity and Mortality Weekly Report confirmed that on January 21, 2022, the Advisory Committee on Immunization Practices recommended two doses (0.5 mL each) to prevent herpes zoster and related complications in immunodeficient or immunosuppressed adults.
Singrix was initially approved in the U.S. in 2017 and Europe in 2018 and is now available in over 20 countries in 2023.
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 World Health Organization (WHO) recently published update Edition #139 on the COVID-19 pandemic.
As of April 20, 2023, the WHO confirmed new COVID-19 cases and deaths decreased by 27% and 32%, respectively, compared to the previous month.
Contrary to the overall global trend, significant increases were seen in some WHO regions and countries, such as the South-East Asia Region (+654%), which includes India.
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.
Aptitude Medical Systems today announced that it had received an award of up to $53.7 million from the U.S. government. The funding supports the development of over-the-counter molecular diagnostics capable of delivering lab-quality results in 15-30 minutes while approaching the cost of antigen tests.
About $19.6 million in funding is targeted to develop and validate at-home COVID and COVID/Flu tests.
And up to $34.1 million was allocated for options to develop additional multiplex tests for other infectious disease threats.
Aptitude aims to make molecular tests as accessible as antigen tests according to JP Wang, Ph.D., Aptitude CSO and co-founder, in a press release on April 20, 2023. "The value of that upgrade is clear – a PCR-quality molecular test means that you can detect infection earlier to avoid spreading to your family, friends, and coworkers."
This work is funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50123C00013.
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 peer-review JAMA Network Open published today results from a study that found more Canadians were hospitalized during later COVID-19 waves compared to the initial year of the pandemic.
However, the health outcomes were less severe in these hospitalized people.
In a cohort study of 55,714 adult and pediatric patients hospitalized with laboratory-confirmed COVID-19 in 155 acute care hospitals in Canada, surveillance data show that during waves 5 and 6 of the COVID-19 pandemic, hospitals experienced a surge in patients hospitalized with COVID-19, an increase in nosocomial transmission of COVID-19, and a decrease in severe outcomes.
These data suggest the importance of COVID-19 vaccination in reducing the burden on the Canadian healthcare system and severe outcomes associated with COVID-19, wrote these researchers.
