Vaccine News

Eisai Co., Ltd. today announced that the U.S. Veterans' Health Administration (VHA) is providing coverage of LEQEMBI™ to veterans living with early stages of Alzheimer's disease (AD).

As of March 13, 2023, VHA healthcare professionals meeting the criteria set forth by the VHA can prescribe LEQEMBI to veterans who fit the VHA's standards and the U.S. Food and Drug Administration's (FDA) current label.

The FDA-approved LEQEMBI under the accelerated approval pathway in January 2023, and was launched in the U.S. on January 18, 2023.

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ),

Treatment with LEQEMBI should only be initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology, the population in which treatment was initiated in clinical trials.

After the first infusion, 38% of LEQEMBI-treated patients had transiently decreased lymphocyte counts to <0.9 x109/L compared to 2% on placebo, and 22% of LEQEMBI-treated patients had transiently increased neutrophil counts to >7.9 x109/L compared to 1% on placebo.

Furthermore, there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

LEQEMBI is not a vaccine but is therapeutically administered via infusion.

In the event of an infusion-related reaction, the infusion rate may be reduced, or the infusion may be discontinued, and appropriate therapy initiated as clinically indicated. Prophylactic treatment with antihistamines, acetaminophen, nonsteroidal anti-inflammatory drugs, or corticosteroids prior to future infusions may be considered. 

The FDA has not approved an Alzheimer's disease vaccine as of March 2023.

The U.K. National History Museum recently reported sea lions in Peru are among the latest victims of a version of the highly pathogenic avian influenza (HPAI) known as bird flu.

The HAPI virus has killed about 3,500 South American sea lions in Peru as of March 9, 2023.

The Peruvian government has reported that since November 2022, around 3% of the country's sea lions have died due to HPAI infections.

Peru, like many South American countries, believes HAPI was brought south by pelicans before jumping into the marine mammals. 

In the Northern Hemisphere, Canada and the United States have reported multiple mammalian fatalities related to bird flu infections.

The United States Department of Agriculture and the World Animal Health Information System reported during March 2023, over 131 HAPI H5N1 detections of wild striped skunks, black bears, raccoons, and red foxes.

• The California Department of Fish and Wildlife received confirmation on February 15, 2023, that an adult bobcat died from the Eurasian strain of HPAI H5N1.
• The Colorado Parks and Wildlife confirmed on February 9, 2023, several cases of HPAI in free-ranging wildlife (black bear, skunk, mountain lion).
• The Montana Department of Fish, Wildlife, and Parks confirmed on January 17, 2023, three juvenile grizzly bears tested positive for HAPI.

While there are no vaccines that protect birds or mammals from H5N1 infections, there are bird flu vaccines for humans.

In the U.S., the Food and Drug Administration authorized CSL Seqirus' Audenz™ vaccine on January 31, 2020, and RAPIVAB® in 2022.

And the U.S. government has financially supported the development of newer bird flu vaccines for people.

Furthermore, the government reminds everyone that annual flu shots are effective against certain types of influenza, but they are not effective against bord flu viruses.

The New York State Department of Health today announced New Yorkers are planning to travel abroad to Israel and other countries with circulating poliovirus to get fully immunized against polio.

Recently, Israel's Ministry of Health confirmed four children had tested positive for poliovirus in Northern Israel.

Furthermore, Israel has reported widespread detection of poliovirus in wastewater systems.

This latest outbreak follows one that was detected in February 2022 when seven children tested positive for poliovirus in Jerusalem.

With the latest polio case, New York health officials have contacted their Israeli counterparts to ensure a coordinated response.

As of March 10, 2023, enhanced precautions are encouraged when visiting the United Kingdom, Ukraine, Afghanistan, Pakistan, Indonesia, Nigeria, Côte d'Ivoire, several other central African countries, and Israel.

In the U.S., polio vaccines are available at health clinics and community pharmacies. 

Additional polio outbreak 2023 news is posted at Vax-Before-Travel.

Reuters recently confirmed GSK plc expects to launch its respiratory syncytial virus (RSV) vaccine in the U.S. in 2023 without supply constraints.

"We are ready to launch without capacity or supply constraints... to supply the market (from its plant in Wavre, Belgium) that we see," Phil Dormitzer, Global Head of Vaccines R&D at GSK, commented in an interview on March 8, 2023.

GSK plc previously announced that the U.S. Food and Drug Administration (FDA) vaccine voted that the available data support the safety and effectiveness of GSK's AREXVY™ vaccine candidate for preventing lower respiratory tract disease caused by RSV in adults aged 60 years and older.

The FDA Committee voted unanimously 12-0 on effectiveness and 10-2 on safety.

As of March 10, 2023, the FDA has yet to authorize AREXVY for use in the U.S.

Phil Dormitzer commented in a press release on March 1, 2023, "Today's vote brings us an important step closer to delivering one of the world's first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems."

AREXVY is also under regulatory review by the European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and several other regulators, with initial decisions expected later in 2023. 

RSV is one of the major remaining infectious diseases for which no vaccine or specific treatment is available for adults. Older adults are at high risk for severe disease due in part to age-related decline in immunity,

Additionally, RSV is a very serious disease in young children.

Unlike seniors, children already have FDA-approved RSV protection from a monoclonal antibody (Synagis®), with another version under final review.

The European Medicines Agency recommended marketing authorization for Beyfortus® (nirsevimab) in 2022 to prevent RSV lower respiratory tract disease in infants during their first RSV season when there is a risk of RSV infection in the local community.

Additional RSV vaccine candidates and antibody therapy news are posted at PrecisionVaccinations.com/RSV.

The U.S. Centers for Disease Control and Prevention (CDC) today published enhanced recommendations for the screening and testing for Hepatitis B Virus (HBV) infection.

As of March 10, 2023, the CDC confirms universal screening of adults for HBV infection is cost-effective compared with risk-based screening and averts liver disease, cirrhosis, and death.

Furthermore, chronic HBV infection is detectable using reliable and inexpensive screening tests.

In addition, although not quantifiable, management of chronic infection through prevention efforts can prevent further transmission to others.

These recommendations consider a more straightforward and less stigmatizing implementation strategy than previous risk-based HBV screening recommendations, says the CDC's Morbidity and Mortality Weekly Report.

The CDC's new recommendations also provide guidance complementary to the 2022 recommendations to vaccinate all adults aged 19–59 years against HBV infection by providing a means to establish immunity, any history of infection, or the need for vaccination to protect from future infection. 

Previously, on February 23, 2022, the CDC's Hepatitis Vaccines Work Group presented an HVB vaccine update.

The CDC says effective vaccines to prevent hepatitis B are available in the U.S.

The World Health Organization (WHO) today announced it would conduct a digital webinar tomorrow discussing Marburg virus vaccine and therapeutic candidates and how research can be integrated during future outbreaks.

The recent emergence of the Marburg virus (MARV) in Equatorial Guinea (Feb. 2023) and Ghana triggered the assembly of the "MARVAC" consortium in 2022 to facilitate a rapid response to this infectious disease threat. 

As of March 9, 2023, several MARV vaccine candidates are conducting early-stage clinical studies. 

On March 10, 2023, at 14:00 CET, from this Zoom link, the WHO R&D Blueprint is organizing a consultation with the MARVAC partners and focal points from at-risk countries to discuss this preliminary agenda:

• Outbreak sit rep, including diagnostics and epidemiology,
• Review of core trial protocols for vaccines and therapeutics,
• Panel discussion from at-risk country focal points

Since 1967, Angola, DR Congo, Equatorial Guinea,  Cameroon, Germany,  Ghana,  Guinea,  Kenya,  Serbia, South Africa, and Uganda have confirmed Marburg cases.

The U.S. Centers for Disease Control and Prevention published the History of Marburg outbreaks.

Charlotte Elton with EuroNews today reported Ibiza health officials are urging tourists to be on alert for symptoms of a Dengue infection.

The scenic Balearic Island, located off Spain's east coast, has recently experienced several dengue outbreaks.

For example, a message from Germany in 2023 alerted Spain to six cases of native dengue reported between May and November last year. 

The Centre for Coordination of Health Alerts and Emergencies (CCAES) recently confirmed one of the potential carriers of dengue is the Aedes albopictus or tiger mosquito.

These mosquitoes are found throughout the Spanish Mediterranean, northern Spain, including France.

From May to December 9, 2022, 272 imported cases of dengue fever were identified in metropolitan France, most from implantation by Aedes albopictus.

In addition to Europe's dengue outbreaks, several countries have reported dengue cases in 2023, including south Florida in the U.S.

Dengue can take up to two weeks to develop, with the illness generally lasting less than a week, says the U.S. CDC.

Health effects from dengue include fever, headache, nausea, vomiting, rash, muscle and joint pain, and minor bleeding. And dengue can become severe within a few hours.

Severe dengue is a medical emergency, usually requiring hospitalization.

Dengue is a vaccine-preventable disease. And there are two dengue vaccines available in specific countries.