Cancer Vaccine Breaking News

The World Health Organization (WHO) published Influenza Update N° 445 on May 15, 2023, stating influenza detections decreased further due to a decline in detections in the northern hemisphere, while some countries in the southern hemisphere reported an increase in influenza detections in recent weeks.

Most influenza activity was very low in North America, the Caribbean, and Central American countries.

In the tropical countries of South America, influenza activity decreased overall during this reporting period, although positivity increased to an extraordinary level in the Plurinational State of Bolivia.

In Europe, overall influenza detections decreased, and influenza positivity from sentinel sites dropped below the epidemic threshold of 10% at the regional level.

Despite continued testing in Central Asia, no influenza detections were reported during this period.

In Northern Africa, no influenza detections were reported.

In Western Asia, influenza activity remained low overall.

In East Asia, influenza activity decreased overall, although detections of mainly influenza A(H1N1)pdm09 continued to increase in Hong Kong Special Administrative Region, China.

A slight increase in influenza detections was reported in the Republic of Korea.

Other influenza and vaccine news for the upcoming 2023-2024 flu season is posted at Precision Vaccinations.

The U.S. Food and Drug Administration today approved Entasis Therapeutics's Xacduro, an intravenous infusion treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for adult patients 18 years of age and older. 

"The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like Acinetobacter baumannii-calcoaceticus complex," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release on May 23, 2023.

"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."

According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health.

Acinetobacter baumannii-calcoaceticus complex (hereafter referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.

These bacteria can cause infections in various body parts, occurring most frequently in healthcare settings and predominantly causing pneumonia.

A. baumannii can become highly resistant to multiple antibacterial drugs, and current treatment options for drug-resistant A. baumannii are limited.  

Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam.

Sulbactam kills A. baumannii, whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii.  

Previously, the FDA granted Xacduro Fast Track, Qualified Infectious Disease Product, and Priority Review designations for this application. 

Additional pneumonia and influenza vaccine news is posted by Precision Vaccinations.

Icosavax, Inc. today announced positive topline interim results from its Phase 1 clinical trial of IVX-A12 against the respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults.

IVX-A12 comprises IVX-121, Icosavax’s RSV prefusion F protein VLP vaccine candidate, and IVX-241, Icosavax’s hMPV prefusion F protein VLP vaccine candidate.

“IVX-A12 is a potential first-in-class combination vaccine candidate designed to address an unmet medical need in older adults, and we believe these interim data for hMPV in an older adult population also break new ground in the field. Furthermore, as has been seen previously with prefusion F antigen approaches for RSV, we expect that a combination vaccine displaying prefusion F antigens for both hMPV and RSV, on our VLP technology, may translate into significant protection against two leading causes of pneumonia. Therefore, we plan to expeditiously proceed towards a Phase 2 trial for IVX-A12 in mid-2023 in older adults as we pursue our goal of developing a broader viral respiratory vaccine,” said Adam Simpson, Chief Executive Officer of Icosavax, in a press release on May 22, 2023.

In this Phase 1 trial, IVX-A12 induced robust immune responses against RSV and hMPV at Day 28 in older adults across dosage levels and with and without adjuvant.

When administered in combination, there was no evidence of immune interference between RSV and hMPV VLPs.

The IVX-121 (RSV) component of IVX-A12 (RSV/hMPV) previously demonstrated positive immunogenicity and tolerability results in a Phase 1/1b study, and a subset of these Phase 1b older adult subjects continue to be followed.

In December 2022, Icosavax reported positive durability data at six months, with twelve-month immunogenicity data expected in mid-2023.

Discovered in 2001, HMPV is in the Pneumoviridae family along with RSV, says the U.S. CDC.

Broader use of molecular diagnostic testing has increased the identification and awareness of HMPV as an important cause of upper and lower respiratory infections.

Other RSV vaccine candidate news is posted by Precision Vaccinations.

According to Paraguay's National Animal Health and Quality Service President, Dr. José Carlos Martin, on May 22, 2023, three confirmed outbreaks of avian influenza (bird flu) in the Chaco region occurred, while two others were still under investigation.

MercoPress, a news agency based in Uruguay, reported bird flu was registered in home-breeding establishments with open-air sheds and backyard poultry, in Mariscal Estigarribia, Colonia Neuland, and Filadelfia, in the department of Boquerón.

On May 18, 2023, the Pan American Health Organization announced bird flu outbreaks are mainly occurring in areas along the Pacific flyway and that outbreaks have occurred in 15 countries in Latin America and the Caribbean, which it said is unprecedented.

In North America, Canada and the United States have been battling the virus since early 2022 and have reported it in wild birds, poultry, and mammals.

Additional bird flu outbreak news regarding mammals and people is posted at Precision Vaccinations.

The Insight Partners today published its latest research report on "Influenza Vaccines Market Size Report, Share, Trends, Growth, Demand & Forecast to 2028, which estimated the CAGR of 7.4% from 2022 to 2028.

During the current flu season, the Centers for Disease Control and Prevention (CDC) reported as of March 4, 2023, about 173.37 million influenza vaccines had been distributed in the U.S.

This amount resembles the 2021-2022 flu season, when 174.9 million doses were distributed.

Additional flu shot news is posted by Precision Vaccinations.

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) confirmed it had scheduled a vaccine review meeting open to the public for June 21-23, 2023.

Conducted at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, this meeting's purpose is to review scientific data and vote on vaccines and candidate recommendations for Respiratory Syncytial Virus vaccines; Recommendations for adult Polio vaccinations; Flu shots for the 2023-2024 season, Chikungunya, COVID-19, Dengue, Meningococcal, and Mpox vaccines.

This meeting's agenda will be led by Dr. Grace Lee, the ACIP Chair.

ACIP recommendations are public health guidance for the safe use of vaccines and related biological products.

The non-binding recommendations include the age(s) when the vaccine should be given, the number of doses needed, the amount of time between doses, and precautions and contraindications.

Pfizer Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316 (ABRYSVO™).

The vaccine candidate is under FDA review for preventing medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant women.

The VRBPAC voted 14 to 0 on effectiveness and 10 to 4 on safety.

“We are encouraged by the outcome of today’s VRBPAC meeting as it is a critical step forward in the scientific community’s long-sought-after goal to help prevent RSV disease in infants during their most vulnerable first six months of life,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer, in a related press release.

Additional RSV vaccine and monoclonal antibody news are posted by Precision Vaccinations.