Vaccine News

Prensa Latina recently reported Cuba's COVID-19 vaccines, Soberana 02, Soberana Plus, and Abdala, received the sanitary registration granted by the Center for State Control of Medicines, Medical Equipment, and Devices for their proven efficacy.

The experts and scientists ratified the safety that characterizes Cuba's COVID-19 vaccines, firstly due to the very nature of the technological platforms used and secondly, because they have high thermo-stability.

Unlike others requiring special storage conditions, Cuba's vaccines can be stored between two and eight degrees Celsius at freezing temperatures.

During the clinical studies, vaccine efficacy was higher than 90%.

As of May 24, 203, Cuba is among the world's top 10 countries with most citizens immunized against the SARS-CoV-2 coronavirus, which raises the level of protection to more than 90% of Cuban inhabitants.

The Pan American Health Organization (PAHO) recently stated the detection of bird flu outbreaks in Latin America and the Caribbean is a situation never recorded before.

The identified influenza type A Highly Pathogenic Avian Influenza (HAPI) outbreaks are mainly located in areas of the Pacific flyway.

As of May 18, 2023, agricultural authorities in Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, Ecuador, Guatemala, Honduras, Mexico, Panama, Peru, U.S., Uruguay, and Venezuela have detected outbreaks of HPAI A(H5N1) viruses in domestic birds, farm poultry and/or wild birds, and in mammals.

Among the mammals identified, red foxes and skunks were the most frequently affected in North America, and fur seals in South America.

To date and since the introduction of avian influenza A (H5N1) in the Americas in 2014, three human infections caused by avian influenza A(H5N1) have been reported: the first in the U.S., reported in April 2022, the second in Ecuador, which was notified in January 2023, and the third in Chile, which was announced in March 2023.

In the U.S., the Audenz™ monovalent cell-based vaccine was authorized on January 31, 2020.

Recently, the U.S. FDA issued a Supplemental Approval in November 2021 for using Audenz in persons at increased risk of exposure to the influenza A virus H5N1 subtype.

The FDA confirmed annual flu shots are not designed to protect people from pandemic influenza.

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.