Vaccine News

Vaccine news brought to you by Precision Vaccinations.

Jul 20, 2024 • 2:09 pm CDT
from Pixabay

With over 24,600 Zika virus cases already confirmed in the Region of the Americas in 2024, a new study published by the journal eBioMedicine, part of The Lancet, disclosed new, unsettling insights.

The Cleveland Clinic announced that this study revealed that maternal Zika virus infections can reprogram fetal immune development, leading to long-term consequences in children's immunity.

On July 18, 2024, the Clinic stated that these changes may occur in children born without the physical characteristics associated with congenital Zika syndrome, such as microcephaly.

This finding suggests that 95% of babies born from Zika-infected pregnancies who did not exhibit symptoms may have been affected by the virus with long-term immunological repercussions.

Additionally, heightened inflammation was observed in Zika-exposed infants with abnormalities at birth, while children exposed to Zika later maintained a chronic Th1-biased immune profile. The impaired response to Th2-biased vaccines raises concerns about the lasting effects of Zika virus exposure on immune responses.

Suan-Sin (Jolin) Foo, PhD, an expert in maternal-fetal virology and the Zika virus, says babies without symptoms are deemed healthy and do not receive any follow-up medical care or attention. 

“Studies have only really focused on what’s happening with the children who were born with visible physical conditions like microcephaly or neurological complications,” Dr. Foo commented in a press release.

“The rest of these kids may not even have a note on their chart mentioning that their mother was infected during pregnancy. Unless they’re part of our study, they’re essentially lost to the medical field.”

Dr. Foo added, “Our study clearly shows there’s much more to this condition than meets the eye. We need to expand diagnostic criteria and conduct more research to ensure these immunologically vulnerable children get the necessary care.” 

From a prevention perspective, no Zika vaccine candidate has been approved by the U.S. FDA as of July 2024.

Jul 20, 2024 • 12:09 pm CDT
WHO Sudan ebola case map

The Sabin Vaccine Institute recently announced the launch of a Phase 2 clinical trial for its vaccine against Sudan ebolavirus at Makerere University Walter Reed Project (MUWRP) in Uganda.

This is a vital development as there are currently no approved vaccines for this strain of ebolavirus.

Based on the cAd3 platform, Sabin’s single-dose investigational Sudan ebolavirus vaccine was found to be promising in Phase 1 clinical and non-clinical studies. Results showed it to be safe while eliciting rapid and robust immune responses that lasted up to 12 months.

“We are delighted to advance a vaccine candidate that can thwart a deadly and devastating disease, especially one that caused a fairly recent outbreak and for which no approved treatments exist,” commented Amy Finan, Sabin’s Chief Executive Officer, in a press release on July 15, 2024.

“Sabin’s vaccine candidate is backed by strong safety and immunogenicity data, and we hope this trial will yield further evidence to move the vaccine closer to licensure.”

This is Sabin’s second Phase 2 clinical trial partnership with MUWRP, based in Uganda’s capital, Kampala. A Phase 2 trial for a Marburg vaccine is already underway, having recently completed enrollment. Initial results from the Marburg trial are expected later this year.

The most recent outbreak of Sudan ebolavirus occurred in Uganda in the fall of 2022. That outbreak ultimately resulted in 55 deaths.

Sabin’s vaccine candidate was the first to arrive in Uganda during that outbreak after the WHO included it as one of three vaccines for possible use in an outbreak trial. The outbreak ended before the vaccine was deployed.

In August 2019, Sabin announced agreements with GSK to advance the development of vaccines against the Zaire and Sudan ebolavirus and Marburg virus. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, acquired by GSK in 2013. 

As of July 20, 2024, the U.S. FDA has approved Zaire Ebolavirus vaccines, which have been offered in Africa since 2019.

Jul 20, 2024 • 10:25 am CDT
US NCI 2024

According to a post on X, the Ministry of Health of the Republic of Belarus recently joined Bosnia and Herzegovina by authorizing a lung cancer vaccine.

On July 12, 2024, the Prensa Latina news agency reported that the CimaVax-EGF vaccine was the first patented and registered therapeutic vaccine against non-small-cell lung carcinoma (NSCLC).

CimaVax-EGF is a recombinant human EGF-rP64K/montanide ISA 51 vaccine that completed a phase 4 clinical trial for NSCLC in 2017 and is approved as a "maintenance treatment for patients with stage IIIB/IV NSCLC.

Developed by Cuba's Center of Molecular Immunology in 2011, the CimaVax-EGF vaccine has been deployed in Cuba and the South American countries of Colombia, Peru, and Paraguay.

This vaccine is not U.S. FDA-approved nor available to U.S. citizens.

However, a Phase 1/2 clinical trial sponsored by Roswell Park Cancer Institute is ongoing. This study says CIMAvax, combined with nivolumab or pembrolizumab, may better treat patients with NSCLC or squamous head and neck cancer.

The U.S. National Cancer Institute says each type of non-small cell lung cancer has different kinds of cancer cells. The cancer cells of each type grow and spread in various ways. The types of non-small cell lung cancer are named for the kinds of cells found in the cancer and how the cells look under a microscope.

Jul 18, 2024 • 10:00 am CDT
Services at Texas Operation Border Health Preparedness 2024

The Texas Department of State Health Services today announced it celebrates the 25th anniversary this month of the Operation Border Health Preparedness (OBHP) exercise, with no-cost health clinics planned at five different locations for South Texas residents to utilize.

These are essential services as Texas is currently reporting increases in diseases such as Dengue (16).

Services vary from location to location, so visit Services at OBHP 2024 or call 2-1-1 to confirm which services are offered in each specific area.

In 2023, OBHP provided 27,427 health services to 6,641 patients, including about 4,000 immunizations during the exercise.

“DSHS is extremely proud to celebrate this milestone with our partners and the communities that have embraced this exercise for a quarter of a century,” said DSHS Commissioner Jennifer Shuford, MD, MPH, in a press release on July 18, 2024.

“Services available to residents are extensive, and the experience gained by communities and emergency planners will help with disaster preparation and response in the future.”  

DSHS is partnering with OBHP in 2024 with Hidalgo County Health and Human Services, Cameron County Public Health, Willacy County, Starr County, Laredo Public Health, Texas Military Department, Texas State Guard, Texas A&M University, local nursing schools, and other nonprofit groups.

Jul 18, 2024 • 9:17 am CDT
Travel-associated chikungunya cases reported to ECDC, by place of infection, 2022

As the global Chikungunya outbreak continues in July 2024, a second vaccine may soon become available.

This is essential news since the World Health Organization recently confirmed the mosquito-borne viral Chikungunya virus was identified in nearly 115 countries in 2024, primarily in the Region of the Americas.

Bavarian Nordic A/S today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) submitted in June 2024 for CHIKV VLP, the Company’s vaccine candidate for immunization to prevent disease caused by chikungunya virus infection in individuals 12 years of age and older.

Validation of the MAA begins the EMA’s centralized review procedure under accelerated assessment.

The accelerated assessment, granted by EMA’s Committee for Medicinal Products for Human Use in February 2024, aims to reduce the timeframe for the CHMP to review an MAA. This could support the European Commission's vaccine approval in the first half of 2025.

Bavarian Nordic also completed the submission of a Biologics License Application for the CHIKV VLP vaccine to the U.S. Food and Drug Administration (FDA) in June 2024, potentially also supporting the approval of the vaccine in the first half of 2025.

CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization to prevent disease caused by CHIKV infection.

“The MAA submission and review marks a pivotal milestone for Bavarian Nordic in 2024....,” said Paul Chaplin, President and CEO of Bavarian Nordic, in a press release on July 18, 2024.

In November 2023, the U.S. FDA approved Valneva SE's monovalent, single-dose, live-attenuated IXCHIQ® Chikungunya vaccine. It has been available in the U.S. since the beginning of 2024.

 

Jul 17, 2024 • 12:52 pm CDT
from Pixabay

According to an email from an Administration for Strategic Preparedness and Response spokesperson on July 15, 2024, the first H5N1 avian influenza vaccine doses are scheduled to roll off the line next week, with the remaining doses following through August 2024.'

Other steps besides filling and finishing the vaccine, such as policy and regulatory decisions, must occur before the vaccine is released for public use.

Avian influenza vaccination has not been recommended for any population segment, and the U.S. government continues to monitor the situation.

Currently, the CDC evaluates the overall risk to human health as low.

On June 27, 2024, the U.S. Centers for Disease Control and Prevention confirmed during its vaccine committee meeting that an avian vaccination program was inactive.

As of July 17, 2024, the U.S. and European (Finland) governments have approved various avian influenza vaccines and recently awarded millions of dollars in vaccine candidate development contracts. Previous U.S. FDA-approved avian vaccines have reported measurable side effects.

Jul 17, 2024 • 9:15 am CDT
by Mircea Iancu

Anixa Biosciences, Inc. today announced that its collaborator, Cleveland Clinic, has received a “Decision to Grant” notice from the Japan Patent Office for the patent application titled “Vaccine Adjuvants and Formulations.”

"This new Japanese patent extends the claims for this novel breast cancer vaccine technology to an additional geographic region, beyond the U.S. and European patents previously awarded," stated Anixa Chairman and CEO Dr. Amit Kumar in a press release on July 17, 2024.

Cleveland Clinic exclusively licensed this technology to Anixa Biosciences.

Cleveland Clinic researchers have identified a protein called alpha-lactalbumin that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child.

Alpha-lactalbumin is never present on any other cell in the body. However, it does show up in many types of breast cancer, including an aggressive and deadly form of the disease known as Triple Negative Breast Cancer.

In addition, Cleveland Clinic researchers have identified that the extracellular domain of anti-Mullerian hormone receptor II (AMHR2-ED) is expressed in normal ovaries and nowhere else in the body, ceasing after menopause. However, this protein is also expressed in cancerous ovary cells.

By developing vaccines targeting alpha-lactalbumin and AMHR2-ED, the immune system can destroy breast and ovarian cancer cells, respectively, as they arise and ultimately prevent tumors from forming.

Following the positive clinical data seen in the breast cancer vaccine Phase 1 clinical trial, in collaboration with Cleveland Clinic, a cancer vaccine discovery program utilizing the same mechanism as breast and ovarian cancer vaccines to develop additional cancer vaccines to address many intractable cancers, including high-incidence malignancies in lung, colon, and prostate.

Jul 17, 2024 • 8:57 am CDT
by Tim Tersluisen

Diakonos Oncology Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s unique dendritic cell vaccine (DCV) for pancreatic ductal adenocarcinoma.

On July 15, 2024, the Houston-based company confirmed that DCVs are made with a patient’s dendritic cells and a tumor sample.

These highly differentiated double-loaded dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that initiate a natural immune response to target and eliminate cancer cells. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs compared to leading cell therapy approaches.

“This second FDA Fast Track designation of our autologous dendritic cell vaccines for pancreatic cancer is another acknowledgment of the incredible potential of this innovative immunotherapy for treating the most deadly cancers,” said Mike Wicks, Diakonos CEO, in a press release.

Pancreatic ductal adenocarcinoma is the most common pancreatic cancer. In 2024, an estimated 51,750 people will die, and 66,440 will be newly diagnosed.

FDA Fast Track designation is intended to speed the development and review of drugs that show early clinical promise in treating severe or life-threatening conditions.

Jul 16, 2024 • 2:44 pm CDT
Canva Pixabay

During today's U.C. CDC Clinician Outreach and Communication Activity call, the presentation offered insights regarding the multi-year Highly Pathogenic Avian Influenza (HPAI) (H5N1) virus outbreak in the United States.

As of July 16, 2024, the HAPI virus is widespread among wild birds and continues to cause outbreaks in poultry and spillover to mammals, including dairy cattle.

To date, three human cases of HPAI A(H5N1) virus infection have been identified in dairy farm workers in the U.S.

The CDC team wrote, 'The risk to the public from HPAI A(H5N1) viruses is low. However, people with job-related or recreational exposure to infected birds or animals, including dairy cattle, are at greater risk of HPAI A(H5N1) virus infection.

As of July 2024, the U.S. government has invested hundreds of millions of dollars in funding avian influenza vaccines and clinical candidates that could be deployed during a pandemic.

Jul 16, 2024 • 11:38 am CDT
by Romeo Spalding

New data published by the World Health Organization (WHO) highlights brighter spots in global immunization coverage. On July 15, 2024, the WHO wrote the steady introduction of new and under-utilized vaccines, including vaccines targeting human papillomavirus (HPV), has produced positive results.

About 85% of people will get an HPV infection in their lifetime.

For example, the share of adolescent girls globally who received at least one dose of the HPV vaccine, which protects against cervical cancer, increased from 20% in 2022 to 27% in 2023.

The use of the single-dose HPV vaccine schedule also helped boost vaccine coverage.

Strong introductions in countries such as Bangladesh, Indonesia, and Nigeria primarily drove this increase.

However, HPV vaccine coverage is well below the 90% target to eliminate cervical cancer as a public health problem, reaching only 56% of adolescent girls in high-income countries and 23% in low- and middle-income countries. 

"The HPV vaccine is one of the most impactful vaccines in Gavi’s portfolio, and it is incredibly heartening that it is now reaching more girls than ever before,” said Dr. Sania Nishtar, CEO of Gavi, the Vaccine Alliance, in a WHO press release.

“With vaccines now available to over 50% of eligible girls in African countries, we have much work to be done, but today, we can see we have a clear pathway to eliminating this terrible disease.”

New insights suggest innovative marketing programs are needed to expand HPV vaccine uptake.

A recent poll of over 400,000 users of UNICEF’s digital platform for young people, U-Report, revealed that over 75% are unaware or unsure of what HPV is, underscoring the need for better vaccine accessibility and public awareness.

When informed about the virus, its link to cancers, and the existence of a vaccine, 52% of respondents indicated they want to receive the HPV vaccine but are hindered by financial constraints (41%) and lack of availability (34%).

As of July 2024, various HPV vaccines were available worldwide.

In the United States, the CDC recommends two doses of HPV vaccine for all adolescents at age 11 or 12 years.

Jul 15, 2024 • 4:23 pm CDT
JHB Public Health 2024

New data published today by the World Health Organization (WHO) revealed that over the last five years, measles outbreaks have hit 103 countries.

In 2023, nearly 35 million children had no or only partial measles protection.

In July 2024, the U.S. CDC listed the top ten international measles outbreaks led by Azerbaijan, Kazakhstan, Iraq, and India. In the United States, the CDC reported 167 measles cases in 24 jurisdictions this year.

On July 15, 2024, the WHO confirmed that only 83% of children worldwide received their first dose of a measles vaccine through routine health services, while the number of children receiving their second dose reached 74%.

These WHO figures fall short of the 95% coverage needed to prevent measles outbreaks.

“Measles outbreaks are the canary in the coal mine, exposing and exploiting gaps in immunization and hitting the most vulnerable first,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.

“This is a solvable problem."

"Measles vaccine is cheap and can be delivered even in difficult places. WHO is committed to working with all our partners to support countries in closing these gaps and protecting the most at-risk children as quickly as possible.”

The CDC confirmed in 2024 that if you are unsure if you or your travel companions are fully protected against measles, schedule an appointment to see your clinician at least six weeks before traveling so that you have enough time to get vaccinated with an MMR vaccine. 

Jul 15, 2024 • 9:55 am CDT
WHO malaria map

Today marks the official rollout of the newly approved R21/Matrix-M™ malaria vaccine, co-developed by the University of Oxford and Serum Institute of India (SII), which has committed to producing 100 million vaccines.

This malaria vaccine utilizes Novavax’s Matrix-M™ adjuvant technology.

The first official vaccination is scheduled for July 15, 2024, in Abidjan, Côte d’Ivoire, and it will be subsequently introduced in 38 districts across the country.

According to a press release, 15 African countries will introduce malaria vaccines with Gavi support in 2024. These countries plan to reach around 6.6 million children with the malaria vaccine in 2024 and 2025.

John Jacobs, President and Chief Executive Officer of Novavax Inc., commented, "The introduction of the R21/Matrix-M™ malaria vaccine in Côte d'Ivoire marks a breakthrough in the fight to protect vulnerable children against a leading cause of death across the region while reinforcing our mission to create innovative vaccines that improve public health."

"Novavax is proud of the contribution of our Matrix-M™ adjuvant in this vaccine and in making this moment possible, and value our continued collaboration with the University of Oxford and SII, as well as the lifesaving work of WHO, Gavi, and UNICEF.”

R21/Matrix-M is a low-dose, highly effective, and affordable vaccine that can be manufactured quickly and scale. Ghana, Nigeria, Burkina Faso, and the Central African Republic have approved the new vaccine, and many others are preparing to receive shipments.

Malaria vaccines are currently unavailable in the United States.

Novavax, based in Gaithersburg, MD., U.S., promotes improved health by discovering, developing, and commercializing innovative vaccines to help protect against serious infectious diseases.

Jul 14, 2024 • 8:33 am CDT
GPEI polio cases map July 9, 2024

According to the Global Polio Eradication Initiative (GPEI), a joint Polio Independent Monitoring Board and Transition Independent Monitoring Board meeting will be held in Geneva, Switzerland, beginning July 15, 2024.

The goal of the meeting is to assess the challenges of eliminating polio in the endemic and outbreak countries.

Unfortunately, the GPEI reported three additional wild poliovirus type 1 (WPV1) cases in Afghanistan last week, bringing the country's total for 2024 to nine.

In 2023, Afghanistan reported six WPV1 cases. 

In this region, Pakistan, which is also fighting the speed of poliovirus, reported eight new WPV1 environmental detections last week.

In addition to these polio disclosures, the U.S. CDC says to interrupt poliovirus transmission, a renewed focus on increasing routine immunization coverage in endemic areas and implementing higher-quality supplementary immunization activities is necessary.

Over the last decade, about 10 billion doses of oral polio vaccine were administered worldwide, reports the GPEI.

The CDC's Global Polio Travel Advisory (May 2024) recommends that before visiting any of the 34 destinations, adults who completed the full, routine polio vaccine series may receive a single, life booster dose of polio vaccine.

In the United States, polio vaccines are generally available at pharmacies and travel clinics.

Jul 13, 2024 • 8:35 am CDT
US CDC Oropouche fever case map June 2024

The U.S. CDC reissued a global warning about Oropouche fever outbreaks in various communities of Brazil, Bolivia, Colombia, Peru, and Cuba in the Region of the Americas.

In late June 2024, the CDC said travelers should seek medical care if they develop high fever, headache, muscle aches, stiff joints, nausea, vomiting, chills, or sensitivity to light during or after travel.

For example, the Ministry of Public Health of Cuba reported the first-ever outbreak of Oropouche virus disease in May, confirming 74 cases from the Province of Santiago de Cuba (54) and the Province of Cienfuegos (20). 

Oropouche virus is primarily transmitted to humans through the bite of the midge, Culicoides paraensis, but the mosquito Culex quinquefasciatus can also transmit it.

The Pan-American Health Organization / World Health Organization urges Member States to intensify surveillance given its clinical presentation and considering the current situation of chikungunya, dengue, zika, and other common vector-borne diseases in the Region.

While there are approved vaccines to prevent chikungunya and dengue diseases, Oropouche and zika viruses do not have vaccines available in July 2024.

Jul 13, 2024 • 5:30 am CDT
by Mario Ohibsky

The board of directors of CSPC Pharmaceutical Group Limited announced on July 11, 2024, that the mRNA Respiratory Syncytial Virus (RSV) vaccine candidate (SYS6016) has obtained approval from the National Medical Products Administration of the People’s Republic of China to conduct human clinical trials in China.

Currently, there is no vaccine available in China that protects people from RSV infection.

In preclinical studies, SYS6016 translated into the prefusion conformation F-protein in vivo and induced high titers of long-lasting neutralizing antibodies.

CSPC wrote that this vaccine candidate exhibits good protection against RSV-A and RSV-B subtype viral strains and has a good safety profile.

CSPC confirmed it would endeavor to advance the clinical research and market SYS6016 as soon as possible to create value for society and shareholders.

As of July 13, 2024, three RSV vaccines and one monoclonal antibody for infants (Beyfortus) were approved for use in the United States.