Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Nov 29, 2022 • 7:12 am CST
U.S. TSA

As the Thanksgiving weekend of 2022 came to a close, the U.S. Transportation Security Administration (TSA) reported airport screening returned to about 95% of activity last seen in 2019.

Individuals planning to travel this holiday season should consider enrolling in TSA PreCheck®.

This TSA screening program allows travelers to keep their electronics and 3-1-1 bags in their carry-on bags.

Furthermore, for international travelers, the U.S. CDC has posted various travel advisories for countries requiring yellow fever vaccination, and some suggesting measles and polio vaccine boosters.

To receive a free travel vaccine newsletter from Vax-Before-Travel, visit this registration page.

Nov 29, 2022 • 4:54 am CST
by Ernesto Eslava

A recent study reported that previously declining cervical cancer incidence has plateaued. And a significant reduction in cervical cancer screening has also been identified, particularly among women aged 21 to 29.

For this age group, cervical cancer incidence has increased by about 2.5% per year since 2012.

Cervical cancer is mainly related to human papillomavirus (HPV), and innovative vaccine screening and access have made this cancer preventable.

Yet, it is estimated that over 14,000 new cases will be diagnosed this year, and more than 4,000 deaths will be attributed to cervical cancer.

Published on November 21, 2022, in the Journal of the American Medical Association, this study by researchers with MUSC Hollings Cancer Center in South Carolina stated, "In the era of the overall decline in cancer incidence, cancers caused by HPV are unfortunately rising."

"For the last two years, we have been trying to understand why the continuous decline in cervical cancer stopped in 2012 and why we have reached a critical turning point," commented Ashish Deshmukh, Ph.D., in a press release.

"Therefore, it is critically important to determine if the increase in cervical cancer incidence in young women is due to the decrease in screening rates or whether it is due to the introduction of more effective HPV testing in recent years."

Deshmukh said that the U.S. urgently needs national campaigns and innovative ways to improve cervical cancer screening uptake and vaccination adherence among women.

In the U.S., HPV vaccination for adolescents has been recommended for women since 2006 and men since 2011.

On October 1, 2022, a peer-reviewed study concluded that one dose of an HPV vaccine in young women might provide sufficient protection against persistent HPV infection. 

HPV vaccines are generally available at most clinics and pharmacies in the U.S.

Additional HPV vaccination information is posted at PrecisionVaccinations.com/HPV.

Note: Dr. Sonawane reported receiving personal fees from Value Analytics Labs outside the submitted work. No other disclosures were reported.

Nov 29, 2022 • 1:02 am CST
Bharat Biotech

Bharat Biotech Tweeted on November 28, 2022, that iNCOVACC became the world's first intranasal COVID-19 vaccine to receive both primary series and Heterologous booster approval in India. 

Previously, ANI Tweeted on November 25, 2022, the Drugs Controller General of India had approved Bharat Biotech's Intranasal 'Five Arms' booster dose of iNCOVACC.

iNCOVACC (ChAd-SARS-CoV-2-S ) is a recombinant replication-deficient adenovirus vectored vaccine with a prefusion stabilized spike protein.

iNCOVACC is formulated to allow intranasal delivery through nasal drops.

The intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T-cell responses. Immune responses at the site of infection (in the nasal mucosa) are essential for blocking both infection and transmission of the SARS-CoV-2 coronavirus. 

The nasal delivery system has been designed and developed in partnership with Washington University in St. Louis, Missouri. 

On September 28, 2022, Ocugen, Inc. announced it entered into an exclusive license agreement with Washington University for the rights to develop, manufacture, and commercialize its proprietary, intranasally delivered COVID-19 vaccine in the United States, Europe, and Japan.

On September 6, 2022, Dr. Mansukh Mandaviya tweeted the 'iNCOVACC nasal vaccine was approved for adults.

"We are proud to announce the approval of iNCOVACC, a global game changer in Intra Nasal vaccines technology and delivery systems," commented Dr. Mandaviya. 

Bharat Biotech's Covaxin™ whole virion, inactivated COVID-19 vaccine, has been widely deployed during the pandemic. It is based on the Asp614Gly variant that uses adjuvant Alhydroxiquim-II to boost immune response and longer-lasting immunity. 

Nov 28, 2022 • 3:57 pm CST
by Gerd Altmann

The U.S. CDC's recent Morbidity and Mortality Weekly Report (MMWR) confirmed that both U.S. FDA-approved measles vaccines are interchangeable for all indications for which measles-mumps-rubella (MMR) vaccination is recommended.

On November 18, 2022, the MMWR stated PRIORIX and M-M-R® II vaccines from different manufacturers would help safeguard the U.S. vaccine supply and mitigate mumps cases and outbreaks.

This is essential news since the CDC recently announced nearly 61 million measles vaccine doses were postponed or missed due to related delays in immunization campaigns in 18 countries. 

"The record number of children under-immunized and susceptible to measles shows the profound damage immunization systems have sustained during the COVID-19 pandemic," said CDC Director Dr. Rochelle P. Walensky in a press release on November 23, 2022.

"Measles outbreaks illustrate weaknesses in immunization programs, but public health officials can use outbreak response to identify communities at risk, understand causes of under-vaccination, and help deliver locally tailored solutions to ensure vaccinations are available to all."

The CDC posts the top ten global measles outbreaks this year, led by India, with 9,489 cases.

PRIORIX is formulated without preservatives and is administered as a subcutaneous injection, the same as M-M-R® II. A single dose after reconstitution is approximately 0.5 mL.

PRIORIX can be administered concomitantly, at different anatomic sites, with other routine childhood vaccines.

Concomitant administration of PRIORIX with other live and nonlive vaccines has been studied, with results indicating no safety concerns or evidence for interference in the immune response to either vaccine.

However, additional live virus vaccines not administered on the same day should be separated by ≥4 weeks.

Other MMR vaccine news is posted at PrecisionVaccinations.com/Measles.

Nov 28, 2022 • 2:49 pm CST
U.K. NHS

The United Kingdom (U.K.) government is expected to announce a Vaccine Taskforce approach today to tackle some of the leading public health issues which damage the economy and drain NHS resources.

Four healthcare missions are scheduled to launch covering obesity, cancer, mental health, and addiction to quickly develop and deliver new treatments, technology, and support to patients to help them lead longer, healthier lives.

Cutting-edge obesity treatments and technologies which can help people shed 20% of their weight could soon be offered to NHS patients.

The research will be focused outside London and the Greater South East, where obesity rates and health disparities are highest.

NHS Health and Social Care Secretary Steve Barclay commented in a press release on November 27, 2022, "Having a fit and healthy population is essential to reducing pressure on the NHS and supporting the economy with obesity, currently estimated to cost the NHS nearly £10 billion per year by 2050."

"We are fast-tracking the most promising treatments and technologies to NHS patients to help them achieve a healthy weight, save the NHS billions of pounds and increase life expectancy."

And, "We are determined to harness the full potential of innovative medical breakthroughs to level up the nation's health."

This innovative initiative builds upon the U.K. Life Sciences Vision published in July 2021, which sets out a 10-year strategy to harness the successes of the pandemic response and accelerate the delivery of innovation to patients.

In Scotland, the Government has also been working to tackle the obesity crisis, with previous research revealing that the average BMI has risen steadily over 23 years.

In 2018, the Scottish Government announced the release of its 'Healthier Future: Scotland's diet and healthy weight delivery plan' to attempt to combat the issue of obesity.

Nov 28, 2022 • 2:32 pm CST
by Chulmin Park

Early in 2022, scientists from the Institute for Molecular Medicine (IMM), their collaborators from the University of California, Irvine (UCI), and the National Institute on Aging (NIA) reported on the efficacy of four DNA vaccines based on the universal MultiTEP platform and targeting various regions of pathological α-Synuclein in a mouse model of Dementia Lewy Body (DLB) and Parkinson disease (PD).

The most effective nucleic acid vaccine, PV-1950D, generated antibodies specific to three regions of α-Synuclein simultaneously, reduced the aggregation of this pathological molecule, and improved motor deficits in the mouse model of disease.

In a new study published in the International Journal of Molecular Sciences, two co-first-author scientists from IMM, Karen Zagorsky, Ph.D., and Gor Chailyan, Ph.D., along with the team of collaborators from IMM, UCI, and the Laboratory of Neurogenetics, NIA, report on the development of the same vaccine in the form of the recombinant protein, PV-1950R, formulated in adjuvant.

Dr. Zagorski commented in a press release on November 28, 2022, "Dementia is one of the biggest problems affecting the health of the aging population."

"Currently, about 1.4 million people in the U.S. have been diagnosed with DLB, and PD affects an estimated one million individuals."

"Development of a safe and immunogenic preventive vaccine against these diseases is one of the goals of our team."

IMM is advancing the MuliTEP, a universal vaccine platform technology that supports the development of multiple vaccine designs based on DNA, RNA, or recombinant proteins.

Dr. Chailyan added, "IMM recently manufactured cGMP grade human Tau vaccine candidate, AV-1980R/A using funding from U01 AG060965 NIH program."

"Using the knowledge we gained, we will manufacture cGMP PV-1950R drug product and use it in IND-enabling safety/ toxicology studies before testing this preventive vaccine in people at risk of DLB."

Other Alzheimers disease vaccine candidate news is posted at PrecisionVaccinations.com/Alzheimers.

Nov 25, 2022 • 8:31 am CST
from Pixabay

Mumbai, India, recently reported 12 new confirmed measles cases, according to a Brihanmumbai Municipal Corporation (BMC) health department bulletin.

In addition, The Mint reported on November 23,  2022, the number of suspected measles cases rose to 3,378.

Around 21 locations and eight hospitals in Mumbai civic wards have reported measles patients during this outbreak.

Along with Mumbai, measles cases have been increasing across India. As a result, BMC has launched a measles vaccination drive for children to reduce the outbreak.

Around 90% of people who are not protected will become infected following exposure to the measles virus.

According to a U.S. Centers for Disease Control and Prevention report on November 23, 2022, India reported the highest number of measles cases (9,489) in the world in 2022.

The CDC focuses on countries with large measles outbreaks and countries with weak health systems, low immunization rates, or gaps in coverage that make it more likely for epidemics to spread, cross borders and possibly enter the U.S.

As of November 17, 2022, a total of 51 measles cases were reported by five U.S. jurisdictions.

Measles vaccines are generally available at clinics and pharmacies in the U.S.

Other measles outbreak news is posted at PrecisionVaccinations.com/Measles.

Nov 25, 2022 • 5:55 am CST
U.S. CDC

The World Health Organization recently announced three Sudan Ebolavirus (SUDV) vaccine candidates had been selected for testing in the Republic of Uganda.

As of November 25, 2022, no U.S. FDA-approved SUDV vaccines are available.

Three candidate vaccines are as follows:

A bivalent adenovirus vectored vaccine (biEBOV) which consists of the replication-deficient simian adenovirus vector ChAdOx1 encoding two antigens: EBOV glycoprotein (Zaire) and SUDV glycoprotein (Sudan) developed by the University of Oxford and the Jenner Institute UK.

A monovalent adenovirus vectored vaccine consists of the simian adenovirus vector ChAd3 encoding the SUDV glycoprotein (ChAd3-SUDV) and is produced by the Sabin Vaccine Institute USA.

A monovalent vaccine that consists of the vesicular stomatitis virus as the backbone with the VSV-G gene replaced with the Ebola-GP gene from the Sudan strain (VSV-SUDV) from the International Aids Vaccine Initiative.

These vaccines will begin human clinical trials in 2022.

Since the outbreak declaration on September 20, 2022, a total of 141 confirmed cases and 55 confirmed deaths (CFR 39%) from Ebola disease caused by the SUDV have been reported.

Overall, 19 cases with seven deaths occurred among healthcare workers.

To notify travelers of their potential health risks during this Ebola outbreak, the U.S. CDC reissued an Alert - Level 2, Practice Enhanced Precautions, on November 15, 2022.

Additional SUDV vaccine development news is posted at PrecisionVaccinations.com/Ebola.

Nov 24, 2022 • 11:01 am CST
by Melanie Tickell

Following the European Commission's approval, the U.K. Medicines and Healthcare products Regulatory Agency recently approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

As of November 24, 2022, Nirsevimab is the first and only single-dose RSV protective option for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

Nirsevimab is being developed jointly by Sanofi and AstraZeneca.

RSV is a common and highly contagious seasonal virus, infecting 90% of children by age two. It is also a leading cause of hospitalization in all infants.

The development of RSV vaccines began in the 1960s and has been identified as a priority for the World Health Organization Initiative for Vaccine Research.

The U.S. FDA is currently evaluating several RSV vaccine candidates but has not issued any approvals.

Nov 24, 2022 • 10:01 am CST
by Combonianos Brasil

The Lancet Infectious Disease previously reported the efficacy of the R21/Matrix-M malaria vaccine, reaching the World Health Organization (WHO) goal of 75% or greater efficacy over 12 months in the target African children.

In this early release report on December 1, 2022, researchers confirmed the safety, immunogenicity, and efficacy results at 12 months following the administration of a booster vaccination.

This double-blind phase 1/2b randomized controlled clinical trial was done in toddlers aged 5–17 months in Nanoro, Burkina Faso.

Eligible children were enrolled and randomly assigned (1:1:1) to receive three vaccinations of either 5 μg R21/25 μg Matrix-M, 5 μg R21/50 μg Matrix-M, or a control vaccine (the Rabivax-S rabies vaccine) before the malaria season, with a booster dose administered 12 months later. 

The study's results showed a booster dose of R21/Matrix-M at one year following the primary three-dose regimen maintained high efficacy against first and multiple episodes of clinical malaria. 

According to the U.S. CDC, malaria is a vaccine-preventable mosquito-borne disease.

R21 and the RTS,S/AS01 vaccine both have a similar immunogen that targets Plasmodium falciparum, the parasite that causes malaria in humans.

However, R21 is adjuvanted with Matrix-M to enhance the immune response.

Additional malaria vaccine information is posted at Vax-Before-Travel.com/Malaria.

Disclosures: This clinical trial was mainly funded by a European and Developing Countries Clinical Trials Partnership grant to the Multi-Stage Malaria Vaccine Consortium, with additional support from the Wellcome Trust through Translation Award, and from the U.K. National Institute for Health Research to the Oxford Biomedical Research Centre's Vaccines for Emerging and Endemic Diseases theme.

The vaccine manufacture and supply were supported and undertaken by the Serum Institute of India, and Novavax provided the Matrix-M adjuvant. And authors declare competing interests.

Nov 24, 2022 • 8:53 am CST
UCSB

Researchers at UC Santa Barbara recently discovered the ecology of the small mammals upon which ticks feed, helping explain the rates of human Lyme disease, at least in California.

As a result, scientists and health officials may be able to predict future disease risk by studying the response of these animals, and their tick parasites, to changing climate and land use.

"This study is unique because it tries to quantify the links connecting climate to mammals to ticks to humans, which requires different types of data, research techniques, and academic backgrounds," said co-author Sam Sambado, a doctoral student in the Department of Ecology, Evolution, and Marine Biology, in a UCSB press release on November 21, 2022.

Lyme disease is primarily caused by the bacterium Borrelia burgdorferi by tick bites.

However, the western blacklegged tick isn't born with the bacterium.

Instead, it can only contract the pathogen by feeding on an infected host, which serves as a reservoir for the microbe.

While no U.S. FDA-approved vaccine prevents Lyme disease infections, a candidate is making significant progress.

Lyme Disease vaccine candidate VLA15 is a multivalent recombinant protein vaccine targeting the outer surface protein A (OspA) of Borrelia, designed for prophylactic, active immunization against Lyme disease to protect people against most human pathogenic Borrelia species.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

Initially developed by Valneva SE, the VLA15 Lyme disease vaccine candidate confers protection by raising antibodies that prevent Borrelia from migrating from ticks to humans.

The VLA15 vaccine program was granted Fast Track designation by the FDA in July 2017.

And in April 2020, Valneva and Pfizer, Inc. announced a development and commercialization collaboration for VLA15.

As of November 2022, VLA15 remains the only active Lyme disease vaccine program in human clinical development.

This study's findings appeared in the journal Environmental Research Letters on November 9, 2022.

Nov 23, 2022 • 8:07 am CST
by Paul Brennan

Takeda announced yesterday that the U.S. Food and Drug Administration (FDA) had accepted and granted priority review for the tetravalent TAK-003 (QDENGA®) dengue vaccine candidate.

In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age.

Recovery from infection by one serotype provides lifelong immunity against only that serotype. Conversely, later exposure to any remaining serotypes is associated with an increased risk of severe disease.

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands, and American Samoa.

Incidence of locally-acquire dengue has increased in Florida during the summer of 2022. Aedes aegypti mosquitoes mainly spread dengue. 

As of November 23, 2022, the only U.S. FDA-approved dengue vaccine is Dengvaxia.

Currently, TAK-003 has not been approved by the FDA or any other health authority outside of Indonesia. Other dengue vaccine news is posted at PrecisionVaccinations.com/Dengue.

Nov 22, 2022 • 7:49 am CST
from Pixabay

VBI Vaccines Inc. today announced that additional biomarker data from the Phase 1/2a clinical study of VBI-1901, the Company's cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), were presented at the 27th Annual Meeting and Education Day of the Society for Neuro-Oncology.

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI's enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. 

In the limited study arms that assessed high-dose VBI-1901 adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), two partial tumor responses (PR) were observed in patients.

One patient with a PR remained on the treatment protocol for more than 28 months, reaching survival of at least 32 months as of November 1, 2022.

An additional five patients demonstrated stable disease for a sustained period of time.

All tumor responders (n=7) reached a minimum survival of 12 months

And the median overall survival (mOS) was 12.9 months, comparing favorably to 8-month mOS for monotherapy standard-of-care.

This new data from extensive biomarker panels suggest that normal baseline CD4+/CD8+ T cell ratios, along with boosting of CMV gB-specific antibody responses, were correlated with tumor and clinical responses.

"In an effort to better help address the significant unmet need for patients with recurrent GBM, a particularly devastating cancer, we continue to analyze comprehensive biomarker data from this Phase 1/2a study to identify potentially predictive correlates of response to treatment," said David E. Anderson, Ph.D., VBI's Chief Scientific Officer, in a press release on November 21, 2022.

"We were pleased to see that the previously identified CD4+/CD8+ T cell ratio, a measure of immunological fitness, was associated with tumor responses and encouraging overall survival benefit compared to historical controls."

"We plan to incorporate this learning into the enrollment eligibility criteria in the next stage of development to help enrich potential VBI-1901 responders."

"We look forward to initiating a randomized, controlled evaluation of VBI-1901 in the recurrent setting in early 2023."

Glioblastoma is the most common and aggressive malignant primary brain cancer in adults, says the U.S. NIH. The prognosis remains poor following standard-of-care treatment with surgery, radiotherapy, and chemotherapy.

Nov 22, 2022 • 4:51 am CST
by Herney Gómez

Blue Water Vaccines Inc. announced the signing of an exclusive, global license agreement to develop a live attenuated, oral Chlamydia vaccine candidate from The University of Texas Health San Antonio.

Developed in the laboratory of Guangming Zhong, Ph.D., at UT Health San Antonio, the novel, pre-human clinical trial vaccine candidate utilizes a live attenuated Chlamydia strain, Chlamydia muridarum.

As of November 22, 2022, no U.S. FDA-approved vaccine is available to prevent chlamydia infection.

“With millions of new and existing infections each year and no preventative treatment available, there remains a large unmet need for an efficacious Chlamydia vaccine both here in the U.S. and on a global scale,” said Joseph Hernandez, Chairman and Chief Executive Officer of Cincinnati-based Blue Water Vaccines, in a press release on November 21, 2022.

“We are thrilled to enter into this partnership with UT Health San Antonio and to pursue the development of this groundbreaking vaccine candidate.”

After oral delivery of the vaccine, C. muridarum was able to colonize in the gastrointestinal tract of mice and induce transmucosal protection against genital tract Chlamydia infection without altering the gut microbiota or the development of gut mucosal resident memory T cell responses to a non-chlamydial infection.

In addition, the vaccine was shown to be nonpathogenic in mice, indicating the potential to develop the live attenuated C. muridarum vaccine into a protective human Chlamydia vaccine.

According to the U.S. CDC, Chlamydia is the most frequently reported bacterial Sexually Transmitted Diseases Infections in the United States, with about 1.6 million new cases reported in 2020.

New cases of Chlamydia may be underrepresented, given many patients are asymptomatic.

And the primary treatment is through antibiotic regimens with the possibility of reinfection after antibiotics have treated the disease.

If undetected or left untreated, Chlamydia represents a significant cause of pelvic inflammatory disease and infertility in women.

Blue Water Vaccines Inc. is a biopharmaceutical company focused on developing transformational vaccines to address significant health challenges globally. 

Nov 21, 2022 • 2:00 pm CST
by David Mark

According to the Alaska Department of Fish and Game, another black bear died after contracting the highly pathogenic avian influenza (HAPI) in Bartlett Cove, Glacier Bay National Park and Preserve.

 This report is only the second HAPI diagnosed in a bear amid an ongoing 'bird-flu' outbreak in 2022.

"The (HAPI) passes really easily to poultry, but mammals aren't really susceptible to it," said Dr. Kimberlee Beckmen, wildlife veterinarian for the department, reported the Juneau Empire on November 18, 2022.

 "It's difficult to get, but we suspect the cub probably ate a bird that died from avian influenza."

The United States Department of Agriculture's Animal and Plant Health Inspection Service says the Eurasian H5N1 strain first appeared in North America in January 2022 and has affected 46 states and led to the loss of about 50 million birds.

In addition to birds and bears, raccoons, seals, foxes, and other mammals have been infected with HAPI.

The only human case in the U.S. in 2022 was reported in a man working around birds in Colorado.

While the annual flu shot does not protect people from HAPI, there are pandemic vaccines approved by the U.S. FDA.

Other avian influenza outbreak news is posted at this link.