Vaccine Breaking News

Vaccine breaking news brought to you by Precision Vaccinations.

Dec 2, 2022 • 8:30 am CST
by David Mark

The city of Columba, Ohio, recently reported the measles outbreak in central Ohio had expanded into several counties. Columbus Public Health indicated the outbreak now spans across Franklin and Ross counties.

Beginning on June 16, 2022, and as of December 1, 2022, there have been 46 measles cases in unvaccinated people and 19 related hospitalizations.

Previously, Ohio’s last confirmed measles outbreak was in 2014, with 382 confirmed cases.

The good news is measles is a vaccine-preventable disease.

Unfortunately, the U.S. CDC reported on November 27, 2022, that in 2021, only 81% of children received their first dose of a measles-containing vaccine (MCV), leaving 25 million children vulnerable to measles.

This is the lowest MCV coverage reported since 2008.

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

People can spread measles up to 4 days before and four days after they have a rash. Measles infections can lead to severe complications, such as pneumonia, and can be fatal.

The CDC confirmed that on December 1, 2022, measles is an ongoing worldwide risk. 

Measles can enter the U.S. through infected travelers entering or traveling through the U.S. and infected U.S. travelers returning from other countries.

Measles vaccines, such as Priori and MMR-II, are generally available at most clinics and pharmacies in the U.S.

Other measles outbreak news is posted at Vax-Before-Travel.

Dec 2, 2022 • 5:37 am CST
U.S. CDC

The U.S. Centers for Disease Control and Prevention (CDC) latest report indicates a slowing consumer demand for Mpox vaccinations.

As of November 29, 2022, the CDC data indicates that both the first and second doses of the two-dose Bavarian Nordic JYNNEOS® vaccine are no longer in excessive demand.

Since May 2022, 1,118,639 JYNNEOS vaccine doses have been administered in 57 U.S. Jurisdictions reporting data to the CDC.

Conversely, Mpox vaccinations in Africa are just beginning.

The government of the Republic of Korea announced on November 29, 2022, that it would donate the first batch of the Mpox vaccine to Africa through the Africa Centres for Disease Control and Prevention.

Africa has yet to receive vaccines to stem the spread of Mpox, which remains a serious public health threat in countries where the virus is endemic.

Dec 2, 2022 • 5:16 am CST
by Alexa P.

The Centre for Health Protection (CHP) of the Department of Health is closely monitoring a human case of avian influenza A(H5N1) in the Mainland.

The case involves a 38-year-old woman living in Qinzhou, Guangxi, who had exposure to live domestic poultry before onset. She developed symptoms on September 22 and was admitted for treatment on September 25.

Unfortunately, she passed away on October 18, 2022.

From 2005 to date, 54 human cases of avian influenza A(H5N1) have been reported by Mainland health authorities.

On November 30, 2022, the CHP urged the public to maintain strict personal, food, and environmental hygiene locally and during travel.

"All novel influenza A infections, including H5N1, are notifiable infectious diseases in Hong Kong," a spokesman for the CHP stated in a related press release.

Avian influenza is caused by those influenza viruses that mainly affect birds and poultry, such as chickens or ducks.

Clinical presentation of avian influenza in humans may range from flu-like symptoms to severe respiratory illness.

The public may visit the CHP's pages for more information: the avian influenza page, global statistics, and affected areas of avian influenza.

The U.S. CDC confirms the annual flu shot does not offer protection against avian or swine influenza.

Additional avian influenza outbreak and vaccine information is posted at PrecisionVaccinations.com/Avian.

Dec 2, 2022 • 4:59 am CST
by Tatiana P.

BioVaxys Technology Corp. announced the successful sterile and bacteria-free test-run production of BVX-0918, a bi-haptenized autologous ovarian cancer vaccine.

The process of haptenization teaches a patient's immune system to recognize and make target proteins more 'visible' as foreign, thereby stimulating a more intense immune response.

Single haptenization only modifies hydrophilic amino acids on antigenic proteins, but utilizing two different haptens modifies both hydrophilic and hydrophobic amino acids on these target proteins, making the protein more foreign to the immune system with modification of additional amino acids. 

The complete manufacturing of BVX-0918 from a cancer patient's ovarian tumor now validates the production protocols that had been in development over the past few months for the successful extraction of tumor cells, the cryo-packaging and cryo-preservation of tumor cells, identification of ovarian cancer cells as the components of the vaccine using specially developed monoclonal antibodies and flow cytometry, sterility processes, and development of the process for double haptenization of the ovarian tumor cells used in the vaccine. 

The production protocols have reduced the time needed to haptenize the tumor cells by 50%, having established a semi-automatic technique for mechanically extracting tumor cells from a tumor mass, resulting in a time savings for GMP manufacturing.

BioVaxys President and Chief Operating Officer Kenneth Kovan stated in a press release on December 1, 2022, "BioVaxys has successfully met a major manufacturing milestone by establishing the process to take surgically excise ovarian cancer cells from a cancer patient, conjugate two haptens, and manufacture a sterile and bacteria-free complete vaccine."

"The next steps now involve GMP product characterization and applying analytical methods to validate that each step of BVX-0918 production is under GMP conditions to the satisfaction of EU regulatory authorities."

"We have completed the clinical study protocol."

"Our EU clinical development and marketing partner, Procare Health Iberia, has selected a CRO and has already begun meeting with prospective Spanish Phase I study investigators."

The CTA is the European equivalent of the U.S. FDA's Investigational New Drug application, which is filed to seek approval for a clinical study.

Based in Vancouver, BioVaxys Technology is a clinical-stage biotechnology company developing viral and oncology vaccine platforms and immuno-diagnostics.

Dec 2, 2022 • 4:20 am CST
GW Public Health

A research team led by George Washington University has developed two mRNA vaccine candidates that are highly effective in reducing malaria infection and transmission.

The team also found that the two experimental vaccines induced a powerful immune response regardless of whether they were given individually or in combination.

“Malaria elimination will not happen overnight, but such vaccines could potentially banish malaria from many parts of the world,” Nirbhay Kumar, a professor of global health at the George Washington University Milken Institute School of Public Health, commented in a press release on December 1, 2022.

Kumar and the research team focused on the parasite Plasmodium falciparum, one of four parasite species that cause malaria and the deadliest to humans.

Transmitted through the bite of the Anopheles mosquito, P. falciparum, together with P. vivax, are responsible for more than 90% of all malaria cases globally and 95% of all malaria-related fatalities.

The researchers immunized one group of mice with an mRNA vaccine targeting a protein that helps the parasites move through the body and invade the liver.

They immunized another group of mice with a vaccine targeting a protein that helps parasites reproduce in a mosquito’s midgut. The immunized mice were challenged with the parasite-causing infection, and vaccine-induced antibodies were tested to interrupt malaria transmission.

The study found both vaccines induced a potent immune response in the mice and were highly effective in reducing infection in the host and the mosquito vector. 

The presence of protective antibodies during the transmission of parasites to healthy mosquitoes dramatically reduced the parasite load in the mosquitoes,  an essential step in disrupting malaria transmission, according to the researchers.

The team also immunized mice with both vaccines and found that co-immunization effectively reduced infection and transmission without compromising the immune response.

To see how the mRNA vaccines stacked up against other nucleic acid-based vaccine platforms, Kumar and the team repeated the experiment using DNA plasmids.

The mRNA vaccines were found to be far superior in inducing an immune response compared to the DNA-based vaccines.

The team hopes to usher the vaccines through additional research, including studies in nonhuman primate models, to produce vaccines that can be used safely in humans.

“To have a vaccine cocktail that can effectively disrupt multiple parts of the malaria parasite’s life cycle is one of the holy grails of malaria vaccine development,” Kumar said.

“This study brings us one step closer to producing vaccines that can be used safely in humans to prevent illness and save lives–with the ultimate goal of defeating this disease.”

The U.S. NIH supported the study. The team, which has filed for a patent, developed the vaccines in partnership with scientists from the University of Pennsylvania and other collaborators.

The study was published in npj Vaccines.

As of December 1, 2022, the U.S. FDA had not approved a malaria vaccine. However, the FDA did approve Artesunate to treat severe malaria in adult and pediatric patients in May 2020.

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

Dec 1, 2022 • 9:41 am CST
From Pixabay

The U.S. Food and Drug Administration (FDA) recently announced that Eli Lilly's monoclonal antibody Bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

Bebtelovimab is an investigational medicine used to treat mild-to-moderate COVID-19 in adults and certain children.

Eli Lilly and its authorized distributors (AmerisourceBergen) have paused the commercial distribution of Bebtelovimab until further notice by the FDA.

Additionally, the Administration for Strategic Preparedness and Response has paused fulfilling any pending requests under its Bebtelovimab Product Replacement Initiative. 

The FDA stated on November 30, 2022, healthcare providers should use other approved or authorized products that are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, which include Paxlovid, Veklury, and Lagevrio.

In addition, COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized to treat COVID-19 in patients with an immunosuppressive disease or receiving immunosuppressive treatments.

Other SARS-CoV-2 monoclonal antibody news is posted at PrecisionVaccinations.com/Antibodies.

Nov 30, 2022 • 2:57 pm CST
USDA

The United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) website stated today stated this year's Highly Pathogenic Avian Influenza (HAPI) outbreak has affected 46 states and led to the loss of over 52 million birds, surpassing the 2015 outbreak.

As of November 30, 2022, the USDA stated the Eurasian H5N1 strain first appeared in North America in January 2022 and has impacted various birds, bears, foxes, and water mammals this year. 

The HAPI outbreak has reached most areas in North America, South America, and the United Kindom.

Avian-origin influenza viruses are broadly categorized based on a combination of two groups of proteins on the surface of the influenza A virus: hemagglutinin or "H" proteins, of which there are 16 (H1-H16), and neuraminidase or "N" proteins, of which there are 9 (N1-N9).

Avian influenza viruses are classified as either "low pathogenic" or "highly pathogenic" based on their genetic features and the severity of the disease they cause in poultry.

Most viruses are of low pathogenicity, meaning they cause no signs or only minor clinical signs of infection in poultry.

Fortunately, only one human avian influenza case was confirmed in the U.S. this year.

From 2005 to date, 54 human cases of avian influenza A(H5N1) have been reported by China's Mainland health authorities.

The U.S. government has approved a vaccine for one type of avian influenza vaccine and could distribute Audenz™ if a person-to-person outbreak occurs.

The annual flu shots do not protect people against avian / pandemic influenza.

Additional avian influenza vaccine information is posted at PrecisionVaccinations.

Nov 30, 2022 • 9:03 am CST
by Tumisu P.

Novavax, Inc. recently announced that the World Health Organization (WHO) had issued an updated Emergency Use Listing (EUL) for the protein-based Nuvaxovid™ COVID-19 vaccine for active immunization to prevent COVID-19 caused by the SARS-CoV-2 as a primary series of two doses in adolescents aged 12 through 17 and as a booster in adults aged 18 and older.

"Today's updated EUL from the WHO allows us to offer our protein-based vaccine as a primary series to adolescents and as a booster for adults around the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release on November 29, 2022.

"WHO member countries now have a vaccine option for these indications developed using an innovative approach to traditional technology that can also be stored in standard refrigeration, making it easy to transport."

The WHO previously granted EUL for Nuvaxovid in adults aged 18 and older in December 2021.

In the 12 through the 17-year-old population, Novavax' vaccine has been authorized in more than ten markets, including the U.S., the European Union, and the U.K.

The vaccine has also been authorized as a booster in the U.S., EU, Japan, Australia, New Zealand, and Switzerland, and several other countries have policy recommendations allowing the use of the vaccine as a heterologous or homologous booster dose.

And Novavax' vaccine is actively under review in other markets for both indications and has ongoing trials further to explore its efficacy and safety as a booster.

The U.S. FDA has not yet approved the trade name Nuvaxovid™.

Nov 30, 2022 • 8:03 am CST
by Margit Winkler

AC Immune SA today announced that based on the Phase 1b/2a interim data, ACI-35.030, a potential first-in-class anti-phosphorylated-Tau (pTau) vaccine candidate, has been selected for further development.

The selection of ACI-35.030 is supported by new clinical data from the Phase 1b/2a trial presented at the Clinical Trials on Alzheimer's Disease (CTAD) Conference 2022.

The results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, ePHF.

The ACI-35.030-induced antibody response was sustained and could be periodically boosted over 72 weeks.

And the vaccine candidate was generally well tolerated.

The decision to select ACI-35.030 follows the comparison presented at CTAD, demonstrating its strengths relative to a protein conjugate vaccine, JACI-35.054, an alternative anti-pTau vaccine also being evaluated in parallel in the Phase 1b/2 trial.

Dr. Andrea Pfeifer, CEO of AC Immune SA, commented in a press release on November 30, 2022, "The selection of ACI-35.030 for further development is a significant step for this collaboration."

"Early clinical testing showed that ACI-35.030 was generally well tolerated and induced specific activity against the pathological species of Tau, including the neurotoxic pTau and enriched paired helical filaments (ePHF) species, both of which are closely implicated in Alzheimer's disease (AD)."

"The excellent performance of ACI-35.030 in the trial participants (average age approximately 65 years) potentially opens promising avenues for AD treatment and prevention, which could offer an important societal impact."

The ACI-35.030 anti-pTau vaccine candidate is being developed in collaboration with Janssen Pharmaceuticals, Inc.

Other Alzheimer's disease vaccine and antibody candidates are posted at PrecisionVaccinations.com/Alzheimers.

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 suggest measles, hepatitis, 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.