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The novel Oral Polio Vaccine type 2 (nOPV2) became the first vaccine authorized under the World Health Organization (WHO) Emergency Use Listing in 2020.
Since then, the nOPV2 vaccine has been rolled out for limited use in countries to tackle vaccine-derived poliovirus, says the WHO.
To date, more than 50 million children in six countries: Benin, Congo, Liberia, Niger, Nigeria, and Sierra Leone have been vaccinated using nOPV2.
Furthermore, no major vaccine safety concerns have been identified.
By the end of 2021, another approximately 30 million children should be vaccinated with nOPV2
Ethiopia, Mauritania, Nigeria, The Gambia, Senegal, and Uganda will be implementing mass immunization campaigns using nOPV2.
In terms of future readiness, 23 countries; Benin, Burkina Faso, Central African Republic, Chad, Congo Republic, Cote d'Ivoire, Democratic Republic of Congo, Ethiopia, Guinea, Kenya, Liberia, Niger, Nigeria, Mali, Mauritania, Senegal, Sierra Leone, South Sudan, The Gambia, Togo, and Uganda have met the criteria for nOPV2 under the WHO's criteria.
And nine countries have already started work to meet these WHO requirements.
The two critical elements to conduct immunization campaigns that will effectively stop polio outbreaks are timely response and the implementation of high-quality campaigns, says the WHO.
Among the significant obstacles that countries experience in their efforts to eradicate polio are overwhelming public health challenges. Diseases such as the COVID-19, cholera, measles, yellow fever, and others deprioritize the polio outbreak response.
This means that more children are at risk of being paralyzed.
The weakened routine immunization in Africa has led to well-documented low vaccination coverage rates due to poor service delivery and few vaccination centers delivering inadequate vaccination strategies. As a result, too many children are being chronically missed in mobile populations and hard-to-reach areas.
Other factors include delayed response due to the difficulty accessing certain areas during vaccination campaigns due to insecurity and conflicts and the inability to sustain the gains made in the polio program. These can only be achieved by having countries integrate the polio functions into their broader public health system.
Timely and effective coordination across country borders for large-scale synchronized mass immunization campaigns is critical so that no child is missed.
New Jersey-based Provention Bio, Inc. announced on October 26, 2021, positive interim results from PROVENT, a first-in-human study of PRV-101, a polyvalent inactivated coxsackievirus B (CVB) vaccine candidate targeting all five key CVB strains associated with type 1 diabetes (T1D) autoimmunity.
Provention is developing PRV-101 to prevent acute CVB infection and the potential delay or prevention of T1D and celiac disease.
In this interim analysis, PRV-101 met the primary endpoint demonstrating that it was well tolerated in this study, with no treatment-emergent Serious Adverse Events, Adverse Events of Special Interest, or Adverse Events that led to study drug discontinuation or study withdrawal.
PRV-101 also met the secondary efficacy endpoint as it induced high titers of viral-neutralizing antibodies against all CVB serotypes included in the vaccine in a dose-dependent fashion.
"These interim results from this first-in-human trial are incredibly exciting," stated Francisco Leon, M.D., Ph.D., chief scientific officer and co-founder of Provention Bio, in a press release.
PRV-101, licensed from Vactech Oy (Tampere, Finland), is designed to prevent acute CVB infections and, in individuals at increased risk due to genetic susceptibility, to prevent CVB-triggered autoimmune damage to pancreatic beta cells that often progress to T1D and damage to intestinal cells that may lead to celiac disease.
"This is a very important milestone creating a solid basis for the continuation of the development program. Furthermore, we are delighted to see that the PRV-101 vaccine induced high neutralizing antibody titers against CVBs since these antibodies mediate protection against CVBs," added Heikki Hyoty, Ph.D. professor of virology Tampere University, Finland, and scientific co-founder of Vactech Oy.
"The causal link between CVB infection in childhood and the onset of T1D is compelling", commented Jeffrey Almond, Ph.D., visiting professor of microbiology, University of Oxford and former global head of research at Sanofi Pasteur.
"Provention Bio has taken the lead by producing a CVB vaccine that is already showing very good results in a Phase 1 study. I look forward to seeing the rapid further development of this vaccine and its use to reduce the burden of T1D in children."
PROVENT is a Phase 1 placebo-controlled, double-blind, randomized first-in-human study conducted at the Clinical Research Services Turku - CRST Oy, a clinical trial unit in Turku, Finland.
The Company has posted an update to its corporate slide presentation containing additional details about the information commented on within this press release. The presentation can be found at www.proventionbio.com in the Investor's section.
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company located in Red Bank, NJ, focused on advancing the development of investigational therapies that may intercept and prevent debilitating and life-threatening immune-mediated disease.
New York-based Pfizer Inc. today announced that the U.S. government had purchased 50 million more doses of the companies' mRNA COVID-19 vaccine, with an expected delivery date of April 30, 2022.
The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations.
This new order of vaccines (Comirnaty) includes securing vaccines for children under five years of age, should they receive regulatory authorization.
"We are extremely proud to provide enough doses of our vaccine to help protect every U.S. child under 12 from COVID-19 if authorized by the FDA," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, in a press release issued on October 28, 2021.
"As we await the agency's review of our application for emergency use of the vaccine in children 5 to under 12 years of age, and clinical trial results in children under 5, we are working with the U.S. government to help ensure communities across the country have access to pediatric doses as soon as possible."
"The introduction of doses for young children will be another critical milestone in addressing this public health crisis."
Pfizer and its Germany-based partner BioNTech SE submitted a request to the U.S. FDA earlier this month for Emergency Use Authorization of their COVID-19 vaccine in children 5 to <12 years of age. The dosage strength for this age group (10 µg) differs from the dosage strength for individuals 12 years and older (30 µg).
In addition, data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to <5 years of age - and those six months to <2 years of age – are expected as soon as fourth-quarter 2021 or early first quarter 2022.
To date, Pfizer and BioNTech have shipped more than 1.8 billion COVID-19 vaccine doses to 149 countries and territories.
In 2022, the companies expect to manufacture 4 billion doses of the Pfizer-BioNTech COVID-19 Vaccine worldwide, including pediatric doses.
According to Pfizer, certain people are eligible to receive four doses.
The Primary Series is a 2-dose series, three weeks apart. A third dose may be administered at least four weeks after the second dose to individuals who are determined to have certain kinds of immunocompromised. Additionally, a fourth booster dose of the Comirnaty vaccine may be administered at least six months after completion of a primary series to individuals.
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 primary vaccination series or a booster dose.
Pfizer says 'data on the administration of this vaccine simultaneously as other vaccines has not yet been submitted to the FDA. Therefore, individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.
And patients should always ask their healthcare providers for medical advice about vaccine adverse events.
The Centre for Health Protection (CHP) of the Department of Health confirmed on October 27, 2021, it is closely monitoring a human case of avian influenza A(H5N6) in Mainland China, and again urged the public to maintain strict personal, food, and environmental hygiene both locally and during travel.
All novel influenza A infections, including H5N6, are notifiable infectious diseases in Hong Kong," a spokesman for the CHP said.
The new case involves a 66-year-old man living in Yongzhou in Hunan Province. He is a farmer and had contact with live domestic poultry. He developed symptoms on September 25, 2021, and was admitted for treatment. He remains in critical condition.
From 2014 to date, 49 human cases, including 25 deaths from avian influenza A(H5N6), have been reported by health authorities.
Furthermore, in February 2021, the Russian Federation notified the WHO of avian influenza A(H5N8) in seven human clinical specimens. These are the first reported cases of avian influenza A(H5N8) in humans.
Avian influenza affected areas and global statistics of avian influenza A cases are available at this link as of October 27, 2021.
Avian influenza (Bird Flu) is a disease caused by influenza type A viruses in animals. Three subtypes of avian influenza A viruses infect people (H5, H7, and H9 viruses).
Among these, Asian lineage H5N1 and H7N9 have caused the majority of infections in people.
These viruses occur naturally among birds and domestic poultry. Whenever avian influenza viruses are circulating, there is a risk for sporadic infection and small clusters of human cases due to exposure to infected poultry or contaminated environments, says the U.S. CDC.
For example, the World Organization for Animal Health reported on October 21, 2021, Germany confirmed an H5N1 outbreak at a goose farm in Schleswig-Holstein state and two episodes involving waterfowl, one in Lower Saxony state and the other in Bavaria state.
Since Avian influenza is different than the seasonal flu, common influenza vaccines are not protective against these viruses.
However, the U.S. FDA licensed the first vaccine in the U.S. to prevent H5N1 influenza, commonly referred to as avian influenza or bird flu, on April 17, 2007.
This inactivated influenza virus vaccine is for use in people 18 through 64 years of age who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine. This vaccine is derived from the A/Vietnam/1203/2004 influenza virus.
The vaccine is manufactured by Sanofi Pasteur Inc. and purchased by the federal government for inclusion within the Nation's National Stockpile.
This vaccine could be used if the H5N1 avian influenza virus develops the capability to spread efficiently from person to person, resulting in the rapid spread of disease across the globe, says the CDC.
Switzerland-based RELIEF THERAPEUTICS Holding SA today announced that its wholly-owned subsidiary, APR Applied Pharma Research SA reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 virus-infected patients.
Relief also reported that data from the study suggest that Sentinox's safety and tolerability could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.
The post-market, confirmatory, interventional, randomized, placebo-controlled clinical study is expected to enroll 57 patients.
The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21).
By contrast, one out of 10 patients in the control group was still positive by Day 21.
All subjects using Sentinox three times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period.
At visits 4, 5, and 6, a trend in favor of the three times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs. 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs. 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs. 40% at V6).
For this study, subjects were considered negative when their COVID-19 test became negative and remained negative throughout the study period.
Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa and lead investigator, commented in a press release, "The interim analysis results are encouraging."
"Indeed, the preliminary efficacy data suggest that using Sentinox, in addition to standard of care, could accelerate the time to a negative SARS-CoV-2 test result, thereby allowing patients to resume their normal daily activities sooner."
"By lowering the viral load in the nasal mucosa, the use of Sentinox could help reduce the transmissibility of the virus and, consequentially, its spread."
"Moreover, it is possible that, by including a larger number of patients and clinical parameters, Sentinox will prove to be a helpful tool for improving clinical outcomes in patients with mild COVID-19 in addition to standard of care."
"In general, we expect that the positive data obtained so far will be confirmed by the end of the study."
Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021, as Class III Medical Device. The device is intended for irrigation, cleansing, and moistening nasal cavities.
Relief's lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. to treat respiratory deficiency due to COVID-19.
The US Department of State issued a high-level travel advisory for the Republic of Columbia on October 26, 2021. The State Department suggests 'Reconsider traveling to Colombia due to COVID-19.'
And, if visiting Columbia, 'exercise increased caution as Colombia is experiencing continuing demonstrations, unrest, and disruptions throughout the country.'
Moreover, nationwide events can cause the shutdown of local roads and major highways, often without prior notice or estimated reopening timelines. Road closures may significantly reduce access to public transportation and airports and disrupt travel within and between cities.
Several cities have seen vandalism, looting, and destruction. In addition, demonstrations have resulted in fatalities and injuries across the country.
Specifically, this Level 3 Travel Advisory says 'Do Not Travel to: Arauca, Cauca (except Popayán), Chocó (except Nuquí), Nariño, and Norte de Santander (except Cúcuta) departments due to crime and terrorism.
If you decide to travel to Colombia, the State Department says:
- Avoid protest areas and crowds, and be aware of your surroundings.
- Monitor local media for breaking events and adjust your plans based on new information.
- Enroll in the Smart Traveler Enrollment Program to receive Alerts and make it easier to locate you in an emergency.
The US Embassy Bogota is located at Calle 24 Bis No. 48-50, Bogotá, D.C. Colombia. The email address for American Citizen Services inquiries: ACSBogota@state.gov.
The non-profit Institute for Molecular Medicine (IMM) confirmed on October 18, 2021, it has licensed its universal vaccine platform technology — called MultiTEP — to Nuravax, a biotech developing therapies for Alzheimer's disease and other disorders of the central nervous system.
MultiTEP is a vaccine platform that can generate very high levels of antibodies against toxic proteins that clump together in the brains of older people, driving neurodegenerative diseases.
In the case of Alzheimer's, the vaccines are targeted against toxic clumps of amyloid-beta and tau proteins, the two hallmarks of the disease.
According to IMM, the MultiTEP platform combines a dozen antigen fragments (epitopes) used in previously established vaccines.
An antigen is a molecule or a molecular structure that can bind to cells of the immune system and trigger an immune response. An epitope is the part of an antigen that is recognized by the immune system.
Together the epitopes induce a potent immune response and boost the production of high antibody titers by activating critical cells of the immune system, namely T helper cells.
"T helper cells are part of the immune system and are crucial to stimulating the production of antibodies by B cells," stated VP of IMM, Dr. Michael Agadjanyan, in a press release issued in September 2021.
He added, "The AD and PD vaccines in development based on our MultiTEP platform contain 12 protein segments (epitopes) from vaccines that have been administered to the general population during their lifespans."
"When linked together, these epitopes strongly activate both naïve and memory T helper cells."
"By leveraging existing memory T cells, we have seen that MultiTEP can elicit a high and quick production of antibodies that could block the accumulation of pathological amyloid-beta and tau in the brains of vaccinated people at risk of AD and at least delay the disease onset."
The Institute for Molecular Medicine is a non-profit organization created with the goal of understanding, preventing, and curing chronic human diseases such as Alzheimer's disease, Parkinson's disease, cancer, fatigue illness, autoimmune diseases, infectious and genetic diseases through innovative basic and translational molecular research programs.
California-based Anixa Biosciences, Inc. announced on October 26, 2021, that, in conjunction with its partner, Cleveland Clinic, it has commenced dosing of patients for a novel study of its vaccine that is being investigated for preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.
Anixa has a worldwide, exclusive license to the vaccine technology originating from Cleveland Clinic.
Funded by the U.S. Department of Defense, the new study is a multiple ascending dose Phase 1 trial to determine the maximum tolerated dose of the vaccine in patients with early-stage, triple-negative breast cancer and monitor immune response.
The study will be conducted at Cleveland Clinic. It will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
During the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed in the third quarter of 2022.
Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated in a press release, "Our vaccine has the potential to prevent the development of the most aggressive form of breast cancer – triple-negative breast cancer."
Despite representing only about 12-15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths and has a higher recurrence rate.
Furthermore, this form of breast cancer is twice as likely to occur in African-American women.
And approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
Anixa's investigational vaccine takes advantage of endogenously produced proteins that function at certain times in life but become "retired" and disappear from the body.
The US Centers for Disease Control and Prevention (CDC) published updated terminology for COVID-19 vaccine dosing schedules on October 25, 2021.
These new CDC terms are as follows:
- Primary series: 2-dose series of an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna) or a single dose of Janssen vaccine
- Additional dose after an initial primary series: a subsequent dose of vaccine administered to people who likely did not mount a protective immune response after primary vaccination in order to optimize vaccine-induced protection. An additional mRNA COVID-19 vaccine dose is recommended for moderately to severely immunocompromised people who received an mRNA vaccine primary series.
- Booster dose: a subsequent dose of vaccine administered to people with protection from primary vaccination is likely to have waned over time.
- Homologous booster dose: a subsequent dose of vaccine that is the same product as the primary series
- Heterologous booster dose (mix-and-match booster): a subsequent dose of vaccine that is a different product than the primary series
The CDC stated these terms could be updated when additional information becomes available or if different vaccine products are approved or authorized.
