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The Illinois Department of Public Health (IDPH) reporting on September 28, 2021, the first human case of rabies and related death in Illinois since 1954.
The IDPH says a Lake County resident in his 80s awoke to a bat on his neck in early August 2021. Subsuquentially, the bat was captured and tested positive for rabies. Wildlife experts did find a bat colony in the home of the individual.
The individual was advised he needed to start postexposure rabies treatment but declined.
One month later, the individual began experiencing symptoms consistent with rabies, including neck pain, headache, difficulty controlling his arms, finger numbness, and difficulty speaking.
People who had contact with secretions from the individual were assessed and given rabies preventive treatment as needed.
The rabies virus infects the central nervous system, ultimately causing disease in the brain and death. Without preventive treatment, rabies is typically fatal.
“Rabies has the highest mortality rate of any disease,” stated IDPH Director Dr. Ngozi Ezike in a press statement.
“However, there is a life-saving treatment for individuals who quickly seek care after being exposed to an animal with rabies. If you think you may have been exposed to rabies, immediately seek medical attention and follow the recommendations of health care providers and public health officials.”
While cases of human rabies in the United States are rare, rabies exposures are still common. At an international level, about 60,000 people die every year from this disease, mainly in Asia and Africa, reports the WHO.
The U.S. CDC estimates 60,000 Americans receive post-exposure vaccination series each year.
Bats are the most commonly identified species with rabies in Illinois and the USA. Globally, dogs are most often infected with rabies.
However, Oneida County Health Department in New York reported a cat tested positive for rabies in the Town of Marcy on September 10, 2021. Two people were exposed to the cat and received post-exposure prophylaxis. Two dogs were also exposed to the cat.
Rabies vaccines are used worldwide to prevent rabies before and for some time after exposure to the rabies virus, says the U.S. CDC.
There are several rabies vaccines available that are both safe and effective. An updated listing is available at this link.
ANI in Mumbai reported on September 29, 2021, MSD Pharmaceuticals announced the launch of the Gardasil 9 Human Papillomavirus (HPV) vaccine to help reduce the HPV-related cancer burden in India.
Gardasil 9 is a 9-valent HPV vaccine that reduces cancers caused by the HPV types contained in the vaccine among girls and women aged 9-26 years and boys aged between 9-15 years.
Additionally, Gardasil 9 helps reduce cervical cancer, vulvar cancer, vaginal cancer, and anal cancer among females.
The vaccine is also recommended to be given to boys to prevent genital warts, anal intraepithelial neoplasia, anal cancer, and precancerous or dysplastic lesions.
The Managing Director of MSD-India region, Rehan A Khan, added in a press statement, "Launching GARDASIL 9 is a crucial step towards advancing the mission of building a healthy young India by reducing the disease burden of HPV-related cancers and disease in the country."
"HPV does not discriminate between males and females. Therefore, vaccinating both boys and girls is a common practice, and today nearly 25 countries recommend 'Gender Neutral Vaccine' programs for protecting both genders against infectious diseases."
First launched in the USA in 2015, Gardasil 9 has been approved in more than 80 countries worldwide. The Gardasil 4-valent vaccine has been approved in India since 2008.
Merck Sharp & Dohme Corp., a Merck & Co., Inc. subsidiary, produces the Gardasil 9 vaccine.
New York-based Regeneron Pharmaceuticals, Inc. announced on September 28, 2021, the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The target action date for the FDA decision is January 30, 2022.
The sBLA is also being reviewed under the FDA's Project Orbis initiative, which will allow for concurrent review by participating health authorities in Australia, Brazil, Canada, and Switzerland. Additional global regulatory submissions are planned, including in the European Union, by the end of 2021.
The use of Libtayo in advanced cervical cancer is investigational, and its safety and efficacy have not been thoroughly evaluated by any regulatory authority.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology. Libtayo is a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.
Regeneron and Sanofi jointly develop it under a global collaboration agreement.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
New Jersey-based Seqirus today announced data supporting the effectiveness of both cell-based and adjuvanted seasonal influenza vaccines from two real-world studies conducted during the 2019-2020 influenza season in the U.S.
The data highlight the effectiveness of cell-based quadrivalent influenza vaccine (QIVc) compared to that of standard-dose egg-based quadrivalent influenza vaccine (QIVe-SD) in preventing hospitalizations and emergency room (ER) visits in the general population (aged 4-64).
For the study, 1,150,134 patients aged 4-64 who received QIVc and 3,924,819 who received QIVe-SD were identified using administrative claims data. Adjusted results show that QIVc was associated with higher relative vaccine effectiveness (rVE) compared to QIVe-SD against influenza-related hospitalizations/ER visits (5.3 percent) and any respiratory hospitalizations/ER visits (8.2 percent).
In an assessment of the high influenza activity period (HIAP), results show that QIVc was associated with a higher rVE compared to QIVe-SD for influenza-related hospitalizations/ER visits (5.7 percent) and any respiratory hospitalizations/ER visits (7.3 percent).
And QIVc effectiveness was higher in a sub-analysis of individuals at higher risk for influenza complications.
A separate poster presentation highlighted findings from a retrospective cohort analysis evaluating rVE of adjuvanted trivalent influenza vaccine (aTIV) compared to non-adjuvanted high-dose trivalent influenza vaccines (HD) in older adults during the 2019/20 influenza season. An adjuvant can help boost a weakened immune system in those 65 and older.
This study found aTIV was statistically comparable to TIV-HD in preventing influenza-related hospitalizations/ER visits and all-cause hospitalizations. Comparable outcomes were also found in the reduction of any hospitalization/ER visits for CRD.
Since the influenza virus is incredibly variant and can change often, real-world evidence (RWE) has become increasingly important in providing an inclusive look at vaccine safety and effectiveness, says Seqirus.
RWE allows for an annual assessment of influenza vaccine effectiveness and provides an ever-growing data set to evaluate real-world outcomes that reflect large, diverse populations of patients and healthcare settings.
Seqirus is part of CSL Limited, one of the largest influenza vaccine providers in the world. With state-of-the-art production facilities in the U.S., the U.K., and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell, and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries worldwide.
Note: The WHO reported on September 27, 2021, Influenza Update N° 403 based on data up to September 12, 2021. Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year. Worldwide, influenza A and B viruses were detected in similar proportions.
The World Health Organization (WHO) and partners launched the first-ever global strategy to defeat meningitis on September 28, 2021. By 2030, the goals are to eliminate epidemics of bacterial meningitis – the most deadly form of the disease – and reduce deaths by 70% and halve the number of cases.
This strategy, the Global Roadmap to Defeat Meningitis by 2030, was launched by a broad coalition of partners involved in meningitis prevention and control at a virtual event hosted by WHO in Geneva.
Meningitis is a dangerous inflammation of the membranes surrounding the brain and spinal cord, predominantly caused by infection with bacteria and viruses.
Meningitis that is caused by bacterial infection tends to be the most serious – leading to around 250,000 deaths a year - and can cause fast-spreading epidemics.
It kills 1 in 10 of those infected – primarily children and young people - and leaves about 25% with long-lasting disabilities.
Over the last ten years, meningitis epidemics have occurred in all world regions, though most commonly in the ‘Meningitis Belt,’ which spans 26 countries across Sub-Saharan Africa.
Several vaccines protect against meningitis, including meningococcal, Haemophilus influenzae type b, and pneumococcal vaccines.
However, not all communities have access to these lifesaving vaccines, and many countries are yet to introduce them into their national programs.
While research is underway to develop vaccines for other causes of meningitis, such as Group B Strep bacteria, there remains an urgent need for innovation, funding, and research to develop more meningitis-preventive vaccines.
The Roadmap results from the resolution on meningitis, passed by the World Health Assembly and endorsed unanimously by WHO member states in 2020.
California-based Nonagen Bioscience Corp today announced Oncuria™, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation.
This FDA designation is granted to technologies that have the potential to provide more effective treatment, diagnosis, or prognosis of life-threatening diseases, such as cancer.
The designation enables close collaboration with an expedited review by the FDA and formally acknowledges Oncuria's utility and potential clinical benefit.
"Oncuria is designed to provide a prediction of response to therapy, allowing for timely interventions that could result in more favorable outcomes for our patients," stated Charles J. Rosser, CEO of Nonagen, in a related press statement.
"We are proud that the FDA has decided to grant Breakthrough Device Designation to our lead diagnostic, Oncuria™, acknowledging growing recognition of the benefit our test can offer to clinicians and patients."
Oncuria is reported more sensitive for bladder cancer detection than urine cytology for both disease stage and by grade, says the Company.
Using a well-established Luminex Corporation platform, we are close to adding a robust diagnostic test in our fight against bladder cancer. Please take a look at our white paper to understand our journey and see how we stack up to competitors, says the Company's website.
The World Rabies Day (WRD), established by the Global Alliance for Rabies Control (GARC) and recognized by the World Health Organization (WHO), is celebrated every September 28th to remind that preventing animal rabies does protect not only animal health but also the health of humans and the environment.
On September 28, 1895, the French scientist Louis Pasteur who created the rabies vaccine, passed away.
In this regard, the theme chosen for the WRD 2021 is "Rabies: facts, not fear."
This theme highlights the importance of raising awareness of the disease, vaccinating the animal population, and educating people on the danger of rabies and how to prevent it.
The Pan American Center for Foot-and-Mouth Disease and Veterinary Public Health of the Pan American Health Organization (PAHO) is responsible for the "Regional Program for the Elimination of Human Rabies Transmitted by Dogs" from 1983.
Since then, the incidence of the disease in the Americas has been reduced by around 98%.
From the past years, nearly all human cases have been mainly transmitted by wild animals, particularly hematophagous bats.
To achieve rabies elimination in the American continent, the countries' commitment and long-term national programs for rabies control are necessary.
Mr. Ottorino Cosivi, director of PANAFTOSA, stated in a press release, "The results attained in the past 38 years allow us to state that we are very close to attaining the elimination of dog-mediated human rabies (variants 1 and 2) in the American continent."
Due to its fatal nature and the lack of a cure, rabies is a public health risk.
At the international level, 60,000 people die every year from this disease, mainly in Asia and Africa.
Rabies vaccines can be used to prevent rabies before and for a period of time after exposure to the rabies virus, says the U.S. CDC.
Unlike the conventional, inactivated rabies vaccine, live-attenuated viruses are genetically modified viruses that can replicate in an inoculated recipient without causing adverse effects while still eliciting robust and effective immune responses against rabies virus infection.
Note: Beginning July 14, 2021, a temporary suspension was launched for dogs imported from high-risk countries for dog rabies. The CDC has the authority to issue a CDC Dog Import Permit for U.S. citizens and lawful residents relocating from high-risk countries to bring their dogs into the United States. After October 14, 2021, dogs coming from high-risk countries with CDC Dog Import Permits must enter only at approved ports of entry.
New York-based Pfizer Inc. and BioNTech SE today announced they had submitted data to the U.S. Food and Drug Administration (FDA) from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.
The Companies previously announced positive topline results from the pivotal trial on September 20, 2021. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
These data have been shared with the FDA for the Agency’s initial review.
A formal submission to request Emergency Use Authorization (EUA) of the companies’ COVID-19 vaccine in children 5 to <12 years of age is expected to follow in the coming weeks.
In addition, submissions to the European Medicines Agency and other regulatory authorities are also planned.
Furthermore, topline immunogenicity and safety readouts for the other two age cohorts from the trial – children 2 to <5 years of age and six months to <2 years of age – are expected as soon as the fourth quarter of 2021.
The Phase 1/2/3 trial initially enrolled up to 4,500 children ages six months to <12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites.
It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to <12 years; ages 2 to <5 years; and ages six months to <2 years.
Based on the Phase 1 dose-escalation portion of the trial, children 5 to <12 years of age received a two-dose schedule of 10 μg each while children under age 5 received a lower 3 μg dose for each injection in the Phase 2/3 study.
The Pfizer-BioNTech Comirnaty COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
The Comirnaty vaccine is administered as a 2-dose series, three weeks apart. In addition, a third dose may be administered at least four weeks after the second dose to individuals determined to have certain kinds of immunocompromise.
France-based Valneva SE and Pfizer Inc. today announced further positive Phase 2 study results, including booster vaccination response, for Lyme disease vaccine candidate VLA15.
VLA15 is the only active Lyme disease vaccine candidate in clinical development.
The Phase 2 study, VLA15-202, evaluates the immunogenicity and safety of VLA15 in a Month 0-2-6 vaccination schedule with 246 healthy adults 18 to 65 years of age in the U.S.
Participants who received a complete primary vaccination series with 180 µg doses of VLA15 were invited to continue the study in a booster extension phase and were randomized to receive an additional 180 µg dose of VLA15 (N=39) or placebo (N=19) at Month 18.
VLA15’s acceptable safety profile was confirmed through a one-month post-booster.
Administration of a booster dose elicited a strong anamnestic response yielding a 2.9-fold (ST3) to 4.2-fold (ST1, ST4) increase (Geometric Mean Fold Rise) in anti-OspA IgG antibody titers compared with titers observed after primary immunization.
All participants seroconverted to anti-OspA IgG after the booster dose, meaning Seroconversion Rates (SCRs) were 100% for all OspA serotypes. SCR was defined as the rate of subjects that changed from seronegative at baseline to seropositive.
Additionally, seropositive subjects at baseline needed to show at least a 4-fold increase in anti-OspA IgG compared to baseline titer.
The functionality of elicited antibodies was demonstrated by Serum Bactericidal activity Assays, leading to SCRs ranging from 86.8% (ST2) to 100.0% (ST3) after the booster. The study is continuing to monitor the persistence of antibody responses.
“The prevalence and geographic reach of Lyme disease are growing, underscoring the major medical need for vaccination against the disease,” commented Kathrin Jansen, Ph.D., SVP, and Head of Pfizer Vaccine Research and Development, in a press statement.
Valneva and Pfizer announced a collaboration for VLA15’s development and commercialization at the end of April 2020. The two companies are working closely together on the subsequent development steps and are planning for a Phase 3 trial in 2022.
Valneva is a specialty vaccine company located in Saint-Herblain (France), focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
U.S. Secretary of Homeland Security Alejandro Mayorkas stated during an Operation Allies Welcome teleconference on September 24, 2021, 'All arrivals — U.S. citizens, lawful permanent residents, and Afghan nationals — are being tested for COVID-19 upon arriving in the United States.'
In addition, 'Afghan nationals who are paroled into the United States — how we admit them here on humanitarian discretionary authority — are required to take the vaccinations for measles, mumps, rubella, polio, and COVID-19, amongst others, as conditions of their humanitarian parole.'
Sec. Mayorkas's statement is consistent with the US Centers for Disease Control and Prevention (CDC) Health Advisory issued on September 20, 2021, which recommended that clinicians be on alert for cases of measles that meet the case definition, as well as other infectious diseases, including mumps, leishmaniasis, and malaria, among evacuees (including both Afghan nationals and U.S. citizens) from Afghanistan.
The CDC had recently been notified of 16 measles cases and 4 cases of mumps among Afghan nationals and U.S. citizens arriving from Afghanistan.
During early August 2021, data reported to the World Health Organization indicated Afghanistan had confirmed 1,273 measles cases in 2021.
Currently, the Department of Defense is providing temporary housing facilities for applicants and other vulnerable Afghans at eight installations in the USA: Marine Corps Base Quantico, Virginia; Fort Pickett, Virginia; Fort Lee, Virginia; Holloman Air Force Base, New Mexico; Fort McCoy, Wisconsin; Fort Bliss, Texas; Joint Base McGuire-Dix-Lakehurst, New Jersey; and Camp Atterbury, Indiana.
