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One of the world’s most formidable public health challenges, human immunodeficiency virus (HIV), is impacting more than 38 million people worldwide.
While there are no U.S. Food and Drug Administration (FDA) approved HIV vaccines in 2023, a novel arenaviral therapeutic vaccine candidate is being evaluated as a potential curative regimen for HIV.
HOOKIPA Pharma Inc. today announced that it has received clearance from the FDA for its Investigational New Drug (IND) application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV.
One vector is based on the lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.
Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.
HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial.
And Gilead Sciences, Inc. has the exclusive right to assume further program development afterward.
Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on November 20, 2023, “The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine (candidate) offers promise in helping to address the unmet need for a functional HIV cure.”
In November 2023, Nature Partner Journals Vaccines published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission.
The data show that arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality, and durable immune responses (antigen-specific T cells and antibodies) in non-human primates.
Additionally, arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.
HIV, a sexually transmitted disease, is one of the world’s most formidable public health challenges.
The virus infects and kills immune cells and, without effective ongoing treatment, leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS in 2023.
The Global Polio Eradication Initiative (GPEI) recently confirmed six countries reported additional polio cases in 2023
These countries include Pakistan, which reported its fifth wild poliovirus type 1 (WPV1) case this year.
According to the GPEI, the other countries include Chad, the Democratic Republic of the Congo (DRC), Guinea, Nigeria, and Somalia, which reported more circulating vaccine-derived poliovirus type 2 cases.
The DRC also reported four more cases involving circulating vaccine-derived poliovirus type 1.
While it has been about three months since the World Health Organization (WHO) confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern, the WHO continues to remind Member States that the risk of the emergence of polio has increased due to low vaccination coverage.
Polio is a crippling and potentially deadly disease that affects the nervous system.
Most people with polio do not feel sick. In rare cases, polio infection causes permanent loss of muscle function (paralysis). Polio can be fatal if the muscles used for breathing are paralyzed or if there is an infection of the brain.
To warn international travelers, the U.S. Centers for Disease Control and Prevention issued an updated Global Polio Alert - Level 2, Practice Enhanced Precautions, Travel Health Notice on September 11, 2023, regarding polio outbreaks and poliovirus detections in 31 countries.
The CDC says that before visiting any of these destinations, adults who previously completed the full, routine polio vaccine series may receive a single, lifetime booster dose of the polio vaccine.
As of November 2023, various polio vaccines are available worldwide.
Since the launch of the World Health Organization's (WHO) global strategy to accelerate the elimination of cervical cancer three years ago, a further 30 countries, including Bangladesh, Indonesia, and Nigeria, have introduced a Human papillomavirus (HPV) vaccine into their vacation schedules.
As of November 17, 2023, 140 countries have now introduced HPV vaccinations into national programs.
Governments and communities are leading the way by declaring commitment and developing strategies to eliminate HPV cervical cancer, a sexually transmitted disease.
On Cervical Cancer Elimination Day of Action, Member States have a renewed commitment to eliminate this vaccine-preventable cancer.
"In the last three years, we have witnessed significant progress, but women in poorer countries and poor and marginalized women in richer countries still suffer disproportionately from cervical cancer," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.
"With enhanced strategies to increase access to vaccination, screening, and treatment, strong political and financial commitment from countries, and increased support from partners, we can realize our vision for eliminating cervical cancer."
There are effective HPV vaccines that protect males and females against cancers caused by HPV.
According to the U.S. Centers for Disease Control and Prevention (CDC), these vaccines include 9vHPV, 4vHPV, and 2vHPV. In the U.S., HPV vaccination has been recommended for women since 2006 and for men since 2011.
As of August 2023, the CDC reported that in 2022, 76% of people aged 13–17 had received one or more HPV vaccine doses.
HPV vaccines are generally available at health clinics and pharmacies in the U.S.
During the 2022–2023 influenza season in the United States, the highest influenza-associated pediatric hospitalization rate was reported in a decade.
To understand this uptick in cases, researchers published a Major Article on November 16, 2023, focused on acute respiratory illness-associated emergency department or urgent care (ED/UC) encounters or hospitalizations among those six months–17 years during October 2022–March 2023.
This U.S. CDC-funded analysis estimated influenza A vaccine effectiveness (VE).
Among ED/UC patients, 15.2% of influenza-positive versus 27.1% of influenza-negative patients were vaccinated. The VE was 48% (95% confidence interval [CI], 44%–52%) overall, 53% (95% CI, 47%–58%) among children aged six months–4 years, and 38% (95% CI, 30%–45%) among those aged 9–17 years.
Among hospitalizations, 17.5% of influenza-positive versus 33.4% of influenza-negative patients were vaccinated; VE was 40% (95% CI, 6%–61%) overall, 56% (95% CI, 23%–75%) among children ages six months–4 years and 46% (95% CI, 2%–70%) among those 5–17 years.
These researchers concluded vaccination against seasonal influenza remains the most effective public health strategy to protect against influenza illness and severe complications and that during the 2022–2023 influenza season, vaccination reduced the risk of influenza-associated ED/UC encounters and hospitalizations by less than half (overall VE 40–48%).
Previous Flu Shot Effectiveness studies are posted at Precision Vax.
While the global flu season has not been very severe, recent data indicates the southern United States is experiencing a sudden spike in influenza cases.
According to the U.S. Centers for Disease Control and Prevention (CDC), during week #45, 3.5% of patient visits reported were due to respiratory illness that included fever plus a cough or sore throat.
As of November 17, 2023, the regions with the highest percentage of respiratory specimens testing positive for influenza were Regions 8 (7.4%), 4 (7.0%), 6 (6.5%) and 9 (5.3%).
For regional and state-level data and age group distribution, please visit FluView Interactive.
From a severity perspective, the National Center for Health Statistics Mortality Surveillance confirmed that during week #44, 21 people died from influenza.
Previously, influenza deaths were reported during weeks #43 (32) and #42 (43).
Furthermore, one influenza-associated pediatric death occurring during the 2023-2024 season has been reported to the CDC.
The CDC continues recommending most people over six months of age get an annual flu vaccine.
From an availability perspective, over 147 million flu vaccine doses have been distributed in the U.S. Various flu shots are available at clinics and pharmacies in the U.S.
The U.S. Centers for Disease Control and Prevention (CDC) today published a Morbidity and Mortality Weekly Report revealing that global coverage of the measles-containing vaccine (MCV) has declined to the lowest levels since 2008.
The CDC confirmed that from 2000 to 2022, measles vaccination prevented approximately 57 million deaths worldwide.
However, there has been an 18% increase in estimated measles cases and a 43% increase in estimated measles deaths in 2022 compared with 2021.
Measles is highly contagious, infecting about 90% of people following exposure to the virus, says the CDC.
As of November 17, 2023, disruptive measles outbreaks were reported globally.
All six World Health Organization regions have committed to eliminating measles; however, no region has achieved and sustained measles elimination.
The CDC recently reported that Yemen (28,247) and India (24,301) have reported the most measles cases over the past year.
Measles is a highly contagious, vaccine-preventable disease that requires high population immunity for transmission to be interrupted.
Measles vaccination programs began in the United States in 1963 and continue in 2023.
As of November 2, 2023, a total of 41 measles cases were reported by 18 jurisdictions.
The majority of these measles cases are related to international travelers.
Furthermore, the CDC published a global Watch-Level 1, Practice Usual Precautions, Travel Health Notice in September 2023, identifying measles outbreaks in 39 countries.
On August 17, 2023, the CDC conducted a COCA webinar urging all healthcare providers to ensure their patients were up to date on the measles vaccination.
Various measles vaccines are available worldwide. In the U.S., most clinics and pharmacies offer measles vaccination services.
PharmaJet® today announced the start of the first human clinical trial for a Venezuelan Equine Encephalitis (VEE) vaccine delivered with PharmaJet Precision Delivery Systems.
The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule, and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.
VEEV is a mosquito-borne alphavirus that has caused sporadic outbreaks and epidemics in North Central and South America. Aerosolized VEEV is highly infectious with greater mortality rates than natural infection and is listed as a potential biothreat agent with no approved human vaccine or therapeutic.
Disease outbreaks frequently involve equines– horses, donkeys, mules, zebras – and humans.
DNA vaccination has proven particularly effective at eliciting protective immune responses against the alphavirus challenge.
As previously reported, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found, in a non-human primate challenge study, that a prime and single boost by either the intramuscular (Stratis) or intradermal route (Tropis) resulted in humoral and cellular immune responses that provided significant protection against VEEV disease and viremia.
These results paved the way for advancing the candidate vaccine into human trials and approval to proceed was recently granted by the Institutional Review Board (IRB), the Army's Office of Human Research Oversight, and the FDA.
President and CEO of PharmaJet, Chris Cappello, said in a press release, "The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe."
"We look forward to the clinical results from the human trial of this promising DNA vaccine candidate with our commercially available needle-free precision delivery systems."
The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency.
The study, in collaboration with USAMRIID, aims to advance further the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal and Stratis Intramuscular.
PharmaJet Systems effectively delivers nucleic acid-based vaccines compatible with military operations and the warfighter environment, in addition to being preferred by end-users compared to other delivery technologies.
According to IDSE News, the recently approved half-life monoclonal antibody offering passive immunization to prevent lower respiratory tract infections in infants caused by the respiratory syncytial virus (RSV) has increased availability.
The U.S. Centers for Disease Control and Prevention (CDC) recommends passive immunization to protect infants under eight months and some older babies at increased risk of severe illness caused by RSV.
“CDC and FDA are committed to expanding access to this important immunization so that more parents have peace of mind during the winter virus season,” said Dr. Nirav D. Shah, CDC’s principal deputy director, in a press release.
On November 16, 2023, the CDC released more than 77,000 additional 100-mg doses of Beyfortus™ (Nirsevimab-alip) to physicians and hospitals through the Federal Vaccines for Children (VFC) Program and commercial channels.
The co-producer of Beyfortus, Sanofi, stated in October 2023 that demand for this RSV product had been higher than anticipated.
On October 23, 2023, the CDC published a Health Alert Network Health Advisory to provide options for clinicians in the context of a limited supply of Betforus. The CDC previously announced it had transitioned to an allocation-based system for distributing Beyfortus.
As of October 2023, Sanofi's price for Beyfortus through the VFC program is $395.00 for 100mg and $395.00 for 50mg through March 2024.
AstraZeneca CEO Pascal Soriot recently informed Reuters, "We've had to deliver what is needed (for the U.S.), and next year, the volume suddenly will go up quite a bit."
Globally, the 2023 RSV season's activity was generally low or decreasing except in some Europe, Central America, Caribbean countries, and the United States as of mid-November 2023.
In the U.S., there are variations in the timing of RSV outbreaks between regions and between communities in the same area, says the CDC.
Note: news article updated on Nov. 18, 2023, to include CDC quote.
