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Since the discovery of the Ebola virus disease (EVD) in 1976, more than 30 outbreaks have been reported in Africa. While Ebola vaccines have been approved for adults, infants have not been protected from the EVD.
Published by The Lancet Global Health in November 2023, this analysis concluded an Ebola vaccine combination was well tolerated and induced strong humoral responses in infants younger than one year.
Furthermore, this phase 2 study concluded there were no safety concerns related to Zabdeno® (Ad26.ZEBOV) and Mvabea® (MVA-BN-Filo) vaccination.
And the reactogenicity profile comprised mild-to-moderate adverse events (grade 1 or 2). Within seven days of administration of either dose, there were no grade 3 solicited adverse events in the Ebola vaccine group.
The two-dose Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen induced robust antibody responses in 100% of infants 21 days after receiving dose two.
The serum antibody levels declined over the follow-up period, but 93% of the younger and 100% of the older infants were still considered responders 12 months post-dose 1.
In addition to its EMA-approved use in individuals aged one year or older, the results of the current Vaccines & Prevention B.V.-funded study could support the use of Ad26.ZEBOV and MVA-BN-Filo in infants aged 4–11 months, as recommended for off-label use in 2021.
As of November 30, 2023, access to Ebola vaccinations in the U.S. is limited. The U.S. CDC updated its Ebola Overbreak History on August 30, 2023.
The World Health Organization (WHO) announced today that 2022, there were an estimated 249 million malaria cases globally, exceeding the pre-pandemic level in 2019 by 16 million cases.
The WHO's 2023 World Malaria Report, published on November 30, 2023, delves into the changes in temperature, humidity, and rainfall that can influence the behavior and survival of the malaria-carrying Anopheles mosquito.
Extreme weather events, such as flooding in Pakistan in 2022, led to a five-fold increase in malaria cases in the country.
The new WHO report also cites achievements such as the phased roll-out of the first WHO-recommended malaria vaccine, Mosquirix™ (RTS,S/AS01), in three African countries.
And in October 2023, WHO recommended a second safe and effective malaria vaccine, R21/Matrix-M.
The availability of two malaria vaccines is expected to increase supply and make broad-scale deployment across Africa possible.
As of late 2023, thee malaria vaccines are not available in the U.S.
The Pan-American Health Organization (PAHO) recently issued an Epidemiological Alert following an increased number of invasive group A streptococcal (iGAS) infection cases, especially in children.
As of November 28, 2023, Argentina had reported 93 fatal cases.
About half of the 643 cases and over 38% of the deaths involved children younger than 16 years.
Previous reports of the National Epidemiological Bulletin of Argentina had alerted about the presence of the M1UK clone and the finding of a hypervirulent M1 sublineage that is being characterized.
Based on these findings, the National Reference Laboratory, the Epidemiology Directorate, and its municipalities are implementing an intensified surveillance protocol for non-invasive Streptococcus pyogenes disease.
PAHO noted that Argentina's developments follow an increase in GAS and scarlet fever cases in Europe and Uruguay in 2022.
Streptococcus pyogenes, or GAS, are gram-positive bacteria that cause a broad spectrum of infections. GASs can lead to life-threatening complications and immune-mediated diseases with chronic sequelae.
According to the PAHO, GASs are responsible for more than 500,000 deaths per year worldwide.
According to the U.S. CDC, most people exposed to someone with a group A strep infection should not receive prophylaxis. However, in some situations, healthcare professionals may recommend prophylaxis for someone exposed to an invasive group A strep infection.
As of November 30, 2023, there is currently no vaccine to prevent group A strep infections, although several vaccines are in development, says the CDC.
The World Health Organization (WHO) recently published Influenza Update N° 459, highlighting current 2023 flu season trends.
As of November 27, 2023, the WHO stated that influenza detections globally increased due to increases in parts of the temperate Northern Hemisphere, including parts of Europe and Central Asia, North America, and Eastern and Western Asia.
Furthermore, in North America, influenza detections increased but remained low or below baseline.
However, Influenza-like illness has increased above the seasonal threshold in the United States, and influenza-associated hospitalizations have increased.
Additional flu season 2023-2024 news is posted at Precision Vax.
Dyadic International, Inc. today announced successful top-line results for the Phase 1 clinical trial of its recombinant protein RBD vaccine candidate, DYAI-100.
This marks the first-in-human use of a recombinant protein vaccine expressed by Dyadic's C1-cell expression platform.
"We are excited to share the top-line results from what we believe marks the first-in-human clinical trial for a vaccine antigen produced using a filamentous fungal cell line, such as our C1 platform," said Mark Emalfarb, CEO of Dyadic, in a press release on November 29, 2023.
"While vaccines and antibodies produced from our C1-cell protein production platform have previously demonstrated safety and efficacy in animal studies, this trial represents the initial evaluation of a C1-cell produced protein in humans and is a key milestone for the Company."
"Notably, no Serious Adverse Events were reported, and the clinical study successfully met its primary endpoint demonstrating that a C1-produced antigen was both safe and well-tolerated in both the low and high dose groups."
DYAI-100, also known as the C1-SARS-CoV-2 RBD vaccine, is a novel receptor-binding domain (RBD) recombinant protein booster vaccine candidate, highly expressed in Dyadic's proprietary C1-cell protein production platform for the prevention of COVID-19.
The C1-SARS-CoV-2 RBD vaccine candidate consists of the SARS-CoV-2 RBD adjuvanted with Alhydrogel 85® 2%.
Dyadic's gene expression and protein production platforms are based on the highly productive and scalable fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila).
Previously, the U.S. FDA conducted a digital workshop, "Next-Gen Vaccines without the right platform limit pandemic effectiveness," posted on YouTube.
Merck today announced results from STRIDE-3, a Phase 3 clinical trial evaluating V116, the company’s investigational 21-valent pneumococcal conjugate vaccine specifically designed to protect adults.
The trial evaluated the immunogenicity, tolerability, and safety of V116 compared to a pneumococcal 20-valent conjugate vaccine (PCV20) in adults who had not previously received a pneumococcal vaccine.
Results from the study’s primary objectives are posted at this PVax link.
“These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on November 28, 2023.
“We are excited by the potential of V116 to impact public health through primary prevention through the use of a population-specific strategy that targets the serotypes responsible for the majority of invasive pneumococcal disease in adults.”
According to U.S. CDC data from 2018-2021, the serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 and older.
Based on the same CDC data, V116 includes eight unique serotypes not covered by currently licensed pneumococcal vaccines, responsible for about 30% of invasive pneumococcal disease in individuals 65 and older.
V116 would be the first pneumococcal conjugate vaccine designed for adults if approved, says Merck.
As of November 29, 2023, various pneumococcal vaccines are U.S. FDA-approved and available at clinics and pharmacies in the U.S.
China is confronting a wave of respiratory illnesses that have sparked conversations on social media, drawing attention to the pneumonia wave in the fourth week of November 2023, announced GlobalData.
On November 30, 2023, Shreyasee Majumder, Social Media Analyst at GlobalData, commented in a press release, "Influencers express varied opinions and concerns about the surge of respiratory illnesses in China.
Some influencers expressed concerns over overwhelmed hospitals, particularly those treating children, undiagnosed cases, and lack of data transparency.
Social media influencers also draw comparisons to recent pandemics, stressing the need for transparent information, global cooperation, and proactive public health strategies to address the evolving pneumonia challenge."
GlobalData's Social Media Analytics Platform captures a few influencer opinions, such as Annie Sparrow, Associate Professor Global Health Icahn School Medicine, who posted on X:
"It's concerning that @WHO's presser doesn't mention confirmed mycoplasma outbreak in South Korea. Mycoplasma is treatable, but there is no vaccine, and there are some indications that the pneumonia may be antimicrobial resistant."
