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CSL Seqirus today announced it was selected by the Health Emergency Preparedness and Response Authority (HERA) to provide 665,000 pre-pandemic vaccine doses for fifteen EU and EEA Member States and the "Union Civil Protection Mechanism.".
The 4-year contract includes an option for participating authorities to purchase up to an additional 40 million doses of the egg-based, non-mRNA pre-pandemic vaccine over the contract duration.
Announced on June 11, 2024, this European Commission (EC) acquisition of pre-pandemic (zoonotic) vaccine will create a stockpile of vaccines available to support the EC’s outbreak and pre-pandemic response.
According to media reporting on June 5, 2024, Finland became the first EU country to offer avian influenza vaccinations to people this year.
Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, with an estimated mortality of up to 50 million people worldwide.
Raja Rajaram, CSL Seqirus, Head of Global Medical Strategy, commented in a press release, “This agreement will help in Europe’s resolve to maintain robust preparedness and rapid response capabilities for this potential threat.”
Under the terms of the agreement, CSL Seqirus will deliver pre-pandemic vaccines that are well-matched to the H5 of the currently circulating H5N1 strain.
The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the novel virus in the human population. The timing and severity of pandemic influenza (bird flu) is unpredictable.
In Europe, various pandemic vaccines have already been approved.
In the U.S., the Food and Drug Administration has already approved CSL Sequirus's AUDENZ™, an inactivated vaccine for active immunization to prevent disease caused by the influenza A virus H5N1 subtype.
As of June 11, 2024, the U.S. CDC says annual flu shots are not designed to protect people from pandemic influenza.
According to a Bloomberg report, Serum Institute of India Pvt. (SII) is the world's largest vaccine manufacturer and currently has the capacity to produce 3 billion doses of vaccines annually.
However, it only sells around 1.5 billion doses yearly, including those for malaria and cervical cancer.
In an interview with Time, Adar Poonawalla, CEO of SII, said, "As countries increase their healthcare budgets, you're going to see a huge uptake of vaccines that can prevent many diseases. Vaccines have been proven to be the most efficient tool for prevention."
For example, when the World Health Organization awarded prequalification status to the SII's R21/Matrix-M™ malaria vaccine, it enabled a mass rollout that could reduce fatalities from the deadly mosquito-borne disease.
SII stated it intends to produce 100 million doses of R21 annually.
Created by the Jenner Institute of Oxford University and developed by SII, the R21/Matrix-M vaccine contains two key ingredients: the malaria-specific R21 antigen and Novavax AB’s saponin-based Matrix-M adjuvant to enhance the immune system response, increasing the magnitude and durability of the antibody response.
"The R21/Matrix-M™ vaccine is a vital new tool to help stop the devastating health and economic impact of malaria on nearly half of the world's population, including the tragic loss of 1,300 children every single day," said John C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on May 20, 2024.
SII was recently included in Time's 100 Most Influential Companies in 2024 and was founded in 1966 by Dr. Cyrus Poonawalla.
A U.S. Food and Drug Administration committee unanimously voted to recommend the approval of an Eli Lilly medication for early Alzheimer’s disease.
According to the New York Times on June 10, 2024, this news indicates the FDA may approve donanemab for people diagnosed with mild cognitive impairment due to Alzheimer’s in late 2024.
To support their request, Lilly submitted data from a JAMA Original Investigation in the early stages of the disease, with either mild cognitive impairment or mild dementia.
Donanemab, similar to the approved LEQEMBI™, is not a vaccine but is given as intravenous infusions.
Researchers recently wrote that combining two monoclonal antibodies for treating chronic herpes simplex 2 (HSV-2) may provide a novel therapeutic option for this expanding disease.
The U.S. CDC says HSV constitutes a significant global health concern due to its wide range of clinical manifestations that can affect the skin and mucous membranes, the eyes, and the nervous system.
On May 28, 2024, the Journal of Biomedical Science published results from a study designed to develop a next-generation therapy by combining different antiviral monoclonal antibodies.
This research showed that the fully human antibody HDIT102 has the potential for further clinical development as a potent novel HSV therapeutic, particularly in combination with its clinical humanized ancestor antibody HDIT101.
HDIT101 is a humanized IgG that was previously investigated in phase 2 clinical trials.
Both antibodies induced the internalization of gB from the cell surface into acidic endosomes by binding distinct epitopes in domain I of gB and competing for binding.
CryoEM analyses revealed the ability to form heterogenic immune complexes consisting of two HDIT102 and one HDIT101 Fab bound to one gB trimeric molecule.
Both antibodies mediated antibody-dependent phagocytosis by antigen presenting cells which stimulated autologous T-cell activation.
In vivo, the combination of HDIT101 and HDIT102 demonstrated synergistic effects on survival and clinical outcome in immunocompetent BALB/cOlaHsd mice.
In conclusion, these researchers wrote, 'Antibody characteristics to inhibit cell-to-cell spread, to mediate uptake of cell-free viruses by phagocytic cells and concomitantly stimulate T-cell responses may promote cellular immunity and may have benefits in preventing recurrences.'
Antibody therapeutics are available to address a variety of diseases, and the U.S. Food and Drug Administration has approved more than 100 products.
Despite years of development, HSV vaccine candidates have yet to be approved. As of June 10, 2024, several herpes vaccines are conducting clinical research.
BioArctic AB's partner, Eisai, announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly Leqembi™ intravenous (IV) maintenance dosing.
A Prescription Drug User Fee Act action date is January 25, 2025.
Leqembi (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.
In the U.S., Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
As of June 10, 2024, Leqembi is approved in Japan, China, and South Korea, and applications have been submitted for review in several countries, including the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.
As part of the monthly IV maintenance regimen, patients who have completed the biweekly IV initiation phase, the exact period under discussion with the FDA, would receive a less frequent monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic amyloid beta (Aβ) protofibrils that can continue to cause neuronal injury.
The sBLA is based on the modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE), as well as the Clarity AD study (Study 301) and its OLE study.
Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing after the FDA granted it Fast Track designation in May 2024.
Alzheimer's disease is a progressive disease caused by toxic amyloid proteins. Once established, this pathophysiological process continues throughout the patient's life, so sustained treatment is necessary.
The company says treatment should be initiated early to maximize patient outcomes.
Data from Studies 201 and 301 and their OLEs show that continued therapy with LEQEMBI beyond the 18-month core phase prolongs the benefit as highly toxic protofibrils are continuously removed.
If approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen, which is less burdensome and makes it easier for patients and care partners to continue long-term.
BioArctic is a Swedish research-oriented biopharma company focused on neurodegenerative disorders. It has a broad and well-diversified project portfolio and the potential to improve patients' health.
Moderna, Inc. today announced that its Phase 3 clinical trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.
mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza and SARS-CoV-2 viruses than licensed flu and COVID vaccines in adults 50 and older, including an enhanced influenza vaccine in adults 65 and older.
"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on June 10, 2024.
"Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine."
Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference, submit them for publication, and engage regulators on the next steps.
mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Moderna says each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.
According to the weekly update of the Global Polio Eradication Initiative (GPEI), three countries confirmed additional polio cases.
As of June 5, 2024, Afghanistan and Pakistan each reported one wild poliovirus type (WPV1) case, the fourth WPV1 case for each country in 2024.
And Niger reported its second circulating vaccine-derived poliovirus type 2 (cVDPV2) case this year.
Additionally, the GPEI posted the results of the Strategic Advisory Group of Experts on immunization meeting results from March 2024 at this link.
The U.S. CDC issued an updated Global Polio Alert on May 23, 2024, regarding polio outbreaks and poliovirus detections in 34 countries.
The World Health Organization recently confirmed that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension through July 2024. Various vaccines are available worldwide to prevent additional polio cases.
GSK plc today announced that the U.S. Food and Drug Administration (FDA) has approved Arexvy™ (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.
In the United States, Arexvy is approved for use in adults 60 and older and recommended by the U.S. CDC and its vaccine committee (ACIP) using shared clinical decision-making.
Professor Ann R. Falsey, University of Rochester School of Medicine, said in a press release on June 7, 2024, "I am thrilled that GSK's vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number—an important number, but not the only factor to consider."
GS has also filed regulatory submissions to extend the use of Arexvy in Europe, Japan, and other geographies, with regulatory decisions undergoing review.
Clinical trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to be completed in H2 2024.
As of June 2024, the U.S. FDA has approved three RSV vaccines.
